Intermittent Claudication
Conditions
Keywords
Peripheral Arterial Disease, Ankle Brachial Index, Absolute Claudication Distance, Initial Claudication Distance, PMR, Cilostazol
Brief summary
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.
Interventions
DRUGCilostazol 200 mg
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.
Sponsors
Genovate Biotechnology Co., Ltd.,
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: * Stable use of Cilostazol of any strength and any dosing frequency for at least 3 months prior to screening, for the treatment of peripheral arterial disease. * Initial claudication distance ≥ 30 meters at the constant workload treadmill test. Main
Exclusion criteria
* Presence of limb-threatening chronic limb ischemia, manifested by ischemic rest pain, ulceration or gangrene. * History of lower-extremity surgical or endovascular arterial reconstructions or sympathectomy within 3 months prior to screening. * Presence of illness(es) (such as angina pectoris, respiratory disease, orthopaedic disease, or neurological disorders, except the study disease) limiting the exercise capacity. * Presence of uncontrolled hypertension (based on physician's judgment) or other unstable cardiovascular disease such as congestive heart failure of any severity and myocardial infarction within 6 months prior to screening. * History of coronary artery bypass graft (CABG) or major cardiovascular surgical procedures within 6 months prior to screening. * History of Buerger's disease or deep vein thrombosis within 3 months prior to screening. * Presence of haemostatic disorders or active pathologic bleeding, such as bleeding peptic ulcer and intracranial bleeding. * Presence or history of ventricular tachycardia, ventricular fibrillation or multifocal ventricular tachycardia with or without adequate treatment, QTc prolongation associated with cardiac disorders, or severe tachyarrhythmia within 6 months prior to screening, which is considered not suitable for this study by Investigator. * History of type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus. * Use of anticoagulant agent(s) within 6 months prior to screening. * Use of two or more than two anti-platelet agents within 3 months prior to screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric mean percent change in initial claudication distance (ICD) | At baseline (day 0) and week 24 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric mean percent change in initial claudication distance (ICD) | At baseline (day 0) and week 12 | 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. |
| Geometric mean percent change in absolute claudication distance (ACD) | At baseline (day 0) and week 12 | 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. |
| Subject assessment of treatment response | At week 24 | 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. |
Countries
Taiwan
Outcome results
None listed