The study is designed to compare the efficacy and safety of once daily PMR treatment with twice daily Pletaal® treatment in patients with intermittent claudication caused by peripheral arterial disease and are currently treated with cilostazol of any strength and any dosing frequency.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
14
Provided as 1# placebo tablet in the morning and 1# PMR 200 mg/tablet in the evening, orally, for 24 weeks.
Provided as 1# Pletaal® 100 mg/tablet, orally twice a day, for 24 weeks.
National Taiwan University Hospital
Taipei, Taiwan
Mackay Memorial Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Cheng Hsin General Hospital
Taipei, Taiwan
Chang Gung Memorial Hospital Linkou
Geometric mean percent change in initial claudication distance (ICD)
The standardized workload treadmill test will be conducted for evaluation of walking performance. ICD is defined as the distance walked to the point of the onset of claudication symptoms.
Time frame: At baseline (day 0) and week 24
Geometric mean percent change in initial claudication distance (ICD)
The standardized workload treadmill test will be conducted for evaluation of walking performance. ICD is defined as the distance walked to the point of the onset of claudication symptoms.
Time frame: At baseline (day 0) and week 12
Geometric mean percent change in absolute claudication distance (ACD)
The standardized workload treadmill test will be conducted for evaluation of walking performance. ACD is defined as the maximal distance walked to the point where severe claudication pain forced cessation of exercise.
Time frame: At baseline (day 0) and week 12
Geometric mean percent change in absolute claudication distance (ACD)
The standardized workload treadmill test will be conducted for evaluation of walking performance. ACD is defined as the maximal distance walked to the point where severe claudication pain forced cessation of exercise.
Time frame: At baseline (day 0) and week 24
Subject assessment of treatment response
Participants will subjectively evaluate the treatment response of study drug on claudication symptoms which will be categorized into: * Much Better * Better * Unchanged * Worse * Much Worse Participants rating their improvement on claudication symptoms as "Much Better" or "Better" are classified as responders.
Time frame: At week 24
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Taoyuan, Taiwan