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

• ClinicalTrials.gov Identifier: NCT02373462
• Recruitment Status: Terminated
• First Posted: February 27, 2015
• Last Update Posted: January 28, 2019
• Sponsor: Yonsei University
• Information provided by (Responsible Party): Yonsei University

Tracking Information

• First Submitted Date: February 14, 2015
• First Posted Date: February 27, 2015
• Last Update Posted Date: January 28, 2019
• Actual Study Start Date: August 25, 2015
• Actual Primary Completion Date: November 17, 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 24, 2019)

Pain free maximum walking distance and time [ Time Frame: 12th week ]

Effect of olmesartan in maximum, pain free walking distance & time

Original Primary Outcome Measures (submitted: February 22, 2015)

Pain free maximum walking distance and time [ Time Frame: 12th week ]

Effect of olmesartan in masimum, pain free walking distance & time

Current Secondary Outcome Measures (submitted: February 22, 2015)

Quality of life as measured by questionnaires [ Time Frame: 24th week ]

Effect of olmesartan in quality of life (WIQ, SF-36)

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: February 22, 2015)

• Pulse wave analysis as measured by PWV [ Time Frame: 24th week ]
  pulse wave velocity
• Blood pressure by measured by 24hr ABPM [ Time Frame: 24th week ]
  24hr ambulatory blood pressure monitoring

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Effect of olmesaRtan on Walking distancE and quaLIty of lifE in Peripheral Artery Disease Patients With Hypertension Treated For Intermittent Claudication (RELIEF)
• Official Title: Not Provided
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Peripheral Artery Disease With Intermittent Claudication

Intervention

• Drug: Olmesartan
• Drug: other anti-hypertensive drug
  CCB, diuretics, alpha blocker, direct vasodilator, beta blocker

Study Arms

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: January 24, 2019): 1
• Original Estimated Enrollment (submitted: February 22, 2015): 208
• Actual Study Completion Date: November 17, 2015
• Actual Primary Completion Date: November 17, 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT02373462
• Other Study ID Numbers: 4-2014-0888
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Yonsei University
• Study Sponsor: Yonsei University
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Yonsei University
• Verification Date: January 2019