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This clinical trial aims to assess the non-inferiority of Sarpogrelate SR 300mg once daily compared to Sarpogrelate 100mg three times daily in patients having intermittent claudication among chronic artery occlusive disease, based on changes in the Ankle-Brachial Index (ABI).
The clinical trial is a randomized, multicenter, open-label, parallel-group, Phase 4 study conducted to evaluate the non-inferiority of Sarpogrelate SR 300mg once daily compared to Sarpogrelate 100mg three times daily in patients having intermittent claudication among chronic artery occlusive disease. Eligible patients who sign the informed consent form voluntarily will receive the investigational products. Subsequently, they will undergo observation and various assessments at the 12-week and 24-week visits. The trial is designed to determine whether Sarpogrelate SR 300mg once daily is inferior to Sarpogrelate 100mg three times daily in terms of changes in the Ankle-Brachial Index (ABI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sarpogrelate SR 300mg, QD | Experimental | Sarpogrelate SR 300mg, QD |
|
| Sarpogrelate 100mg, TID | Active Comparator | Sarpogrelate 100mg, TID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sarpogrelate SR | Drug | Sarpogrelate SR 300mg, once a daily, for 24weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Ankle-Brachial Index (ABI) | To evaluate the efficacy following administration of Sarpogrelate SR | from baseline to the 12-week and 24-week |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Lower Limb Pain Visual Analogue Scale (VAS) | To evaluate the efficacy following administration of Sarpogrelate SR | from baseline to the 12-week and 24-week timepoints |
| Change in Medication Adherence Index (MMAS-8) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jungyo Gwon | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GangNeung Asan Hospital | Gangneung-si | Gangwon-do | 25440 | South Korea | ||
| Inje University Ilsan Paik Hospital |
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| Sarpogrelate | Drug | Sarpogrelate 100mg, 3 times a day, for 24weeks |
|
|
To evaluate the efficacy following administration of Sarpogrelate SR
| from baseline to the 12-week and 24-week timepoints. |
| Change in Walking Impairment Questionnaire (WIQ) | To evaluate the efficacy following administration of Sarpogrelate SR | from baseline to the 12-week and 24-week timepoints |
| the Rate of subjects with grades of Spontaneous Pain, Numbness, and Coldness | To evaluate the efficacy following administration of Sarpogrelate SR | at baseline, 12-week, and 24-week timepoints |
| Goyang-si |
| Gyeonggi-do |
| 10380 |
| South Korea |
| Dong-A University Hospital | Busan | 49201 | South Korea |
| Korea University ANAM Hospital | Seoul | 02841 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| The Catholic University of Korea, Seoul ST. Mary's Hospital | Seoul | 06591 | South Korea |
| Ulsan University Hospital | Ulsan | 44602 | South Korea |
| ID | Term |
|---|---|
| D001157 | Arterial Occlusive Diseases |
| D007383 | Intermittent Claudication |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D058729 | Peripheral Arterial Disease |
| D016491 | Peripheral Vascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C064294 | sarpogrelate |
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