Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-29 @ 10:05 AM
Study NCT ID:
NCT00032734
Status:
COMPLETED
Last Update Posted:
2008-06-17
First Post:
2002-03-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D007177', 'term': 'Inappropriate ADH Syndrome'}, {'id': 'D007010', 'term': 'Hyponatremia'}], 'ancestors': [{'id': 'D010900', 'term': 'Pituitary Diseases'}, {'id': 'D007027', 'term': 'Hypothalamic Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014883', 'term': 'Water-Electrolyte Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C103281', 'term': 'satavaptan'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-06'}, 'statusVerifiedDate': '2008-06', 'completionDateStruct': {'date': '2003-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-06-16', 'studyFirstSubmitDate': '2002-03-29', 'studyFirstSubmitQcDate': '2002-03-29', 'lastUpdatePostDateStruct': {'date': '2008-06-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'serum sodium concentration'}], 'secondaryOutcomes': [{'measure': 'safety assessment'}]}, 'conditionsModule': {'keywords': ['Low Blood Sodium (Hyponatremia)', 'SIADH', 'Inappropriate ADH Syndrome'], 'conditions': ['Syndrome of Inappropriate ADH (SIADH) Secretion', 'Hyponatremia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.centerwatch.com', 'label': 'Related Info'}, {'url': 'http://www.sanofi-aventis.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': '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).\n\nThis double blind period study is followed by 2 open label extension studies with flexible doses of satavaptan.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'SIADH of any origin'}, 'identificationModule': {'nctId': 'NCT00032734', 'briefTitle': 'Efficacy of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'DFI4488'}, 'secondaryIdInfos': [{'id': 'SR121463'}, {'id': 'LTS5066'}, {'id': 'LTS10208'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'satavaptan (SR121463B)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Diegem', 'country': 'Belgium', 'facility': 'Sanofi-aventis Administrative Office', 'geoPoint': {'lat': 50.89727, 'lon': 4.43354}}, {'city': 'Paris', 'country': 'France', 'facility': 'Sanofi-aventis Administrative Office', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Sanofi-aventis Administrative Office', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Budapest', 'country': 'Hungary', 'facility': 'Sanofi-aventis Administrative Office', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}], 'overallOfficials': [{'name': 'ICD CSD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'ICD Study Director', 'oldOrganization': 'sanofi-aventis'}}}}