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

NCT ID: NCT02373462

Last Updated: 2019-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-25

Study Completion Date

2015-11-17

Brief Summary

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To study the effect of olmesartan on walking distance and quality of life in peripheral artery disease patients with hypertension treated For intermittent claudication.

Detailed Description

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Conditions

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Peripheral Artery Disease With Intermittent Claudication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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olmesartan group

olmesartan (20mg qd then 40mg qd for titrating BP \<140/90 mmHg)

Group Type EXPERIMENTAL

Olmesartan

Intervention Type DRUG

other group

other anti-hypertensive drug (titrating BP \<140/90 mmHg)

Group Type ACTIVE_COMPARATOR

other anti-hypertensive drug

Intervention Type DRUG

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

Interventions

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Olmesartan

Intervention Type DRUG

other anti-hypertensive drug

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Division of Cardiology, Department of Internal Medicine, Severance Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2014-0888

Identifier Type: -

Identifier Source: org_study_id

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