Clinical Trial: Efficacy and Safety of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomized, Double-Blind, Placebo-Group, Multicenter Study Evaluating the Efficacy and Safety of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone
Brief Summary:
To assess the efficacy of SR121463B in correcting hyponatremia in patients with syndrome of inappropriate antidiuretic secretion (SIADH).To assess the long-term efficacy of SR121463B in maintaining normal levels of serum sodium in patients with SIADH. To assess the safety and tolerability of SR121463B in patients with SIADH.
The double blind period is followed by an open label extension study with flexible doses of satavaptan.
Detailed Summary:
Sponsor: Sanofi
Current Primary Outcome: Serum sodium
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Urinary and serum osmolality, free water clearance, urinary volume, urinary electrolytes, weight, thirst,
- Safety: Physical examination, vital signs, adverse events, ECG, hematology, serum chemistry
Original Secondary Outcome: Same as current
Information By: Sanofi
Dates:
Date Received: December 12, 2005
Date Started: May 2004
Date Completion:
Last Updated: December 9, 2008
Last Verified: December 2008
