Clinical Trial: A Phase III Study Evaluating the Efficacy and Safety of Satavaptan Versus Placebo in Patients With Dilutional Hyponatremia
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Double-Blind, Randomized, Placebo-Controlled Multicenter Study Evaluating the Efficacy and Safety of Two Doses of Satavaptan (SR121463B) Versus Placebo in Patients With Dilutional Hyponatremia Due t
Brief Summary:
The primary objective of this study is to assess the efficacy of satavaptan versus placebo in participants with dilutional hyponatremia due to SIADH.
Secondary objectives are to assess the safety of satavaptan, the maintenance of effect, and the clinical benefit in these participants.
Detailed Summary:
Sponsor: Sanofi
Current Primary Outcome: serum sodium change from baseline [ Time Frame: At Day 5 pre-dose ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- responder rate [ Time Frame: At Day 5 pre-dose ]
- presence and intensity of clinical symptoms related to hyponatremia [ Time Frame: At each scheduled visit ]
- change from baseline in cognitive function [ Time Frame: At Day 5 and 30 ]
Original Secondary Outcome: Same as current
Information By: Sanofi
Dates:
Date Received: July 31, 2008
Date Started: July 2008
Date Completion:
Last Updated: April 26, 2016
Last Verified: April 2016
