Clinical Trial: 8-Week Study of Tolvaptan Dose Forms in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase 2, Multicenter, Randomized, Placebo-controlled, Double-blind, Placebo-masked, Parallel-group Pilot Trial to Compare the Efficacy, Tolerability, and Safety of Tolvaptan Modified-release and Imm
Brief Summary: The purpose of this study is to compare the short-term effects of two tolvaptan formulations in patients with ADPKD.
Detailed Summary:
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Current Primary Outcome: Percent change in Total Kidney Volume (TKV) [ Time Frame: 3 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change in total score of the ADPKD-Urinary Impact Scale (UIS) [ Time Frame: 8 weeks ]
- Percent change in Total Kidney Volume (TKV) [ Time Frame: 8 weeks ]
Original Secondary Outcome: Same as current
Information By: Otsuka Pharmaceutical Development & Commercialization, Inc.
Dates:
Date Received: October 11, 2011
Date Started: October 2011
Date Completion:
Last Updated: June 12, 2014
Last Verified: June 2014
