Study Stopped
The data of the paper referenced in the preparation of the protocols in this task were manipulated and the paper was withdrawn.
Effect of olmesaRtan on Walking distancE and quaLIty of lifE in Peripheral Artery Disease Patients With Hypertension Treated For Intermittent Claudication (RELIEF)
1 other identifier
interventional
1
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Aug 2015
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 14, 2015
CompletedFirst Posted
Study publicly available on registry
February 27, 2015
CompletedStudy Start
First participant enrolled
August 25, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 17, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 17, 2015
CompletedJanuary 28, 2019
January 1, 2019
3 months
February 14, 2015
January 24, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Pain free maximum walking distance and time
Effect of olmesartan in maximum, pain free walking distance \& time
12th week
Secondary Outcomes (1)
Quality of life as measured by questionnaires
24th week
Other Outcomes (2)
Pulse wave analysis as measured by PWV
24th week
Blood pressure by measured by 24hr ABPM
24th week
Study Arms (2)
olmesartan group
EXPERIMENTALolmesartan (20mg qd then 40mg qd for titrating BP \<140/90 mmHg)
other group
ACTIVE COMPARATORother anti-hypertensive drug (titrating BP \<140/90 mmHg)
Interventions
CCB, diuretics, alpha blocker, direct vasodilator, beta blocker
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Division of Cardiology, Department of Internal Medicine, Severance Hospital
Seoul, 120-752, South Korea
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2015
First Posted
February 27, 2015
Study Start
August 25, 2015
Primary Completion
November 17, 2015
Study Completion
November 17, 2015
Last Updated
January 28, 2019
Record last verified: 2019-01