Ignite Creation Date:
2025-12-25 @ 12:41 AM
Ignite Modification Date:
2025-12-25 @ 10:52 PM
Study NCT ID:
NCT00239967
Status:
COMPLETED
Last Update Posted:
2009-04-07
First Post:
2005-10-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An International Study of Rimonabant in Dyslipidemia With AtheroGenic Risk In Abdominally Obese Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': 803}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-04-06', 'studyFirstSubmitDate': '2005-10-13', 'studyFirstSubmitQcDate': '2005-10-13', 'lastUpdatePostDateStruct': {'date': '2009-04-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HDL cholesterol and TG plasma levels over a period of one year.'}], 'secondaryOutcomes': [{'measure': 'Cholesterol content of HDL2 and HDL3 subfractions,HDL particle size,ApoB,ApoA1,ApoCIII, FFA, indeces of LDL size,hs-CRP,adipokines, fasting glycemia and insulinemia, HbA1c),waist and weight measurements,visceral fat measured by CT scan'}]}, 'conditionsModule': {'keywords': ['dyslipidemia', 'obesity'], 'conditions': ['Dyslipidemia', 'Obesity']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effect of rimonabant 20 mg on HDL (high density lipoprotein) cholesterol and on TG (triglycerides) plasma levels over a period of one year when prescribed with a hypocaloric diet (600 kcal deficit per day) in abdominally obese patients with atherogenic dyslipidemia (low HDL and/or high TG plasma levels). The secondary objectives are to evaluate specific metabolic parameters, visceral fat (in selected sites), safety and tolerability of rimonabant 20 mg.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female patients aged \\>= 18 years\n* Waist circumference \\> 102 cm in men and \\> 88 cm in women\n* Dyslipidemia consisting of:\n* Triglyceridemia \\>= 1.5g/L (i.e. 1.69mmol/L) and ≤ 7.0g/L (i.e. 7.90mmol/L) AND/OR\n* HDL cholesterol \\< 50mg/dL (1.29mmol/L) in women, \\< 40mg/dL (1.04mmol/L) in men\n* If patient with type 2 diabetes are included they must be on a stable dose of oral antidiabetic medication (excluding glitazones) and should not be on insulin therapy\n* Written informed consent\n\nExclusion Criteria:\n\n* Weight change \\> 5 kg within 3 months prior to screening visit\n* Pregnancy or lactation, or women planning to become pregnant\n* Absence of medically approved contraceptive methods for females of childbearing potential\n* Presence of any other condition (e.g. geographic, social…) actual or anticipated, that the Investigator feels that would restrict or limit the subject's participation for the duration of the study.\n* Presence of any clinically significant endocrine disease (other than type 2 diabetes) according to the Investigator\n* History of severe depression that could be defined as depression which necessitated the patient to be hospitalized, or patients with 2 or more recurrent episodes of depression or a history of suicide attempt.\n* Presence or history of DSM-IV bulimia or anorexia nervosa- Positive test for hepatitis B surface antigen and/or hepatitis C antibody; Abnormal TSH level (TSH \\> ULN or \\< LLN ); Hemoglobin \\< 11g/dL and/or neutrophils \\> 1,500/mm3 and/or platelets \\< 100,000/mm3; Positive urine pregnancy test in females of childbearing potential.\n* Within 3 months prior to screening visit and between the screening and the inclusion visit:\n* Administration of anti obesity drugs (e.g., sibutramine, orlistat)\n* Administration of other drugs for weight reduction including herbal preparations (phentermine, amphetamines)\n* Thyroid preparations or thyroxine treatment (except in patients on replacement therapy on a stable dose)\n* If patients with type 2 diabetes are included they must be on a stable dose of oral antidiabetic medication for at least 3 months and should not be expected to receive insulin therapy within 12 months: Insulin, Glitazones\n* Any change in lipid lowering treatment (i.e. introduction of a new drug, change, cessation)- Administration of systemic long-acting corticosteroids- Prolonged use (more than 1 week) of systemic corticosteroids (or if daily dosage \\> 1000 µg equivalent beclomethasone\n* Prolonged administration (more than one week) of antidepressants (including bupropion)\n* Prolonged administration (more than one week) of neuroleptics."}, 'identificationModule': {'nctId': 'NCT00239967', 'acronym': 'ADAGIO-lipids', 'briefTitle': 'An International Study of Rimonabant in Dyslipidemia With AtheroGenic Risk In Abdominally Obese Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Randomized, Double-Blind, Two-Arm Placebo-Controlled, Parallel-Group, Multicenter Study of Rimonabant 20 mg Once Daily in the Treatment of Atherogenic Dyslipidemia in Abdominally Obese Patients', 'orgStudyIdInfo': {'id': 'EFC5823'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Rimonabant (SR141716)', 'type': 'DRUG'}, {'name': 'Placebo', 'type': 'DRUG'}]}, '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': 'Macquarie Park', 'country': 'Australia', 'facility': 'Sanofi-aventis Administrative Office', 'geoPoint': {'lat': -33.78105, 'lon': 151.12757}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Sanofi-aventis Administrative Office', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'Laval', 'country': 'Canada', 'facility': 'Sanofi-aventis Administrative Office', 'geoPoint': {'lat': 45.56995, 'lon': -73.692}}, {'city': 'Hørsholm', 'country': 'Denmark', 'facility': 'Sanofi-aventis Administrative Office', 'geoPoint': {'lat': 55.88098, 'lon': 12.50111}}, {'city': 'Causeway Bay', 'country': 'Hong Kong', 'facility': 'Sanofi-aventis Administrative Office', 'geoPoint': {'lat': 22.28189, 'lon': 114.18515}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Sanofi-aventis Administrative Office', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'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': 'Singapore', 'country': 'Singapore', 'facility': 'Sanofi-aventis Administrative Office', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'city': 'Midrand', 'country': 'South Africa', 'facility': 'Sanofi-aventis Administrative Office', 'geoPoint': {'lat': -25.976, 'lon': 28.118}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Sanofi-aventis Administrative Office', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Bromma', 'country': 'Sweden', 'facility': 'Sanofi-aventis Administrative Office', 'geoPoint': {'lat': 59.34, 'lon': 17.94}}, {'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Sanofi-aventis Administrative Office', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'ICD CSD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'ICD Study Director', 'oldOrganization': 'sanofi-aventis'}}}}