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

Purpose

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.

Condition	Intervention	Phase
Syndrome of Inappropriate ADH (SIADH) Secretion Hyponatremia	Drug: satavaptan (SR121463B)	Phase II

ChemIDplus related topics:

Argipressin Vasopressins

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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.

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

serum sodium concentration

Secondary Outcome Measures:

safety assessment

Enrollment:	35
Study Start Date:	June 2001
Study Completion Date:	July 2003

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

SIADH of any origin

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00032734

Locations


Belgium
	Sanofi-aventis Administrative Office
	Diegem, Belgium

France
	Sanofi-aventis Administrative Office
	Paris, France

Germany
	Sanofi-aventis Administrative Office
	Berlin, Germany

Hungary
	Sanofi-aventis Administrative Office
	Budapest, Hungary

Sponsors and Collaborators

Sanofi-Aventis

Investigators


Study Director:	ICD CSD	Sanofi-Aventis

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	sanofi-aventis ( ICD Study Director )
Study ID Numbers:	DFI4488, SR121463, LTS5066, LTS10208
First Received:	March 29, 2002
Last Updated:	June 16, 2008
ClinicalTrials.gov Identifier:	NCT00032734
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

Low Blood Sodium (Hyponatremia)

SIADH

Inappropriate ADH Syndrome

Study placed in the following topic categories:

Inappropriate ADH Syndrome

Hypothalamic Diseases

Dilutional hyponatremia

Metabolic Diseases

Pituitary Diseases

Hyponatremia

Central Nervous System Diseases

Endocrine System Diseases

Brain Diseases

Arginine Vasopressin

Vasopressins

Water-Electrolyte Imbalance

Endocrinopathy

Metabolic disorder

Additional relevant MeSH terms:

Disease

Coagulants

Hematologic Agents

Nervous System Diseases

Physiological Effects of Drugs

Cardiovascular Agents

Pharmacologic Actions

Hemostatics

Pathologic Processes

Natriuretic Agents

Syndrome

Therapeutic Uses

Vasoconstrictor Agents

Antidiuretic Agents

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00032734