NCT00032734

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

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Escalation, Multicenter Study Evaluating the Efficacy and Safety of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is designed to assess the efficacy of an investigational drug called SR121463B (vasopressin receptor antagonist) in the treatment of low levels of sodium in the blood associated with the Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH). This double blind period study is followed by 2 open label extension studies with flexible doses of satavaptan.

Detailed description

This is a multicenter worldwide study with 32 participating men and women aimed to figure out whether SR121463B is safe and effective in correcting low levels of sodium in blood in subjects with SIADH. The participation in the study lasts up to 34 days. After screening, during the first part of the study (maximum 5 days), the subjects receive either capsules of SR121463B or a matching placebo. During the second part of the study (23 days), subjects receive either capsules of SR121463B or no treatment. The subjects will be assessed by physical examinations, electrocardiograms, blood samplings, and urine collections. Women of childbearing potential must have an approved method of contraception.

Conditions

• Syndrome of Inappropriate ADH (SIADH) Secretion
• Hyponatremia

Interventions

Type	Name	Description
DRUG	satavaptan (SR121463B)

Timeline

• Start date: 2001-06-01
• Completion: 2003-07-01
• First posted: 2002-04-01
• Last updated: 2008-06-17

Locations

4 sites across 4 countries: Belgium, France, Germany, Hungary