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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02373462
Other study ID # 4-2014-0888
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
Start date August 25, 2015
Est. completion date November 17, 2015

Study information

Verified date January 2019
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 1
Est. completion date November 17, 2015
Est. primary completion date November 17, 2015
Accepts healthy volunteers No
Gender All
Age group 20 Years to 85 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Olmesartan

other anti-hypertensive drug
CCB, diuretics, alpha blocker, direct vasodilator, beta blocker

Locations

Country Name City State
Korea, Republic of Division of Cardiology, Department of Internal Medicine, Severance Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Other Pulse wave analysis as measured by PWV pulse wave velocity 24th week
Other Blood pressure by measured by 24hr ABPM 24hr ambulatory blood pressure monitoring 24th week
Primary Pain free maximum walking distance and time Effect of olmesartan in maximum, pain free walking distance & time 12th week
Secondary Quality of life as measured by questionnaires Effect of olmesartan in quality of life (WIQ, SF-36) 24th week