Ignite Creation Date:
2025-12-24 @ 3:59 PM
Ignite Modification Date:
2026-02-03 @ 1:22 PM
Study NCT ID:
NCT00626392
Status:
COMPLETED
Last Update Posted:
2009-09-02
First Post:
2008-02-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate the EFFECTS of Acetylsalicylic Acid (ASA) on Niaspan®-Induced Flushing in Subjects With Dyslipidemia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009525', 'term': 'Niacin'}, {'id': 'D001241', 'term': 'Aspirin'}], 'ancestors': [{'id': 'D009539', 'term': 'Nicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-633-9110', 'title': 'Medical Information Specialist', 'organization': 'Abbott'}, 'certainAgreement': {'otherDetails': 'Provide Abbott at least sixty (60) days prior to submission for review, Abbott shall return comments within sixty (60) days of receipt of draft. Proposed draft shall be delayed an additional sixty (60) days in addition to the Review Period.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Any Acetylsalicylic Acid', 'description': 'Pooled arms that received acetylsalicylic acid (ASA) 325 mg during run-in and/or coadministration.', 'otherNumAffected': 119, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'No Acetylsalicylic Acid', 'description': 'Pooled arms that received acetylsalicylic acid placebo (ASA Pbo) during run-in and coadministration.', 'otherNumAffected': 72, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Blood uric acid increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10-1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 117}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 71}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}], 'seriousEvents': [{'term': 'Esophageal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Severity of Flushing Events During Week 1 of Niacin Extended-release (NER) Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Any Acetylsalicylic Acid', 'description': 'Pooled arms that received acetylsalicylic acid (ASA) 325 mg during run-in and/or coadministration.'}, {'id': 'OG001', 'title': 'No Acetylsalicylic Acid', 'description': 'Pooled arms that received acetylsalicylic acid placebo (ASA Pbo) during run-in and coadministration.'}], 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'None/mild', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Very severe', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.010', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'No adjustments were made for multiple comparisons. P-values \\<= 0.05 were reported as statistically significant.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline to end of Week 1', 'description': 'The maximum severity of flushing events subjects experienced during Week 1 of NER treatment was categorized as none, mild, moderate, severe, or very severe using the Flushing Assessment Tool via an e-diary. Flushing was assessed daily and the percentage of subjects with maximum flushing severity in each category was calculated.', 'unitOfMeasure': 'Percentage of Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects in the modified intent-to-treat population, defined as all subjects who took at least 1 dose of study medication and who had at least 1 entry in the Flushing Assessment Tool e-diary (n = 251).'}, {'type': 'SECONDARY', 'title': 'Maximum Severity of Flushing Events Overall During 4 Weeks of Niacin Extended-release (NER) Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Any Acetylsalicylic Acid', 'description': 'Pooled arms that received acetylsalicylic acid (ASA) 325 mg during run-in and/or coadministration.'}, {'id': 'OG001', 'title': 'No Acetylsalicylic Acid', 'description': 'Pooled arms that received acetylsalicylic acid placebo (ASA Pbo) during run-in and coadministration.'}], 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'None/Mild', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Very severe', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks', 'description': 'The maximum severity of flushing events subjects experienced during 4 weeks of NER treatment was categorized as none, mild, moderate, severe, or very severe using the Flushing Assessment Tool via an e-diary. Flushing was assessed daily and the percentage of subjects with maximum flushing severity in each category was calculated.', 'unitOfMeasure': 'Percentage of Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects in the modified intent-to-treat population, defined as all subjects who took at least 1 dose of study medication and who had at least 1 entry in the Flushing Assessment Tool e-diary (n = 251).'}, {'type': 'SECONDARY', 'title': 'Mean of Maximum Severity of Flushing Events Overall During 4 Weeks of Niacin Extended-release (NER) Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Any Acetylsalicylic Acid', 'description': 'Pooled arms that received acetylsalicylic acid (ASA) 325 mg during run-in and/or coadministration.'}, {'id': 'OG001', 'title': 'No Acetylsalicylic Acid', 'description': 'Pooled arms that received acetylsalicylic acid placebo (ASA Pbo) during run-in and coadministration.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'spread': '2.86', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '3.16', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Subjects assessed the severity of flushing events on a 10-point numeric rating scale of 1-3 (mild), 4-6 (moderate), 7-9 (severe), and 10 (very severe) using the Flushing Assessment Tool via an e-diary. For subjects who did not experience flushing, a score of 0 was assigned. Flushing was assessed daily.', 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects in the modified intent-to-treat population, defined as all subjects who took at least 1 dose of study medication and who had at least 1 entry in the Flushing Assessment Tool e-diary (n = 251).'}, {'type': 'SECONDARY', 'title': 'Mean Number of Moderate or Greater Flushing Events Per Subject Per Week Overall During 4 Weeks of Niacin Extended-release (NER) Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Any Acetylsalicylic Acid', 'description': 'Pooled arms that received acetylsalicylic acid (ASA) 325 mg during run-in and/or coadministration.'}, {'id': 'OG001', 'title': 'No Acetylsalicylic Acid', 'description': 'Pooled arms that received acetylsalicylic acid placebo (ASA Pbo) during run-in and coadministration.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '1.10', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Flushing was assessed daily using the Flushing Assessment Tool via an e-diary and the mean number of flushing events per subject per week considered moderate or greater in severity was calculated. Flushing events were rated by the subject using a categorical scale of mild, moderate, severe, or very severe.', 'unitOfMeasure': 'Number of Events per Subject per Week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects in the modified intent-to-treat population, defined as all subjects who took at least 1 dose of study medication and who had at least 1 entry in the Flushing Assessment Tool e-diary (n = 251).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'NER 500; ASA run-in, ASA Coadmin', 'description': 'Aspirin (ASA) 325 mg daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release (\\[NER\\], 500 mg starting dose), daily during coadministration (4 weeks)'}, {'id': 'FG001', 'title': 'NER 500; ASA Pbo run-in, ASA Coadmin', 'description': 'Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release (\\[NER\\], 500 mg starting dose), daily during coadministration (4 weeks)'}, {'id': 'FG002', 'title': 'NER 500; ASA Pbo run-in, ASA Pbo Coadmin', 'description': 'Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA Pbo 30 min prior to niacin extended-release (\\[NER\\], 500 mg starting dose), daily during coadministration (4 weeks)'}, {'id': 'FG003', 'title': 'NER 1000; ASA run-in; ASA Coadmin', 'description': 'Aspirin (ASA) 325 mg daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release (\\[NER\\], 1000 mg starting dose), daily during coadministration (4 weeks)'}, {'id': 'FG004', 'title': 'NER 1000; ASA Pbo run-in, ASA Coadmin', 'description': 'Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release (\\[NER\\], 1000 mg starting dose), daily during coadministration (4 weeks)'}, {'id': 'FG005', 'title': 'NER 1000; ASA Pbo run-in, ASA Pbo Coadmin', 'description': 'Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA Pbo 30 min prior to niacin extended-release (\\[NER\\], 1000 mg starting dose), daily during coadministration (4 weeks)'}], 'periods': [{'title': 'Run-in Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '44'}, {'groupId': 'FG002', 'numSubjects': '44'}, {'groupId': 'FG003', 'numSubjects': '44'}, {'groupId': 'FG004', 'numSubjects': '45'}, {'groupId': 'FG005', 'numSubjects': '45'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '43'}, {'groupId': 'FG002', 'numSubjects': '41'}, {'groupId': 'FG003', 'numSubjects': '43'}, {'groupId': 'FG004', 'numSubjects': '41'}, {'groupId': 'FG005', 'numSubjects': '44'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Coadministration Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '43'}, {'groupId': 'FG002', 'numSubjects': '41'}, {'groupId': 'FG003', 'numSubjects': '43'}, {'groupId': 'FG004', 'numSubjects': '41'}, {'groupId': 'FG005', 'numSubjects': '44'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '38'}, {'groupId': 'FG002', 'numSubjects': '31'}, {'groupId': 'FG003', 'numSubjects': '36'}, {'groupId': 'FG004', 'numSubjects': '36'}, {'groupId': 'FG005', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were enrolled at 47 study sites in the United States between February and April, 2008.', 'preAssignmentDetails': 'This study had a 1-week run-in (acetylsalicylic acid \\[ASA\\] 325 mg or ASA placebo \\[Pbo\\] once daily) prior to 4 weeks of niacin extended-release (NER) plus ASA/ASA Pbo coadministration. Ten of 277 randomized subjects discontinued before run-in due to withdrawal of consent (4), lost to follow-up (4), protocol violation (1), and other (1).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}, {'value': '41', 'groupId': 'BG004'}, {'value': '44', 'groupId': 'BG005'}, {'value': '256', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'NER 500; ASA run-in, ASA Coadmin', 'description': 'Aspirin (ASA) 325 mg daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release (\\[NER\\], 500 mg starting dose), daily during coadministration (4 weeks)'}, {'id': 'BG001', 'title': 'NER 500; ASA Pbo run-in, ASA Coadmin', 'description': 'Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release (\\[NER\\], 500 mg starting dose), daily during coadministration (4 weeks)'}, {'id': 'BG002', 'title': 'NER 500; ASA Pbo run-in, ASA Pbo Coadmin', 'description': 'Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA Pbo 30 min prior to niacin extended-release (\\[NER\\], 500 mg starting dose), daily during coadministration (4 weeks)'}, {'id': 'BG003', 'title': 'NER 1000; ASA run-in, ASA Coadmin', 'description': 'Aspirin (ASA) 325 mg daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release (\\[NER\\], 1000 mg starting dose), daily during coadministration (4 weeks)'}, {'id': 'BG004', 'title': 'NER 1000; ASA Pbo run-in, ASA Coadmin', 'description': 'Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA 325 mg 30 min prior to niacin extended-release (\\[NER\\], 1000 mg starting dose), daily during coadministration (4 weeks)'}, {'id': 'BG005', 'title': 'NER 1000; ASA Pbo run-in, ASA Pbo Coadmin', 'description': 'Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA Pbo 30 min prior to niacin extended-release (\\[NER\\], 1000 mg starting dose), daily during coadministration (4 weeks)'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.5', 'spread': '10.62', 'groupId': 'BG000'}, {'value': '49.0', 'spread': '10.48', 'groupId': 'BG001'}, {'value': '51.5', 'spread': '12.58', 'groupId': 'BG002'}, {'value': '53.7', 'spread': '12.4', 'groupId': 'BG003'}, {'value': '54.8', 'spread': '11.08', 'groupId': 'BG004'}, {'value': '52.3', 'spread': '12.45', 'groupId': 'BG005'}, {'value': '52.8', 'spread': '11.73', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'description': 'Includes only those subjects who entered the coadministration period and received at least one dose of study medication.', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '23', 'groupId': 'BG005'}, {'value': '124.0', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '21', 'groupId': 'BG005'}, {'value': '132.0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Includes only those subjects who entered the coadministration period and received at least one dose of study medication.', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}, {'value': '41', 'groupId': 'BG004'}, {'value': '44', 'groupId': 'BG005'}, {'value': '256.0', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'description': 'Includes only those subjects who entered the coadministration period and received at least one dose of study medication.', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 277}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-08-26', 'studyFirstSubmitDate': '2008-02-21', 'resultsFirstSubmitDate': '2009-04-16', 'studyFirstSubmitQcDate': '2008-02-21', 'lastUpdatePostDateStruct': {'date': '2009-09-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-07-15', 'studyFirstPostDateStruct': {'date': '2008-02-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-08-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Severity of Flushing Events During Week 1 of Niacin Extended-release (NER) Treatment', 'timeFrame': 'From Baseline to end of Week 1', 'description': 'The maximum severity of flushing events subjects experienced during Week 1 of NER treatment was categorized as none, mild, moderate, severe, or very severe using the Flushing Assessment Tool via an e-diary. Flushing was assessed daily and the percentage of subjects with maximum flushing severity in each category was calculated.'}], 'secondaryOutcomes': [{'measure': 'Maximum Severity of Flushing Events Overall During 4 Weeks of Niacin Extended-release (NER) Treatment', 'timeFrame': '4 weeks', 'description': 'The maximum severity of flushing events subjects experienced during 4 weeks of NER treatment was categorized as none, mild, moderate, severe, or very severe using the Flushing Assessment Tool via an e-diary. Flushing was assessed daily and the percentage of subjects with maximum flushing severity in each category was calculated.'}, {'measure': 'Mean of Maximum Severity of Flushing Events Overall During 4 Weeks of Niacin Extended-release (NER) Treatment', 'timeFrame': '4 weeks', 'description': 'Subjects assessed the severity of flushing events on a 10-point numeric rating scale of 1-3 (mild), 4-6 (moderate), 7-9 (severe), and 10 (very severe) using the Flushing Assessment Tool via an e-diary. For subjects who did not experience flushing, a score of 0 was assigned. Flushing was assessed daily.'}, {'measure': 'Mean Number of Moderate or Greater Flushing Events Per Subject Per Week Overall During 4 Weeks of Niacin Extended-release (NER) Treatment', 'timeFrame': '4 weeks', 'description': 'Flushing was assessed daily using the Flushing Assessment Tool via an e-diary and the mean number of flushing events per subject per week considered moderate or greater in severity was calculated. Flushing events were rated by the subject using a categorical scale of mild, moderate, severe, or very severe.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dyslipidemia']}, 'referencesModule': {'references': [{'pmid': '19331435', 'type': 'RESULT', 'citation': 'Thakkar RB, Kashyap ML, Lewin AJ, Krause SL, Jiang P, Padley RJ. Acetylsalicylic acid reduces niacin extended-release-induced flushing in patients with dyslipidemia. Am J Cardiovasc Drugs. 2009;9(2):69-79. doi: 10.1007/BF03256578.'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study was to assess the effect of aspirin (ASA) on niacin extended-release (NER)-induced flushing in subjects with dyslipidemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject must be 18 years of age or older.\n* If female, subject is either not of childbearing potential, defined as postmenopausal for at least one year or surgically sterile, or is of childbearing potential and must agree to practice birth control for the duration of the study.\n* Have dyslipidemia as demonstrated by laboratory results.\n\nExclusion Criteria:\n\n* Have glycosylated hemoglobin (HbA1c) \\>/= 9.0%.\n* Have nephrotic syndrome, dysproteinemias, or severe renal failure (glomerular filtration rate \\[GFR\\] \\< 30 mL/minute, as calculated from creatinine clearance).\n* Have had unstable angina or an acute myocardial infarction (MI) within three months of the Screening Visit.\n* Have had severe peripheral artery disease as evidenced by intermittent claudication within three months of the Screening Visit.\n* Have had uncontrolled cardiac arrhythmias within three months of the Screening Visit.\n* Have symptomatic heart failure defined as dyspnea at rest or with exertion (mild peripheral edema is not exclusionary).\n* Have a systolic blood pressure measurement of \\> 180 mmHg or a diastolic blood pressure measurement of \\> 110 mmHg at the Screening or Baseline Visit.\n* Have active gout or uric acid \\>/= 11 mg/dL.\n* Have a history of hepatitis (acute or chronic), obstructive liver disease, or alanine aminotransferase (ALT; serum glutamic pyruvic transaminase \\[SGPT\\]) or aspartate aminotransferase (AST; serum glutamic oxaloacetic transaminase \\[SGOT\\]) values \\>/= 1.3 times the upper limit of normal (ULN) at the Screening Visit.\n* Have creatine phosphokinase (CPK) \\>/= 3 x ULN at the Screening Visit.\n* Have used an investigational study drug or participated in an investigational study within 30 days of the Screening Visit.\n* Have a health condition or laboratory abnormality (inclusive of clinically significant laboratory results at Screening Visit), which, in the opinion of the Investigator, may be adversely affected by the procedures or study medications in this study.'}, 'identificationModule': {'nctId': 'NCT00626392', 'acronym': 'ASA EFFECTS', 'briefTitle': 'Study to Evaluate the EFFECTS of Acetylsalicylic Acid (ASA) on Niaspan®-Induced Flushing in Subjects With Dyslipidemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': 'Multicenter, Randomized, Double-Blind, Parallel, Acetylsalicylic Acid (ASA) Run-In Study to Evaluate the EFFECTS of Acetylsalicylic Acid on Niaspan®-Induced Flushing in Subjects With Dyslipidemia', 'orgStudyIdInfo': {'id': 'M10-241'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NER 500; ASA run-in, ASA coadmin', 'description': 'Aspirin (ASA) daily during run-in (1 week); ASA 30 min prior to niacin extended-release (\\[NER\\], 500 mg starting dose), daily during coadministration period (4 weeks)', 'interventionNames': ['Drug: niacin extended-release (NER)', 'Drug: aspirin (ASA)']}, {'type': 'EXPERIMENTAL', 'label': 'NER 500; ASA Pbo run-in, ASA coadmin', 'description': 'Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA 30 min prior to niacin extended-release (\\[NER\\], 500 mg starting dose), daily during coadministration period (4 weeks)', 'interventionNames': ['Drug: niacin extended-release (NER)', 'Drug: aspirin (ASA)', 'Drug: aspirin placebo (ASA Pbo)']}, {'type': 'EXPERIMENTAL', 'label': 'NER 500; ASA Pbo run-in, ASA Pbo coadmin', 'description': 'Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA Pbo 30 min prior to niacin extended-release (\\[NER\\], 500 mg starting dose), daily during coadministration period (4 weeks)', 'interventionNames': ['Drug: niacin extended-release (NER)', 'Drug: aspirin placebo (ASA Pbo)']}, {'type': 'EXPERIMENTAL', 'label': 'NER 1000; ASA run-in, ASA coadmin', 'description': 'Aspirin (ASA) daily during run-in (1 week); ASA 30 min prior to niacin extended-release (\\[NER\\], 1000 mg starting dose), daily during coadministration period (4 weeks)', 'interventionNames': ['Drug: niacin extended-release (NER)', 'Drug: aspirin (ASA)']}, {'type': 'EXPERIMENTAL', 'label': 'NER 1000; ASA Pbo run-in, ASA coadmin', 'description': 'Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA 30 min prior to niacin extended-release (\\[NER\\], 1000 mg starting dose), daily during coadministration period (4 weeks)', 'interventionNames': ['Drug: niacin extended-release (NER)', 'Drug: aspirin (ASA)', 'Drug: aspirin placebo (ASA Pbo)']}, {'type': 'EXPERIMENTAL', 'label': 'NER 1000; ASA Pbo run-in, ASA Pbo coadmin', 'description': 'Aspirin placebo (ASA Pbo) daily during run-in (1 week); ASA Pbo 30 min prior to niacin extended-release (\\[NER\\], 1000 mg starting dose), daily during coadministration period (4 weeks)', 'interventionNames': ['Drug: niacin extended-release (NER)', 'Drug: aspirin placebo (ASA Pbo)']}], 'interventions': [{'name': 'niacin extended-release (NER)', 'type': 'DRUG', 'otherNames': ['Niaspan'], 'description': 'Tablets administered once daily; titrated to 2000 mg maximum dose during coadministration period', 'armGroupLabels': ['NER 1000; ASA Pbo run-in, ASA Pbo coadmin', 'NER 1000; ASA Pbo run-in, ASA coadmin', 'NER 1000; ASA run-in, ASA coadmin', 'NER 500; ASA Pbo run-in, ASA Pbo coadmin', 'NER 500; ASA Pbo run-in, ASA coadmin', 'NER 500; ASA run-in, ASA coadmin']}, {'name': 'aspirin (ASA)', 'type': 'DRUG', 'otherNames': ['acetylsalicylic acid'], 'description': '325 mg tablets administered once daily', 'armGroupLabels': ['NER 1000; ASA Pbo run-in, ASA coadmin', 'NER 1000; ASA run-in, ASA coadmin', 'NER 500; ASA Pbo run-in, ASA coadmin', 'NER 500; ASA run-in, ASA coadmin']}, {'name': 'aspirin placebo (ASA Pbo)', 'type': 'DRUG', 'otherNames': ['placebo'], 'description': 'Tablets administered once daily', 'armGroupLabels': ['NER 1000; ASA Pbo run-in, ASA Pbo coadmin', 'NER 1000; ASA Pbo run-in, ASA coadmin', 'NER 500; ASA Pbo run-in, ASA Pbo coadmin', 'NER 500; ASA Pbo run-in, ASA coadmin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '85251', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '85710', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '90057', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92660', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '95204', 'city': 'Stockton', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.9577, 'lon': -121.29078}}, {'zip': '90057', 'city': 'Vista', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.20004, 'lon': -117.24254}}, {'zip': '91361', 'city': 'Westlake Village', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.14584, 'lon': -118.80565}}, {'zip': '33134', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '32259', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33186', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33027', 'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'zip': '33407', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '02747', 'city': 'North Dartmouth', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 41.63899, 'lon': -70.97032}}, {'zip': '14609', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '28262', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '19047', 'city': 'Penndel', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.15205, 'lon': -74.91656}}, {'zip': '02919', 'city': 'Johnston', 'state': 'Rhode Island', 'country': 'United States', 'geoPoint': {'lat': 41.82186, 'lon': -71.50675}}, {'zip': '29464', 'city': 'Mt. Pleasant', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 32.79407, 'lon': -79.86259}}, {'zip': '29681', 'city': 'Simpsonville', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 34.73706, 'lon': -82.25428}}, {'zip': '76034', 'city': 'Colleyville', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.88096, 'lon': -97.15501}}, {'zip': '77074', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Roopal Thakkar, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abbott'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Scott Krause, Associate Director', 'oldOrganization': 'Abbott'}}}}