Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2026-02-23 @ 12:23 PM
Study NCT ID:
NCT01870466
Status:
COMPLETED
Last Update Posted:
2015-05-27
First Post:
2012-05-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacodynamic Drug Interaction Between Cilostazol and Statins
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077407', 'term': 'Cilostazol'}, {'id': 'D019821', 'term': 'Simvastatin'}, {'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}], 'ancestors': [{'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'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'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-22', 'studyFirstSubmitDate': '2012-05-04', 'studyFirstSubmitQcDate': '2013-06-03', 'lastUpdatePostDateStruct': {'date': '2015-05-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'lipid lowering effect', 'timeFrame': '7 days', 'description': 'lipid panel'}], 'secondaryOutcomes': [{'measure': 'anti-platelet effect', 'timeFrame': '7 days', 'description': 'platelet aggregation test'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate pharmacodynamic drug interaction between cilostazol and statins (simvastatin as a CYP3A substrate and rosuvastatin as a non-CYP3A substrate) in healthy male subjects.', 'detailedDescription': 'Subjects suitable for this study will visit to the Clinical Trial Center, Samsung Medical Center for 7 days and pharmacodynamic samplings will be performed following the administration of study drugs.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male subjects aged 20 - 55 years\n* A body mass index in the range 18.5 - 27 kg/m2\n* Willingness to participate during the entire study period\n* Written informed consent after being fully informed about the study procedures\n\nExclusion Criteria:\n\n* Any past medical history of hepatic, renal, neurologic, cardiovascular, respiratory, endocrine, hemato-oncologic or psychiatric disease\n* Active bleeding or bleeding tendency\n* History of gastrointestinal disease or surgery possibly affecting drug absorption\n* History of clinically significant drug hypersensitivity\n* Use of medication within 7 days before the first dose\n* Heavy drinker (\\>140 g/week)\n* Whole blood donation during 60 days before the study\n* Judged not eligible for study participation by investigator'}, 'identificationModule': {'nctId': 'NCT01870466', 'acronym': 'SMCCPT-100', 'briefTitle': 'Pharmacodynamic Drug Interaction Between Cilostazol and Statins', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacodynamic Drug Interaction Between Cilostazol and Statins in Healthy Male Volunteer', 'orgStudyIdInfo': {'id': '2011-11-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'C -> C + S', 'description': 'cilostazol (C) in period 1, cilostazol + simvastatin (C+S) in period 2', 'interventionNames': ['Drug: Cilostazol', 'Drug: Simvastatin']}, {'type': 'EXPERIMENTAL', 'label': 'C + S -> C', 'description': 'cilostazol + simvastatin (C+S) in period 1, cilostazol (C) in period 2', 'interventionNames': ['Drug: Cilostazol', 'Drug: Simvastatin']}, {'type': 'EXPERIMENTAL', 'label': 'S -> S + C', 'description': 'simvastatin (S) in period 1, simvastatin + cilostazol (S+C) in period 2', 'interventionNames': ['Drug: Cilostazol', 'Drug: Simvastatin']}, {'type': 'EXPERIMENTAL', 'label': 'C + S -> S', 'description': 'cilostazol + simvastatin (C+S) in period 1, simvastatin (S) in period 2', 'interventionNames': ['Drug: Cilostazol', 'Drug: Simvastatin']}, {'type': 'EXPERIMENTAL', 'label': 'R -> C + R', 'description': 'rosuvastatin (R) in period 1, cilostazol + rosuvastatin (C+R) in period 2', 'interventionNames': ['Drug: Cilostazol', 'Drug: Rosuvastatin']}, {'type': 'EXPERIMENTAL', 'label': 'C + R -> R', 'description': 'cilostazol + rosuvastatin (C+R) in period 1, rosuvastatin (R) in period 2', 'interventionNames': ['Drug: Cilostazol', 'Drug: Rosuvastatin']}], 'interventions': [{'name': 'Cilostazol', 'type': 'DRUG', 'otherNames': ['cilostazol (C); Plettal 100 mg'], 'description': 'cilostazol bid for 7 days', 'armGroupLabels': ['C + R -> R', 'C + S -> C', 'C + S -> S', 'C -> C + S', 'R -> C + R', 'S -> S + C']}, {'name': 'Simvastatin', 'type': 'DRUG', 'otherNames': ['simvastatin (S); Zocor 40 mg'], 'description': 'simvastatin qd for 7 days', 'armGroupLabels': ['C + S -> C', 'C + S -> S', 'C -> C + S', 'S -> S + C']}, {'name': 'Rosuvastatin', 'type': 'DRUG', 'otherNames': ['Rosuvastatin (R); Crestor 20 mg'], 'description': 'rosuvastatin qd for 7 days', 'armGroupLabels': ['C + R -> R', 'R -> C + R']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jae-Wook Ko, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}