Peripheral Arterial Disease Clinical Trial
Official title:
ACE Inhibition; A Potential New Therapy for Peripheral Arterial Disease
Verified date | April 2012 |
Source | Bayside Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | Australia: National Health and Medical Research Council |
Study type | Interventional |
Leg pain caused by peripheral arterial disease (PAD) can severely impede walking ability. Our preliminary findings indicate that the drug ramipril is much more effective in improving walking ability than current therapies. To be accepted as a new treatment for PAD these findings require validation in a much larger clinical trial.We propose to examine the effects of ramipril therapy for 6 months in a randomized, controlled trial of patients with PAD. If positive, this study will identify ramipril as a potential new therapy for PAD.
Status | Completed |
Enrollment | 200 |
Est. completion date | January 2012 |
Est. primary completion date | August 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Ankle brachial index of <0.9 in at least one leg - History of intermittent claudication (unilateral or bilateral) - A stable medication regimen for at least 6 months Exclusion Criteria: - Limiting coronary artery disease - Renal failure (serum creatinine > 0.20 mmol/L) - Current treatment or treatment within the previous 6 months with ACE inhibitors or angiotensin II receptor antagonists |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Baker Heart Research Institute | Melbourne | Victoria |
Lead Sponsor | Collaborator |
---|---|
Bayside Health |
Australia,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | walking time | baseline and 6 months | No | |
Secondary | walking impairment questionnaire | baseline and 6 months | No |
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