Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:04 AM
Study NCT ID:
NCT00120718
Status:
COMPLETED
Last Update Posted:
2008-09-30
First Post:
2005-07-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Fasudil on Vascular Function in Humans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D006937', 'term': 'Hypercholesterolemia'}], 'ancestors': [{'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C049347', 'term': 'fasudil'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-09', 'completionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-09-26', 'studyFirstSubmitDate': '2005-07-12', 'studyFirstSubmitQcDate': '2005-07-18', 'lastUpdatePostDateStruct': {'date': '2008-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-07-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vascular reactivity'}], 'secondaryOutcomes': [{'measure': 'Rho kinase expression'}, {'measure': 'Rho kinase activity'}, {'measure': 'eNOS expression'}, {'measure': 'eNOS activity'}, {'measure': 'inflammatory markers'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Atherosclerosis', 'Hypercholesterolemia']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate how the rho kinase inhibitor, fasudil, affects vascular function in patients with atherosclerosis and hyperlipidemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Coronary artery disease\n* Hyperlipidemia -OR-\n* Healthy adults\n\nExclusion Criteria:\n\n* Unstable angina, myocardial infarction or revascularization within 3 months\n* Symptomatic heart failure\n* Creatinine \\> 3.0 mg/dl\n* Liver enzymes \\> 3X upper limit of normal\n* Chronic hypoxia\n* Significant anemia\n* Chronic inflammatory disease\n* Pregnancy\n* Willing to withdraw statins for duration of study'}, 'identificationModule': {'nctId': 'NCT00120718', 'briefTitle': 'The Effect of Fasudil on Vascular Function in Humans', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'The Effect of Fasudil on Vascular Function in Humans', 'orgStudyIdInfo': {'id': '2002-P-000890'}}, 'armsInterventionsModule': {'interventions': [{'name': 'fasudil', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Mark A Creager, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Mark A. Creager, MD', 'oldOrganization': "Brigham and Women's Hospital"}}}}