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

Study Identifier:

156-12-298

ClinicalTrials.gov Identifier:

NCT02964273

EudraCT Identifier:

2016-000187-42

Sponsor:

Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Contact Information:

N/A

Study Complete

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Results Available

Study Protocol

Available Languages: English

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Statistical Analysis Plan

Available Languages: English

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Study Details

Medical Condition

Kidney Disease

Study Drug

Drug: Tolvaptan
Drug: Tolvaptan Matching-placebo

Date

Sep 2016 - Nov 2021

Phase 1

Phase 2

Phase 3

Phase 4

N/A

Patient Requirements

Sex: Female & Male

Age: 4 - 17 Years

Requirements Information

Protocol Summary

The primary objective of the study is to assess the long term safety of treatment with tolvaptan in children and adolescents with autosomal dominant polycystic kidney disease (ADPKD). The secondary objective is to assess the pharmacodynamics, pharmacokinetics, and efficacy of tolvaptan in the same participant population.

Study Locations

Location

Status

Location

Gent, Oost-Vlaanderen, Belgium, 9000

Status

N/A

Location

Leuven, Vlaams Brabant, Belgium, 3000

Status

N/A

Location

Brussels, Belgium, 1200

Status

N/A

Location

Bruxelles, Belgium, 1020

Status

N/A

Location

Montegnee, Belgium, 4420

Status

N/A

Location

Cologne, Germany, 50937

Status

N/A