Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2025-12-27 @ 1:13 AM
Study NCT ID:
NCT03882892
Status:
COMPLETED
Last Update Posted:
2024-05-10
First Post:
2019-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-Term Safety and Tolerability of Ezetimibe (SCH 58235, MK-0653) With Atovastatin (P02154, MK-0653-017)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069438', 'term': 'Ezetimibe'}], 'ancestors': [{'id': 'D001384', 'term': 'Azetidines'}, {'id': 'D001385', 'term': 'Azetines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2002-08-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-08', 'studyFirstSubmitDate': '2019-03-19', 'studyFirstSubmitQcDate': '2019-03-19', 'lastUpdatePostDateStruct': {'date': '2024-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2002-08-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Experiencing ≥1 Adverse Event (AE)', 'timeFrame': 'Up to 12 months'}, {'measure': 'Percentage of Participants Discontinuing from Study Treatment due to an Adverse Event (AE)', 'timeFrame': 'Up to 12 months'}], 'secondaryOutcomes': [{'measure': 'Mean Percent Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)', 'timeFrame': 'Baseline and 1.5, 3, 6, 9, and 12 months'}, {'measure': 'Mean Percent Change from Baseline in High-Density Lipoprotein Cholesterol (HDL-C)', 'timeFrame': 'Baseline and 1.5, 3, 6, 9, and 12 months'}, {'measure': 'Mean Percent Change from Baseline in Triglyceride Levels', 'timeFrame': 'Baseline and 1.5, 3, 6, 9, and 12 months'}, {'measure': 'Mean Percent Change from Baseline in Total Cholesterol (TC)', 'timeFrame': 'Baseline and 1.5, 3, 6, 9, and 12 months'}, {'measure': 'Mean Percent Change from Baseline in Calculated Low-Density Lipoprotein Cholesterol (LDL-C)', 'timeFrame': 'Baseline and 1.5, 3, 6, 9, and 12 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypercholesterolemia']}, 'referencesModule': {'references': [{'pmid': '15311720', 'type': 'RESULT', 'citation': 'Ballantyne CM, Lipka LJ, Sager PT, Strony J, Alizadeh J, Suresh R, Veltri EP. Long-term safety and tolerability profile of ezetimibe and atorvastatin coadministration therapy in patients with primary hypercholesterolaemia. Int J Clin Pract. 2004 Jul;58(7):653-8. doi: 10.1111/j.1368-5031.2004.00278.x.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the long-term safety and tolerability of ezetimibe (SCH 58235) 10 mg once daily or placebo in combination with atorvastatin (10 to 80 mg/day) for up to 12 consecutive months in participants with primary hypercholesterolemia.', 'detailedDescription': 'This study is a long-term extension study of the protocol P00692 parent study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '86 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has successfully completed the 12-week double-blind, efficacy and safety parent study (P00692).\n* If female, has a negative pregnancy test prior to study entry and, if of childbearing potential, agrees to practice an effective barrier method of birth control for the duration of the study and for 30 days after the last statin dose.\n* If postmenopausal female receiving hormone therapy, a stable estrogen (ERT), estrogen/progestin (HRT) or raloxifene regimen must be maintained during the study period.\n* Is willing to continue to follow their prescribed National Cholesterol Education Program (NCEP) Step 1 diet for the duration of the study.\n\nExclusion Criteria:\n\n* Has discontinued from the parent study (P00692) prior to study completion.\n* Is in a situation, or has any condition which, in the opinion of the investigator may interfere with optimal participation.\n* Is a pregnant or lactating female.\n* Is human immunodeficiency virus (HIV) positive.'}, 'identificationModule': {'nctId': 'NCT03882892', 'briefTitle': 'Long-Term Safety and Tolerability of Ezetimibe (SCH 58235, MK-0653) With Atovastatin (P02154, MK-0653-017)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organon and Co'}, 'officialTitle': 'Long-Term, Safety and Tolerability Study of SCH 58235 or Placebo in Addition to Atorvastatin in Subjects With Primary Hypercholesterolemia', 'orgStudyIdInfo': {'id': 'P02154'}, 'secondaryIdInfos': [{'id': 'MK-0653-017', 'type': 'OTHER', 'domain': 'Merck Protocol Number'}, {'id': 'P02154', 'type': 'OTHER', 'domain': 'Schering-Plough Protocol Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo + Atorvastatin', 'description': 'Participants who received placebo in the parent study (P00692) receive placebo (blinded) + atorvastatin (10 mg/day; open-label) in this study.', 'interventionNames': ['Drug: Atovastatin', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Ezetimibe + Atorvastatin', 'description': 'Participants who received ezetimibe + atorvastatin, or atorvastatin alone, in the parent study (P00692) receive ezetimibe (blinded) + atorvastatin (10 mg/day; open-label) in this study.', 'interventionNames': ['Drug: Ezetimibe', 'Drug: Atovastatin']}], 'interventions': [{'name': 'Ezetimibe', 'type': 'DRUG', 'otherNames': ['SCH 58235'], 'description': 'Ezetimibe 10 mg tablets', 'armGroupLabels': ['Ezetimibe + Atorvastatin']}, {'name': 'Atovastatin', 'type': 'DRUG', 'description': 'Atorvastatin 10, 20, and 40 mg tablets at a daily dose of 10 to 80 mg', 'armGroupLabels': ['Ezetimibe + Atorvastatin', 'Placebo + Atorvastatin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo tablets matched to ezetimibe', 'armGroupLabels': ['Placebo + Atorvastatin']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Organon and Co', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}