Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-25 @ 7:43 PM
Study NCT ID:
NCT00029835
Status:
COMPLETED
Last Update Posted:
2009-04-20
First Post:
2002-01-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Obese Patients With Untreated Dyslipidemias
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'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': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic 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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1033}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2003-11', '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': '2003-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in body weight at 1 year.'}], 'secondaryOutcomes': [{'measure': 'Metabolic parameters'}]}, 'conditionsModule': {'keywords': ['Obesity'], 'conditions': ['Obesity', 'Dyslipidemia']}, 'referencesModule': {'references': [{'pmid': '16291982', 'type': 'RESULT', 'citation': 'Despres JP, Golay A, Sjostrom L; Rimonabant in Obesity-Lipids Study Group. Effects of rimonabant on metabolic risk factors in overweight patients with dyslipidemia. N Engl J Med. 2005 Nov 17;353(20):2121-34. doi: 10.1056/NEJMoa044537.'}]}, 'descriptionModule': {'briefSummary': 'To assess the effect on weight loss and weight maintenance over a period of one year when prescribed with a hypocaloric diet in obese patients with untreated dyslipidemia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* BMI must be greater than 27 and less than 40\n* Patients with untreated dyslipidemia\n* Stable weight (variation of less than 5 kg within 3 months prior to screening visit)'}, 'identificationModule': {'nctId': 'NCT00029835', 'acronym': 'RIO-Lipids', 'briefTitle': 'Obese Patients With Untreated Dyslipidemias', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dose, Multi-Center Study of Weight-Reducing Effect and Safety in Obese Patients With Untreated Dyslipidemias', 'orgStudyIdInfo': {'id': 'EFC4735'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Rimonabant (SR141716)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85201', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Clinic of Physicians and Surgeons, LTD', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Clinical Research Center, Inc.', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92618', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'Irvine Center for Clinical Research (ICCR)', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '90064', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Los Angeles Clinical Trials', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92705', 'city': 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