Clinical Trial: Safety and Efficacy of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: An Open-Label, Multicenter Study Evaluating the Long-Term Safety and Efficacy of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion

Brief Summary:

To determine the long-term safety and tolerability of SR121463B 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.

Long term safety is evaluated further in an open label extension study with flexible doses of satavaptan.

Detailed Summary:
Sponsor: Sanofi

Current Primary Outcome: Safety : Physical examination, vital signs, adverse events, electrocardiogram, hematology, serum chemistry

Original Primary Outcome: Same as current

Current Secondary Outcome: Serum sodium

Original Secondary Outcome: Same as current

Information By: Sanofi

Dates:
Date Received: December 12, 2005
Date Started: July 2005
Date Completion:
Last Updated: January 19, 2009
Last Verified: January 2009