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

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

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

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.

Resource links provided by NLM:

Drug Information available for: Vasopressins Argipressin SR-121463B

U.S. FDA Resources

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

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

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

Keywords provided by Sanofi-Aventis:

Low Blood Sodium (Hyponatremia)
SIADH
Inappropriate ADH Syndrome

Additional relevant MeSH terms:

Inappropriate ADH Syndrome
Coagulants
Hyponatremia
Physiological Effects of Drugs
Hematologic Agents
Brain Diseases
Arginine Vasopressin
Pathologic Processes
Syndrome
Therapeutic Uses
Vasopressins
Vasoconstrictor Agents
Water-Electrolyte Imbalance

Hypothalamic Diseases
Disease
Metabolic Diseases
Pituitary Diseases
Nervous System Diseases
Endocrine System Diseases
Central Nervous System Diseases
Cardiovascular Agents
Pharmacologic Actions
Hemostatics
Natriuretic Agents
Antidiuretic Agents

ClinicalTrials.gov processed this record on November 30, 2009