Arterial Occlusive Diseases, Intermittent Claudication
Conditions
Keywords
Sarpogrelate Sustained Release, Sarpogrelate
Brief summary
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
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).
Interventions
DRUGSarpogrelate SR
Sarpogrelate SR 300mg, once a daily, for 24weeks
DRUGSarpogrelate
Sarpogrelate 100mg, 3 times a day, for 24weeks
Sponsors
Yuhan Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Ankle-Brachial Index (ABI) | from baseline to the 12-week and 24-week | To evaluate the efficacy following administration of Sarpogrelate SR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Lower Limb Pain Visual Analogue Scale (VAS) | from baseline to the 12-week and 24-week timepoints | To evaluate the efficacy following administration of Sarpogrelate SR |
| Change in Medication Adherence Index (MMAS-8) | from baseline to the 12-week and 24-week timepoints. | To evaluate the efficacy following administration of Sarpogrelate SR |
| Change in Walking Impairment Questionnaire (WIQ) | from baseline to the 12-week and 24-week timepoints | To evaluate the efficacy following administration of Sarpogrelate SR |
| the Rate of subjects with grades of Spontaneous Pain, Numbness, and Coldness | at baseline, 12-week, and 24-week timepoints | To evaluate the efficacy following administration of Sarpogrelate SR |
Countries
South Korea
Outcome results
None listed