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NCT00032734 Clinical Trial

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

Hyponatremia Clinical Trial

Official title:
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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00032734
Other study ID # DFI4488
Secondary ID SR121463LTS5066L
Status Completed
Phase Phase 2
First received March 29, 2002
Last updated June 16, 2008
Start date June 2001
Est. completion date July 2003

Study information
Verified date June 2008
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 35
Est. completion date July 2003
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility SIADH of any origin

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• satavaptan (SR121463B)

Locations
Country Name City State
Belgium Sanofi-aventis Administrative Office Diegem
France Sanofi-aventis Administrative Office Paris
Germany Sanofi-aventis Administrative Office Berlin
Hungary Sanofi-aventis Administrative Office Budapest

Sponsors (1)
Lead Sponsor Collaborator
Sanofi

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Hungary, 

Outcome
Type Measure Description Time frame Safety issue
Primary serum sodium concentration
Secondary safety assessment
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