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

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ClinicalTrials.gov Identifier: NCT00032734
Recruitment Status : Completed
First Posted : April 1, 2002
Last Update Posted : June 17, 2008
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Syndrome of Inappropriate ADH (SIADH) Secretion Hyponatremia Drug: satavaptan (SR121463B) Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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.
Study Start Date : June 2001
Study Completion Date : July 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. serum sodium concentration

Secondary Outcome Measures :
  1. safety assessment

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
SIADH of any origin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00032734

Sanofi-aventis Administrative Office
Diegem, Belgium
Sanofi-aventis Administrative Office
Paris, France
Sanofi-aventis Administrative Office
Berlin, Germany
Sanofi-aventis Administrative Office
Budapest, Hungary
Sponsors and Collaborators
Study Director: ICD CSD Sanofi

Additional Information:
Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00032734     History of Changes
Other Study ID Numbers: DFI4488
First Posted: April 1, 2002    Key Record Dates
Last Update Posted: June 17, 2008
Last Verified: June 2008

Keywords provided by Sanofi:
Low Blood Sodium (Hyponatremia)
Inappropriate ADH Syndrome

Additional relevant MeSH terms:
Inappropriate ADH Syndrome
Diabetes Insipidus
Pathologic Processes
Water-Electrolyte Imbalance
Metabolic Diseases
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases
Arginine Vasopressin
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antidiuretic Hormone Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Vasoconstrictor Agents
Antidiuretic Agents