Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-27 @ 4:26 AM
Study NCT ID:
NCT00384293
Status:
TERMINATED
Last Update Posted:
2015-09-30
First Post:
2006-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Carotid IMT (Intima Media Thickening) Study (0524A-041)(TERMINATED)
Sponsor:
Organization:
Raw JSON
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Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'After a detailed review of pooled carotid IMT data from contemporary studies, the Steering Committee recommended that Merck prematurely stop the study; as designed, the study was significantly underpowered. Efficacy analyses were not performed.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'MK0524A Active Run-In Period', 'description': 'Patients who received MK0524A during active run-in (Visit 2). Per protocol, patients were scheduled to receive MK0524A 1g orally once daily for 4 weeks. 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218, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 937, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'seriousEvents': [{'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 937, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 937, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 0}, 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'numAtRisk': 214, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 937, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 937, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Intervertebral disc 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'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Lung cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 937, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Papillary thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 937, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 937, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 937, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 937, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 937, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Arterial stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 937, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 218, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Mean Carotid Intima Media Thickness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MK0524A Active Run-In Period', 'description': 'Patients who received MK0524A during active run-in (Visit 2). Per protocol, patients were scheduled to receive MK0524A 1g orally once daily for 4 weeks. The MK0524A dose was then increased to 2g (2x 1g tablets), once daily, at Visit 3 for an additional 4 weeks prior to randomization.'}, {'id': 'OG001', 'title': 'MK0524A, 2 g (Postrandomization Period)', 'description': 'Patients who were randomized to MK0524A, 2 g (oral administration) once daily.'}, {'id': 'OG002', 'title': 'Placebo (Postrandomization Period)', 'description': 'Patients who were randomized to placebo'}], 'timeFrame': 'after 96 weeks of postrandomization treatment', 'description': 'change in mean carotid intima media thickness defined as a composite measure of the left and right common, bulb, and internal carotid artery.', 'reportingStatus': 'POSTED', 'populationDescription': 'study prematurely terminated, no efficacy analyses were performed'}, {'type': 'SECONDARY', 'title': 'Change in Lipid Profile', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MK0524A Active Run-In Period', 'description': 'Patients who received MK0524A during active run-in (Visit 2). Per protocol, patients were scheduled to receive MK0524A 1g orally once daily for 4 weeks. The MK0524A dose was then increased to 2g (2x 1g tablets), once daily, at Visit 3 for an additional 4 weeks prior to randomization.'}, {'id': 'OG001', 'title': 'MK0524A, 2 g (Postrandomization Period)', 'description': 'Patients who were randomized to MK0524A, 2 g (oral administration) once daily.'}, {'id': 'OG002', 'title': 'Placebo (Postrandomization Period)', 'description': 'Patients who were randomized to placebo'}], 'timeFrame': 'after 96 weeks of postrandomization treatment', 'reportingStatus': 'POSTED', 'populationDescription': 'study prematurely terminated, no efficacy analyses were performed'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MK0524A Active Run-In Period', 'description': 'Patients who received MK0524A during active run-in (Visit 2). Per protocol, patients were scheduled to receive MK0524A 1g orally once daily for 4 weeks. The MK0524A dose was then increased to 2g (2x 1g tablets), once daily, at Visit 3 for an additional 4 weeks prior to randomization.'}, {'id': 'FG001', 'title': 'MK0524A, 2 g (Postrandomization Period)', 'description': 'Patients who were randomized to MK0524A, 2 g (oral administration) once daily.'}, {'id': 'FG002', 'title': 'Placebo (Postrandomization Period)', 'description': 'Patients who were randomized to placebo'}], 'periods': [{'title': 'MK0524A Active Run-In, Pre-randomization', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '937'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Entered Active run-in, MK0524A 1 g', 'achievements': [{'comment': 'Entered active run-in period and received MK0524A 1 g', 'groupId': 'FG000', 'numSubjects': '937'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'MK0524A Dose Increased to 2 g', 'achievements': [{'comment': 'MK0524A dose increased to 2 g in active run-in period', 'groupId': 'FG000', 'numSubjects': '813'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '433'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '504'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '120'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Not cIMT eligible at Visit 3', 'reasons': [{'groupId': 'FG000', 'numSubjects': '340'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Trial Termination', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Certified Sonographer Not Available', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Patient Unable to Complete cIMT Scan', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Post-randomization Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '214'}, {'groupId': 'FG002', 'numSubjects': '219'}]}, {'type': 'Received ≥1 Dose of MK0524A Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Received at least one dose of randomized study drug (All Patients as Treated Population)', 'groupId': 'FG001', 'numSubjects': '214'}, {'groupId': 'FG002', 'numSubjects': '218'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '214'}, {'groupId': 'FG002', 'numSubjects': '219'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Trial Termination', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '180'}, {'groupId': 'FG002', 'numSubjects': '204'}]}, {'type': 'Patient Randomized in Error', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'There was an MK0524A active run-in period prior to randomization. Per protocol, patients were scheduled to receive MK0524A 1g orally once daily for 4 weeks. The MK0524A dose was then increased to 2g (2x 1g tablets), once daily, for an additional 4 weeks prior to randomization.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'BG000'}, {'value': '218', 'groupId': 'BG001'}, {'value': '432', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'MK0524A, 2 g (Postrandomization Period)', 'description': 'Patients who were randomized to MK0524A, 2 g (oral administration) once daily.'}, {'id': 'BG001', 'title': 'Placebo (Postrandomization Period)', 'description': 'Patients who were randomized to placebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.1', 'spread': '8.94', 'groupId': 'BG000'}, {'value': '54.5', 'spread': '8.22', 'groupId': 'BG001'}, {'value': '53.8', 'spread': '8.60', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '158', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '138', 'groupId': 'BG000'}, {'value': '136', 'groupId': 'BG001'}, {'value': '274', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 937}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-28', 'studyFirstSubmitDate': '2006-10-03', 'resultsFirstSubmitDate': '2009-07-23', 'studyFirstSubmitQcDate': '2006-10-05', 'lastUpdatePostDateStruct': {'date': '2015-09-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-07-23', 'studyFirstPostDateStruct': {'date': '2006-10-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-09-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Mean Carotid Intima Media Thickness', 'timeFrame': 'after 96 weeks of postrandomization treatment', 'description': 'change in mean carotid intima media thickness defined as a composite measure of the left and right common, bulb, and internal carotid artery.'}], 'secondaryOutcomes': [{'measure': 'Change in Lipid Profile', 'timeFrame': 'after 96 weeks of postrandomization treatment'}]}, 'conditionsModule': {'conditions': ['Hypercholesterolemia, Familial']}, 'descriptionModule': {'briefSummary': 'This is a 105-week clinical study in patients with heterozygous familial hypercholesterolemia on intensive Low Density Lipoprotein-cholesterol (LDL-C) lowering therapy intended to assess the affects of MK0524A on carotid intima media thickening using ultrasound compared to patients taking placebo. There will be 12 scheduled clinic visits involving review of medical history, physical exam, vital signs, laboratory testing, ultrasound imaging, and electrocardiograms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are 18 to 70 years of age with Heterozygous Familial Hypercholesterolemia and a LDL-C greater than or equal to 100mg/dL and triglycerides less than or equal to 400mg/dL at Visit 1 while on a stable dose of intensive LDL-C lowering therapy\n\nExclusion Criteria:\n\n* A condition which, in the opinion of the investigator, might pose a risk to the patient or interfere with participating in the study\n* Patients with less than 80% drug study compliance\n* Patients with chronic medical conditions known to influence serum lipids or lipoproteins or significantly affect the ultrasound acoustic window\n* Patients with unstable dose of medications\n* Pregnant or lactating women, or women intending to become pregnant are excluded\n* Patient with diabetes mellitus that is poorly controlled, or is taking new or recently adjusted antidiabetic pharmacotherapy (with the exception of +/- 10 units of insulin)\n* Patients with the following conditions: high grade stenosis (greater than 75%) of the carotid artery, chronic heart failure, uncontrolled/unstable cardiac arrhythmias, unstable hypertension, active or chronic hepatobiliary or hepatic disease, HIV positive, episode of gout (within 1 year)'}, 'identificationModule': {'nctId': 'NCT00384293', 'acronym': 'ACHIEVE', 'briefTitle': 'Carotid IMT (Intima Media Thickening) Study (0524A-041)(TERMINATED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Worldwide, Double-Blind, Randomized, Placebo-Controlled Study of MK0524A 2g Coadministered With Intensive LDL-C Lowering Therapy Compared to Intensive LDL-C Lowering Therapy Alone on Carotid Artery Intima Media Thickening (cIMT) in Patients With Heterozygous Familial Hypercholesterolemia (heFH)', 'orgStudyIdInfo': {'id': '0524A-041'}, 'secondaryIdInfos': [{'id': '2006_506'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'MK0524A', 'interventionNames': ['Drug: Comparator: niacin (+) laropiprant (MK0524A)']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'placebo', 'interventionNames': ['Drug: Comparator: placebo']}], 'interventions': [{'name': 'Comparator: niacin (+) laropiprant (MK0524A)', 'type': 'DRUG', 'otherNames': ['MK0524A'], 'description': 'niacin (+) laropiprant (2 g) po qd.', 'armGroupLabels': ['1']}, {'name': 'Comparator: placebo', 'type': 'DRUG', 'description': 'niacin (+) laropiprant (2 g) placebo po qd.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}