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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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ClinicalTrials.gov Identifier: NCT02373462
Recruitment Status : Terminated (The data of the paper referenced in the preparation of the protocols in this task were manipulated and the paper was withdrawn.)
First Posted : February 27, 2015
Last Update Posted : January 28, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Tracking Information
First Submitted Date  ICMJE February 14, 2015
First Posted Date  ICMJE February 27, 2015
Last Update Posted Date January 28, 2019
Actual Study Start Date  ICMJE August 25, 2015
Actual Primary Completion Date November 17, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE 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  ICMJE Effect of olmesaRtan on Walking distancE and quaLIty of lifE in Peripheral Artery Disease Patients With Hypertension Treated For Intermittent Claudication (RELIEF)
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Peripheral Artery Disease With Intermittent Claudication
Intervention  ICMJE
  • Drug: Olmesartan
  • Drug: other anti-hypertensive drug
    CCB, diuretics, alpha blocker, direct vasodilator, beta blocker
Study Arms  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 24, 2019)
1
Original Estimated Enrollment  ICMJE
 (submitted: February 22, 2015)
208
Actual Study Completion Date  ICMJE November 17, 2015
Actual Primary Completion Date November 17, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02373462
Other Study ID Numbers  ICMJE 4-2014-0888
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yonsei University
Study Sponsor  ICMJE Yonsei University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Yonsei University
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP