Tolvaptan Phase 3 Efficacy and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD)

PHASE3CompletedINTERVENTIONAL
Enrollment

1,445

Participants

Timeline

Start Date

January 31, 2007

Primary Completion Date

January 31, 2012

Study Completion Date

January 31, 2012

Conditions
Polycystic Kidney Disease, Autosomal Dominant
Interventions
DRUG

Tolvaptan

Tolvaptan was supplied as tablets.

DRUG

Placebo

Placebo was supplied as tablets.

Trial Locations (133)

1090

UZ Brussel, Brussels

1200

Ucl-St Luc, Brussels

1307

Universitätsklinikum Carl Gustav Carus, Dresden

1425

Instituto de Nefrología, Nefrology SA, Buenos Aires

1602

Hospital Municipal de Vicente Lopez, Dr Bernardo Houssay, Buenos Aires

2065

Royal North Shore Hospital, Sydney

2145

Westmead Hospital, Sydney

2730

Herlev Amtssygehus, Herlev

3050

Royal Melbourne Hospital, Melbourne

3121

Melbourne Renal Research Group, Melbourne

4102

Princess Alexandra Hospital, Brisbane

5000

Royal Adelaide Hospital, Adelaide

Odense Universitetshospital, Odense

5011

Queen Elizebeth Hospital, Adelaide

6054

Royal Perth Hospital, Perth

9000

UZ Gent, Ghent

10021

The Rogosin Institute, New York

10032

Columbia University Medical Center, New York

10532

Nephrology Associates of Westchester, Hawthorne

10731

Spitalul Clinic de Nefrologie Dr. Carol Davila, Bucharest

13005

Hôpital de la Conception, Marseille

14033

CHU - Hôpital Clémenceau, Caen

14215

Erie County Medical Center, Buffalo

19104

University of Pennsylvania Medical Center, Philadelphia

20132

Università Vita e Salute, Ospedale San Raffaele, Milan

21205

John Hopkins School of Medicine, Baltimore

22328

Institutul Clinic Fundeni, Bucharest

22908

University of Virginia, Nephrology Clinical Research Center, Charlottesville

24128

Ospedali Riuniti di Bergamo, Bergamo

27100

IRCCS Fondazione Salvatore Maugeri, Pavia

27599

University of North Carolina, UNC, Kidney Center, Chapel Hill

27834

East Carolina University, Greenville

29405

Charleston Nephrology Associates, Charleston

30308

Emory University School of Medicine, Atlanta

31059

Hopital Rangueil, Toulouse

32216

Jacksonville Center for Clinical Research, Jacksonville

33076

CHU-Hopital Pellegrin, Bordeaux

33952

Coastal Nephrology Associates Research Center, LLC, Port Charlotte

34295

CHU - Hôpital Lapeyronie, Montpellier

36608

Coastal Clinical Research, Mobile

36617

University of South Alabama, Mobile

37205

Nephrology Associates, P.C., Nashville

40210

Nephrologische Gemeinschaftspraxis/Dialysezentrum, Düsseldorf

41100

Policlinico di Modena, Modena

42055

CHU - Hôpital Nord, Saint-Etienne

44106

University Hospitals of Cleveland/Case, Cleveland

45147

Klinik für Nieren- und Hochdruckkrankheiten, Essen

45220

Kidney and Hypertension Center, Cincinnati

51092

Centre Hospitalier Universitaire, Reims

55905

Mayo Medical Center, Rochester

60611

Northwestern University, Chicago

66160

University of Kansas Medical Center, Kansas City

69120

Universitätskliniken Heidelberg, Heidelberg

69437

Hôpital Edouard Herriot, Lyon

70809

Renal Associates of Baton Rough, L.L.C., Baton Rouge

75018

Hopital Bichat-Claude Bernard, Paris

78106

Universitätsklinikum Freiburg, Freiburg im Breisgau

80131

Policlinico, Napoli

80262

University of Colorado Health Sciences Center, Denver

90471

UH Erlangen/Nürnberg, Nuremberg

92503

Apex Research of Riverside, Riverside

97210

Northwest Renal Clinic, Inc., Portland

123060

City Clinical Hospital #52, Moscow

191104

City Mariinskiy Hospital, Saint Petersburg

194291

Leningrad Regional Clinical Hospital, Saint Petersburg

608648

Hokkaido University Hospital, Sapporo

634063

Tomsk Regional Clinical Hospital, Tomsk

650061

Kemerovo Medical Academy, Regional Clinical Hospital, Kemerovo

700503

"Spitalul Clinic C.I.Parhon", Iași

1058470

Toranomon Hospital, Minato-ku

1058471

The Jikei University Hospital, Minato-Ku

1138519

Tokyo Medical & Dental University Hospital, Faculty of Medicine, Bunkyo-ku

1138603

Nippon Medical School Hospital, Bunkyo-ku

1628666

Tokyo Women's Medical University Hospital, Shinjuku-ku

1738606

Teikyo University Hospital, Itabashi-ku

1818611

Kyorin University Hospital, Mitaka

2138587

Toranomon Hospital Kajigaya, Kawasaki

2288555

Kitasato University Hospital, Sagamihara

2591193

Tokai University Hospital, Isehara

2608677

Chiba University Hospital, Chiba

2608712

National Hospital Organization Chiba-East Hospital, Chiba

3290498

Jichi Medical School Hospital, Shimotsuke

3308503

Saitama Medical Center Jichi Medical University, Saitama

3440035

Shuwa General Hospital, Kasukabe

3508500

Saitama Medical Center, Kawagoe

4313192

Hamamatsu University School of Medicine, University Hospital, Hamamatsu

4701192

Fujita Health University Hospital, Toyoake

5458586

Osaka City University Hospital, Osaka

5500015

Ohno Memorial Hospital, Osaka

5650871

Osaka University Hospital, Suita

6068507

Kyoto University Hospital, Kyoto

7348551

Hiroshima University Hospital, Hiroshima

8128582

Kyusyu University Hospital, Fukuoka

8608556

Kumamoto Univeristy Hospital, Kumamoto

9518520

Niigata University Medical & Dental Hospital, Niigata

9601295

Fukushima Medical University Hospital, Fukushima

9808574

Tohoku University Hospital, Sendai

94305-5114

Stanford University Medical Center, Stanford

06510

Yale University School of Medicine, New Haven

02111

Tufts- New England Medical Center, Boston

02215

Beth Israel Deaconess Medical Center, Boston

37232-1371

Vanderbilt University Medical Center, Nashville

B1664INZ

Hosptial Universitario Austral, Buenos Aires

X5000IUP

Sanatorio Allende, Córdoba

X5016KEA

Hospital Privado-Centro Medico de Cordoba, Córdoba

B3H1v8

Queen Elizabeth II Health Science Center, Division of Nephrology, Halifax

H3A1A1

Royal Victoria Hospital, Montreal

H4J1C5

Hospital du Sacre- Coeur de Montreal, Montreal

612-8555

National Hospital Organization Kyoto Medical Center, Kyoto

1081 HV

VU Medisch Centrum, Amsterdam

9713 GZ

UMCG Groningen, Groningen

06-400

Oddział Nefrologiczny Stacja Dializ, Ciechanów

80-952

Akademickie Centrum Kliniczne AMG, Gdansk

Samodzielny Publiczny Szpital Kliniczny nr 1, Akademickie Centrum Kliniczne AMG, Gdansk

31-501

Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Szpital Uniwersytecki w Krakowie, Krakow

90-153

SOP ZOZ Uniwersytecki Szpital Kliniczny, Lodz

20-954

Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie, Lublin

02-507

Klinika Chorób Wewnętrznych i Nefrologii, Warsaw

03-401

Szpital Praski p.w. Przemienienia Panskiego, Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Warsaw

Szpital Praski, Samodzielny Publiczny ZOZ, Warsaw

04-749

Międzyleski Szpital Specjalistyczny w Warszawie, Warsaw

50-417

Akademicki Szpital Kliniczny im J Mikulicza Radeckiego, Wroclaw

BT9 7AB

Belfast City Hospital, Belfast

B15 2TH

Oueen Elizabeth Hospital, Birmingham

BN2 5BE

Sussex Renal Unit Royal Sussex County Hospital, Brighton

CV2 2DX

Uhcw Mhs Trust, Coventry

EH16 4SA

Royal Infirmary, Edinburgh

IV2 3UJ

Raigmore Hospital, Inverness

NW3 2PF

Royal Free and University College Medical School, London

SE5-9RS

King's College Hospital, London

SW170RE

St. George's Hospital, London

S5 7AU

Royal Hallamshire Hospital, Sheffield

SA6 6NL

Morriston Hospital, Swansea

Sponsors
All Listed Sponsors
collaborator

Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

lead

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY