Research Project

Project Title:

A Phase 3b, Two-part, Multicenter, One Year Randomized, Double-blind, Placebo-controlled Trial of the Safety, Pharmacokinetics, Tolerability,and Efficacy of Tolvaptan Followed by a 2 Year Open-label Extension in Children and Adolescent Subjects With ADPKD

Project Type:

Clinical Trial, Enrolment terminated

Disease group(s):

AD structural kidney disorders

Project 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 subject population.

Lead principal investigator(s):

Giovanni Montini, Milano

Project Period:

09/2016   -   12/2021

Sponsors:

Industry

ClinicalTrials.gov:

NCT02964273

EudraCT Nr.:

2016-000187-42

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