Efficacy of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion - Tabular View

Tracking Information

First Received Date ^ICMJE

March 29, 2002

Last Updated Date

June 16, 2008

Start Date ^ICMJE

June 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

serum sodium concentration

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00032734 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

safety assessment

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

Brief 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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Syndrome of Inappropriate ADH (SIADH) Secretion
Hyponatremia

Intervention ^ICMJE

Drug: satavaptan (SR121463B)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2003

Primary Completion Date

Eligibility Criteria ^ICMJE

SIADH of any origin

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Belgium, France, Germany, Hungary

Administrative Information

NCT ID ^ICMJE

NCT00032734

Responsible Party

ICD Study Director, sanofi-aventis

Study ID Numbers ^ICMJE

DFI4488, SR121463, LTS5066, LTS10208

Study Sponsor ^ICMJE

Sanofi-Aventis

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

ICD CSD

Sanofi-Aventis

Information Provided By

Sanofi-Aventis

Verification Date

June 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP