Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-29 @ 1:13 AM
Study NCT ID:
NCT00154050
Status:
COMPLETED
Last Update Posted:
2006-09-12
First Post:
2005-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Dose Candesartan Versus Quinapril for Restenosis Prophylaxis After Stent Angioplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C081643', 'term': 'candesartan'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D000077583', 'term': 'Quinapril'}], 'ancestors': [{'id': 'D044005', 'term': 'Tetrahydroisoquinolines'}, {'id': 'D007546', 'term': 'Isoquinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-09', 'completionDateStruct': {'date': '2006-07'}, 'lastUpdateSubmitDate': '2006-09-11', 'studyFirstSubmitDate': '2005-09-08', 'studyFirstSubmitQcDate': '2005-09-09', 'lastUpdatePostDateStruct': {'date': '2006-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Restenosis/reintervention after 6 months'}], 'secondaryOutcomes': [{'measure': 'pain-free walking distance'}, {'measure': 'crurobrachial pressure ratios'}]}, 'conditionsModule': {'keywords': ['restenosis', 'intima hyperproliferation', 'stent angioplasty', 'pain-free walking distance'], 'conditions': ['Arterial Occlusive Diseases']}, 'descriptionModule': {'briefSummary': 'The study is designed to test the hypothesis that high dose candesartan treatment compared to quinapril is able to reduce intima hyperproliferation and the restenosis rate after stent angioplasty in peripheral occlusive artery disease.', 'detailedDescription': 'Patients are randomly assigned to treatment with either candesartan 32 mg/d or Quinapril 20 mg/d before the angioplasty. Walking distance, intima media thickness and crurobrachial pressure ratios are compared after 6 weeks, 3 months and 6 months. After 6 months an angiographic control is performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male and female\n* peripheral occlusive arterial disease Stad IIb Fontaine classification\n\nExclusion Criteria:\n\n* patients with lesions not available for PTA\n* renal insufficiency\n* patients on calcium-antagonists'}, 'identificationModule': {'nctId': 'NCT00154050', 'briefTitle': 'High Dose Candesartan Versus Quinapril for Restenosis Prophylaxis After Stent Angioplasty', 'organization': {'class': 'OTHER', 'fullName': 'Technische Universität Dresden'}, 'orgStudyIdInfo': {'id': 'IKPD KARDCHEM 02-04'}}, 'armsInterventionsModule': {'interventions': [{'name': 'candesartan (drug) or quinapril (drug)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '09313', 'city': 'Chemnitz', 'country': 'Germany', 'facility': 'Chemnitz Hospital, Dept. of Internal Medicine I', 'geoPoint': {'lat': 50.8357, 'lon': 12.92922}}], 'overallOfficials': [{'name': 'Wilhelm Kirch, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Institute of Clinical Pharmacology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technische Universität Dresden', 'class': 'OTHER'}}}}