Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-28 @ 7:15 AM
Study NCT ID:
NCT00704535
Status:
COMPLETED
Last Update Posted:
2022-02-09
First Post:
2008-06-23
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of the Safety, Tolerability and Efficacy of Ezetimibe on a Select Population of Filipinos With Hypercholesterolemia (Study P04748)(COMPLETED)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Philippines']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000090542', 'term': 'Homozygous Familial Hypercholesterolemia'}], 'ancestors': [{'id': 'D006938', 'term': 'Hyperlipoproteinemia Type II'}, {'id': 'D008052', 'term': 'Lipid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006951', 'term': 'Hyperlipoproteinemias'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'title': 'Senior Vice President,Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp'}, 'certainAgreement': {'otherDetails': 'The prescribing physicians and investigators of this trial will not publish the results of any part of the study without previous written authorization from the sponsor.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Protocol deviations may have occurred that resulted in quality issues associated with reporting of the data.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Ezetimibe as Prescribed by the Physician in Normal Practice', 'description': 'Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin', 'otherNumAtRisk': 4105, 'otherNumAffected': 0, 'seriousNumAtRisk': 4105, 'seriousNumAffected': 3}], 'seriousEvents': [{'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4105, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4105, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Haemorrhagic cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4105, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 12.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Safety as Measured by Number of Subjects With at Least One Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4105', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ezetimibe as Prescribed by the Physician in Normal Practice', 'description': 'Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin'}], 'classes': [{'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 days after Visit 1', 'description': 'Evaluation of the overall safety of ezetimibe as measured by number of subjects who experienced at least one adverse event', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'To Evaluate the Efficacy of Ezetimibe in Lowering Serum Cholesterol Levels 28 Days After Visit 1 (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4083', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ezetimibe as Prescribed by the Physician in Normal Practice', 'description': 'Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin'}], 'classes': [{'categories': [{'measurements': [{'value': '-62.70', 'spread': '47.05', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '28 days after Visit 1', 'description': 'Change in mean total cholesterol values', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled subjects who had both baseline and post-treatment samples collected for cholesterol measurements'}, {'type': 'PRIMARY', 'title': 'Safety as Measured by Number and Type of Adverse Events.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4105', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ezetimibe as Prescribed by the Physician in Normal Practice', 'description': 'Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin'}], 'classes': [{'title': 'gastrointestinal upset', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'abdominal pain', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'body weakness', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'constipation', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'crampy abdominal pain', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'diarrhea', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'dizziness', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'epigastric discomfort', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'flatulence', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'headache', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'leg cramps/muscle pain', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'mild myalgia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'myalgia', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'nausea', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'oily flatus', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'urticaria', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'vague abdominal discomfort', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 days after Visit 1', 'description': 'Evaluation of the overall safety of ezetimibe as measured by the number and type of adverse events.', 'unitOfMeasure': 'adverse events', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Safety as Measured by Severity of Adverse Events as Determined by the Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4105', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ezetimibe as Prescribed by the Physician in Normal Practice', 'description': 'Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin'}], 'classes': [{'title': 'Mild adverse events', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}]}]}, {'title': 'Moderate adverse events', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Severe adverse events', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 days after Visit 1', 'description': 'To evaulate the safety of ezetimibe as measured by severity of adverse events, as determined by the investigator', 'unitOfMeasure': 'adverse events', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Safety as Measured by Adverse Event Relatedness to Study Drug as Reported by the Investigator.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4105', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ezetimibe as Prescribed by the Physician in Normal Practice', 'description': 'Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin'}], 'classes': [{'title': 'Related to treatment', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'Not related to treatment', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Relatedness not reported', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 days after Visit 1', 'description': 'To evaluate the overall safety of ezetimibe as measured by adverse event relatedness to study drug as reported by the investigator.', 'unitOfMeasure': 'adverse events', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Safety as Measured by Dose Adjustment Upon Incidence of an Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4105', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ezetimibe as Prescribed by the Physician in Normal Practice', 'description': 'Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin'}], 'classes': [{'title': 'Treatment dosage unchanged', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}]}]}, {'title': 'Treatment dosage reduced', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Treatment temporarily discontinued', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 days after Visit 1', 'description': 'To evaluate the overall safety of ezetimibe as measured by action taken by the investigator upon incidence of an adverse event', 'unitOfMeasure': 'adverse event', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Safety as Measured by Outcome of Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4105', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ezetimibe as Prescribed by the Physician in Normal Practice', 'description': 'Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin'}], 'classes': [{'title': 'Adverse event cleared', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}]}]}, {'title': 'Adverse event still present', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Adverse event outcome not reported', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 days after Visit 1', 'description': 'To evaluate overall safety of ezetimibe as measured by outcome of adverse events', 'unitOfMeasure': 'adverse events', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Tolerability as Measured by Subject Self-assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4105', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ezetimibe as Prescribed by the Physician in Normal Practice', 'description': 'Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin'}], 'classes': [{'title': 'Excellent', 'categories': [{'measurements': [{'value': '1325', 'groupId': 'OG000'}]}]}, {'title': 'Very good', 'categories': [{'measurements': [{'value': '1956', 'groupId': 'OG000'}]}]}, {'title': 'Good', 'categories': [{'measurements': [{'value': '713', 'groupId': 'OG000'}]}]}, {'title': 'Fair', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}]}]}, {'title': 'Poor', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Not reported', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 days after Visit 1', 'description': 'Evaluation of the overall tolerability of ezetimibe as measured by subject self-assessment', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ezetimibe as Prescribed by the Physician in Normal Practice', 'description': 'Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4105'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3959'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '146'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Completed status not on Case Report Form', 'reasons': [{'groupId': 'FG000', 'numSubjects': '124'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4105', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Ezetimibe as Prescribed by the Physician in Normal Practice', 'description': 'Filipino subjects with hypercholesterolemia who are using ezetimibe either alone or in combination with a statin'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.62', 'spread': '11.60', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Age was not reported for 10 subjects', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '2175', 'groupId': 'BG000'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '1930', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Gender was not reported for 13 subjects', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-07', 'studyFirstSubmitDate': '2008-06-23', 'resultsFirstSubmitDate': '2009-05-21', 'studyFirstSubmitQcDate': '2008-06-23', 'lastUpdatePostDateStruct': {'date': '2022-02-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-05-21', 'studyFirstPostDateStruct': {'date': '2008-06-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety as Measured by Number of Subjects With at Least One Adverse Event', 'timeFrame': '28 days after Visit 1', 'description': 'Evaluation of the overall safety of ezetimibe as measured by number of subjects who experienced at least one adverse event'}, {'measure': 'Safety as Measured by Number and Type of Adverse Events.', 'timeFrame': '28 days after Visit 1', 'description': 'Evaluation of the overall safety of ezetimibe as measured by the number and type of adverse events.'}, {'measure': 'Safety as Measured by Severity of Adverse Events as Determined by the Investigator', 'timeFrame': '28 days after Visit 1', 'description': 'To evaulate the safety of ezetimibe as measured by severity of adverse events, as determined by the investigator'}, {'measure': 'Safety as Measured by Adverse Event Relatedness to Study Drug as Reported by the Investigator.', 'timeFrame': '28 days after Visit 1', 'description': 'To evaluate the overall safety of ezetimibe as measured by adverse event relatedness to study drug as reported by the investigator.'}, {'measure': 'Safety as Measured by Dose Adjustment Upon Incidence of an Adverse Event', 'timeFrame': '28 days after Visit 1', 'description': 'To evaluate the overall safety of ezetimibe as measured by action taken by the investigator upon incidence of an adverse event'}, {'measure': 'Safety as Measured by Outcome of Adverse Events', 'timeFrame': '28 days after Visit 1', 'description': 'To evaluate overall safety of ezetimibe as measured by outcome of adverse events'}, {'measure': 'Tolerability as Measured by Subject Self-assessment', 'timeFrame': '28 days after Visit 1', 'description': 'Evaluation of the overall tolerability of ezetimibe as measured by subject self-assessment'}], 'secondaryOutcomes': [{'measure': 'To Evaluate the Efficacy of Ezetimibe in Lowering Serum Cholesterol Levels 28 Days After Visit 1 (Baseline)', 'timeFrame': '28 days after Visit 1', 'description': 'Change in mean total cholesterol values'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Primary Hypercholesterolemia', 'Homozygous Familial Hypercholesterolemia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the overall safety, tolerability, and efficacy of Ezetimibe when used alone or in combination with a statin in patients with hypercholesterolemia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Filipino subjects with hypercholesterolemia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Outpatient men or women, age 18 years and above.\n* Patients with primary (heterozygous familial and non-familial) hypercholesterolemia or homozygous familial hypercholesterolemia.\n\nExclusion Criteria:\n\n* Known hypersensitivity to Ezetimibe.\n* Moderate to severe hepatic insufficiency.\n* Persistent elevation of serum transaminase levels of more than 1.5 times the upper limit of normal.\n* Pregnancy or lactation.\n* Concomitant intake of bile acid sequestrants (resins), nicotinic acid (niacin), fibric acid (fibrates), or cyclosporine'}, 'identificationModule': {'nctId': 'NCT00704535', 'briefTitle': 'Evaluation of the Safety, Tolerability and Efficacy of Ezetimibe on a Select Population of Filipinos With Hypercholesterolemia (Study P04748)(COMPLETED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organon and Co'}, 'officialTitle': 'Post-marketing Surveillance of the Safety, Tolerability and Efficacy of Ezetimibe Among Filipino Patients', 'orgStudyIdInfo': {'id': 'P04748'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subjects with hypercholesterolemia', 'description': 'Subjects with hypercholesterolemia that are using Ezetimibe either alone or in combination with a statin', 'interventionNames': ['Drug: Ezetimibe']}], 'interventions': [{'name': 'Ezetimibe', 'type': 'DRUG', 'otherNames': ['SCH 58235'], 'description': '1 tablet of 10 mg once daily', 'armGroupLabels': ['Subjects with hypercholesterolemia']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Organon and Co', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}