Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2026-01-01 @ 8:14 PM
Study NCT ID:
NCT00941603
Status:
COMPLETED
Last Update Posted:
2018-09-25
First Post:
2009-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase 2 Dose-Ranging Efficacy and Safety Trial of SCH 900271 in Participants With Primary Hypercholesterolemia or Mixed Hyperlipidemia (P05675)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006938', 'term': 'Hyperlipoproteinemia Type II'}], 'ancestors': [{'id': 'D008052', 'term': 'Lipid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006951', 'term': 'Hyperlipoproteinemias'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, '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': 'The investigator agrees not to publish or publicly present any interim results of the trial without the prior written consent of the sponsor. The investigator further agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'up to approximately 96 days (including 30 days following last dose for serious adverse events)', 'description': 'Non-serious adverse events: treatment-emergent adverse events are reported. One participant in the SCH 900271 15 mg group was randomized but did not receive study drug. This participant was not included in the analyses of serious and non-serious adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'SCH 900271 15 mg', 'description': 'Participants receive SCH 900271 15 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks', 'otherNumAtRisk': 103, 'otherNumAffected': 41, 'seriousNumAtRisk': 103, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'SCH 900271 10 mg', 'description': 'Participants receive SCH 900271 10 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks', 'otherNumAtRisk': 105, 'otherNumAffected': 41, 'seriousNumAtRisk': 105, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'SCH 900271 5 mg', 'description': 'Participants receive SCH 900271 5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks', 'otherNumAtRisk': 104, 'otherNumAffected': 19, 'seriousNumAtRisk': 104, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'SCH 900271 2.5 mg', 'description': 'Participants receive SCH 900271 2.5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks', 'otherNumAtRisk': 104, 'otherNumAffected': 8, 'seriousNumAtRisk': 104, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'SCH 900271 1 mg', 'description': 'Participants receive SCH 900271 1 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks', 'otherNumAtRisk': 105, 'otherNumAffected': 14, 'seriousNumAtRisk': 105, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Placebo', 'description': 'Participants receive two placebo tablets once daily in the morning with water in a fasted state for 8 weeks', 'otherNumAtRisk': 97, 'otherNumAffected': 5, 'seriousNumAtRisk': 97, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 20, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 24, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 104, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 105, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 21, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 104, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 105, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 97, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 104, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 105, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 97, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 19, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 105, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 97, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'seriousEvents': [{'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hepatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Jaundice', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Facial bones fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Direct LDL-C at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}, {'value': '101', 'groupId': 'OG003'}, {'value': '105', 'groupId': 'OG004'}, {'value': '96', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'SCH 900271 15 mg', 'description': 'Participants receive SCH 900271 15 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks'}, {'id': 'OG001', 'title': 'SCH 900271 10 mg', 'description': 'Participants receive SCH 900271 10 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks'}, {'id': 'OG002', 'title': 'SCH 900271 5 mg', 'description': 'Participants receive SCH 900271 5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks'}, {'id': 'OG003', 'title': 'SCH 900271 2.5 mg', 'description': 'Participants receive SCH 900271 2.5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks'}, {'id': 'OG004', 'title': 'SCH 900271 1 mg', 'description': 'Participants receive SCH 900271 1 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Participants receive two placebo tablets once daily in the morning with water in a fasted state for 8 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.0', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '-4.2', 'spread': '1.3', 'groupId': 'OG002'}, {'value': '0.2', 'spread': '1.3', 'groupId': 'OG003'}, {'value': '1.2', 'spread': '1.3', 'groupId': 'OG004'}, {'value': '1.5', 'spread': '1.4', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.06', 'groupIds': ['OG000', 'OG005'], 'paramType': 'Difference in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.5', 'ciLowerLimit': '-7.2', 'ciUpperLimit': '0.2', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Least-square (LS) means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.'}, {'pValue': '0.10', 'groupIds': ['OG001', 'OG005'], 'paramType': 'Difference in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.1', 'ciLowerLimit': '-6.7', 'ciUpperLimit': '0.6', 'pValueComment': 'LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.01', 'groupIds': ['OG002', 'OG005'], 'paramType': 'Difference in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.7', 'ciLowerLimit': '-9.4', 'ciUpperLimit': '-2.0', 'groupDescription': 'LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.48', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Difference in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.3', 'ciLowerLimit': '-5.0', 'ciUpperLimit': '2.4', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.'}, {'pValue': '0.85', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Difference in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-4.0', 'ciUpperLimit': '3.3', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 8', 'description': "The percentage change from baseline in the participants' LDL-C was to be evaluated at study Week 8. Standard error presented below is least squares standard error.", 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population defined as all participants who receive randomized treatment assignment, and have a baseline and at least one post-baseline LDL-C determination.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Direct Non-HDL-C at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '104', 'groupId': 'OG002'}, {'value': '102', 'groupId': 'OG003'}, {'value': '105', 'groupId': 'OG004'}, {'value': '97', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'SCH 900271 15 mg', 'description': 'Participants receive SCH 900271 15 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks'}, {'id': 'OG001', 'title': 'SCH 900271 10 mg', 'description': 'Participants receive SCH 900271 10 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks'}, {'id': 'OG002', 'title': 'SCH 900271 5 mg', 'description': 'Participants receive SCH 900271 5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks'}, {'id': 'OG003', 'title': 'SCH 900271 2.5 mg', 'description': 'Participants receive SCH 900271 2.5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks'}, {'id': 'OG004', 'title': 'SCH 900271 1 mg', 'description': 'Participants receive SCH 900271 1 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Participants receive two placebo tablets once daily in the morning with water in a fasted state for 8 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.1', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '-2.7', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '-3.5', 'spread': '1.2', 'groupId': 'OG002'}, {'value': '-0.5', 'spread': '1.3', 'groupId': 'OG003'}, {'value': '1.6', 'spread': '1.2', 'groupId': 'OG004'}, {'value': '0.9', 'spread': '1.3', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.09', 'groupIds': ['OG000', 'OG005'], 'paramType': 'Difference in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.0', 'ciLowerLimit': '-6.5', 'ciUpperLimit': '0.4', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.'}, {'pValue': '0.04', 'groupIds': ['OG001', 'OG005'], 'paramType': 'Difference in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.6', 'ciLowerLimit': '-7.1', 'ciUpperLimit': '-0.2', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.'}, {'pValue': '0.01', 'groupIds': ['OG002', 'OG005'], 'paramType': 'Difference in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.4', 'ciLowerLimit': '-7.9', 'ciUpperLimit': '-1.0', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.'}, {'pValue': '0.41', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Difference in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.4', 'ciLowerLimit': '-4.9', 'ciUpperLimit': '2.0', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.'}, {'pValue': '0.68', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Difference in percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '-2.7', 'ciUpperLimit': '4.2', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 8', 'description': "The percentage change from baseline in the participants' non-HDL-C was to be evaluated at study Week 8. Standard error presented below is least squares standard error.", 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population defined as all participants who receive randomized treatment assignment and have a baseline and at least one post-baseline non-HDL-C determination.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SCH 900271 15 mg', 'description': 'Participants receive SCH 900271 15 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks'}, {'id': 'FG001', 'title': 'SCH 900271 10 mg', 'description': 'Participants receive SCH 900271 10 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks'}, {'id': 'FG002', 'title': 'SCH 900271 5 mg', 'description': 'Participants receive SCH 900271 5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks'}, {'id': 'FG003', 'title': 'SCH 900271 2.5 mg', 'description': 'Participants receive SCH 900271 2.5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks'}, {'id': 'FG004', 'title': 'SCH 900271 1 mg', 'description': 'Participants receive SCH 900271 1 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks'}, {'id': 'FG005', 'title': 'Placebo', 'description': 'Participants receive two placebo tablets once daily in the morning with water in a fasted state for 8 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '104'}, {'groupId': 'FG001', 'numSubjects': '105'}, {'groupId': 'FG002', 'numSubjects': '104'}, {'groupId': 'FG003', 'numSubjects': '104'}, {'groupId': 'FG004', 'numSubjects': '105'}, {'groupId': 'FG005', 'numSubjects': '97'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '93'}, {'groupId': 'FG001', 'numSubjects': '89'}, {'groupId': 'FG002', 'numSubjects': '99'}, {'groupId': 'FG003', 'numSubjects': '100'}, {'groupId': 'FG004', 'numSubjects': '101'}, {'groupId': 'FG005', 'numSubjects': '94'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'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': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Did not meet protocol eligibility', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}, {'value': '104', 'groupId': 'BG003'}, {'value': '105', 'groupId': 'BG004'}, {'value': '97', 'groupId': 'BG005'}, {'value': '619', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'SCH 900271 15 mg', 'description': 'Participants receive SCH 900271 15 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks'}, {'id': 'BG001', 'title': 'SCH 900271 10 mg', 'description': 'Participants receive SCH 900271 10 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks'}, {'id': 'BG002', 'title': 'SCH 900271 5 mg', 'description': 'Participants receive SCH 900271 5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks'}, {'id': 'BG003', 'title': 'SCH 900271 2.5 mg', 'description': 'Participants receive SCH 900271 2.5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks'}, {'id': 'BG004', 'title': 'SCH 900271 1 mg', 'description': 'Participants receive SCH 900271 1 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks'}, {'id': 'BG005', 'title': 'Placebo', 'description': 'Participants receive two placebo tablets once daily in the morning with water in a fasted state for 8 weeks'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.5', 'spread': '9.5', 'groupId': 'BG000'}, {'value': '56.0', 'spread': '10.8', 'groupId': 'BG001'}, {'value': '56.1', 'spread': '10.3', 'groupId': 'BG002'}, {'value': '56.5', 'spread': '8.7', 'groupId': 'BG003'}, {'value': '57.5', 'spread': '9.4', 'groupId': 'BG004'}, {'value': '55.2', 'spread': '9.5', 'groupId': 'BG005'}, {'value': '56.5', 'spread': '9.7', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}, {'value': '52', 'groupId': 'BG004'}, {'value': '47', 'groupId': 'BG005'}, {'value': '300', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}, {'value': '53', 'groupId': 'BG004'}, {'value': '50', 'groupId': 'BG005'}, {'value': '319', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 619}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'dispFirstSubmitDate': '2010-04-13', 'completionDateStruct': {'date': '2010-02-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-27', 'studyFirstSubmitDate': '2009-07-16', 'dispFirstSubmitQcDate': '2010-04-13', 'resultsFirstSubmitDate': '2016-03-14', 'studyFirstSubmitQcDate': '2009-07-16', 'dispFirstPostDateStruct': {'date': '2010-04-15', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2018-09-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-03-14', 'studyFirstPostDateStruct': {'date': '2009-07-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-04-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Direct LDL-C at Week 8', 'timeFrame': 'Baseline and Week 8', 'description': "The percentage change from baseline in the participants' LDL-C was to be evaluated at study Week 8. Standard error presented below is least squares standard error."}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Direct Non-HDL-C at Week 8', 'timeFrame': 'Baseline and Week 8', 'description': "The percentage change from baseline in the participants' non-HDL-C was to be evaluated at study Week 8. Standard error presented below is least squares standard error."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Primary Hypercholesterolemia', 'Mixed Hyperlipidemia']}, 'referencesModule': {'availIpds': [{'url': 'http://www.merck.com/clinical-trials/study.html?id=P05675&kw=P05675&tab=access', 'type': 'CSR Synopsis'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of SCH 900271 compared to placebo on the reduction of low-density lipoprotein cholesterol (LDL-C) from baseline to 8 weeks of treatment in participants with primary hypercholesterolemia (familial and nonfamilial) or mixed hyperlipidemia. The study will also evaluate the effect of SCH 900271 on non-high density lipoprotein cholesterol (non-HDL-C) and various other lipids and lipoproteins. The safety of SCH 900271 in this participant population will also be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults of either sex 18 to 75 years of age, inclusive, with a diagnosis of primary hypercholesterolemia (familial and nonfamilial) or mixed hyperlipidemia (increased LDL-C and triglycerides \\[TG\\])\n* must be free of any clinically significant disease, other than primary hypercholesterolemia or mixed hyperlipidemia that would knowingly interfere with study evaluations\n* must be willing to adhere to dietary recommendations, protocol requirements, and provide written informed consent\n\nExclusion Criteria:\n\nThe participant will be excluded from entry if ANY of the criteria listed below are met:\n\n* use of any investigational drug within 30 days of study entry\n* female of childbearing potential or lactating\n* postmenopausal (or perimenopausal) woman who is currently experiencing hot flashes (e.g. within 30 days of study entry\n* homozygous familial hypercholesterolemia\n* congestive heart failure New York Heart Association (NYHA) Class III or IV\n* uncontrolled hypertension on or off therapy\n* cardiac arrhythmia requiring medication\n* clinical atherosclerotic disease that confers high risk for coronary heart disease (CHD) events (e.g. clinical CHD, symptomatic carotid artery disease, peripheral arterial disease, abdominal aortic aneurysm)\n* Type 1 Diabetes Mellitus\n* Type 2 Diabetes Mellitus\n* history of mental instability, drug/alcohol abuse or who has been treated or is being treated for severe psychiatric illness, which in the opinion of the investigator, may interfere with optimal participation in the study\n* gastrointestinal ulcer within 3 months of study entry\n* history of coagulopathy\n* history of gout\n* known active or chronic hepatic or biliary disease.\n* known significant impairment of renal function, dysproteinemia, nephrotic syndrome, or other renal disease\n* body mass index \\>40 kg/m\\^2\n* taking non-steroidal anti-inflammatory drugs (NSAIDS) (acetaminophen and cyclooxygenase-2 \\[COX-2\\] inhibitors are allowed)\n* taking more than 100 mg aspirin per day\n* being treated with corticosteroids (oral, intramuscular, or intravascular)\n* more than 3 alcoholic beverages per day or its equivalent (one drink equals 1.5 ounces of 80 proof liquor or equivalent) during study participation'}, 'identificationModule': {'nctId': 'NCT00941603', 'briefTitle': 'Phase 2 Dose-Ranging Efficacy and Safety Trial of SCH 900271 in Participants With Primary Hypercholesterolemia or Mixed Hyperlipidemia (P05675)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase 2 Randomized, Double-Blind, Dose-Response Efficacy and Safety Study of SCH 900271 Compared to Placebo in Subjects With Primary Hypercholesterolemia (Familial and Nonfamilial) or Mixed Hyperlipidemia', 'orgStudyIdInfo': {'id': 'P05675'}, 'secondaryIdInfos': [{'id': 'MK-8271-004', 'type': 'OTHER', 'domain': 'Merck protocol number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SCH 900271 15 mg', 'description': 'Participants receive SCH 900271 15 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks', 'interventionNames': ['Drug: SCH 900271 15mg']}, {'type': 'EXPERIMENTAL', 'label': 'SCH 900271 10 mg', 'description': 'Participants receive SCH 900271 10 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks', 'interventionNames': ['Drug: SCH 900271']}, {'type': 'EXPERIMENTAL', 'label': 'SCH 900271 5 mg', 'description': 'Participants receive SCH 900271 5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks', 'interventionNames': ['Drug: SCH 900271']}, {'type': 'EXPERIMENTAL', 'label': 'SCH 900271 2.5 mg', 'description': 'Participants receive SCH 900271 2.5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks', 'interventionNames': ['Drug: SCH 900271']}, {'type': 'EXPERIMENTAL', 'label': 'SCH 900271 1 mg', 'description': 'Participants receive SCH 900271 1 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks', 'interventionNames': ['Drug: SCH 900271']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants receive two placebo tablets once daily in the morning with water in a fasted state for 8 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'SCH 900271 15mg', 'type': 'DRUG', 'description': 'oral tablets; SCH 900271 - 15 mg taken once daily for 8 weeks', 'armGroupLabels': ['SCH 900271 15 mg']}, {'name': 'SCH 900271', 'type': 'DRUG', 'description': 'oral tablets; SCH 900271 10 mg taken once daily for 8 weeks', 'armGroupLabels': ['SCH 900271 10 mg']}, {'name': 'SCH 900271', 'type': 'DRUG', 'description': 'oral tablets; SCH 900271- 5 mg taken once daily for 8 weeks', 'armGroupLabels': ['SCH 900271 5 mg']}, {'name': 'SCH 900271', 'type': 'DRUG', 'description': 'oral tablets; SCH 900271- 2.5 mg taken once daily for 8 weeks', 'armGroupLabels': ['SCH 900271 2.5 mg']}, {'name': 'SCH 900271', 'type': 'DRUG', 'description': 'oral tablets; SCH 900271- 1 mg taken once daily for 8 weeks', 'armGroupLabels': ['SCH 900271 1 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'oral tablets; placebo administered once daily during the 5-week single-blind placebo run-in and diet stabilization period and during the 8 week double-blind treatment period.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'http://engagezone.msd.com/ds_documentation.php', 'ipdSharing': 'YES', 'description': 'https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}