Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2025-12-25 @ 2:16 PM
Study NCT ID:
NCT00501566
Status:
COMPLETED
Last Update Posted:
2007-07-16
First Post:
2007-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Satavaptan Dose-Ranging Study in Normonatraemic Patients With Cirrhotic Ascites
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001201', 'term': 'Ascites'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}]}, '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': 148}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-07', 'completionDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-07-13', 'studyFirstSubmitDate': '2007-07-13', 'studyFirstSubmitQcDate': '2007-07-13', 'lastUpdatePostDateStruct': {'date': '2007-07-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in body weight', 'timeFrame': 'within 14 days'}], 'secondaryOutcomes': [{'measure': 'Abdominal girth and discomfort', 'timeFrame': '14 days'}, {'measure': 'Paracentesis', 'timeFrame': '14 days'}, {'measure': 'Quality of life', 'timeFrame': '14 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cirrhotic ascites'], 'conditions': ['Ascites', 'Liver Cirrhosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.sanofi-aventis.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The primary objective is to determine the optimal dose or range of doses of SR121463B for the treatment of ascites when used concomitantly with a standard dose regimen of spironolactone and furosemide.\n\nThe secondary objective is to determine the tolerability of different fixed doses of SR121463B over a 14 day treatment period in cirrhotic ascites.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Cirrhosis of the liver confirmed by ultrasound, endoscopic examination or biochemical evidence\n* Moderate or tense ascites\n* Serum sodium of \\>130 mmol/l.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT00501566', 'acronym': 'Normo~CAT', 'briefTitle': 'Satavaptan Dose-Ranging Study in Normonatraemic Patients With Cirrhotic Ascites', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'SR121463B in Cirrhotic Ascites Treatment With Normonatraemia: A Placebo-Controlled, Dose-Comparison Study', 'orgStudyIdInfo': {'id': 'DFI5563'}, 'secondaryIdInfos': [{'id': 'SR121463'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'satavaptan (SR121463B)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Cove', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Sanofi-Aventis Administrative Office'}, {'city': 'Diegem', 'country': 'Belgium', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 50.89727, 'lon': 4.43354}}, {'city': 'Laval', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 45.56995, 'lon': -73.692}}, {'city': 'Zagreb', 'country': 'Croatia', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'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}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}}}}