Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2025-12-29 @ 3:55 AM
Study NCT ID:
NCT00029861
Status:
COMPLETED
Last Update Posted:
2009-04-20
First Post:
2002-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Obese Patients With or Without Comorbidities (RIO-North America)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001836', 'term': 'Body Weight Changes'}]}, '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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3045}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2004-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-04-17', 'studyFirstSubmitDate': '2002-01-23', 'studyFirstSubmitQcDate': '2002-01-23', 'lastUpdatePostDateStruct': {'date': '2009-04-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-01-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in body weight'}], 'secondaryOutcomes': [{'measure': 'Metabolic parameters'}]}, 'conditionsModule': {'keywords': ['Weight Loss', 'Obesity', 'Weight Reduction', 'Overweight'], 'conditions': ['Obesity', 'Weight Loss']}, 'referencesModule': {'references': [{'pmid': '16478899', 'type': 'RESULT', 'citation': 'Pi-Sunyer FX, Aronne LJ, Heshmati HM, Devin J, Rosenstock J; RIO-North America Study Group. Effect of rimonabant, a cannabinoid-1 receptor blocker, on weight and cardiometabolic risk factors in overweight or obese patients: RIO-North America: a randomized controlled trial. JAMA. 2006 Feb 15;295(7):761-75. doi: 10.1001/jama.295.7.761.'}]}, 'descriptionModule': {'briefSummary': 'To assess the effects of weight loss and weight maintenance over a period of two years when prescribed with a hypocaloric diet in obese patients with or without comorbidities'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* Stable weight (variation of less than 5 kg within 3 months prior to screening visit)\n* BMI (Body Mass Index) of 30 or greater in patients with or without comorbidities, or BMI greater than 27 in patients with treated or untreated hypertension and/or treated or untreated dyslipidemia'}, 'identificationModule': {'nctId': 'NCT00029861', 'briefTitle': 'Obese Patients With or Without Comorbidities (RIO-North America)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dose, Multicenter Study of Weight-Reducing and Prevention of Weight Regain Effects and Safety in Obese Patients With or Without Comorbidities', 'orgStudyIdInfo': {'id': 'EFC4743'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Rimonabant (SR141716)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Radiant Research', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Radiant Research', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '94520', 'city': 'Concord', 'state': 'California', 'country': 'United States', 'facility': 'East Bay Clinical Trial Center', 'geoPoint': {'lat': 37.97798, 'lon': -122.03107}}, {'zip': '92121', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Feighner Research Institute', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92130', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Scripps Clinic', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94598', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Diablo Clinical Research, Inc.', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'zip': '80130', 'city': 'Highlands Ranch', 'state': 'Colorado', 'country': 'United States', 'facility': 'Ranch View Family Medicine', 'geoPoint': {'lat': 39.55388, 'lon': -104.96943}}, {'zip': '80501', 'city': 'Longmont', 'state': 'Colorado', 'country': 'United States', 'facility': 'Longmont Medical Research Network', 'geoPoint': {'lat': 40.16721, 'lon': -105.10193}}, {'zip': '19713', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Health Core, Inc.', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '20037', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'George Washington Univ. 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