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| Sponsor: | Sanofi-Aventis |
|---|---|
| Information provided by: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00264927 |
Purpose
To assess the efficacy of SR121463B in correcting hyponatremia in patients with syndrome of inappropriate antidiuretic secretion (SIADH).To assess the long-term efficacy of SR121463B in maintaining normal levels of serum sodium in patients with SIADH. To assess the safety and tolerability of SR121463B in patients with SIADH.
The double blind period is followed by an open label extension study with flexible doses of satavaptan.
| Condition | Intervention | Phase |
|---|---|---|
|
Inappropriate ADH Syndrome Hyponatremia |
Drug: SR121463B |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo-Group, Multicenter Study Evaluating the Efficacy and Safety of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion |
| Enrollment: | 77 |
| Study Start Date: | May 2004 |
| Study Completion Date: | September 2007 |
| Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, New Jersey | |
| Sanofi-Aventis Administrative Office | |
| Bridgewater, New Jersey, United States, 08807 | |
| Belgium | |
| Sanofi-Aventis Administrative Office | |
| Diegem, Belgium | |
| Brazil | |
| Sanofi-Aventis Administrative Office | |
| Sao Paulo, Brazil | |
| Canada | |
| Sanofi-Aventis Administrative Office | |
| Laval, Canada | |
| Croatia | |
| Sanofi-Aventis Administrative Office | |
| Zagreb, Croatia | |
| Germany | |
| Sanofi-Aventis Administrative Office | |
| Berlin, Germany | |
| Hong Kong | |
| Sanofi-Aventis Administrative Office | |
| Causeway Bay, Hong Kong | |
| Hungary | |
| Sanofi-Aventis Administrative Office | |
| Budapest, Hungary | |
| Netherlands | |
| Sanofi-Aventis Administrative Office | |
| Gouda, Netherlands | |
| Portugal | |
| Sanofi-Aventis Administrative Office | |
| Porto Salvo, Portugal | |
| Spain | |
| Sanofi-Aventis Administrative Office | |
| Barcelona, Spain | |
| Study Director: | ICD CSD | Sanofi-Aventis |
More Information
| Responsible Party: | ICD Study Director, sanofi-aventis |
| ClinicalTrials.gov Identifier: | NCT00264927 History of Changes |
| Other Study ID Numbers: | EFC4489 |
| Study First Received: | December 12, 2005 |
| Last Updated: | December 9, 2008 |
| Health Authority: | United States: Food and Drug Administration |
|
Inappropriate ADH Syndrome Hyponatremia |
|
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 |