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
Trial end date:
2015-11-17
Target enrollment:
0
Participant gender:
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 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Yonsei University
Treatments:
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