Ignite Creation Date:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2025-12-31 @ 10:49 PM
Study NCT ID:
NCT00489606
Status:
COMPLETED
Last Update Posted:
2007-06-21
First Post:
2007-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I Study to Investigate the Drug Interaction After Oral Administration of Tamsulosin and SK3530
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007172', 'term': 'Erectile Dysfunction'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C518762', 'term': '2-(5-(4-(2-hydroxyethyl)piperazin-1-ylsulfonyl)-2-n-propoxyphenyl)-5-ethyl-7-n-propyl-3,5-dihydro-4H-pyrrolo(3,2-d)pyrimidin-4-one dihydrochloride'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-06', 'completionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-06-20', 'studyFirstSubmitDate': '2007-06-20', 'studyFirstSubmitQcDate': '2007-06-20', 'lastUpdatePostDateStruct': {'date': '2007-06-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximal decrease from baseline in supine SBP', 'timeFrame': 'within 6 hrs after SK3530 or placebo'}], 'secondaryOutcomes': [{'measure': 'Maximal decrease from baseline in standing SBP, supine/standing DBP & HR', 'timeFrame': 'within 6 hrs after SK3530 or placebo'}, {'measure': 'Outlier analysis: i) Standing/supine SBP < 85 mmHg, DBP < 45 mmHg; ii) Change in standing/supine SBP > 30 mmHg, DBP > 20 mmHg', 'timeFrame': 'within 6 hrs after SK3530 or placebo'}, {'measure': 'Incidence of postural hypotension', 'timeFrame': 'within 6 hrs after SK3530 or placebo'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['SK3530', 'tamsulosin', 'hemodynamic interaction', 'safety'], 'conditions': ['Erectile Dysfunction']}, 'descriptionModule': {'briefSummary': 'To assess the pharamcodynamic effects of coadministrated SK3530(PDE5 inhibitor) and tamsulosin, phase I study in healthy volunteers was designed.', 'detailedDescription': 'During each of the two periods of a randomized, double-blind, placebo-controlled, crossover study, 16 healthy men received tamsulosin 0.2 mg daily for 7 days and either a single 100 mg of SK3530 or placebo on day7. The blood pressure and heart rate were monitored before and for 24 hours after SK3530 or placebo.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ages 20 to 50\n* body weight of IBM±20%\n\nExclusion Criteria:\n\n* cardiovascular disease\n* color-blindness or weakness\n* hypotension, hypertension, orthostatic hypertension\n* abmormal QTc (\\>430 ms)'}, 'identificationModule': {'nctId': 'NCT00489606', 'briefTitle': 'Phase I Study to Investigate the Drug Interaction After Oral Administration of Tamsulosin and SK3530', 'organization': {'class': 'INDUSTRY', 'fullName': 'SK Chemicals Co., Ltd.'}, 'officialTitle': 'Clinical Trial to Investigate the Influence of Drug Interaction After Oral Administration of Tamsulosin and SK3530 in Healthy Male Volunteers', 'orgStudyIdInfo': {'id': 'SK3530_DI_TS'}}, 'armsInterventionsModule': {'interventions': [{'name': 'SK3530', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'In-Jin Chang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SK Chemicals Co., Ltd.', 'class': 'INDUSTRY'}}}}