Effect of olmesaRtan on Walking distancE and quaLIty of lifE in Peripheral Artery Disease Patients With Hypertension Treated For Intermittent Claudication (RELIEF)

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02373462

Enrollment

Registered

2015-02-27

Start date

2015-08-25

Completion date

2015-11-17

Last updated

2019-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Artery Disease With Intermittent Claudication

Brief 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.

Interventions

DRUGOlmesartan

DRUGother anti-hypertensive drug

CCB, diuretics, alpha blocker, direct vasodilator, beta blocker

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Pain free maximum walking distance and time	12th week	Effect of olmesartan in maximum, pain free walking distance & time

Secondary

Measure	Time frame	Description
Quality of life as measured by questionnaires	24th week	Effect of olmesartan in quality of life (WIQ, SF-36)

Other

Measure	Time frame	Description
Pulse wave analysis as measured by PWV	24th week	pulse wave velocity
Blood pressure by measured by 24hr ABPM	24th week	24hr ambulatory blood pressure monitoring

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026