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, Milan
Project Period:	09/2016 - 12/2021
Sponsors:	Industry
ClinicalTrials.gov:	NCT02964273
EudraCT Nr.:	2016-000187-42