Clinical Trial to Evaluate the Efficacy and Safety of Sarpogrelate SR in Patients With Chronic Artery Occlusive Disease

Study Overview
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Brief Summary
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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).

Detailed Description
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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).

Official Title
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A Randomized, Multicenter, Open-label, Parallel, Phase 4 Clinical Trial to Evaluate the Efficacy and Safety of Sarpogrelate SR in Patients Having Intermittent Claudication Among Chronic Artery Occlusive Disease

Conditions
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Arterial Occlusive Diseases, Intermittent Claudication

Intervention / Treatment
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* Drug: Sarpogrelate SR
* Drug: Sarpogrelate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female adults aged ≥ 19 Diagnosis of chronic arterial occlusive disease Experience of intermittent claudication symptoms for at least 3 months Receiving Sarpogrelate for a minimum of 4 weeks prior to the baseline Lower limb pain measured at VAS 40mm or higher at baseline Exclusion Criteria: Patients with coronary artery disease or cerebrovascular disease related to arteriosclerosis undergoing or scheduled for surgery or medication treatment Patients with a history of severe heart failure within the 6 months prior to the screening Patients with a history of bleeding Patients receiving anticoagulants or medications with antiplatelet activity at baseline Patients diagnosed with peripheral neuropathy and currently taking neuropathic pain medications Patients with infectious or progressive fibrotic diseases such as rheumatoid arthritis, systemic lupus erythematosus, idiopathic pulmonary fibrosis, etc

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sarpogrelate SR 300mg, QD<br>Sarpogrelate SR 300mg, QD | Drug: Sarpogrelate SR<br>* Sarpogrelate SR 300mg, once a daily, for 24weeks<br>* Other names: Anplag SR Tab. 300mg;|
| Active Comparator: Sarpogrelate 100mg, TID<br>Sarpogrelate 100mg, TID | Drug: Sarpogrelate<br>* Sarpogrelate 100mg, 3 times a day, for 24weeks<br>* Other names: Anplag Tab. 100mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sarpogrelate Sustained Release, Sarpogrelate