|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsored by: |
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. |
| 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: | 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 |
| Health Authority: | United States: Food and Drug Administration |
|
Low Blood Sodium (Hyponatremia) SIADH Inappropriate ADH Syndrome |
|
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 |
|
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 |
