Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:38 PM
Study NCT ID:
NCT00168467
Status:
COMPLETED
Last Update Posted:
2009-01-29
First Post:
2005-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of Ramipril on Clinical Symptoms in Patients With Peripheral Arterial Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017257', 'term': 'Ramipril'}], 'ancestors': [{'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'lastUpdateSubmitDate': '2009-01-28', 'studyFirstSubmitDate': '2005-09-09', 'studyFirstSubmitQcDate': '2005-09-09', 'lastUpdatePostDateStruct': {'date': '2009-01-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to onset of claudication'}, {'measure': 'Total exercise time during a standard treadmill test'}, {'measure': 'Walking ability measured using the standard Walking Impairment Questionnaire'}], 'secondaryOutcomes': [{'measure': 'Leg Blood Flow using Duplex Ultrasound'}]}, 'conditionsModule': {'conditions': ['Peripheral Arterial Disease']}, 'referencesModule': {'references': [{'pmid': '16670135', 'type': 'RESULT', 'citation': 'Ahimastos AA, Lawler A, Reid CM, Blombery PA, Kingwell BA. Brief communication: ramipril markedly improves walking ability in patients with peripheral arterial disease: a randomized trial. Ann Intern Med. 2006 May 2;144(9):660-4. doi: 10.7326/0003-4819-144-9-200605020-00009.', 'retractions': [{'pmid': '26544086', 'source': 'Ann Intern Med. 2015 Dec 1;163(11):884'}]}]}, 'descriptionModule': {'briefSummary': 'One important clinical challenge in older individuals is maintaining mobility in the absence of pain. Peripheral arterial disease affects up to 12% of adults over 50 and impairs quality of life due to intermittent claudication causing pain and limiting mobility.\n\nConventional therapies have only modest effect in improving symptoms. The investigators hypothesise that angiotensin converting enzyme inhibition (with ramipril), which causes arterial vasodilation, also improves clinical symptoms in patients with peripheral arterial disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ankle-brachial index of \\<0.9 at rest in at least one leg\n* History of intermittent claudication (unilateral or bilateral) which was stable for 6 months\n* Evidence of superficial femoral artery stenosis or occlusion on duplex scan\n* Blood pressure \\<=160/90 mmHg\n* Stable medication regimen for at least 6 months and not previously treated with ACE inhibitors\n\nExclusion Criteria:\n\n* Limiting coronary artery disease\n* Renal Failure\n* History of hypertension\n* History of type 2 diabetes mellitus'}, 'identificationModule': {'nctId': 'NCT00168467', 'briefTitle': 'The Effects of Ramipril on Clinical Symptoms in Patients With Peripheral Arterial Disease', 'organization': {'class': 'OTHER', 'fullName': 'Baker Heart Research Institute'}, 'officialTitle': 'The Effects of Ramipril on Clinical Symptoms in Patients With Peripheral Arterial Disease', 'orgStudyIdInfo': {'id': '20/03'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ramipril', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Alfred Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'overallOfficials': [{'name': 'Bronwyn A Kingwell, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baker Heart Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baker Heart Research Institute', 'class': 'OTHER'}}}}