|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| 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: | 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. |
| Enrollment: | 35 |
| Study Start Date: | June 2001 |
| Study Completion Date: | July 2003 |
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 |
SIADH of any origin
Contacts and 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 | |
| Study Director: | ICD CSD | Sanofi-Aventis |
More Information
| 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 |
|
Low Blood Sodium (Hyponatremia) SIADH Inappropriate ADH Syndrome |
|
Diabetes Insipidus Hyponatremia Inappropriate ADH Syndrome Kidney Diseases Urologic Diseases Pituitary Diseases Endocrine System Diseases Water-Electrolyte Imbalance Metabolic Diseases Hypothalamic Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Arginine Vasopressin Vasopressins Hemostatics Coagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Vasoconstrictor Agents Cardiovascular Agents Antidiuretic Agents Natriuretic Agents Physiological Effects of Drugs |
