Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2025-12-30 @ 5:29 AM
Study NCT ID:
NCT00935259
Status:
COMPLETED
Last Update Posted:
2015-10-08
First Post:
2009-07-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Lipid Biomarker Study in Men With Dyslipidemia After Simvastatin Treatment (Study MK-0000-140)(COMPLETED)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}, {'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'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': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp'}, 'certainAgreement': {'otherDetails': 'Publications should include input from the investigator(s), and Sponsor personnel. Such input should be reflected in publication authorship. The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication guidelines.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Simvastatin', 'description': 'Simvastatin 40 mg tablets once daily for 2 weeks in either Period 1 or Period 2', 'otherNumAtRisk': 30, 'otherNumAffected': 1, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo to simvastatin tablets once daily for 2 weeks in either Period 1 or Period 2', 'otherNumAtRisk': 30, 'otherNumAffected': 2, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Tension headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Arachidonic Acid Level After 2 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Simvastatin 40 mg', 'description': 'Simvastatin 40 mg once daily for 2 weeks followed by placebo once daily for 2 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo once daily for 2 weeks followed by simvastatin 40 mg daily for 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '259.1', 'spread': '89.1', 'groupId': 'OG000'}, {'value': '269.6', 'spread': '85.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.455', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-10.4', 'pValueComment': 'Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '52.1', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'An unstructured covariance and Kenward Roger degrees of freedom were assumed.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'Arachidonic acid level (20:4n6) in the cholesterol ester lipid class.\n\nThe mean reported was an adjusted mean, which was obtained from running a 2-period crossover model that had fixed treatment and period terms and a random participant term.', 'unitOfMeasure': 'nmol', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants with complete arachidonic acid data were included.'}, {'type': 'SECONDARY', 'title': 'Fasting Blood Lipidomic Levels After 2 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Simvastatin 40 mg', 'description': 'Simvastatin 40 mg once daily for 2 weeks followed by placebo for 2 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo once daily for 2 weeks followed by Simvastatin 40 mg once daily for 2 weeks'}], 'classes': [{'title': 'Cholesterol ester lipid 16:00', 'categories': [{'measurements': [{'value': '288.9', 'spread': '102.1', 'groupId': 'OG000'}, {'value': '345.1', 'spread': '87.3', 'groupId': 'OG001'}]}]}, {'title': 'Cholesterol ester lipid 18:3n3', 'categories': [{'measurements': [{'value': '10.0', 'spread': '4.8', 'groupId': 'OG000'}, {'value': '14.4', 'spread': '6.7', 'groupId': 'OG001'}]}]}, {'title': 'Cholesterol ester lipid 20:3n6', 'categories': [{'measurements': [{'value': '20.9', 'spread': '10.5', 'groupId': 'OG000'}, {'value': '23.5', 'spread': '10.2', 'groupId': 'OG001'}]}]}, {'title': 'Cholesterol ester lipid 20:3n9', 'categories': [{'measurements': [{'value': '1.3', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'Cholesterol ester lipid 22:5n6', 'categories': [{'measurements': [{'value': '1.0', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '0.4', 'groupId': 'OG001'}]}]}, {'title': 'Cholesterol ester lipid 22:6n3', 'categories': [{'measurements': [{'value': '12.7', 'spread': '5.1', 'groupId': 'OG000'}, {'value': '14.8', 'spread': '6.8', 'groupId': 'OG001'}]}]}, {'title': 'Lysophosphatidyl-choline lipid 20:4n6', 'categories': [{'measurements': [{'value': '11.1', 'spread': '3.8', 'groupId': 'OG000'}, {'value': '10.3', 'spread': '2.7', 'groupId': 'OG001'}]}]}, {'title': 'Phosphatidyl-choline lipid 18:2n6', 'categories': [{'measurements': [{'value': '684.8', 'spread': '224.9', 'groupId': 'OG000'}, {'value': '824.9', 'spread': '196.2', 'groupId': 'OG001'}]}]}, {'title': 'Phosphatidyl-choline lipid 20:3n6', 'categories': [{'measurements': [{'value': '117.4', 'spread': '54.3', 'groupId': 'OG000'}, {'value': '127.1', 'spread': '58.8', 'groupId': 'OG001'}]}]}, {'title': 'Phosphatidyl-choline lipid 20:4n6', 'categories': [{'measurements': [{'value': '458.0', 'spread': '138.4', 'groupId': 'OG000'}, {'value': '443.2', 'spread': '98.1', 'groupId': 'OG001'}]}]}, {'title': 'Phosphatidyl-choline lipid 22:5n3', 'categories': [{'measurements': [{'value': '30.3', 'spread': '10.2', 'groupId': 'OG000'}, {'value': '34.3', 'spread': '12.8', 'groupId': 'OG001'}]}]}, {'title': 'Phosphatidyl-choline lipid 22:5n6', 'categories': [{'measurements': [{'value': '11.4', 'spread': '6.4', 'groupId': 'OG000'}, {'value': '12.1', 'spread': '4.1', 'groupId': 'OG001'}]}]}, {'title': 'Phosphatidyl-ethanolamine lipid 18:2n6', 'categories': [{'measurements': [{'value': '21.8', 'spread': '9.3', 'groupId': 'OG000'}, {'value': '32.1', 'spread': '15.5', 'groupId': 'OG001'}]}]}, {'title': 'Triacylglycerol 16:00', 'categories': [{'measurements': [{'value': '788.3', 'spread': '431.6', 'groupId': 'OG000'}, {'value': '1005.1', 'spread': '662.2', 'groupId': 'OG001'}]}]}, {'title': 'Triacylglycerol 20:3n9', 'categories': [{'measurements': [{'value': '4.5', 'spread': '5.5', 'groupId': 'OG000'}, {'value': '4.9', 'spread': '2.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.014', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-51.7', 'pValueComment': 'Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.', 'groupDescription': 'Cholesterol Ester 16:00', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'An unstructured covariance and Kenward Roger degrees of freedom were assumed.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-4.5', 'pValueComment': 'Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.', 'groupDescription': 'Cholesterol Ester 18:3n3', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'An unstructured covariance and Kenward Roger degrees of freedom were assumed.', 'testedNonInferiority': False}, {'pValue': '0.217', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-2.5', 'pValueComment': 'Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.', 'groupDescription': 'Cholesterol Ester 20:3n6', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'An unstructured covariance and Kenward Roger degrees of freedom were assumed.', 'testedNonInferiority': False}, {'pValue': '0.666', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.1', 'pValueComment': 'Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.', 'groupDescription': 'Cholesterol Ester 20:3n9', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'An unstructured covariance and Kenward Roger degrees of freedom were assumed.', 'testedNonInferiority': False}, {'pValue': '0.776', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.0', 'pValueComment': 'Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.', 'groupDescription': 'Cholesterol Ester 22:5n6', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'An unstructured covariance and Kenward Roger degrees of freedom were assumed.', 'testedNonInferiority': False}, {'pValue': '0.018', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-2.5', 'pValueComment': 'Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.', 'groupDescription': 'Cholesterol Ester 22:6n3', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'An unstructured covariance and Kenward Roger degrees of freedom were assumed.', 'testedNonInferiority': False}, {'pValue': '0.152', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '1.1', 'pValueComment': 'Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.', 'groupDescription': 'Lysophosphatidylcholine 20:4n6', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'An unstructured covariance and Kenward Roger degrees of freedom were assumed.', 'testedNonInferiority': False}, {'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-132.1', 'pValueComment': 'Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.', 'groupDescription': 'Phosphatidylcholine 18:2n6', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'An unstructured covariance and Kenward Roger degrees of freedom were assumed.', 'testedNonInferiority': False}, {'pValue': '0.325', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-11.8', 'pValueComment': 'Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.', 'groupDescription': 'Phosphatidylcholine 20:3n6', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'An unstructured covariance and Kenward Roger degrees of freedom were assumed.', 'testedNonInferiority': False}, {'pValue': '0.419', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '18.3', 'pValueComment': 'Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.', 'groupDescription': 'Phosphatidylcholine 20:4n6', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'An unstructured covariance and Kenward Roger degrees of freedom were assumed.', 'testedNonInferiority': False}, {'pValue': '0.070', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-4.7', 'pValueComment': 'Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.', 'groupDescription': 'Phosphatidylcholine 22:5n3', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'An unstructured covariance and Kenward Roger degrees of freedom were assumed.', 'testedNonInferiority': False}, {'pValue': '0.769', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.2', 'pValueComment': 'Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.', 'groupDescription': 'Phosphatidylcholine 22:5n6', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'An unstructured covariance and Kenward Roger degrees of freedom were assumed.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-11.1', 'pValueComment': 'Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.', 'groupDescription': 'Phosphatidylethanolamine 18:2n6', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'An unstructured covariance and Kenward Roger degrees of freedom were assumed.', 'testedNonInferiority': False}, {'pValue': '0.016', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-240.8', 'pValueComment': 'Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.', 'groupDescription': 'Triacylglycerol 16:00', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'An unstructured covariance and Kenward Roger degrees of freedom were assumed.', 'testedNonInferiority': False}, {'pValue': '0.833', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.1', 'pValueComment': 'Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.', 'groupDescription': 'Triacylglycerol 20:3n9', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'An unstructured covariance and Kenward Roger degrees of freedom were assumed.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'Change in fasting blood cholesterol ester, lysophosphatidylcholine, phosphatidylcholine, phosphatidylethanolamine, and triacylglycerol levels compared to placebo.\n\nThe mean reported was an adjusted mean.', 'unitOfMeasure': 'nmol', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants with complete blood lipidomic data were included.\n\nFor cholesterol ester 22:5n6, n=26 for the simvastatin arm and n=27 for the placebo arm.'}, {'type': 'SECONDARY', 'title': 'Serum Proprotein Convertase Subtilisin-like/Kexin Type 9 (PCSK9) Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Simvastatin 40 mg', 'description': 'Simvastatin 40 mg once daily for 2 weeks followed by placebo for 2 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo once daily for 2 weeks followed by Simvastatin 40 mg once daily for 2 weeks'}], 'classes': [{'title': 'Fed', 'categories': [{'measurements': [{'value': '6.06', 'spread': '2.34', 'groupId': 'OG000'}, {'value': '4.69', 'spread': '1.66', 'groupId': 'OG001'}]}]}, {'title': 'Fasted', 'categories': [{'measurements': [{'value': '6.47', 'spread': '2.11', 'groupId': 'OG000'}, {'value': '5.51', 'spread': '1.91', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.027', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.90', 'pValueComment': 'Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.', 'groupDescription': 'Fasted', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'An unstructured covariance and Kenward Roger degrees of freedom were assumed.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '1.40', 'pValueComment': 'Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.', 'groupDescription': 'Fed', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'An unstructured covariance and Kenward Roger degrees of freedom were assumed.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'Two days of standardized, pre-packaged meals were provided prior to the 10-hour fast required before blood collection. To assess how consumption of a meal would affect levels of plasma PCSK9, following each of the fasting blood draws, participants were asked to consume a high fat meal (heavy whipping cream + vanilla ice cream in a 1:4 ratio \\[dose = 162 g/m\\^2\\]) within 20 minutes. For the duration of the test, participants were to remain seated or recumbent until blood samples were drawn 4 h after meal completion.\n\nThe mean reported was an adjusted mean (defined in first outcome measure).', 'unitOfMeasure': 'nmol', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants with complete PCSK9 data were included.'}, {'type': 'SECONDARY', 'title': 'Blood Linoleic Acid Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Simvastatin 40 mg', 'description': 'Simvastatin 40 mg once daily for 2 weeks followed by placebo for 2 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo once daily for 2 weeks followed by Simvastatin 40 mg once daily for 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1184.7', 'spread': '393.4', 'groupId': 'OG000'}, {'value': '1504.7', 'spread': '327.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'Change in blood linoleic acid levels for Cholesterol Ester compared to placebo.', 'unitOfMeasure': 'nmol', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants with complete blood linoleic acid data were included.'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Delta 5 Desaturase Enzyme Activity Compared to Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Simvastatin 40 mg', 'description': 'Simvastatin 40 mg once daily for 2 weeks followed by placebo for 2 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo once daily for 2 weeks followed by Simvastatin 40 mg once daily for 2 weeks'}], 'classes': [{'title': 'Cholesterol ester c20:4n6 / c20:3n6', 'categories': [{'measurements': [{'value': '12.2234', 'spread': '3.413', 'groupId': 'OG000'}, {'value': '11.5662', 'spread': '3.684', 'groupId': 'OG001'}]}]}, {'title': 'Cholesterol Ester c20:5n3/c20:4n3', 'categories': [{'measurements': [{'value': '17.9161', 'spread': '7.738', 'groupId': 'OG000'}, {'value': '16.3024', 'spread': '9.465', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.247', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Cholesterol ester c20:4n6 / c20:3n6', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.151', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Cholesterol ester c20:5n3 / c20:4n3', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'Change in fasting delta 5 desaturase enzyme activity compared to placebo. Delta 5 desaturase enzyme activity is defined as the ratios of C20:4n-6 to C20:3n-6 and C20:5n-3 to C20:4n-3.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants with complete fasting delta 5 desaturase enzyme activity data were included.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Simvastatin 40 mg, Then Placebo', 'description': 'Simvastatin 40 mg once daily for 2 weeks followed by placebo once daily for 2 weeks'}, {'id': 'FG001', 'title': 'Placebo First, Then Simvastatin 40 mg', 'description': 'Placebo once daily for 2 weeks followed by simvastatin 40 mg daily for 2 weeks'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Administrative (scheduling conflict)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'All enrolled participants'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-07', 'studyFirstSubmitDate': '2009-07-07', 'resultsFirstSubmitDate': '2010-12-17', 'studyFirstSubmitQcDate': '2009-07-07', 'lastUpdatePostDateStruct': {'date': '2015-10-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-01-17', 'studyFirstPostDateStruct': {'date': '2009-07-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-02-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Arachidonic Acid Level After 2 Weeks of Treatment', 'timeFrame': '2 weeks', 'description': 'Arachidonic acid level (20:4n6) in the cholesterol ester lipid class.\n\nThe mean reported was an adjusted mean, which was obtained from running a 2-period crossover model that had fixed treatment and period terms and a random participant term.'}], 'secondaryOutcomes': [{'measure': 'Fasting Blood Lipidomic Levels After 2 Weeks of Treatment', 'timeFrame': '2 weeks', 'description': 'Change in fasting blood cholesterol ester, lysophosphatidylcholine, phosphatidylcholine, phosphatidylethanolamine, and triacylglycerol levels compared to placebo.\n\nThe mean reported was an adjusted mean.'}, {'measure': 'Serum Proprotein Convertase Subtilisin-like/Kexin Type 9 (PCSK9) Level', 'timeFrame': '2 weeks', 'description': 'Two days of standardized, pre-packaged meals were provided prior to the 10-hour fast required before blood collection. To assess how consumption of a meal would affect levels of plasma PCSK9, following each of the fasting blood draws, participants were asked to consume a high fat meal (heavy whipping cream + vanilla ice cream in a 1:4 ratio \\[dose = 162 g/m\\^2\\]) within 20 minutes. For the duration of the test, participants were to remain seated or recumbent until blood samples were drawn 4 h after meal completion.\n\nThe mean reported was an adjusted mean (defined in first outcome measure).'}, {'measure': 'Blood Linoleic Acid Levels', 'timeFrame': '2 weeks', 'description': 'Change in blood linoleic acid levels for Cholesterol Ester compared to placebo.'}, {'measure': 'Change in Fasting Delta 5 Desaturase Enzyme Activity Compared to Placebo', 'timeFrame': '2 weeks', 'description': 'Change in fasting delta 5 desaturase enzyme activity compared to placebo. Delta 5 desaturase enzyme activity is defined as the ratios of C20:4n-6 to C20:3n-6 and C20:5n-3 to C20:4n-3.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hypercholesterolemia, Dyslipidemia, simvastatin, Zocor'], 'conditions': ['Hypercholesterolemia, Dyslipidemia']}, 'referencesModule': {'references': [{'pmid': '21417623', 'type': 'DERIVED', 'citation': "Chen F, Maridakis V, O'Neill EA, Hubbard BK, Strack A, Beals C, Herman GA, Wong P. The effects of simvastatin treatment on plasma lipid-related biomarkers in men with dyslipidaemia. Biomarkers. 2011 Jun;16(4):321-33. doi: 10.3109/1354750X.2011.561367. Epub 2011 Mar 21."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to provide human lipidomics standards with simvastatin treatment that were to be used for comparison with similar preclinical studies.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant is a Caucasian (including Hispanic) male\n* Participant has a maximum waist size of 40 inches\n* Participant does not currently use any lipid-altering medications\n* Participant is in good health other than the diagnosis of dyslipidemia\n\nExclusion Criteria:\n\n* Participant has had stomach ulcers within the last 3 months\n* Participant has had a heart attack in the last 6 months or has angina\n* Participant has chronic heart failure\n* Participant has a history of stroke, seizures, or major neurological disorder\n* Participant has a history of cancer\n* Participant has a gastrointestinal condition that affects bowel movements\n* Participant has type 1 or 2 diabetes'}, 'identificationModule': {'nctId': 'NCT00935259', 'briefTitle': 'Lipid Biomarker Study in Men With Dyslipidemia After Simvastatin Treatment (Study MK-0000-140)(COMPLETED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Randomized, Placebo Controlled Clinical Trial to Evaluate the Effects of Simvastatin Treatment on Measurements of Lipidomic Biomarkers in Men With Dyslipidemia', 'orgStudyIdInfo': {'id': '0000-140'}, 'secondaryIdInfos': [{'id': '2009_609'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Simvastatin 40 mg first, then placebo', 'description': 'Simvastatin 40 mg tablets once daily for 2 weeks followed by placebo for 2 weeks', 'interventionNames': ['Drug: Simvastatin', 'Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo first, then simvastatin 40 mg once daily', 'description': 'Placebo for 2 weeks followed by simvastatin 40 mg once daily for 2 weeks', 'interventionNames': ['Drug: Simvastatin', 'Drug: Placebo']}], 'interventions': [{'name': 'Simvastatin', 'type': 'DRUG', 'otherNames': ['Zocor'], 'description': '40 mg once daily for 2 weeks', 'armGroupLabels': ['Placebo first, then simvastatin 40 mg once daily', 'Simvastatin 40 mg first, then placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo, matching the simvastatin (40 mg) tablet as a single oral daily dose for 2 weeks', 'armGroupLabels': ['Placebo first, then simvastatin 40 mg once daily', 'Simvastatin 40 mg first, then placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}