Overview
Effect of olmesaRtan on Walking distancE and quaLIty of lifE in Peripheral Artery Disease Patients With Hypertension Treated For Intermittent Claudication (RELIEF)
Status:
Terminated
Terminated
Trial end date:
2015-11-17
2015-11-17
Target enrollment:
0
0
Participant gender:
All
All
Summary
To study the effect of olmesartan on walking distance and quality of life in peripheral artery disease patients with hypertension treated For intermittent claudication.Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Yonsei UniversityTreatments:
Antihypertensive Agents
Olmesartan
Olmesartan Medoxomil
Criteria
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