Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2026-01-01 @ 4:19 PM
Study NCT ID:
NCT00653835
Status:
COMPLETED
Last Update Posted:
2024-08-15
First Post:
2008-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ezetimibe Plus Simvastatin Versus Simvastatin in Untreated Subjects With High Cholesterol (P03435)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}, {'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069499', 'term': 'Ezetimibe, Simvastatin Drug Combination'}, {'id': 'D000069438', 'term': 'Ezetimibe'}, {'id': 'D019821', 'term': 'Simvastatin'}], 'ancestors': [{'id': 'D008148', 'term': 'Lovastatin'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001384', 'term': 'Azetidines'}, {'id': 'D001385', 'term': 'Azetines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 153}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2004-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-13', 'studyFirstSubmitDate': '2008-04-01', 'studyFirstSubmitQcDate': '2008-04-04', 'lastUpdatePostDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-04-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent change in LDL-C from baseline to endpoint.', 'timeFrame': '6 weeks'}], 'secondaryOutcomes': [{'measure': 'Percent of subjects who achieve LDL-C ESC goal (ie, <3 mmol/L [115 mg/dL]) at endpoint.', 'timeFrame': '6 weeks'}, {'measure': 'Percent change from baseline to endpoint in total cholesterol, HDL-C and triglycerides.', 'timeFrame': '6 weeks'}, {'measure': 'Safety: adverse events, laboratory test results, vital signs.', 'timeFrame': 'Throughout study'}]}, 'conditionsModule': {'conditions': ['Hypercholesterolaemia', 'Atherosclerosis']}, 'referencesModule': {'references': [{'pmid': '16893434', 'type': 'RESULT', 'citation': 'Patel JV, Hughes EA. Efficacy, safety and LDL-C goal attainment of ezetimibe 10 mg-simvastatin 20 mg vs. placebo-simvastatin 20 mg in UK-based adults with coronary heart disease and hypercholesterolaemia. Int J Clin Pract. 2006 Aug;60(8):914-21. doi: 10.1111/j.1742-1241.2006.01023.x.'}]}, 'descriptionModule': {'briefSummary': 'This study will assess whether co-administration of ezetimibe 10 mg with simvastatin 20 mg will be more effective than treatment with simvastatin 20 mg alone in reducing LDL-C concentrations when administered for 6 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>=18 years and \\<= 75 years of age\n* LDL-C concentration \\>= 3.3 mmol/L (130 mg/dL) to \\<= 4.9 mmol/L (190 mg/dL) at baseline.\n* Triglyceride concentration \\<3.99 mmol/L (350 mg/dL) at baseline.\n* Documented coronary heart disease (CHD), which will include one or more of the following features: documented stable angina (with evidence of ischemia on exercise testing); history of MI; history of PCI (primarily PTCA with or without stent replacement); symptomatic peripheral vascular disease; documented history of atherothrombotic cerebrovascular disease; and/or documented history of non-Q wave MI.\n* Stable weight history for at least 4 weeks prior to entry into study at baseline.\n* Female subjects of childbearing potential must be using an acceptable method of birth control or be surgically sterilized.\n\nExclusion Criteria:\n\n* Body mass index (BMI) \\>=35 kg/m\\^2 at baseline.\n* Subjects whose liver transaminases (ALT, AST) are \\>1.5 times the upper limit of normal and with active liver diseases at baseline.\n* Subjects with evidence of current myopathy (including subjects with CK\\>1.5 times above the upper limit of normal) at baseline.\n* Subjects with clinical laboratory tests (CBC, blood chemistries, urinalysis) outside the normal range that are clinically acceptable to the investigator at baseline.\n* Subjects with Type II diabetes mellitus who are poorly controlled (HbA1c\\>9%) or newly diagnosed (within 3 months) or who have had a change in anti-diabetic therapy within 3 months of baseline.\n* Subjects with Type I diabetes mellitus who have not been on a stable insulin regimen for 3 months prior to baseline, or who have a recent history of repeated hypoglycaemia or unstable glycaemic control.\n* Subjects who have known hypersensitivity to HMG-CoA reductase inhibitors.\n* Female subjects who consume \\>14 units and male subjects who consume \\>21 units of alcohol per week.\n* Female subjects who are pregnant or breast feeding.\n* Subjects who have not observed the designated washout periods for any of the prohibited medications.'}, 'identificationModule': {'nctId': 'NCT00653835', 'briefTitle': 'Ezetimibe Plus Simvastatin Versus Simvastatin in Untreated Subjects With High Cholesterol (P03435)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organon and Co'}, 'officialTitle': 'SCH 58235: A Multicenter, Randomised, Parallel Groups, Placebo-Controlled Study Comparing The Efficacy, Safety, and Tolerability Of The Daily Co-Administration of Ezetimibe 10 mg With Simvastatin 20 mg vs Ezetimibe Placebo With Simvastatin 20 mg in Untreated Subjects With Primary Hypercholesterolaemia And Coronary Heart Disease (Protocol P03435)', 'orgStudyIdInfo': {'id': 'P03435'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ezetimibe + Simvastatin', 'interventionNames': ['Drug: Ezetimibe + Simvastatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Simvastatin', 'interventionNames': ['Drug: Simvastatin']}], 'interventions': [{'name': 'Ezetimibe + Simvastatin', 'type': 'DRUG', 'otherNames': ['SCH 58235', 'Zetia', 'Zocor'], 'description': 'oral tablets: ezetimibe 10 mg + simvastatin 20 mg once daily for 6 weeks', 'armGroupLabels': ['Ezetimibe + Simvastatin']}, {'name': 'Simvastatin', 'type': 'DRUG', 'otherNames': ['Zocor'], 'description': 'oral tablets: simvastatin 20 mg + ezetimibe placebo once daily for 6 weeks', 'armGroupLabels': ['Simvastatin']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Organon and Co', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}