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Clinical trial

A Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind, Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/Day, Split-dose) in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease

NCT02160145 is registered in ClinicalTrials.gov with Otsuka Pharmaceutical Development & Commercialization, Inc. as lead sponsor.

NCT NCT02160145
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Registry record

As filed in ClinicalTrials.gov.

Title
A Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind, Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/Day, Split-dose) in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Phase
Phase 3
Overall status
Completed
Start date
May 31, 2014
Completion date
April 18, 2017
Enrollment
1,370 (actual)
Sites
230

Conditions

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

autosomal dominant polycystic kidney disease, chronic kidney disease