Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2026-02-20 @ 6:06 PM
Study NCT ID:
NCT00576667
Status:
TERMINATED
Last Update Posted:
2016-05-18
First Post:
2007-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Efficacy and Safety Study of Rimonabant for Treatment of Nonalcoholic Steatohepatitis (NASH) in Patients Without Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Bulgaria', 'Canada']}, 'conditionBrowseModule': {'meshes': [{'id': 'D005234', 'term': 'Fatty Liver'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077285', 'term': 'Rimonabant'}], 'ancestors': [{'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010880', 'term': 'Piperidines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 165}}, 'statusModule': {'whyStopped': 'Company decision taken in light of demands by certain national health authorities', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'dispFirstSubmitDate': '2016-04-18', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-18', 'studyFirstSubmitDate': '2007-12-18', 'dispFirstSubmitQcDate': '2016-04-18', 'studyFirstSubmitQcDate': '2007-12-18', 'dispFirstPostDateStruct': {'date': '2016-05-18', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-05-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean change per year in Non-Alcoholic Fatty Liver Disease [NAFLD] Activity Score (NAS)', 'timeFrame': 'Baseline to 24 months'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in hepatic fibrosis score', 'timeFrame': 'Baseline to 24 months'}, {'measure': 'Change from baseline in serum hyaluronate (HA)', 'timeFrame': 'Baseline to 24 months'}, {'measure': 'Change from baseline in hepatic transaminases (AST/ALT)', 'timeFrame': 'Baseline to 24 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['NASH', 'chronic liver disease'], 'conditions': ['Fatty Liver']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effect of Rimonabant treatment on the histological features of Nonalcoholic Steatohepatitis (NASH).', 'detailedDescription': 'The total duration per patient will be approximately 28 months including a 24-month double-blind treatment period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with diagnosis of NASH\n\nExclusion Criteria:\n\n* Excessive alcohol use\n* Presence of diabetes mellitus\n* Other chronic liver disease\n* Previous or current hepatocellular carcinoma\n* Use of medication known to cause steatosis\n* Previous bariatric surgery\n* Pregnancy or breastfeeding\n* Presence of any severe medical or psychological condition that, in the opinion of the investigator, would compromise the patient's safe participation including uncontrolled serious psychiatric illness such a major depression within the last 2 years, and history of other severe psychiatric disorders.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT00576667', 'briefTitle': 'An Efficacy and Safety Study of Rimonabant for Treatment of Nonalcoholic Steatohepatitis (NASH) in Patients Without Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Double-blind, Randomized, Placebo-controlled, Parallel Group Study of Rimonabant 20 mg Daily for the Treatment of Non-diabetic Patients With Nonalcoholic Steatohepatitis (NASH)', 'orgStudyIdInfo': {'id': 'EFC10143'}, 'secondaryIdInfos': [{'id': '2007-003013-14', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rimonabant', 'description': 'Rimonabant 20 mg once daily.', 'interventionNames': ['Drug: Rimonabant']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo (for Rimonabant) once daily.', 'interventionNames': ['Drug: Placebo (for Rimonabant)']}], 'interventions': [{'name': 'Rimonabant', 'type': 'DRUG', 'otherNames': ['SR141716', 'Acomplia'], 'description': 'Tablet, oral administration', 'armGroupLabels': ['Rimonabant']}, {'name': 'Placebo (for Rimonabant)', 'type': 'DRUG', 'description': 'Tablet, oral administration', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08807', 'city': 'Bridgewater', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 40.60079, 'lon': -74.64815}}, {'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': 'São Paulo', 'country': 'Brazil', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'Santiago', 'country': 'Chile', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'city': 'Shanghai', 'country': 'China', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Bogotá', 'country': 'Colombia', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}, {'city': 'Zagreb', 'country': 'Croatia', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'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': 'Kuala Lumpur', 'country': 'Malaysia', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}, {'city': 'México', 'country': 'Mexico', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 31.00435, 'lon': -108.15213}}, {'city': 'Makati City', 'country': 'Philippines', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 14.55027, 'lon': 121.03269}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Porto Salvo', 'country': 'Portugal', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 38.72293, 'lon': -9.30473}}, {'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}, {'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}}, {'city': 'Geneva', 'country': 'Switzerland', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}, {'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Guildford', 'state': 'Surrey', 'country': 'United Kingdom', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 51.23536, 'lon': -0.57427}}], 'overallOfficials': [{'name': 'ICD CSD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}