Peripheral Artery Disease With Intermittent Claudication Clinical Trial
| Verified date | January 2019 |
| Source | Yonsei University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
To study the effect of olmesartan on walking distance and quality of life in peripheral artery disease patients with hypertension treated For intermittent claudication.
| Status | Terminated |
| Enrollment | 1 |
| Est. completion date | November 17, 2015 |
| Est. primary completion date | November 17, 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years to 85 Years |
| Eligibility |
Inclusion Criteria: - Aged between 20 and 85 years at visit 1 - Patients with ankle-brachial index (ABI) of less than 0.9 in one or both legs with history of intermittent claudication stable for the previous 6 months - Patients whose statins, anti hypertensive medications and antiplatelet medications are stable for the past 6 months. Statins and cilostazol are allowed but needs to be stable for the past 6 months (diabetic medications may be changed) - Patients whose blood pressure is more than 140/90 mmHg with/without anti-hypertension treatment Exclusion Criteria: - Blood pressure of more than 180/110 mmHg - Patients taking ARBs or ACE inhibitors treatment for at least 6 months before - Patients taking aldosterone receptor antagonists at least 6 months before - Patients with serum creatinine of more than 3 mg/dL - serum potassium (K+) > 5.5mg/dl - History of bilateral renal artery stenosis - History of acute coronary syndrome or heart failure hospitalization within 6 months - Peripheral arterial revascularization planned within 1 month - Critical limb ischemia - Patients with impaired cognition (e.g. dementia) - pregnancy or women at age of childbearing potential |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Division of Cardiology, Department of Internal Medicine, Severance Hospital | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Yonsei University |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Pulse wave analysis as measured by PWV | pulse wave velocity | 24th week | |
| Other | Blood pressure by measured by 24hr ABPM | 24hr ambulatory blood pressure monitoring | 24th week | |
| Primary | Pain free maximum walking distance and time | Effect of olmesartan in maximum, pain free walking distance & time | 12th week | |
| Secondary | Quality of life as measured by questionnaires | Effect of olmesartan in quality of life (WIQ, SF-36) | 24th week |