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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00032734
First received: March 29, 2002
Last updated: June 16, 2008
Last verified: June 2008
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:


Further study details as provided by Sanofi:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Study Director: ICD CSD Sanofi
  More Information

Additional Information:
No publications provided

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

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

Additional relevant MeSH terms:
Diabetes Insipidus
Hyponatremia
Inappropriate ADH Syndrome
Syndrome
Brain Diseases
Central Nervous System Diseases
Disease
Endocrine System Diseases
Hypothalamic Diseases
Kidney Diseases
Metabolic Diseases
Nervous System Diseases
Pathologic Processes
Pituitary Diseases
Urologic Diseases
Water-Electrolyte Imbalance
Arginine Vasopressin
Vasopressins
Antidiuretic Agents
Cardiovascular Agents
Coagulants
Hematologic Agents
Hemostatics
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on October 23, 2014