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

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Yonsei University

Status and phase

Terminated
Phase 4

Conditions

Peripheral Artery Disease With Intermittent Claudication

Treatments

Drug: other anti-hypertensive drug
Drug: Olmesartan

Study type

Interventional

Funder types

Other

Identifiers

NCT02373462
4-2014-0888

Details and patient eligibility

About

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

Enrollment

1 patient

Sex

All

Ages

20 to 85 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1 participants in 2 patient groups

olmesartan group
Experimental group
Description:
olmesartan (20mg qd then 40mg qd for titrating BP \<140/90 mmHg)
Treatment:
Drug: Olmesartan
other group
Active Comparator group
Description:
other anti-hypertensive drug (titrating BP \<140/90 mmHg)
Treatment:
Drug: other anti-hypertensive drug

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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