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| Descriptive Information Fields | |||||
| Brief Title † | Efficacy of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion | ||||
| 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. | ||||
| 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. |
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| 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. |
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| Study Phase | Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Primary Outcome Measure † | serum sodium concentration | ||||
| Secondary Outcome Measure † | safety assessment | ||||
| Condition † | Syndrome of Inappropriate ADH (SIADH) Secretion Hyponatremia |
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| Intervention † | Drug: satavaptan (SR121463B) | ||||
| MEDLINE PMIDs | |||||
| Links | Related Info  Related Info |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 35 | ||||
| Start Date † | June 2001 | ||||
| Completion Date | July 2003 | ||||
| Eligibility Criteria † | SIADH of any origin |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | Belgium, France, Germany, Hungary | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00032734 | ||||
| Organization ID | DFI4488 | ||||
| Secondary IDs †† | SR121463, LTS5066, LTS10208 | ||||
| Study Sponsor † | Sanofi-Aventis | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | Sanofi-Aventis | ||||
| Verification Date | June 2008 | ||||
| First Received Date † | March 29, 2002 | ||||
| Last Updated Date | June 16, 2008 | ||||
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