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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PMR | Experimental | Cilostazol 200 mg, tablet, PO, QN |
|
| Pletaal® | Active Comparator | Cilostazol 100 mg, tablet, PO, BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cilostazol 200 mg | Drug | Provided as 1# placebo tablet in the morning and 1# PMR 200 mg/tablet in the evening, orally, for 24 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At baseline (day 0) and week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At baseline (day 0) and week 12 |
| Geometric mean percent change in absolute claudication distance (ACD) |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jen-Kuang Lee, M.D. | National Taiwan University Hospital | Principal Investigator |
| Chern-En Chiang, M.D., Ph.D. | Taipei Veterans General Hospital, Taiwan | Principal Investigator |
| Jen-Yuan Kuo, M.D. | Mackay Memorail Hospital | Principal Investigator |
| Ming-Shien Wen, M.D. | Chang Gung Memorial Hospital | Principal Investigator |
| Yin-Wei Hsian, M.D., Ph.D. | Cheng-Hsin General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Taipei | 10016 | Taiwan | |||
| Mackay Memorial Hospital |
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| Cilostazol 100 mg | Drug | Provided as 1# Pletaal® 100 mg/tablet, orally twice a day, for 24 weeks. |
|
|
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. |
| 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. | 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:
Participants rating their improvement on claudication symptoms as "Much Better" or "Better" are classified as responders. | At week 24 |
| Taipei |
| 10449 |
| Taiwan |
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| Cheng Hsin General Hospital | Taipei | 112 | Taiwan |
| Chang Gung Memorial Hospital Linkou | Taoyuan | 333 | Taiwan |
| ID | Term |
|---|---|
| D007383 | Intermittent Claudication |
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D016491 | Peripheral Vascular Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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| ID | Term |
|---|---|
| D000077407 | Cilostazol |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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