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Clinical trial

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 Two Year Open-label Extension in Children and Adolescent Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)

NCT02964273 is registered in ClinicalTrials.gov with Otsuka Pharmaceutical Development & Commercialization, Inc. as lead sponsor.

NCT NCT02964273
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Registry record

As filed in ClinicalTrials.gov.

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 Two Year Open-label Extension in Children and Adolescent Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Phase
Phase 3
Overall status
Completed
Start date
September 23, 2016
Completion date
November 17, 2021
Enrollment
91 (actual)
Sites
20

Conditions

As the registry lists them; a condition with its own page is linked.

autosomal dominant polycystic kidney disease (adpkd)