NCT02964273View on ClinicalTrials.gov

Safety, Pharmacokinetics, Tolerability and Efficacy of Tolvaptan in Children and Adolescents With ADPKD (Autosomal Dominant Polycystic Kidney Disease)

PHASE3CompletedINTERVENTIONAL

Enrollment

Participants

Timeline

Start Date

September 23, 2016

Primary Completion Date

November 17, 2021

Study Completion Date

November 17, 2021

Conditions

Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Interventions

DRUG

Tolvaptan

Tolvaptan spray-dried, immediate release tablets

DRUG

Tolvaptan Matching-placebo

Tolvaptan matching-placebo tablets

Trial Locations (20)

1020

Brussels

1200

Brussels

3000

Leuven

4420

Montegnée

9000

Ghent

20122

Milan

20246

Hamburg

27100

Pavia

30625

Hanover

50937

Cologne

69120

Heidelberg

72076

Tübingen

80129

Napoli

80131

Napoli

04103

Leipzig

B4 6NH

Birmingham

SE1 7EH

London

WC1N 3JH

London

M13 9WL

Manchester

NG7 2UH

Nottingham

All Listed Sponsors

lead

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

NCT02964273 - Safety, Pharmacokinetics, Tolerability and Efficacy of Tolvaptan in Children and Adolescents With ADPKD (Autosomal Dominant Polycystic Kidney Disease) | Biotech Hunter | Biotech Hunter