NCT00264914

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Inappropriate ADH Syndrome
• Hyponatremia

Interventions

Type	Name	Description
DRUG	SR121463B

Timeline

• Start date: 2005-07-01
• Primary completion: 2007-08-01
• Completion: 2007-08-01
• First posted: 2005-12-13
• Last updated: 2009-01-21

Locations

11 sites across 11 countries: United States, Australia, Belgium, Brazil, Canada, France, Germany, Hong Kong, Hungary, Russia, Switzerland