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

January 24, 2019 updated by: Yonsei University
To study the effect of olmesartan on walking distance and quality of life in peripheral artery disease patients with hypertension treated For intermittent claudication.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Division of Cardiology, Department of Internal Medicine, Severance Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: olmesartan group
olmesartan (20mg qd then 40mg qd for titrating BP <140/90 mmHg)
Drug: Olmesartan
Active Comparator: other group
other anti-hypertensive drug (titrating BP <140/90 mmHg)
Drug: other anti-hypertensive drug
CCB, diuretics, alpha blocker, direct vasodilator, beta blocker

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2015

Primary Completion (Actual)

November 17, 2015

Study Completion (Actual)

November 17, 2015

Study Registration Dates

First Submitted

February 14, 2015

First Submitted That Met QC Criteria

February 22, 2015

First Posted (Estimate)

February 27, 2015

Study Record Updates

Last Update Posted (Actual)

January 28, 2019

Last Update Submitted That Met QC Criteria

January 24, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2014-0888

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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