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登记号 CTR20140661 试验状态 主动暂停 申办者联系人 康越 首次公示信息日期 2014-12-26 申办者名称 AbbVie Inc./AbbVie Inc.AbbVie Ireland NL B.V./AbbVie Ireland NL B.V.伯维医药贸易(上海)有限公司/ 一、题目和背景信息 登记号 CTR20140661 适应症 糖尿病肾病 试验通俗题目 Atrasentan 的糖尿病肾病研究 试验专业题目 评价 Atrasentan 对Ⅱ型糖尿病肾病受试者肾脏预后影响的 随机多国家多中心双盲平行安慰剂对照研究 SONAR: Atrasentan 的糖尿病肾病研究 试验方案编号 M11-352 受理号 企业选择不公示 药物名称 Atrasentan (ABT-627) 药物类型 化学药物 二、申办者信息 申办者名称 AbbVie Inc./AbbVie Inc. AbbVie Ireland NL B.V./AbbVie Ireland NL B.V. 艾伯维医药贸易(上海)有限公司/ 联系人姓名 康越 联系人电话 021-62631384 联系人 Email [email protected] 联系人邮政地址 上海市南京西路 288 号创兴金融中 心 17 楼 联系人邮编 200003 经费来源 完全自筹 三、临床试验信息 1、试验目的 评价与安慰剂相比, Atrasentan 对 2 型糖尿病肾病受试者血清肌酐倍增所需时 间或终末期肾病(ESRD)出现时间的影响。此外,本研究评估与安慰剂相比, Atrasentan 对下述结果的影响:心血管发病率和死亡率、尿白蛋白排泄率、估 算的肾小球滤过率变化,还评估对Ⅱ型糖尿病肾病受试者生活质量的影响。 2、试验设计 试验分类 安全性和有效性 试验分期 III 期 设计类型 平行分组 随机化 随机化 盲法 双盲 试验范围 国际多中心试验 3、受试者信息 年龄 18 岁至 85 岁 性别 男+女 健康受试者

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Page 1: CTR20140661 试验状态 主动暂停 首次公示信息日期 2014-12-26 艾zy.yaozh.com/linchuangshiyan/pdf/CTR20140661.pdf · Osama Sayed United States Michigan Flint 4 6 Clinical

登记号 CTR20140661 试验状态 主动暂停

申办者联系人 康越 首次公示信息日期 2014-12-26

申办者名称 AbbVie Inc./AbbVie Inc.AbbVie Ireland NL B.V./AbbVie Ireland NL B.V.艾

伯维医药贸易(上海)有限公司/

一、题目和背景信息

登记号 CTR20140661

适应症 糖尿病肾病

试验通俗题目 Atrasentan的糖尿病肾病研究

试验专业题目 评价 Atrasentan 对Ⅱ型糖尿病肾病受试者肾脏预后影响的

随机多国家多中心双盲平行安慰剂对照研究 SONAR:

Atrasentan的糖尿病肾病研究

试验方案编号 M11-352

受理号 企业选择不公示

药物名称 Atrasentan (ABT-627)

药物类型 化学药物

二、申办者信息

申办者名称 AbbVie Inc./AbbVie Inc.

AbbVie Ireland NL B.V./AbbVie Ireland NL B.V.

艾伯维医药贸易(上海)有限公司/

联系人姓名 康越

联系人电话 021-62631384 联系人 Email [email protected]

联系人邮政地址 上海市南京西路

288号创兴金融中

心 17楼

联系人邮编 200003

经费来源 完全自筹

三、临床试验信息

1、试验目的

评价与安慰剂相比, Atrasentan对 2型糖尿病肾病受试者血清肌酐倍增所需时

间或终末期肾病(ESRD)出现时间的影响。此外,本研究评估与安慰剂相比,

Atrasentan对下述结果的影响:心血管发病率和死亡率、尿白蛋白排泄率、估

算的肾小球滤过率变化,还评估对Ⅱ型糖尿病肾病受试者生活质量的影响。

2、试验设计

试验分类 安全性和有效性

试验分期 III期

设计类型 平行分组

随机化 随机化

盲法 双盲

试验范围 国际多中心试验

3、受试者信息

年龄 18岁至

85岁

性别 男+女

健康受试者 无

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入选标准 1.受试者身患Ⅱ型糖尿病,在筛选期之前 3个月内,至少接受一

种降糖药物和 ACEi/或 ARB(RAS抑制剂)治疗。受试者不能为Ⅰ

型糖尿病患者(定义为:在 35岁之前发病,并在 1型糖尿病确诊

后 12月内需要长期胰岛素治疗)。

2.HbA1c ≤ 12%

3.为了进入准备期,根据实验室筛选指标,受试者必须满足下述

标准:估算的 GFR 为 25~75mL/min/1.73m2,UACR≥300、<5000 mg/g

(eGFR在 60~75 mL/min/1.73m2 之间的受试者人数应占总人群的

10%以下;血清白蛋白≥3.0g/dL(30 g/L);BNP≤200pg/mL(200

ng/L);SBP≥100、≤160 mmHg;血钾>3.0(3 mmol/L)、≤5.5

mEq/L(5.5 mmol/L);

4.为了进入强化期,根据准备期最后一次访视结果,受试者必须

满足下述标准:接受 RAS抑制剂 MTLDD剂量已治疗 4周,且未调

整过剂量;在筛选时,接受 RAS抑制剂 MTLDD 剂量治疗、但未接

受利尿剂治疗(除非有医疗禁忌症)的受试者必须进入至少两周

的准备期。

5.为了进入双盲治疗期,根据强化期最后一次访视结果,受试者

必须满足下述标准:在强化期内,已接受 RAS抑制剂 MTLDD剂量

治疗过 6周,且未曾调整过剂量;接受任一剂量利尿剂,除非经

研究者判断有医疗禁忌症或临床不能耐受(即:低血压或低钾血

症);从强化期开始的 6周强化期间,体重变化<3kg,血清 BNP

绝对值<300pg/mL(300 ng/L);在强化期结束时,受试者不得发

生 AKI事件(定义为:在强化期第 6周访视时即访视 E5,血清肌

酐相对基线变化升高 0.5 mg/dL以上,相对基线升高率大于 20%)。

排除标准 1.在筛选前 6个月内,有中度或重度外周水肿、与外伤无关的肺

水肿或面部水肿等病史的受试者,或有粘液性水肿病史的受试者;

2. 有肺动脉高血压病史且需要输氧治疗和/或内皮素受体拮抗剂

或磷酸二酯酶治疗的受试者;或有任一种肺病(比如:慢性阻塞

性肺病、肺气肿、肺纤维化)且需要输氧治疗的受试者;

3. 受试者已有记录诊断为心衰,或因心衰或与心衰相符的症状(运

动性呼吸困难、脚肿、端坐呼吸、发作性夜间呼吸困难;其他原

因未能解释这些症状)而住院,且治疗心衰的药物或其他治疗措

施有变化。

4. 已知受试者罹患非糖尿病肾病(肾结石除外);

5. 在过去 6个月内,受试者有症状性低血压病史;

目标入组人数

国际多中心试验:总体 4148人中国 280人

实际入组人数

国际多中心试验:总体 3668人,中国 203人;

4、试验分组

试验药 序号 名称 用法

1. Atrasentan

(ABT-627)

薄膜衣片;规格 0.75mg;口服,一

日一次,48个月。

对照药 序号 名称 用法

Page 3: CTR20140661 试验状态 主动暂停 首次公示信息日期 2014-12-26 艾zy.yaozh.com/linchuangshiyan/pdf/CTR20140661.pdf · Osama Sayed United States Michigan Flint 4 6 Clinical

1. 安慰剂 薄膜衣片;口服,一日一次,48个

月。

5、终点指标

主要终点指标

及评价时间

指标 评价时间 终点指标选择

1 首次出现肾脏复合终点所

需时间:血清肌酐倍增(30

天血清肌酐确认)或 ESRD

发病(需要长期透析或肾

移植或肾死亡)。

大约 48个月 有效性指标+

安全性指标

次要终点指标

及评价时间

指标 评价时间 终点指标选择

1 UACR从基线至随机分组

第 24个月访视时的变化;

从第 0天至第 24

个月

有效性指标+

安全性指标

2 从随机分组起治疗 3个月

后,eGFR下降 30%所需时

间;

大约 24个月 有效性指标+

安全性指标

3 出现心肾复合终点所需时

间:血清肌酐倍增、ESRD、

CV死亡、非致命性心肌梗

死、非致命性卒中;

大约 48个月 有效性指标+

安全性指标

4 出现 CV复合终点所需时

间:CV死亡、非致命性心

肌梗死和非致命性卒中;

大约 48个月 有效性指标+

安全性指标

6、数据安全监

察 委 员 会

(DMC)

7、为受试者购

买试验伤害保

四、第一例受试者入组日期

2015-02-02 国内

2013-06-12 国际

五、试验终止日期

2017-11-10 国内

2017-11-10 国际

六、研究者信息

1、主要研究者信息

侯凡凡 职称 教授,主任医师,中国科学

院院士

020-61641591 Email [email protected]

广东省广州市广州大道北 1838号 邮编 510515

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南方医科大学南方医院

2、各参加机构信息

机构名称 主要研究者 国家 省(州) 城市

1 南方医科大学南

方医院

侯凡凡 中国 广东省 广州

2 广东省人民医院 史伟 中国 广东省 广州

3 复旦大学附属华

山医院

郝传明 中国 上海 上海

4 北京大学人民医

左力 中国 北京 北京

5 北京大学人民医

纪立农 中国 北京 北京

6 北京协和医院 李玉秀 中国 北京 北京

7 北京大学第一医

郭晓蕙 中国 北京 北京

8 北京大学第三医

王松 中国 北京 北京

9 上海交通大学医

学院附属仁济医

倪兆慧 中国 上海 上海

1

0

武汉大学人民医

丁国华 中国 湖北省 武汉

1

1

上海交通大学医

学院附属瑞金医

陈楠 中国 上海 上海

1

2

山东省立医院 赵家军 中国 山东省 济南

1

3

青岛大学附属医

徐岩 中国 山东省 青岛

1

4

第四军医大学第

一附属医院(西京

医院)

姬秋和 中国 陕西省 西安

1

5

第四军医大学第

一附属医院(西京

医院)

孙世仁 中国 陕西省 西安

1

6

中国人民解放军

第三军医大学第

一附属医院

吴雄飞 中国 重庆 重庆

Page 5: CTR20140661 试验状态 主动暂停 首次公示信息日期 2014-12-26 艾zy.yaozh.com/linchuangshiyan/pdf/CTR20140661.pdf · Osama Sayed United States Michigan Flint 4 6 Clinical

1

7

南京医科大学第

一附属医院

邢昌赢 中国 江苏省 南京

1

8

西安交通大学第

一附属医院

施秉银 中国 陕西省 西安

1

9

佛山市第一人民

医院

肖观清 中国 广东省 佛山

2

0

华中科技大学同

济医学院附属同

济医院

徐钢 中国 湖北省 武汉

2

1

四川大学华西医

付平 中国 四川省 成都

2

2

东南大学附属中

大医院

刘必成 中国 江苏省 南京

2

3

复旦大学附属中

山医院

丁小强 中国 上海 上海

2

4

上海市第六人民

医院

贾伟平 中国 上海 上海

2

5

首都医科大学附

属北京同仁医院

杨金奎 中国 北京 北京

2

6

大连医科大学附

属第二医院

苏本利 中国 辽宁省 大连

2

7

中山大学附属第

三医院

翁建平 中国 广东省 广州

2

8

北京大学第一医

赵明辉 中国 北京 北京

2

9

上海长征医院 郁胜强 中国 上海 上海

3

0

Apex Medical

Research, Inc.

Ahmed

Azazuddin

United

States

Illinois Chicago

3

1

Farmington

Research LLC

Amin Mohammad United

States

Missouri Farmington

3

2

Biolab Research,

LLC

Belledonne

Mario

United

States

MARYLAND Rockville

3

3

California

Institute of

Renal Research

Belo Diogo United

States

CALIFORNIA Chula Vista

3

4

Academic Medical

Research

Institute

El-Shahawy

Mohamed

United

States

California Los Angeles

3

5

California

Institute of

Renal Research

Fadda George United

States

California La Mesa

3

6

East West

Medical Research

Fitz-Patrick

David

United

States

Hawaii Honolulu

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Institute

3

7

Brookview Hills

Research

Associates, LLC

Greenwood

Gregory

United

States

North

Carolina

Winston-Sa

lem

3

8

Hypertension and

Renal Research

Group

Herman

Theodore

United

States

New York Orchard

Park

3

9

North Shore

Diabetes and

Endocrine

Associates

Hershon

Kenneth

United

States

NEW YORK New Hyde

Park

4

0

North America

Research

Institute

Jamal Aamir United

States

CALIFORNIA Azusa

4

1

Metabolic

Research

Institute, Inc.

Kaye William United

States

FLORIDA West Palm

Beach

4

2

Northeast

Clinical

Research

Centers, LLC

Kopyt Nelson United

States

Pennsylvan

ia

Bethlehem

4

3

South Texas

Kidney

Specialists, PA

Mangoo-Karim

Roberto

United

States

Texas McAllen

4

4

Model Clinical

Research

Mersey James United

States

MARYLAND Baltimore

4

5

Hurley Medical

Center

Osama Sayed United

States

Michigan Flint

4

6

Clinical

Advancement

Center, PLLC

Pergola Pablo United

States

Texas San Antonio

4

7

Creighton

University

Medical Center

Rendell Marc United

States

Nebraska Omaha

4

8

Tulane

University

Health Sciences

Center

Simon Eric United

States

Louisiana New Orleans

4

9

Pines Clinical

Research, Inc.

Zeig Steven United

States

Florida Pembroke

Pines

5

0

Metrolina

Nephrology

Associates, PA

Chuang Peale United

States

North

Carolina

Charlotte

5 Sansum Clinic Elder John United California Santa

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1 States Barbara

5

2

Desert Medical

Group, Inc.

Jardula

Michael

United

States

California Palm

Springs

5

3

Texas Tech

University

Health Sciences

Center

Ahmed Vaqar United

States

Texas Lubbock

5

4

George

Washington

University

Medical Faculty

Associates

Cohen Scott United

States

District of

Columbia

Washington

5

5

MetroHealth

Medical Center

Sedor John United

States

Ohio Cleveland

5

6

Rhode Island

Hospital

Bayliss George United

States

Rhode

Island

Providence

5

7

Axis Clinical

Trials

Hazan Lydie United

States

California Los Angeles

5

8

FPA Family

Health Care

Clinical Studies

Link Michael United

States

FLORIDA Kissimmee

5

9

Down East

Medical

Associates, P.A.

Lawrence Mary United

States

North

Carolina

Morehead

6

0

University of

Cincinnati,

College of

Medicine

El-Khatib

Mahmoud

United

States

Ohio Cincinnati

6

1

Gwinnett

Biomedical

Research

Lalwani Tarik United

States

Georgia Lawrencevi

lle

6

2

San Diego

Coastal

Endocrinology

Group, aMC

Argoud Georges United

States

California Chula Vista

6

3

PrimeCare

Medical Group

Doshi Ankur United

States

Texas Houston

6

4

Green Clinic LLC Nammour

Michael

United

States

Louisiana Ruston

6

5

Eastern

Nephrology

Associates, PLCC

Montero Manuel United

States

North

Carolina

New Bern

6

6

St. Jude

Hospital

Gilbert John United

States

California Fullerton

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6

7

University of

Chicago

Bakris George United

States

Illinois Chicago

6

8

Emory University

Hospital

Guasch Antonio United

States

Atlanta Georgia

6

9

Providence

Clinical

Research

Sligh Teresa United

States

North

Hollywood

California

7

0

University of

Tennessee Health

Sciences Center

Kovesdy Csaba United

States

Memphis Tennessee

7

1

Hypertension and

Nephrology

Associates PA

Liss Kenneth United

States

Eatontown New Jersey

7

2

Endocrinology

Associates, Inc.

Christofides

Elena

United

States

Columbus Ohio

7

3

Louisiana State

University

Health Sciences

Center

Reisin Efrain United

States

New Orleans Louisiana

7

4

Clinical

Research

Development

Associates, LLC

Scott David United

States

Rosedale New York

7

5

University of

Mississippi

Medical Center

Juncos Luis United

States

Jackson Mississipp

i

7

6

Capital

Nephrology

Medical Group

Atray Naveen United

States

Sacramento California

7

7

East Carolina

University

Nephrology

Research

Hames Melanie United

States

Greenville North

Carolina

7

8

Boice-Willis

Clinic, P.A.

Jere Charles United

States

Rocky Mount North

Carolina

7

9

My Kidney

Center, LLC

Bedros Fadi United

States

Manhattan Kansas

8

0

Jersey Shore

University

Medical Center

Asnani Sunil United

States

Neptune New Jersey

8

1

Sierra Nevada

Nephrology

Consultants

Vicks Steven United

States

Reno Nevada

8 Stamford Brown Eric United Connecticu Stamford

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2 Nephrology States t

8

3

Briggs Clinical

Research, LLC

Gaona, Sr.

Raul

United

States

Texas San Antonio

8

4

National

Research

Institute

Frias Juan United

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California Los Angeles

8

5

Cooper

Nephrology

McFadden

Christopher

United

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New Jersey Camden

8

6

Herman Clinical

Research, LLC

Herman Lee United

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Georgia Suwanee

8

7

Columbia

Nephrology

Associates, PA

Buerkert John United

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South

Carolina

Columbia

8

8

Apex Medical

Research,

MI,Inc.

Arif Ahmed United

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Michigan Flint

8

9

Alta

Pharmaceutical

Research Center,

Inc.

Miller Alan United

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GEORGIA Dunwoody

9

0

University of

Utah

Beddhu

Srinivasan

United

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Utah Salt Lake

City

9

1

Central Florida

Internists

Khan Muhammad United

States

Florida St. Cloud

9

2

Remedica LLC Tatu Horia United

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Michigan Rochester

9

3

Lucita M. Cruz MD Cruz Lucita United

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California Norwalk

9

4

Knoxville Kidney

Center, PLLC

Newman George United

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Tennessee Knoxville

9

5

West Virginia

University,

School of

Medicine

Schmidt

Rebecca

United

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West

Virginia

Morgantown

9

6

Nephrology

Associates of

Northern

Virginia, Inc.

Assefi Ali United

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VIRGINIA Fairfax

9

7

Kaufman, New

York, NY

Kaufman Allen United

States

New York New York

9

8

Lee County

Internal

Medicine

Associates

Bohm Guillermo United

States

Florida Fort Myers

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9

9

California

Institute of

Renal Research

Boiskin Mark United

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CALIFORNIA San Diego

1

0

0

Nephrology

Associates P.C.

Brantley Roman United

States

Alabama Birmingham

1

0

1

Houston

Nephrology Group

Chatha Rupi United

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Texas Houston

1

0

2

Hanson Clinical

Research Center

Hanson Lenita United

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Florida Port

Charlotte

1

0

3

South Florida

Nephrology

Group, PA

Jacob Radu United

States

Florida Coral

Springs

1

0

4

Seacoast Kidney

and Hypertension

Specialists,

PLLC

Joshi Sucharit United

States

New

Hampshire

Portsmouth

1

0

5

Oregon Health

and Science

University

Rueda Jose United

States

Oregon Portland

1

0

6

Palm Research

Center, Inc.

Nakhle Samer United

States

Nevada Las Vegas

1

0

7

Preferred

Primary Care

Physicians, Inc

Purighalla

Raman

United

States

Pennsylvan

ia

Pittsburgh

1

0

8

Anne Arundel

Medical Center

(AAMC)

Welker James United

States

Maryland Annapolis

1

0

9

Diagnostic

Clinic Of

Houston

Varghese

Freemu

United

States

Texas Houston

1

1

0

University of

Louisville

Jacobs

Alfred

United

States

Kentucky Louisville

1

1

1

Texas Health

Physicians Group

Arauz-Pacheco

Carlos

United

States

Texas Dallas

1

1

2

Thomas Jefferson

University

Hospital

Jabbour Serge United

States

Pennsylvan

ia

Philadelph

ia

1 Renal Medicine Kumar Jayant United New Mexico Albuquerqu

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1

3

Associates States e

1

1

4

NYU Langone

Medical Center

Wissner-Green

e Loren

United

States

New York New York

1

1

5

East Texas

Nephrology

Associates

Nazeer Imran United

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Texas Lufkin

1

1

6

Rogosin

Institute

Perlman Alan United

States

New York New York

1

1

7

Drexel

University

College of

Medicine

Ahmed Ziauddin United

States

Pennsylvan

ia

Philadelph

ia

1

1

8

Arizona Kidney

Disease and

Hypertension

Center

Desai Sachin United

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Arizona Phoneix

1

1

9

Carolina Health

Specialists

Eagerton

Donald

United

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South

Carolina

Myrtle

Beach

1

2

0

Penn State,

Milton S.

Hershey Medical

Center

Farooq Umar United

States

Pennsylvan

ia

Hershey

1

2

1

Diabetes

Associates

Medical Group

Madu Ivy-Joan United

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California Orange

1

2

2

Fletcher Allen

Health Care,

Burlington,

Vermont

Solomon

Richard

United

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Vermont Burlington

1

2

3

APEX Research of

Riverside

Lee Joseph United

States

CALIFORNIA Riverside

1

2

4

Univ of Texas

Health Science

Center at San

Antonio

Bansal Shweta United

States

Texas San Antonio

1

2

5

University of

New Mexico

Adolphe Allen United

States

New Mexico Albuquerqu

e

1 University of Dixon Brad United Iowa Iowa City

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2

6

Iowa States

1

2

7

Temple

University

Hospital

Benjamin

Joseph

United

States

Pennsylvan

ia

Philadelph

ia

1

2

8

North Texas

Endocrine Center

Bressler Peter United

States

Texas Dallas

1

2

9

Northside

Internal

Medicine DEXA

Cathcart

Harold

United

States

Washington Spokane

1

3

0

Kaiser

Foundation

Health Plan of

Georgia, Inc.

Muoneke

Rosemary

United

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Georgia Duluth

1

3

1

Atlanta

Nephrology

Referral Center

Sharon Zeev United

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Georgia Decatur

1

3

2

San Antonio

Kidney Disease

Center

Physicians

Group, PLLC

Gouge Steven United

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Texas San Antonio

1

3

3

Ladan

Golestaneh, MD,

MS

Golestaneh

Laden

United

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New York Bronx

1

3

4

Maine Research

Associates

Weiss Robert United

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Maine Auburn

1

3

5

Mohammed Ismail,

MD, Inc.

Ismail

Mohammad

United

States

California Paramount

1

3

6

Four Rivers

Clinical

Research, Inc.

De La Rosa,

Raymond

United

States

Kentucky Paducah

1

3

7

Internal

Medicine

Specialists

Rodriguez-Ara

ya Eduardo

United

States

Louisiana New Orleans

1

3

8

Community

Clinical

Research Center

Bakdash Wa'el United

States

Indiana Anderson

1

3

9

Independent

Clinical

Research

Butt Salman United

States

Texas McKinney

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1

4

0

Yale Univ School

of Medicine

Dahl Neera United

States

Connecticu

t

New Haven

1

4

1

San Marcus

Research Clinic,

Inc.

Acosta Idalia United

States

Florida Miami

1

4

2

Compass

Research, LLC

Stoica

George

United

States

Florida Orlando

1

4

3

Texas Renal Care Ijaz Adeel United

States

TEXAS Greenville

1

4

4

Pines Care

Research Center,

Inc.

Moya

Hechevarria

Jaynier

United

States

Florida Pembroke

Pines

1

4

5

Cleveland Clinic

Foundation

Taliercio

John

United

States

Ohio Cleveland

1

4

6

Ochsner Clinic

Foundation

Reichel Ronald United

States

Louisiana New Orleans

1

4

7

NY Clinical

Trials

Bloom Scott United

States

New York New York

1

4

8

Erie County

Medical Center

Gundroo Aijaz United

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New York Buffalo

1

4

9

Angiocardiac

Care of Texas, PA

Karim Amin United

States

Texas Houston

1

5

0

SUNY Downstate

Medical Center

Markell

Mariana

United

States

New York Brooklyn

1

5

1

Sensenbrenner

Primary Care,

Charlotte, NC

Sensenbrenner

John

United

States

NORTH

CAROLINA

Charlotte

1

5

2

Pentucket

Medical

Associates, LLC

Dulude Emily United

States

Massachuse

tts

Haverhill

1

5

3

Crescent City

Clinical

Research Center,

LLC

Wise Jonathan United

States

Louisiana Metairie

1 Diagnostic Tulloch Brian United Texas Houston

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5

4

Clinic Of

Houston

States

1

5

5

National

Institute of

Clinical

Research

Joshi Sudhir United

States

California Bakersfiel

d

1

5

6

Kidney

Innovations

Levine Andrew United

States

Texas Weslaco

1

5

7

Renaissance

Renal Research

Institute, LLC

Khairullah

Quresh

United

States

Michigan Detroit

1

5

8

Kidney Care

Center

Awua-Larbi

Stella

United

States

Illinois Joliet

1

5

9

Kidney and

Hypertension

Care Center

Khan Mehreen United

States

Texas Houston

1

6

0

Meridien

Research Group

Chaykin Louis United

States

Florida Bradenton

1

6

1

Premier Research

Associate, Inc

De la Calle

Gilda

United

States

Florida Hialeah

1

6

2

Nephrology

Associates

Research Center

Minga Todd United

States

Florida Panama City

1

6

3

NorthShore

University

HealthSystem

Sarav Menaka United

States

Illinois Evanston

1

6

4

Innovative

Medical Research

of South

Florida, Inc.

Schlessinger

Fabiola

United

States

Florida Aventura

1

6

5

University of

Florida

Hall Karen United

States

Florida Gainesvill

e

1

6

6

Southern Utah

Kidney and

Hypertension

Center

Leon-Forero

Carlos

United

States

Utah Saint

George

1

6

7

AKDHC Medical

Research

Services, LLC

Nica Romanita United

States

Arizona Prescott

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1

6

8

California Renal

Research

Network, LLC

Minasian Raffi United

States

California Glendale

1

6

9

Professional

Health Care of

Pinellas

Saba Fadi United

States

Florida St.

Petersburg

1

7

0

Clinical

Research of

Brandon, LLC

Alvarez German United

States

Florida Brandon

1

7

1

Audie L. Murphy

VA Hospital,

STVHCS

Fanti Paolo United

States

Texas San Antonio

1

7

2

Pentucket

Medical

Associates, LLC

Tarkan Joshua United

States

Massachuse

tts

Newburypor

t

1

7

3

VAMC Cincinnati Thakar

Charuhas

United

States

Ohio Cincinnati

1

7

4

Emory University

and Atlanta VA

Medical Center

Phillips

Lawrence

United

States

Georgia Decatur

1

7

5

Zablocki VA

Medical Center

Blumenthal

Samuel

United

States

Wisconsin Milwaukee

1

7

6

VA Long Beach

Healthcare

System

Levin Ellis United

States

CALIFORNIA Long Beach

1

7

7

CEREHA Elbert Alicia Argenti

na

Avellaneda Avellaneda

1

7

8

Instituto de

Investigaciones

Clinicas Bahia

Blanca

Vogel Daniel Argenti

na

Buenos

Aires

Buenos

Aires

1

7

9

Instituto de

Investigaciones

Medicas Alfredo

Lanari

Zucchini

Alfredo

Argenti

na

Buenos

Aires

Buenos

Aires

1

8

0

Consultorios

Asociados de

Endocrinologia /

Inv Clin

Aplicado

Maffei Laura Argenti

na

Buenos

Aires

Buenos

Aires

1 Hospital Greloni Argenti Buenos Buenos

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8

1

Italiano de

Buenos Aires

Gustavo na Aires Aires

1

8

2

CEMIC (Centro

Educacion Medica

e Investigacion

Clinica)

Diaz Carlos Argenti

na

Buenos

Aires

Buenos

Aires

1

8

3

Instituto

Latinoamericano

de

Investigaciones

Medicas

Ulla Maria Argenti

na

Cordoba Cordoba

1

8

4

Fundacion J.

Robert Cade

Juncos Luis Argenti

na

Cordoba Cordoba

1

8

5

Blossom DMO Garcia Nestor Argenti

na

Cordoba Cordoba

1

8

6

Instituto

Cardiologia de

Corrientes Juana

Francisca Cabral

Farias Eduardo Argenti

na

Corrientes Corrientes

1

8

7

Centro de Salud

Renal Junin

S.R.L.

Vallejos

Augusto

Argenti

na

Junin Junin

1

8

8

Instituto de

Nefrologia

Pergamino S.R.L.

Cusumano Ana Argenti

na

Pergamino Pergamino

1

8

9

Investigaciones

Clinicas Tucuman

Santos Juan Argenti

na

San Miguel

de Tucuman

San Miguel

de Tucuman

1

9

0

Royal Prince

Alfred Hospital

Chadban Steve Austral

ia

New South

Wales

Camperdown

1

9

1

Renal Research Roger Simon Austral

ia

New South

Wales

Gosford

1

9

2

Liverpool

Hospital

Suranyi

Michael

Austral

ia

New South

Wales

Liverpool

1

9

3

The Prince of

Wales Hospital

Endre Zoltan Austral

ia

New South

Wales

Randwick

1

9

Royal North

Shore Hospital

Pollock Carol Austral

ia

New South

Wales

St Leonards

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4

1

9

5

Nambour General

Hospital

Gray Nicholas Austral

ia

Queensland Nambour

1

9

6

Southern

Adelaide

Diabetes

Endocrine

Services

Stranks

Stephen

Austral

ia

South

Australia

Daw Park

1

9

7

Royal Melbourne

Hospital

Toussaint

Nigel

Austral

ia

Victoria Parkville

1

9

8

Fremantle

Hospital

Davis Tim Austral

ia

Western

Australia

Fremantle

1

9

9

Sir Charles

Gairdner

Hospital

Chan Doris Austral

ia

Western

Australia

Nedlands

2

0

0

Box Hill

Hospital

Fraenkel

Margaret

Austral

ia

Box Hill Box Hill

2

0

1

Concord

Repatriation and

General Hospital

Gallagher

Martin

Austral

ia

Concord Concord

2

0

2

Launceston

General Hospital

Cooke Duncan Austral

ia

Launceston Launceston

2

0

3

John Hunter

Hospital

Acharya

Shamasunder

Austral

ia

New Lambton New Lambton

2

0

4

St. Vincents

Hospital

Melbourne

MacIsaac

Richard

Austral

ia

Victoria Victoria

2

0

5

CHR de la

Citadelle

Warling Xavier Belgium Liege Liege

2

0

6

Cliniques

Universitaires

Saint Luc

Jadoul Michel Belgium Brussels Brussels

2

0

7

Onze Lieve Vrouw

Hospital

Van Vlem Bruno Belgium Aalst Aalst

2

0

Universitair

Ziekenhuis

Gillard Pieter Belgium Leuven Leuven

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8 Leuven

2

0

9

Centro de

Estudos em

Diabetes e

Hipertensao

Forti Adriana

Costa

Brazil Ceara Fortaleza

2

1

0

Hospital Geral

de Goiania

Rassi Nelson Brazil Goias Goiania

2

1

1

Hospital Sao

Lucas-PUCRS

D'Avila

Domingos

Brazil Rio Grande

do Sul

Porto

Alegre

2

1

2

Irmandade da

Santa Casa de

Misericordia de

Porto Alegre

Keitel Elizete Brazil Rio Grande

do Sul

Porto

Alegre

2

1

3

Clinica de

Endocrinologia

Fraige Filho

Fadlo

Brazil Sao Paulo Sao Paulo

2

1

4

University

Federal de Sao

Paulo

Chacra Antonio Brazil Sao Paulo Sao Paulo

2

1

5

IPEC - Instituto

de Pesquisa

Clinica

Salles, Joao

Eduardo

Brazil Sao Paulo Sao Paulo

2

1

6

Instituto Dante

Pazzanese de

Cardiologia

Amodeo Celso Brazil Sao Paulo Sao Paulo

2

1

7

The Bailey

Clinic

Bailey Gordon Canada Alberta Red Deer

2

1

8

St. Paul's

Hospital

Levin Adeera Canada British

Columbia

Vancouver

2

1

9

Clinical

Research

Solutions Inc.

Jolly

Shivinder

Canada Ontario Kitchener

2

2

0

OTT Healthcare

Inc.

Tam Paul Canada Ontario Scarboroug

h

2

2

1

Toronto East

General Medical

Centre

Chow Stephen Canada Ontario East York

2

2

LMC Diabetes and

Endocrinology

Bajaj

Harpeet

Canada Ontario Brampton

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2

2

2

3

LMC Diabetes and

Endocrinology

Khandwala

Hasnain

Canada Ontario Etobicoke

2

2

4

LMC Diabetes and

Endocrinology

Aronson Ronnie Canada Ontario Toronto

2

2

5

Co-Medica

Research

Network, Inc

Steele Andrew Canada Ontario Courtice

2

2

6

Humber River

Regional

Hospital

Nesrallah

Gihad

Canada Ontario Toronto

2

2

7

JBN Medical

Diagnostic

Services Inc.

Berlingieri

Joseph

Canada Ontario Burlington

2

2

8

St. Joseph's

Healthcare

Rabbat

Christian

Canada Ontario Hamilton

2

2

9

Medicor Research

Inc.

Goluch Richard Canada Ontario Sudbury

2

3

0

Centre de Sante

et de Services

Sociaux

Champlain

Cournoyer

Serge

Canada Quebec Greenfield

Park

2

3

1

Hospital

Maisonneuve-Ros

emont

Pichette

Vincent

Canada Quebec Montreal

2

3

2

CHUM - Hopital

Saint-Luc

Roy Louise Canada Quebec Montreal

2

3

3

CALMED Castillo

Alvaro

Chile La Serena La Serena

2

3

4

Servicios

Medicos Godoy

Limitada

Godoy Gonzalo Chile Santiago Santiago

2

3

5

Biomedica

Research Group

Gutierrez

Vicente

Chile Santiago Santiago

2

3

6

Hospital Clinico

Regional Dr.

Guillermo Grant

Munoz Rodrigo Chile Concepcion Concepcion

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Benavente

2

3

7

Hospital del

Salvador

Gonzalez

Fernando

Chile Providenci

a, Santiago

Providenci

a, Santiago

2

3

8

Petr Bucek

s.r.o.

Bucek Petr Czech

Republi

c

Frydek-Mis

tek

Frydek-Mis

tek

2

3

9

Masarykova

mestska

nemocnice

Oplustilova

Alexandra

Czech

Republi

c

Jilemnice Jilemnice

2

4

0

Fakultni

Nemocnice

Ostrava

Valkovsky Ivo Czech

Republi

c

Ostrava-Po

ruba

Ostrava-Po

ruba

2

4

1

Diabetologicka

ambulance

Pavlickova

Jirina

Czech

Republi

c

Pardubice Pardubice

2

4

2

PeMedica.CZ,

s.r.o.

Petr Martin Czech

Republi

c

Prague Prague

2

4

3

Vseobecna

fakultni

nemocnice v

Praze (VFN)

Tesar Vladimir Czech

Republi

c

Prague Prague

2

4

4

Fakultni

Nemocnice

Kralovske

Vinohrady FNKV

Rychlik Ivan Czech

Republi

c

Prague 10 Prague 10

2

4

5

Milan Kvapil

s.r.o.

Bartaskova

Dagmar

Czech

Republi

c

Prague 4 Prague 4

2

4

6

Nemocnice Trebic Chmelickova

Hana

Czech

Republi

c

Trebic Trebic

2

4

7

Slagelse

Hospital

Gaede Peter Denmark Slagelse Slagelse

2

4

8

University

Hospital of

Frederiskberg

Urhammer Soren Denmark Frederiksb

erg

Frederiksb

erg

2

4

9

Roskilde

Hospital

Ostergaard Ove Denmark Rosklide Rosklide

2

5

Regional

Hospital

Oczachowska-K

ulik, Anna Ewa

Denmark Holstebro Holstebro

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0 Holstebro

2

5

1

Aarhus

University

Hospital, Skejby

Povlsen Johan Denmark Aarhus C Aarhus C

2

5

2

Steno Diabetes

Center

Rossing Peter Denmark Gentofte Gentofte

2

5

3

Terveystalo Oulu Strand Jorma Finland Oulu Oulu

2

5

4

Tampere

University

Hospital

Lahtela Jorma Finland Tampere Tampere

2

5

5

Turku University

Hospital

Kantola Ilkka Finland Turku Turku

2

5

6

CHU de Grenoble -

Hopital Albert

Michallon

Zaoui Philippe France Grenoble Grenoble

2

5

7

CHU de Nice Esnault

Vincent

France Nice Nice

2

5

8

Clinique du

Landy

Urena Torres

Pablo

France Saint Ouen Saint Ouen

2

5

9

Hopital de la

Conception

Dussol

Bertrand

France Marseille Marseille

2

6

0

Hospital

European,

Georges Pompidou

Thervet Eric France Paris Paris

2

6

1

Dimokritio

University

Hospital of

Alexandroupoli

Passadakis

Ploumis

Greece Alexandrou

polis

Alexandrou

polis

2

6

2

Interbalkan

Medical Center

Papadimitriou

Menelaos

Greece Thessaloni

ki

Thessaloni

ki

2

6

3

University

General Hospital

of Patras

Goumenos

Dimitrios

Greece Patras Patras

2

6

4

University

General Hospital

Liakopoulos

Vasilios

Greece Thessaloni

ki

Thessaloni

ki

Page 22: CTR20140661 试验状态 主动暂停 首次公示信息日期 2014-12-26 艾zy.yaozh.com/linchuangshiyan/pdf/CTR20140661.pdf · Osama Sayed United States Michigan Flint 4 6 Clinical

2

6

5

University

General Hospital

of Ioannina

Siamopoulos

Konstantinos

Greece Ionnina Ionnina

2

6

6

SISMANOGLEIO

General Hospital

of Komotini

Mavromatidis

Konstantinos

Greece Komotini Komotini

2

6

7

General Hospital

of Athens,

Evangelismos

Apostolou

Theofanis

Greece Athens Athens

2

6

8

Universitaetskl

inikum Aachen

Muehlfeld Anja Germany Aachen Aachen

2

6

9

Klinische

Forschung Berlin

GbR

Schenkenberge

r Isabella

Germany Berlin Berlin

2

7

0

Charite Campus

Mitte

Budde

Klemens

Germany Berlin Berlin

2

7

1

Universitaetkli

nikum Dresden

Hugo Christian Germany Dresden Dresden

2

7

2

Studienzentrum

Karlstrasse GmbH

Dellanna

Frank-Hans

Germany Duesseldor

f

Duesseldor

f

2

7

3

St.

Josefskrankenha

us

Hasslacher

Christoph

Germany Heidelberg Heidelberg

2

7

4

Nephrologisches

Zentrum

Pistrosch

Frank

Germany Hoyerswerd

a

Hoyerswerd

a

2

7

5

Universitaetskl

inikum Jena

Wolf Gunter Germany Jena Jena

2

7

6

Ludwig

Maximiliam

Universitaet

Muenchen

Vielhauer

Volker

Germany Munich Munich

2

7

7

Diabetologische

Schwerpunktprax

is Pirna

Kosch

Christine

Germany Pirna Pirna

2

7

8

Bieler, Riesa,

DE

Bieler Tasso Germany Riesa Riesa

2 Diabetologische Segiet Thomas Germany Speyer Speyer

Page 23: CTR20140661 试验状态 主动暂停 首次公示信息日期 2014-12-26 艾zy.yaozh.com/linchuangshiyan/pdf/CTR20140661.pdf · Osama Sayed United States Michigan Flint 4 6 Clinical

7

9

Schwerpunktprax

is

2

8

0

Robert-Bosch-Kr

ankenhaus

Alscher Mark Germany Stuttgart Stuttgart

2

8

1

Universitaetskl

inikum Wuerzburg

Wanner

Christoph

Germany Wuerzburg Wuerzburg

2

8

2

Cork University

Hospital

Eustace Joesph Ireland Cork Cork

2

8

3

St. Vincent's

University

Hospital

O'Shea Donal Ireland Dublin 4 Dublin 4

2

8

4

The Adelaide and

Meath Hospital

Lavin Peter Ireland Dublin 24 Dublin 24

2

8

5

Connolly

Hospital

Sreenan Seamus Ireland Dublin 15 Dublin 15

2

8

6

Maccabi Health

Services

Cohen Josef Israel Rishon Le

zion

Rishon Le

zion

2

8

7

Ziv Medical

Center

Adawi Faiad Israel Safed Safed

2

8

8

Ha'Emek Medical

Center

Mazen Elias Israel Afula Afula

2

8

9

Carmel Medical

Center

Frajewicki

Victor

Israel Haifa Haifa

2

9

0

Barzilai Medical

Center

Yagil Yoram Israel Ashkelon Ashkelon

2

9

1

The Edith

Wolfson Medical

Center

Bar-Dayan

Yosefa

Israel Holon Holon

2

9

2

Meir Medical

Center

Nacasch

Naomi

Israel Kfar Saba Kfar Saba

2

9

3

IRCCS Fondazione

Salvatore

Maugeri

Esposito Ciro Italy Pavia Pavia

Page 24: CTR20140661 试验状态 主动暂停 首次公示信息日期 2014-12-26 艾zy.yaozh.com/linchuangshiyan/pdf/CTR20140661.pdf · Osama Sayed United States Michigan Flint 4 6 Clinical

2

9

4

Azienda ASST

Paga Giovanni

XXIII

Ruggenenti

Piero

Italy Bergamo Bergamo

2

9

5

Azi Soc

Sanitaria

Territoriale

Rombola

Giuseppe

Italy Varese Varese

2

9

6

Azienda

Ospedaliera

Sant' Andrea

Pugliese

Giuseppe

Italy Rome Rome

2

9

7

Universita della

Campania Luig

Capasso

Giovabattista

Italy Naples Naples

2

9

8

Ospedale S.

Maria della

Pieta di Naples

Nappi Felice Italy Naples Naples

2

9

9

Policlinico

Universitario

degli Federico

II di Naples

Russo Domenico Italy Naples Naples

3

0

0

Azienda

Ospedaliera

Bianchi

Melacrino

Morelli

Marino

Francesco

Italy Reggio

Calabria

Reggio

Calabria

3

0

1

Nakadori General

Hospital

Awasaki

Hiroshi

Japan Akita-shi Akita-shi

3

0

2

National

Hospital

Organization

Asahikawa

Medical Center

Hirano

Fuminori

Japan Asahikawa-

shi

Asahikawa-

shi

3

0

3

Shimizu Internal

Medicine Clinic

Taya Noriyasu Japan Asahikawa-

shi

Asahikawa-

shi

3

0

4

National

Hospital

Organization

Chiba-East-Hosp

ital

Nishimura

Motonobu

Japan Chiba-shi Chiba-shi

3

0

5

Fukuoka

University

Chikushi

Hospital

Kobayashi

Kunihisa

Japan Chikushino

-shi

Chikushino

-shi

Page 25: CTR20140661 试验状态 主动暂停 首次公示信息日期 2014-12-26 艾zy.yaozh.com/linchuangshiyan/pdf/CTR20140661.pdf · Osama Sayed United States Michigan Flint 4 6 Clinical

3

0

6

Kyushu Central

Hospital of

Mutual Aid

Association

Goto Daisuke Japan Fukuoka Fukuoka

3

0

7

Japanese Red

Cross Fukuoka

Hospital

Sasaki

Nobuhiro

Japan Fukuoka-sh

i

Fukuoka-sh

i

3

0

8

Funabashi

Municipal

Medical Center

Iwaoka Hideaki Japan Fukuyama-s

hi

Fukuyama-s

hi

3

0

9

Anzai Clinic Anzai Jiichi Japan Hakodate Hakodate

3

1

0

Harada Clinic Harada

Hiroyuki

Japan Hakodate-s

hi

Hakodate-s

hi

3

1

1

Takahashi

Hospital, Social

Medical

Corporation

Tsutsui

Masahiro

Japan Hakodate-s

hi

Hakodate-s

hi

3

1

2

Hamamatsu

Medical Center

Nagayama Koji Japan Hamamatsu-

shi

Hamamatsu-

shi

3

1

3

Higashihiroshim

a Medical Center

Kishimoto

Rui

Japan Higashihir

oshima

Higashihir

oshima

3

1

4

Iwata City

Hospital

FURUYA

Ryuichi

Japan Iwata-shi Iwata-shi

3

1

5

Rinku General

Medical Center

KASHINE

Susumu

Japan Izumisano-

shi

Izumisano-

shi

3

1

6

Shimane

University

Hospital

Yamamoto

Masahiro

Japan Izumo Izumo

3

1

7

Tempozan Clinic

of Internal

Medicine

Hashiguchi

Yasuhiro

Japan Kagoshima Kagoshima

3

1

8

Kawanishi City

Hospital

Ueda

Shinichiro

Japan Kawanishi-

shi

Kawanishi-

shi

3

1

9

St. Marianna

University

School of

Shibagaki Yugo Japan Kawasaki-s

hi

Kawasaki-s

hi

Page 26: CTR20140661 试验状态 主动暂停 首次公示信息日期 2014-12-26 艾zy.yaozh.com/linchuangshiyan/pdf/CTR20140661.pdf · Osama Sayed United States Michigan Flint 4 6 Clinical

Medicine

Hospital

3

2

0

Kokura Memorial

Hospital

Kanai

Hidetoshi

Japan Kitakyushu Kitakyushu

3

2

1

Kobe City

Medical Center

West Hospital

Nakamura

Takehiro

Japan Kobe-shi Kobe-shi

3

2

2

Showa General

Hospital

Fujita Akira Japan Kodaira-sh

i

Kodaira-sh

i

3

2

3

Itabashi Clinic Itabashi Naoki Japan Koga-shi Koga-shi

3

2

4

Koshigaya

Municipal

Hospital

Makita

Yuichiro

Japan Koshigaya Koshigaya

3

2

5

Dokkyo Medical

University

Koshigaya

Hospital

Takeda Tetsuro Japan Koshigaya-

shi

Koshigaya-

shi

3

2

6

Kumamoto Medical

Center

ONO Keiko Japan Kumamoto-s

hi

Kumamoto-s

hi

3

2

7

Kawasaki Medical

School Hospital

Kashihara

Naoki

Japan Kurashiki-

shi

Kurashiki-

shi

3

2

8

St. Mary's

Hospital

SATO Yuichi Japan Kurume-shi Kurume-shi

3

2

9

Rakuwakai Otowa

Hosptial

YAMAGUCHI

Yukinari

Japan Kyoto Kyoto

3

3

0

Kyoto City

Hospital

Iehara

Noriyuki

Japan Kyoto-shi Kyoto-shi

3

3

1

Takeda General

Hospital

Azuma Nobuyuki Japan Kyoto-shi Kyoto-shi

3

3

2

Matsue Red Cross

Hospital

Sato Toshiaki Japan Matsue-shi Matsue-shi

3

3

Saiseikai

Matsuyama

Miyaoka

Hiroaki

Japan Matsuyama-

shi

Matsuyama-

shi

Page 27: CTR20140661 试验状态 主动暂停 首次公示信息日期 2014-12-26 艾zy.yaozh.com/linchuangshiyan/pdf/CTR20140661.pdf · Osama Sayed United States Michigan Flint 4 6 Clinical

3 Hospital

3

3

4

Chita Kosei

Hospital

Nimura

Toshinori

Japan Mihama-cho Mihama-cho

3

3

5

Miyazaki

Prefectural

Miyazaki

Hospital

Ikeda Naoko Japan Miyazaki-s

hi

Miyazaki-s

hi

3

3

6

Ato Internal

Medicine Clinic

Ato Keita Japan Muroran Muroran

3

3

7

Chubu Rosai

Hospital

Nakashima

Eitaro

Japan Nagoya-shi Nagoya-shi

3

3

8

Meitetsu

Hospital

Okamoto Hideki Japan Nagoya-shi Nagoya-shi

3

3

9

NHO Nagoya

Medical Center

Yambe Yuko Japan Nagoya-shi Nagoya-shi

3

4

0

Nakakinen Clinic Osonoi Takeshi Japan Naka Naka

3

4

1

Saiseikai

Niigata Daini

Hospital

Suzuki

Katsunori

Japan Niigata-sh

i

Niigata-sh

i

3

4

2

Kobari General

Clinic

Watanabe

Shuichi

Japan Noda Noda

3

4

3

Jiyugaoka Yamada

Clinic

Yamada

Daishiro

Japan Obihiro Obihiro

3

4

4

Obihiro Dai-ichi

Hospital

Sakai Takashi Japan Obihiro-sh

i

Obihiro-sh

i

3

4

5

Takagi Hospital Ono Yasuhiro Japan Okawa-shi Okawa-shi

3

4

6

Osaka Gyoumeikan

Hospital

Makino Shinya Japan Osaka Osaka

3

4

7

Osaka General

Medical Center

Umayahara

Yutaka

Japan Osaka-shi Osaka-shi

Page 28: CTR20140661 试验状态 主动暂停 首次公示信息日期 2014-12-26 艾zy.yaozh.com/linchuangshiyan/pdf/CTR20140661.pdf · Osama Sayed United States Michigan Flint 4 6 Clinical

3

4

8

Otsu Municipal

Hospital

Isono Motohide Japan Otsu-shi Otsu-shi

3

4

9

Ibaraki Seinan

Medical Center

Hospital

Iitsuka

Tadashi

Japan Sakai-mach

i

Sakai-mach

i

3

5

0

Asama General

Hospital

Naka Motoji Japan Saku-shi Saku-shi

3

5

1

Sanuki Municipal

Hospital

Inoue

Toshihiko

Japan Sanuki-shi Sanuki-shi

3

5

2

Sapporo Medical

Center NTT EC

Nagai Sou Japan Sapporo-sh

i

Sapporo-sh

i

3

5

3

Manda Memorial

Hospital

Tsuchida

Kenichi

Japan Sapporo-sh

i

Sapporo-sh

i

3

5

4

Suruga Clinic Yamauchi Akira Japan Shizuoka Shizuoka

3

5

5

Shunan City

Shinnanyo

Hospital

Matsutani

Akira

Japan Shunan-shi Shunan-shi

3

5

6

Takamatsu Red

Cross Hospital

ISHIKO

Tamayo

Japan Takamatsu Takamatsu

3

5

7

Takatsuki Red

Cross Hospital

Kaneko Shizuka Japan Takatsuki-

shi

Takatsuki-

shi

3

5

8

Tamana Central

Hospital

Matsuda

Hirofumi

Japan Tamana-shi Tamana-shi

3

5

9

Tokushima

University

Hospital

Matsuhisa

Munehide

Japan Tokushima Tokushima

3

6

0

Tokyo Kamata

Medical Center

TAKEMOTO

Ikutake

Japan Tokyo Tokyo

3

6

1

National Center

for Global

Health and

Medicine

Hospital

TSUJIMOTO

Tetsuro

Japan Tokyo Tokyo

Page 29: CTR20140661 试验状态 主动暂停 首次公示信息日期 2014-12-26 艾zy.yaozh.com/linchuangshiyan/pdf/CTR20140661.pdf · Osama Sayed United States Michigan Flint 4 6 Clinical

3

6

2

MAKITA General

Hospital

Kosuge

Keiichiro

Japan Tokyo Tokyo

3

6

3

The Institute

for Adult

Diseases

Onishi Yukiko Japan Tokyo Tokyo

3

6

4

Tokyo-Eki

Center-Building

Clinic

Kiyosue

Arihiro

Japan Tokyo Tokyo

3

6

5

JA Toride

Medical Center

Maeda

Yoshitaka

Japan Toride-shi Toride-shi

3

6

6

Toyota Memorial

Hospital

Shinoda Junji Japan Toyota-shi Toyota-shi

3

6

7

Mie Central

Medical Center

Tanaka

Tsuyoshi

Japan Tsu Tsu

3

6

8

Fujii Clinic Fujii Shinya Japan Ube Ube

3

6

9

National

Hospital

Organization

Shinshu Ueda

Medical Center

Tanaka Yukio Japan Ueda Ueda

3

7

0

Urasoe Sogo

Hospital

Ishikawa Kazuo Japan Urasoe-shi Urasoe-shi

3

7

1

Okamoto Internal

Medicine Office

Imura Mitsuo Japan Yaizu Yaizu

3

7

2

National

Hospital

Organization

Yokohama Medical

Center

Ujihara Makoto Japan Yokohama-s

hi

Yokohama-s

hi

3

7

3

Tokui Internal

Medicine Clinic

Tokui Mikiya Japan Yokohama-s

hi

Yokohama-s

hi

3

7

4

Nakajima Naika

Clinic

MUKASA Koji Japan Yokosuka-s

hi

Yokosuka-s

hi

3 Korea University Kim Nan Hee Korea, Ansan Ansan

Page 30: CTR20140661 试验状态 主动暂停 首次公示信息日期 2014-12-26 艾zy.yaozh.com/linchuangshiyan/pdf/CTR20140661.pdf · Osama Sayed United States Michigan Flint 4 6 Clinical

7

5

Ansan Hospital Republi

c Of

3

7

6

Korea University

Ansan Hospital

Cha Dae-Ryong Korea,

Republi

c Of

Ansan Ansan

3

7

7

Soonchunhayng

University

Bucheon Hospital

Mok Ji Oh Korea,

Republi

c Of

Bucheon-si Bucheon-si

3

7

8

Dong-A

University

Hospital

Suh Sung Korea,

Republi

c Of

Busan Busan

3

7

9

Inje University

Busan Paik

Hospital

Park Jeong

Hyun

Korea,

Republi

c Of

Busan Busan

3

8

0

Chungbuk

National

University

Hospital

Oh Tae Keun Korea,

Republi

c Of

Cheongju-s

i

Cheongju-s

i

3

8

1

Chuncheon Sacred

Heart Hospital

Choi Moon-Gi Korea,

Republi

c Of

Chuncheon Chuncheon

3

8

2

Kyungpook

National

University

Hospital

Lee In-Kyu Korea,

Republi

c Of

Daegu Daegu

3

8

3

Daegu Catholic

University

Medical Center

Shon Ho Sang Korea,

Republi

c Of

Daegu Daegu

3

8

4

Keimyung

University

Dongsan Hospital

Cho Ho Chan Korea,

Republi

c Of

Daegu Daegu

3

8

5

Yeungnam

University

Medical Center

Lee Hyoung Woo Korea,

Republi

c Of

Daegu Daegu

3

8

6

Chungnam

National

University

Hospital

Lee Kang-Wook Korea,

Republi

c Of

Daejeon Daejeon

3

8

7

Myongji Hospital Lee Jae Hyuk Korea,

Republi

c Of

Goyang Goyang

3

8

8

Hanyang

University Guri

Hospital

Yi, Joo Hark Korea,

Republi

c Of

Guri Guri

Page 31: CTR20140661 试验状态 主动暂停 首次公示信息日期 2014-12-26 艾zy.yaozh.com/linchuangshiyan/pdf/CTR20140661.pdf · Osama Sayed United States Michigan Flint 4 6 Clinical

3

8

9

Chosun

University

Hospital

Kim Sang Yong Korea,

Republi

c Of

Gwangju Gwangju

3

9

0

Wonkwang

University

School Of

Medicine &

Hospital

Cho, Chung Gu Korea,

Republi

c Of

Iksan Iksan

3

9

1

Gachon

University Gil

Hospital

Kim Byung-Joon Korea,

Republi

c Of

Incheon Incheon

3

9

2

Jeju National

University

Hospital

Lee Sang Ah Korea,

Republi

c Of

Jeju-si Jeju-si

3

9

3

Chonbuk National

University

Hospital

Park Tae-Sun Korea,

Republi

c Of

Jeonju Jeonju

3

9

4

Pusan National

University

Hospital

Kim In-Joo Korea,

Republi

c Of

Pusan Pusan

3

9

5

Seoul National

University

Bundang Hospital

Jang Hak-Chul Korea,

Republi

c Of

Seongnam Seongnam

3

9

6

Bundang Cha

Hospital

Cho Yong-Wook Korea,

Republi

c Of

Seongnam Seongnam

3

9

7

Gangnam

Severance

Hospital

Ahn Chul Woo Korea,

Republi

c Of

Seoul Seoul

3

9

8

Hallym

University

Kangdong Sacred

Heart Hospital

Kim Doo-Man Korea,

Republi

c Of

Seoul Seoul

3

9

9

Samsung Medical

Center

Lee Moon-Kyu Korea,

Republi

c Of

Seoul Seoul

4

0

0

Seoul National

University

Hospital

Park Kyong-Soo Korea,

Republi

c Of

Seoul Seoul

4

0

1

Gangdong

Kyunghee

University

Hospital

Ahn Kyu Jeung Korea,

Republi

c Of

Seoul Seoul

4 Kyunghee Woo Jeong-Taek Korea, Seoul Seoul

Page 32: CTR20140661 试验状态 主动暂停 首次公示信息日期 2014-12-26 艾zy.yaozh.com/linchuangshiyan/pdf/CTR20140661.pdf · Osama Sayed United States Michigan Flint 4 6 Clinical

0

2

University

Medical Center

Republi

c Of

4

0

3

The Catholic

Univ. of Korea

Seoul, St.

Mary's Hospital

Yoon Kun-Ho Korea,

Republi

c Of

Seoul Seoul

4

0

4

Korea Universtiy

Guro Hospital

Choi Kyung Korea,

Republi

c Of

Seoul Seoul

4

0

5

Korea University

Anam Hospital

Kim Sin-Gon Korea,

Republi

c Of

Seoul Seoul

4

0

6

The Catholic

University of

Korea St. Paul's

Hospital

Kim Byung Soo Korea,

Republi

c Of

Seoul Seoul

4

0

7

Asan Medical

Center

Kim Min Seon Korea,

Republi

c Of

Seoul Seoul

4

0

8

Severance

Hospital

Kim Beom Seok Korea,

Republi

c Of

Seoul Seoul

4

0

9

Ajou University

Hospital

Lee Kwan-Woo Korea,

Republi

c Of

Suwon Suwon

4

1

0

Uijeongbu St.

Mary's Hospital

Yoon Sun Ae Korea,

Republi

c Of

Uijeongbu Uijeongbu

4

1

1

Ulsan University

Hospital

Nam-Goong

II-Seong

Korea,

Republi

c Of

Ulsan Ulsan

4

1

2

Yonsei

University Wonju

Severance

Christian

Hospital

Chung Choon

Hee

Korea,

Republi

c Of

Wonju Wonju

4

1

3

Hospital

Selayang

Wong Hin Seng Malaysi

a

Batu Caves Batu Caves

4

1

4

Hospital Serdang Goh Bak Leong Malaysi

a

Kajang Kajang

4

1

University Sains

Malaysia

Mohamed

Mafauzy

Malaysi

a

Kota Bharu Kota Bharu

Page 33: CTR20140661 试验状态 主动暂停 首次公示信息日期 2014-12-26 艾zy.yaozh.com/linchuangshiyan/pdf/CTR20140661.pdf · Osama Sayed United States Michigan Flint 4 6 Clinical

5

4

1

6

Hospital Raja

Perempuan Zainab

II

Hassen Wan

Hasnul Halimi

Malaysi

a

Kota Bharu Kota Bharu

4

1

7

Hospital Kuala

Lumpur

Ahmad Ghazali Malaysi

a

Kuala

Lumpur

Kuala

Lumpur

4

1

8

Hospital

Universiti

Kebangsaan

Malaysia

Sukor Norlela Malaysi

a

Kuala

Lumpur

Kuala

Lumpur

4

1

9

Hospital Tengku

Ampuan Afzan

Nik Ahmad Nik Malaysi

a

Kuantan Kuantan

4

2

0

Hospital Melaka Shalini

Vijayasingham

Malaysi

a

Melaka Melaka

4

2

1

Hospital Pulua

Pinang c/o

Penang Medical

College

Aziz Nor

Azizah

Malaysi

a

Pulau

Pinang

Pulau

Pinang

4

2

2

Hospital

Putrajaya

Hussein

Zanariah

Malaysi

a

Putrajaya Putrajaya

4

2

3

Hospital Tuanku

Jafaar

Adam Noor Malaysi

a

Seremban Seremban

4

2

4

Hospital Taiping Ramanathan GR Malaysi

a

Taiping Taiping

4

2

5

Hospital Taiping Vaithilingam

Indralingan

Malaysi

a

Taiping Taiping

4

2

6

Centro de

Investigacion

Clinica del

Pacifico

Leguizamo-Dim

as Aniceto

Mexico Acapulco Acapulco

4

2

7

Clinica San

Cosme

Chew Wong

Alfredo

Mexico Aguascalie

ntes

Aguascalie

ntes

4

2

8

Instituto de

Diabetes

Obesidad y

Nutricion S.C.

Sauque Reyna

Leobardo

Mexico Cuernavaca

, Morelos

Cuernavaca

, Morelos

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4

2

9

Investigacion

Nefrologica S.C.

Bochicchio-Ri

cardelli

Tomasso

Mexico Cuernavaca

, Morelos

Cuernavaca

, Morelos

4

3

0

Instituto

Jalisciense de

Investigacion en

Diabetes

Obesidad

Gonzalez-Galv

ez Guillermo

Mexico Guadalajar

a

Guadalajar

a

4

3

1

Area Medica

SANEFRO

Renoirte Lopez

Karina

Mexico Guadalajar

a

Guadalajar

a

4

3

2

Instituto

Nacioanl de

Ciencias Medicas

Nutricion S.

Zubiran

Nino, Jose

Antonio

Mexico Mexico City Mexico City

4

3

3

Instituto

Nacional de

Cardiologia

Madero Rovalo

Magdalena

Mexico Mexico City Mexico City

4

3

4

Hospital

Universitario

Dr. Jose

Eleuterio

Gonzalez

Gonzalez

Gonzalez Jose

Mexico Monterrey,

N.L.

Monterrey,

N.L.

4

3

5

Hospital y

Clinica OCA

Rico Hernandez

Raul

Mexico Monterrey,

Nuevo Leon

Monterrey,

Nuevo Leon

4

3

6

Unidad de

Prevencion y

Atencion

Cardiometabolic

a (UPAC)

Carranza-Madr

igal Jaime

Mexico Morelia,

Michoacan

Morelia,

Michoacan

4

3

7

Hospital Central

Dr. Ignacio

Morones Prieto

Chevaile-Ramo

s Jose

Mexico San Luis

Potosi

San Luis

Potosi

4

3

8

Universitair

Medisch Centrum

Groningen

Gansevoort Ron Netherl

ands

Groningn Groningn

4

3

9

Albert

Schweitzer

Ziekenhuis

Smak Gregoor

Peter

Netherl

ands

Dordrecht Dordrecht

4

4

0

Ziekenhuis Groep

Twente

Laverman

Gozewijn

Netherl

ands

Almelo Almelo

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4

4

1

Gelre Hospital

Apeldoorn

Barendregt JNM

(Jos)

Netherl

ands

Apeldoorn Apeldoorn

4

4

2

Meander Medisch

Centrum

Luik Peter Netherl

ands

Amersfoort Amersfoort

4

4

3

Auckland City

Hospital

Pilmore Helen New

Zealand

Auckland Auckland

4

4

4

Dunedin Hospital Schollum John New

Zealand

Dunedin Dunedin

4

4

5

Waikato Hospital Rabindranath

Kannaiyan

New

Zealand

Hamilton Hamilton

4

4

6

Taranaki Base

Hospital

Hayat Ashik New

Zealand

New

Plymouth

New

Plymouth

4

4

7

North Shore

Hospital

Miller Steven New

Zealand

Takapuna Takapuna

4

4

8

Instituto

Endocronolocigo

Farfan E.I.R.L

Farfan-Aspilc

ueta Julio

Peru Arequipa Arequipa

4

4

9

Exacta Lab SAC Burga Nunez

Jose

Peru Arequipa Arequipa

4

5

0

Instituto

Delgado de

Investigacion

Medica

Delgado-Butro

n Cesar

Peru Arequipa Arequipa

4

5

1

Hospital

Nacional Alberto

Sabogal

Sologuren

Herrada Orue

Benjamin

Peru Callao Callao

4

5

2

Hospital

Nacional Adolfo

Guevara Velasco

Essalud

Zea-Nunez

Carlos Antonio

Peru Cusco Cusco

4

5

3

Centro de

Investigacion y

Atencion

Cardiovascular

SAC.

Calderon

Ticona Jorge

Peru Lima Lima

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4

5

4

Clinica de

Diabetes S.A.C.

Zapata-Rincon

Luis

Peru Lima Lima

4

5

5

Centro Medico

Clinica San

Judas Tadeo

Dextre

Espinoza

Augusto

Peru Lima Lima

4

5

6

Hospital

Nacional

Arzobispo Loayza

Medina-Santan

der Boris

Peru Lima Lima

4

5

7

Clinica Virgen

Maria

Auxiliadora

Vargas-Gonzal

es Rolando

Peru Piura Piura

4

5

8

NZOZ

Specjalistyczny

Osrodek

Arciszewska

Malgorzata

Poland Bialystok Bialystok

4

5

9

NZOZ Diab Serwis

S.C.

Popenda

Grazyna

Poland Chorzow Chorzow

4

6

0

NZOZ SALVIA Madej Andrzej Poland Katowice Katowice

4

6

1

Krakowskie

Centrum Medyczne

Sp. z o.o.

Kowalczyk-Mic

halek Martyna

Poland Krakow Krakow

4

6

2

NZOZ Centrum

Medyczne

ProMiMed Sp. z

o.o., sp.k

Necki Miroslaw Poland Krakow Krakow

4

6

3

SPZOZ

Uniwersytecki

Szpital

Kliniczny nr 1

Nowicki Michal Poland Lodz Lodz

4

6

4

NZOZ Przychodnia

Specjalistyczna

MEDICA

Skokowska Ewa Poland Lublin Lublin

4

6

5

Centrum Medyczne

Medyk

Mazur

Stanislaw

Poland Rzeszow Rzeszow

4

6

6

Samodzielny

Publiczny

Szpital

Kliniczny Nr 2

PUM w Szczecini

Ciechanowski

Kazimierz

Poland Szczecin Szczecin

4 Centrum Uslug Wruk Michal Poland Szczecinek Szczecinek

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6

7

Medycznych

Dializa

4

6

8

Medica pro

Familia Sp. z

o.o. S.K.A

Klodawska

Katarzyna

Poland Warsaw Warsaw

4

6

9

Hospital Curry

Cabral,PT

Ferreira

Annibal

Portuga

l

Lisbon Lisbon

4

7

0

Associacao

Protectora dos

Diabeticos de

Portugal

Brine Rita Portuga

l

Lisbon Lisbon

4

7

1

Centro

Hospitalar do

Porto

Cabrita

Antonio

Portuga

l

Porto Porto

4

7

2

Health

Preventive

Services

Comulada-Rive

ra Angel

Puerto

Rico

Bayamon Bayamon

4

7

3

Instituto Renal

del Este

Galindo Ramos

Eugenia

Puerto

Rico

Caguas Caguas

4

7

4

Caparra Internal

Medicine

Matta Fontanet

Evelyn

Puerto

Rico

Rio Grande Rio Grande

4

7

5

University of

Puerto Rico

Burgos-Calder

on Rafael

Puerto

Rico

Rio Piedras Rio Piedras

4

7

6

PR Renal Health

and Research

INC.

Calderon-Orti

z, Ricardo

Puerto

Rico

Toa Baja Toa Baja

4

7

7

O.D. Medica SRL Tivadar Simona Romania Bucharest Bucharest

4

7

8

Centrul Medical

Unirea SRL

Hancu Nicolae Romania Cluj-Napoc

a

Cluj-Napoc

a

4

7

9

Spitalul Clinic

Judetean de

Urgenta

Cluj-Napoca

Duma Livia Romania Cluj-Napoc

a

Cluj-Napoc

a

4

8

0

Spitalul Clinic

Judetean de

Urgenta

Constanta

Tuta Liliana Romania Constanta Constanta

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4

8

1

Milena Sante SRL Mistodie

Cristina

Romania Galati Galati

4

8

2

Consultmed SRL Pintilei Ella Romania Iasi Iasi

4

8

3

Municipal

Clinical

Hospital

Bako Gabriel Romania Oradea Oradea

4

8

4

Spitalul

Judetean de

Urgenta Pitesti

Tutescu

Adriana

Romania Pitesti Pitesti

4

8

5

SC Centrul

Medical

Munteanu

Mircea

Romania Timisoara Timisoara

4

8

6

Sptalul Clinic

Judetean de

Urgenta

Timisoara

Petrica Ligia Romania Timisoara Timisoara

4

8

7

Sptalul Clinic

Judetean de

Urgenta

Timisoara

Timar Romulus Romania Timisoara Timisoara

4

8

8

City Hospital No

6

Kuzin Anatoly Russian

Federat

ion

Chelyabins

k

Chelyabins

k

4

8

9

Gatchina Central

District

Clinical

Hospital

Yavdosyuk

Andrey

Russian

Federat

ion

Gatchina Gatchina

4

9

0

Irkutsk State

Medical Academy

of Postgraduate

Education

Bardymova

Tatiana

Russian

Federat

ion

Irkutsk Irkutsk

4

9

1

Kazan State

Medical

University

Sigitova Olga Russian

Federat

ion

Republic of

Tatarstan

Kazan

4

9

2

Kazan State

Medical

University

Maksudova

Adelya

Russian

Federat

ion

Republic of

Tatarstan

Kazan

4

9

3

Kirov City

Clinical

Hospital 1

Solovev Oleg Russian

Federat

ion

Kirov Kirov

4 Krasnoyarsk Rechkova Elena Russian Krasnoyars Krasnoyars

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9

4

Interdistrict

Clinical

Emergency Care

Hospital

Federat

ion

k k

4

9

5

Endocrinology

Research Center

Shamkhalova

Minara

Russian

Federat

ion

Moscow Moscow

4

9

6

Moscow -

Out-patient

Clinic #3

Pikalova

Natalia

Russian

Federat

ion

Moscow Moscow

4

9

7

City Hosp 33 of

Leninskiy

District of City

Nizhniy Novgorod

Pichkov Dmitry Russian

Federat

ion

Nizhniy

Novgorod

Nizhniy

Novgorod

4

9

8

Scientific

Instituti of

Clinical and

Experimental

Lymphology

Klimontov

Vadim

Russian

Federat

ion

Novosibirs

k

Novosibirs

k

4

9

9

Orenburg State

Medical Academy

Sayfutdinov

Rustam

Russian

Federat

ion

Orenburg Orenburg

5

0

0

Perm Regional

Hospital for War

Veterans

Koziolova

Natalya

Russian

Federat

ion

Perm Perm

5

0

1

Republican

Hospital named

after V. A.

Baranov

Barysheva Olga Russian

Federat

ion

Petrozavod

sk

Petrozavod

sk

5

0

2

City Out-patient

Clinic #17

Lantseva Olga Russian

Federat

ion

Saint-Pete

rsburg

Saint-Pete

rsburg

5

0

3

City Clinical

Hospital # 38

named after N.A.

Semashko

Zrazhevskiy

Konstantin

Russian

Federat

ion

Saint-Pete

rsburg

Saint-Pete

rsburg

5

0

4

St. Petersburg

Medical Univ na

I.P. Pavlov

Karonova

Tatiana

Russian

Federat

ion

Saint-Pete

rsburg

Saint-Pete

rsburg

5

0

5

City Clinical

Hospital # 31

Essaian Ashot Russian

Federat

ion

Saint-Pete

rsburg

Saint-Pete

rsburg

5

0

GBOU VPO Saratov

State Medical

Shvarts Yuri Russian

Federat

Saratov Saratov

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6 University ion

5

0

7

Smolensk State

Medical Academy

Reshedko

Galina

Russian

Federat

ion

Smolensk Smolensk

5

0

8

Federal State

Institution

Sardinov

Ruslan

Russian

Federat

ion

Republic of

Tatarstan

St.

Petersburg

5

0

9

Siberian State

Medical

University

Samoylova

Yulia

Russian

Federat

ion

Tomsk Tomsk

5

1

0

Research

Institute for

Cardiology

Mordovin

Viktor

Russian

Federat

ion

Tomsk Tomsk

5

1

1

Regional

Clinical

Hospital of

Yaroslavl Region

Marasaev

Vyacheslav

Russian

Federat

ion

Republic of

Tatarstan

Yaroslavl

5

1

2

Tan Tock Seng

Hospital

Liew Adrian Singapo

re

Singapore Singapore

5

1

3

Khoo Teck Puat

Hospital

Yeoh Lee Ying Singapo

re

Singapore Singapore

5

1

4

National

University

Hospital

Teo, Boon Wee Singapo

re

Singapore Singapore

5

1

5

Metabolic Center

of Dr K.Raslova,

ltd

Raslova

Katarina

Slovaki

a

Bratislava Bratislava

5

1

6

Medispektrum,

sro

Ilavska

Adriana

Slovaki

a

Bratislava Bratislava

5

1

7

FMC Dialysis

Services

Fekete Jozef Slovaki

a

Bratislava Bratislava

5

1

8

Slovenska

Zdravotnica

Univerzita

Oksa Adrian Slovaki

a

Bratislava Bratislava

5

1

9

ProVitae-Medica

l Centre

Zachar Andrej Slovaki

a

Bratislava Bratislava

5

2

0

FMC-dialyzacne

sluzby, spol.s

r.o

Obetkova Ida Slovaki

a

Hlohovec Hlohovec

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5

2

1

Medikol s.r.o. Kolesarova Eva Slovaki

a

Kosice Kosice

5

2

2

AGTO spol.

s.r.o.

Tkac Ivan Slovaki

a

Kosice Kosice

5

2

3

FMC Dialyzacne

sluzby s.r.o.

Rosenberger

Jaroslav

Slovaki

a

Kosice Kosice

5

2

4

SMOLKO s.r.o. Smolko Peter Slovaki

a

Kosice Kosice

5

2

5

Interna SK

s.r.o.

Fulopova Alla Slovaki

a

Svidnik Svidnik

5

2

6

Groote Schuur

Hospital

Okpechi Ikechi South

Africa

Western

Cape

Cape Town

5

2

7

Langeberg

Clinical Trials

Trokis Julien South

Africa

Western

Cape

Cape Town

5

2

8

Dr P J Sebastian Sebastian

Peter

South

Africa

KwaZulu-Na

tal

Durban

5

2

9

Newkwa Medical

Centre

Ramlachan

Padaruth

South

Africa

KwaZulu-Na

tal

Durban

5

3

0

St. Augustine's

Hospital

Naiker

Puvanesveri

South

Africa

KwaZulu-Na

tal

Durban

5

3

1

Centre for

Diabetes and

Endocrinology

Distiller

Lawrence

South

Africa

Gauteng Johannesbu

rg

5

3

2

Makan, Lenasia,

SA

Makan Hemant South

Africa

Lenasia Lenasia

5

3

3

Paarl Research

Centre

Coetzee

Kathleen

South

Africa

Western

Cape

Paarl

5

3

4

Soweto Clinical

Trial Centre

Bhorat Asad South

Africa

Soweto Soweto

5

3

Clinical

Projects

van Zyl Louis South

Africa

Western

Cape

Worcester

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5 Research

5

3

6

Complejo

Hospitalario

Universitario de

A Coruna

Soto Gonzalez

Alfonso

Spain A Coruna A Coruna

5

3

7

Hospital

Universitario

Germans Trias i

Pujol

Bonet Jose Spain Badalona -

Barcelona

Badalona -

Barcelona

5

3

8

Hospital Parc de

Salut del Mar

Pascual Santos

Julio

Spain Barcelona Barcelona

5

3

9

Hospital

Universitario

Bellvitge

Grinyo Josep Spain Barcelona Barcelona

5

4

0

Hospital

Universitario

Vall d'Hebron

Seron Daniel Spain Barcelona Barcelona

5

4

1

Fundacion

Puigvert

Calero

Gonzalez

Francesca

Spain Barcelona Barcelona

5

4

2

Hospital

Universitario de

Basurto

Arrieta

Lezarna Javier

Spain Bilbao Bilbao

5

4

3

Hospital da

Costa

Cigarran

Guldris

Secundino

Spain Burela Burela

5

4

4

Hospital

Universitario

Reina Sofia

Santamaria

Olmo Rafael

Spain Cordoba Cordoba

5

4

5

Hospital

Universitario de

Gran Canarias

Dr. Negrin

Rodriguez-Per

ez Jose

Spain Las Palmas Las Palmas

5

4

6

Hospital

Universitario

Arnau de

Vilanova

Fernandez

Giraldez

Elvira

Spain Lleida Lleida

5

4

7

Hospital

Universitario

Fundacion

Alcorcon

Fernandez

Juarez Gema

Spain Madrid Madrid

5

4

Fundacion

Jimenez Diaz

Egido Jesus Spain Madrid Madrid

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8

5

4

9

Hospital Clinico

San Carlos

Herrero Calvo

Jose

Spain Madrid Madrid

5

5

0

Hospital

Universitario 12

de Octubre

Praga Terente

Manuel

Spain Madrid Madrid

5

5

1

Hospital

Universitarrio

Puerta de Hierro

Majadahonda

Marques Vidas

Maria

Spain Madrid Madrid

5

5

2

Hospital

Universitario

Virgen de la

Victoria

Valera Cortes

Ildefonso

Spain Malaga Malaga

5

5

3

Hospital

Universitario

Marques de

Valdecilla

Fernandez

Fresnedo Gema

Spain Santander

(Cantabria

)

Santander

(Cantabria

)

5

5

4

Hospital

Universitario

Nuestra Senora

de Candelaria

Navarro

Gonzalez Juan

Spain Tenerife Tenerife

5

5

5

Hospital General

Univ de Valencia

Galan Antonio Spain Valencia Valencia

5

5

6

Hospital

Universitario

Dr. Peset

Gorriz Jose Spain Valencia Valencia

5

5

7

Hospital

Universitari i

Politecnin la Fe

Hernandez-Jar

as Julio

Spain Valencia Valencia

5

5

8

Hospital de

Txagorritxu

Minguela

Pesquera Jose

Ignacio

Spain Vitoria Vitoria

5

5

9

Orebro

Universitetssju

khus

Hellberg Olof Sweden Orebro Orebro

5

6

0

Uppsala

University

Hospital

Fellstrom

Bengt

Sweden Uppsala Uppsala

5

6

1

Hualien Tzu Chi

Hospital

Wu Du-An China Taiwan Hualien

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5

6

2

Far Eastern

Memorial

Hospital

Jiang Ju-Ying China Taiwan New Taipei

5

6

3

Cardinal Tien

Hospital

Dee Pei China Taiwan New Taipei

5

6

4

China Medical

University

Hospital

Chen Ching-Chu China Taiwan Taichung

5

6

5

Taichung

Veterans General

Hospital

Sheu Wayne China Taiwan Taichung

5

6

6

Chung Shan

Medical

University

Huang

Chien-Ning

China Taiwan Taichung

5

6

7

Kuang Tien

General Hospital

Tseng

Shih-Ting

China Taiwan Taichung

5

6

8

Taichung

Hospital

Sheen Yi-Jing China Taiwan Taichung

5

6

9

Chi-Mei Medical

Center

Tien Kai-Jen China Taiwan Tainan

5

7

0

Cathay General

Hospital

Lin Ching-Ling China Taiwan Taipei

5

7

1

Taipei Medical

University

Hospital

Wu Mai-Szu China Taiwan Taipei

5

7

2

MacKay Memorial

Hospital

Chien Ming-Nan China Taiwan Taipei

5

7

3

Baskent

University

School of

Medicine

Sezer Siren Turkey Ankara Ankara

5

7

4

Akdeniz

University

School of

Medicine

Sari Ramazan Turkey Ankara Ankara

5

7

5

Adnan Menderes

University

Yenicerioglu

Yavuz

Turkey Aydin Aydin

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5

7

6

Istanbul

University

Medical Faculty

Satman Ilhan Turkey Istanbul Istanbul

5

7

7

Istanbul

University

Medical Faculty

Yildiz

Alaattin

Turkey Istanbul Istanbul

5

7

8

Kocaeli

University

Medical Faculty

Kalender

Gonullu Betul

Turkey Kocaeli Kocaeli

5

7

9

Chernivtsi

Regional

Clinical

Hospital

Zub Lilia Ukraine Chernivtsi Chernivtsi

5

8

0

Ukrainian State

Institution of

Medical and

Social Problems

Panina

Svitlana

Ukraine Dnipropetr

ovsk

Dnipropetr

ovsk

5

8

1

Ivano-Frankivsk

Regional

Clinical

Hospital

Legun Oleg Ukraine Ivano-Fran

kivsk

Ivano-Fran

kivsk

5

8

2

Kharkiv City

Clinical

Emergency

Hospital

Bilchenko

Oleksandr

Ukraine Kharkiv Kharkiv

5

8

3

Kharkov City

Clinical

Hospital #27

Zolotaikina

Viktoriia

Ukraine Kharkiv Kharkiv

5

8

4

SI Institute of

Therapy AMS of

Ukraine n.a.

Mala L.T.

Topchii Ivan Ukraine Kharkiv Kharkiv

5

8

5

VP Komissarenko

National Academy

of Medical

Sciences

Korpachev

Vadym

Ukraine Kiev Kiev

5

8

6

Kiev Regional

Clinical

Hospital

Shen Andriy Ukraine Kyiv Kyiv

5

8

7

Polyclinic of

Administration

of Medical

Services

Mankovskyy

Borys

Ukraine Kyiv Kyiv

5 Communal Petrosyan Ukraine Odesa Odesa

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8

8

Institution

Odesa Regional

Clinical

Hospital

Olena

5

8

9

Transcarpathian

Regional Clin.

Hos. Named after

Andriy Novak

Stryzhak Vasyl Ukraine Uzhgorod Uzhgorod

5

9

0

Clinic of

Scientific

Research

Institute for

Hadicapped

Shevchuk

Sergii

Ukraine Vinnytsya Vinnytsya

5

9

1

Vinnytsya

National Medical

University n.a.

M.I. Pyrogov

Stanislavchuk

Mykola

Ukraine Vinnytsya Vinnytsya

5

9

2

Regional

Clinical

Hospital of

Zhytomyr

Kuskalo Petro Ukraine Zhytomyr Zhytomyr

5

9

3

Belfast City

Hospital

Maxwell Peter United

Kingdom

Belfast Belfast

5

9

4

Ninewells

Hospital

Brennan

Geraldine

United

Kingdom

Dundee Dundee

5

9

5

South Glasgow

Universita Hospi

Mark Patrick United

Kingdom

Glasgow Glasgow

5

9

6

Kings College

Hospital

Kon, Sui Phin United

Kingdom

London London

5

9

7

Guy's Hospital Gnudi Luigi United

Kingdom

London London

5

9

8

The Royal Free

Hospital

Patel Dipesh United

Kingdom

London London

5

9

9

North Middlesex

Hospital NHS

Trust

Tindall Hilary United

Kingdom

London London

6

0

Salford Royal

NHS Foundation

Kalra Phillip United

Kingdom

Salford Salford

Page 47: CTR20140661 试验状态 主动暂停 首次公示信息日期 2014-12-26 艾zy.yaozh.com/linchuangshiyan/pdf/CTR20140661.pdf · Osama Sayed United States Michigan Flint 4 6 Clinical

0 Trust

6

0

1

Queen Mary

Hospital

Sydney Tang 中国 Hong Kong Hong Kong

6

0

2

Prince of Wales

Hospital

Risa Ozaki 中国 Hong Kong Hong Kong

6

0

3

Queen Mary

Hospital

Kathryn Tan 中国 Hong Kong Hong Kong

6

0

4

河北医科大学第

二医院

傅淑霞 中国 河北省 石家庄

6

0

5

宁波市第二医院 罗群 中国 浙江省 宁波

6

0

6

郑州大学第一附

属医院

刘章锁 中国 河南省 郑州

七、伦理委员会信息

序号 名称 审查结论 审查日期

1 南方医科大学南方医院医学伦理

委员会

同意 2014-10-23

八、试验状态

主动暂停 艾伯维因收集的终点事件远低于预期,决定提前终止研究