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
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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TERMINATED
PHASE4
1 participants
INTERVENTIONAL
2015-08-25
2015-11-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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olmesartan group
olmesartan (20mg qd then 40mg qd for titrating BP \<140/90 mmHg)
Olmesartan
other group
other anti-hypertensive drug (titrating BP \<140/90 mmHg)
other anti-hypertensive drug
CCB, diuretics, alpha blocker, direct vasodilator, beta blocker
Interventions
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Olmesartan
other anti-hypertensive drug
CCB, diuretics, alpha blocker, direct vasodilator, beta blocker
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
85 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Locations
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Division of Cardiology, Department of Internal Medicine, Severance Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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4-2014-0888
Identifier Type: -
Identifier Source: org_study_id
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