Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-01-07 @ 5:34 PM
Study NCT ID:
NCT00673660
Status:
COMPLETED
Last Update Posted:
2021-02-21
First Post:
2008-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Observational Study On Compliance Of Statin Treatment Of Patients With High Blood Cholesterol Levels
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D010349', 'term': 'Patient Compliance'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003187', 'term': 'Compliance'}], 'ancestors': [{'id': 'D004548', 'term': 'Elasticity'}, {'id': 'D055595', 'term': 'Mechanical Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The registered endpoint - observing reasons of compliance or non-compliance to statin treatment - was separated into outcome measure 6 and 7 because observing reasons for compliance with statin treatment were not collected or analyzed.'}}, 'adverseEventsModule': {'description': 'The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Statins at Visit 2', 'description': 'Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).', 'otherNumAtRisk': 153, 'otherNumAffected': 5, 'seriousNumAtRisk': 153, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Statins at Visit 3', 'description': 'Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).', 'otherNumAtRisk': 76, 'otherNumAffected': 4, 'seriousNumAtRisk': 76, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Statins at Visit 4', 'description': 'Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).', 'otherNumAtRisk': 44, 'otherNumAffected': 4, 'seriousNumAtRisk': 44, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Statins Visit 5', 'description': 'Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).', 'otherNumAtRisk': 268, 'otherNumAffected': 6, 'seriousNumAtRisk': 268, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 268, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Allergic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 268, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 268, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 268, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 268, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Gas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 268, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 268, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Elevated liver enzyme levels', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Rash on hands', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 268, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 268, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 268, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 268, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 268, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Who Were Compliant With Statin Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '375', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Statins', 'description': 'Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).'}], 'classes': [{'categories': [{'measurements': [{'value': '86.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12', 'description': 'The physician asked participants about their compliance with medication use, which was defined as not skipping or forgetting dosing or not delaying the dosing time at least 80 percent (%) of the days in which the medication was used.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary analysis population: participants diagnosed with dyslipidemia who were taking or planning to take statin treatment. Subset of evaluable participants were analyzed.'}, {'type': 'SECONDARY', 'title': 'Available Lipid Profiles of Compliant and Non-compliant Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Compliant With Statin Treatment', 'description': 'Participants with dyslipidemia who were compliant with statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).'}, {'id': 'OG001', 'title': 'Non-compliant With Statin Treatment', 'description': 'Participants with dyslipidemia who were non-compliant with statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).'}], 'classes': [{'title': 'Total cholesterol', 'categories': [{'measurements': [{'value': '178.94', 'spread': '41.17', 'groupId': 'OG000'}, {'value': '231.59', 'spread': '45.89', 'groupId': 'OG001'}]}]}, {'title': 'Low Density Lipoprotein (LDL) cholesterol', 'categories': [{'measurements': [{'value': '101.61', 'spread': '33.50', 'groupId': 'OG000'}, {'value': '156.48', 'spread': '41.22', 'groupId': 'OG001'}]}]}, {'title': 'High Density Lipoprotein (HDL) cholesterol', 'categories': [{'measurements': [{'value': '50.70', 'spread': '14.47', 'groupId': 'OG000'}, {'value': '53.33', 'spread': '23.76', 'groupId': 'OG001'}]}]}, {'title': 'Triglyceride', 'categories': [{'measurements': [{'value': '137.80', 'spread': '70.24', 'groupId': 'OG000'}, {'value': '156.89', 'spread': '65.32', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'p-Values less than 0.05 were considered statistically significant.', 'groupDescription': 'Total cholesterol', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'p-Values less than 0.05 were considered statistically significant.', 'groupDescription': 'LDL cholesterol', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.972', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'p-Values less than 0.05 were considered statistically significant.', 'groupDescription': 'HDL cholesterol', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.034', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'p-Values less than 0.05 were considered statistically significant.', 'groupDescription': 'Triglycerides', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Month 12', 'description': 'Available laboratory measurements of participants were recorded in CRFs.', 'unitOfMeasure': 'milligrams per deciliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary analysis population, subset of evaluable participants.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Reasons of Compliance to Statin Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Statins', 'description': 'Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).'}], 'timeFrame': 'Month 12', 'description': 'Compliance with medication use defined as not skipping or forgeting dosing or not delaying the dosing time at least 80 percent (%) of the days in which the medication was used. Participants were called for a final visit . Compliance with drug dosage was recorded.', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary analysis population. The number of participants with reasons of compliance to statin treatment were not collected or analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Reasons of Non-compliance to Statin Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Statins', 'description': 'Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).'}], 'classes': [{'title': 'Lab parameters were normal in final assessment', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Difficulty obtaining prescribed drugs', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Forgot to take drug', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': "Don't like taking drugs", 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Thought it not necessary to take drug', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Was late in taking drug', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': "Don't think it necesary to take drug continuously", 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': "Don't want to use drugs for a long time", 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Experienced adverse events (AEs)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Think they are useless', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Afraid of becoming an addict', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'I am resting my liver', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': "Can't take drugs regularly due to high drug price", 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12', 'description': 'Participants were called for a final visit and reasons for non-compliance were recorded.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary analysis population, subset of evaluable participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Statins', 'description': 'Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '375'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '268'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '107'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '107'}]}]}], 'recruitmentDetails': 'This was an observational study evaluating compliance to statin treatment in participants with dyslipidemia. Data available at each visit was recorded in case report forms (CRFs). No laboratory measurements were performed. The gender of 2 subjects was not recorded.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '375', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Statins', 'description': 'Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics).'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.7', 'spread': '10.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '186', 'groupId': 'BG000'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '187', 'groupId': 'BG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'No biospecimen is retained'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 375}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-17', 'studyFirstSubmitDate': '2008-05-01', 'resultsFirstSubmitDate': '2010-10-06', 'studyFirstSubmitQcDate': '2008-05-01', 'lastUpdatePostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-10-06', 'studyFirstPostDateStruct': {'date': '2008-05-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-11-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Who Were Compliant With Statin Treatment', 'timeFrame': 'Month 12', 'description': 'The physician asked participants about their compliance with medication use, which was defined as not skipping or forgetting dosing or not delaying the dosing time at least 80 percent (%) of the days in which the medication was used.'}], 'secondaryOutcomes': [{'measure': 'Available Lipid Profiles of Compliant and Non-compliant Participants', 'timeFrame': 'Month 12', 'description': 'Available laboratory measurements of participants were recorded in CRFs.'}, {'measure': 'Number of Participants With Reasons of Compliance to Statin Treatment', 'timeFrame': 'Month 12', 'description': 'Compliance with medication use defined as not skipping or forgeting dosing or not delaying the dosing time at least 80 percent (%) of the days in which the medication was used. Participants were called for a final visit . Compliance with drug dosage was recorded.'}, {'measure': 'Number of Participants With Reasons of Non-compliance to Statin Treatment', 'timeFrame': 'Month 12', 'description': 'Participants were called for a final visit and reasons for non-compliance were recorded.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Statins', 'Compliance', 'Dyslipidemia'], 'conditions': ['Dyslipidemia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A2581156&StudyName=Observational%20Study%20On%20Compliance%20Of%20Statin%20Treatment%20Of%20Patients%20With%20High%20Blood%20Cholesterol%20Levels', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to show the compliance rates of the patients to statin treatment and the reasons of non-compliance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with dyslipidemia and taking or planning to take statin treatment. Patients living in the same city of the study center. Patients aged 18 years old and over.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with dyslipidemia and taking or planning to take statin treatment.\n* Patients living in the same city of the study center. o Patients aged 18 years and over.\n\nExclusion Criteria:\n\n* Patients with severe systemic disease\n* Patients with alcohol and drug addiction and/or mental disease\n* Patients nursing or pregnant, or planning to get pregnant during the study'}, 'identificationModule': {'nctId': 'NCT00673660', 'briefTitle': 'Observational Study On Compliance Of Statin Treatment Of Patients With High Blood Cholesterol Levels', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Assessment Of Statin Treatment Compliance In Dyslipidemia Patients: An Observational Study', 'orgStudyIdInfo': {'id': 'A2581156'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Statins', 'description': 'Patients with dyslipidemia who are taking or planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin or generics).', 'interventionNames': ['Behavioral: Patient Compliance']}], 'interventions': [{'name': 'Patient Compliance', 'type': 'BEHAVIORAL', 'description': 'Compliance of patients to statin treatment and reasons of compliance or non compliance will be obtained by Patient Reported Outcomes (PROs) every 3 months.', 'armGroupLabels': ['Statins']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34394', 'city': 'Mecidiyeköy', 'state': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.06667, 'lon': 29.0}}, {'city': 'Bolu', 'country': 'Turkey (Türkiye)', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 40.73583, 'lon': 31.60611}}, {'zip': '34390', 'city': 'Haseki/Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Pfizer Investigational Site'}, {'zip': '34098', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Pfizer's Upjohn has merged with Mylan to form Viatris Inc.", 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}