Long Term Safety of Immediate-release Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease

PHASE3CompletedINTERVENTIONAL
Enrollment

1,803

Participants

Timeline

Start Date

October 17, 2014

Primary Completion Date

November 9, 2018

Study Completion Date

November 9, 2018

Conditions
Polycystic Kidney, Autosomal Dominant
Interventions
DRUG

Tolvaptan

Tolvaptan tablets (15 or 30 mg) self-administered orally as split-dose regimens, once upon awakening and another approximately 8 to 9 hours later

Trial Locations (210)

1032

Budapest

1090

Brussels

1200

Brussels

2050

Camperdown

2065

St Leonards

2145

Westmead

2305

New Lambton Heights

2650

Edegem

3000

Leuven

3050

Parkville

3073

Reservoir

3121

Richmond

4000

Liège

4001

Durban

4102

Woolloongabba

5000

Adelaide

5021

Bergen

6000

Junín

Perth

6720

Szeged

7250

Launceston

7500

Holstebro

7623

Pécs

7925

Cape Town

8200

Aarhus N

8500

Kortrijk

9000

Ghent

9100

Aalborg

9300

Aalst

10021

New York

10032

New York

10117

Berlin

11413

Laurelton

11501

Mineola

13005

Ciudad Real

14186

Stockholm

14219

Buffalo

17176

Stockholm

18017

Bethlehem

18901

Doylestown

19104

Philadelphia

20122

Milan

20132

Milan

20770

Greenbelt

20850

Rockville

21201

Baltimore

21224

Baltimore

22207

Arlington

22908

Charlottesville

23507

Norfolk

23900

Lecco

25018

Montichiari

26506

Morgantown

27100

Pavia

27103

Winston-Salem

27599

Chapel Hill

28041

Madrid

28046

Madrid

28207

Charlotte

28801

Asheville

29118

Orangeburg

29203

Columbia

29425

Charleston

30322

Atlanta

30909

Augusta

32216

Jacksonville

33150

Miami

33614

Tampa

33952

Port Charlotte

34471

Ocala

34667

Hudson

35233

Birmingham

35805

Huntsville

36617

Mobile

37205

Nashville

37232

Nashville

37923

Knoxville

40210

Düsseldorf

41124

Modena

43210

Columbus

44106

Cleveland

44302

Akron

45147

Essen

45206

Cincinnati

45229

Cincinnati

46017

Valencia

48066

Roseville

48202

Detroit

48341

Pontiac

49007

Kalamazoo

49506

Grand Rapids

51401

Jilemnice

52621

Ramat Gan

55905

Rochester

58102

Fargo

58185

Linköping

60611

Chicago

60637

Chicago

63110

St Louis

65191

Wiesbaden

66160

Kansas City

67214

Wichita

69120

Heidelberg

70124

Bari

70808

Baton Rouge

75185

Uppsala

76015

Arlington

77004

Houston

77030

Houston

78278

Ashkelon

78503

McAllen

80045

Aurora

80138

Napoli

80204

Denver

80210

Denver

81675

Munich

83642

Meridian

85284

Tempe

85381

Phoenix

85745

Tucson

89106

Las Vegas

89511

Reno

90022

Los Angeles

90095

Los Angeles

90471

Nuremberg

92037

La Jolla

94143

San Francisco

94305

Stanford

97210

Portland

98801

Wenatchee

150062

Yaroslavl

197022

Saint Petersburg

410469

Oradea

491004

Petah Tikva

650002

Kemerovo

660062

Krasnoyarsk

2210001

Nahariya

6423906

Tel Aviv

9112001

Jerusalem

19401344

Saint Petersburg

06520

New Haven

02111

Boston

01107

Springfield

07724

Eatontown

08043

Voorhees Township

05401

Burlington

C1093AAS

Ciudad Autonoma de Buenos Aires

C1425APQ

Ciudad Autonoma de Buenos Aires

C1429BWN

Ciudad Autonoma de Buenos Aires

C1431FWO

Ciudad Autonoma de Buenos Aires

B2700CPM

Pergamino

B1629ODT

Pilar

X5000JHQ

Córdoba

X5016KEH

Córdoba

X5166BPW

Córdoba

T6G 2B7

Edmonton

A1N 3J5

Mount Pearl

M1H 3G4

Scarborough Village

M4C 5T2

Toronto

M5G 2N2

Toronto

H4J 1C5

Montreal

625 00

Brno

370 87

České Budějovice

500 05

Hradec Králové

586 01

Jihlava

460 63

Liberec

708 52

Ostrava

128 08

Prague

140 21

Prague

01307

Dresden

1081 HV

Amsterdam

9713 GZ

Groningen

6525 GA

Nijmegen

06-400

Ciechanów

80-952

Gdansk

87-400

Golub-Dobrzyń

31-559

Krakow

92-213

Lodz

93-347

Lodz

20-954

Lublin

70-111

Szczecin

04-749

Warsaw

50-556

Wroclaw

010731

Bucharest

011794

Bucharest

022328

Bucharest

0002

Pretoria

08907

Barcelona

413 45

Gothenburg

BT9 7AB

Belfast

EX2 5DW

Exeter

HU3 2JZ

Hull

BN2 5BE

Brighton

NW3 2QG

London

SE5 9RS

London

SW17 0QT

London

M13 9WL

Manchester

M6 8HD

Salford

SG1 4AB

Stevenage

IV2 3UJ

Inverness

LE5 4PW

Leicester

EH16 4SA

Edinburgh

L7 8XP

Liverpool

S5 7AU

Sheffield

ST4 7LN

Stoke-on-Trent

NE7 7DN

Newcastle upon Tyne

CV2 2DX

Coventry

B15 2GW

Birmingham

TS4 3BW

Middlesbrough

SA6 6NL

Swansea

All Listed Sponsors
lead

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

NCT02251275 - Long Term Safety of Immediate-release Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease | Biotech Hunter | Biotech Hunter