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
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 148
- Locations
- 7
- Primary Endpoint
- Change in Ankle-Brachial Index (ABI)
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Sarpogrelate SR 300mg, QD
Sarpogrelate SR 300mg, QD
Intervention: Sarpogrelate SR (Drug)
Sarpogrelate 100mg, TID
Sarpogrelate 100mg, TID
Intervention: Sarpogrelate (Drug)
Outcomes
Primary Outcomes
Change in Ankle-Brachial Index (ABI)
Time Frame: from baseline to the 12-week and 24-week
To evaluate the efficacy following administration of Sarpogrelate SR
Secondary Outcomes
- the Rate of subjects with grades of Spontaneous Pain, Numbness, and Coldness(at baseline, 12-week, and 24-week timepoints)
- Change in Medication Adherence Index (MMAS-8)(from baseline to the 12-week and 24-week timepoints.)
- Change in Lower Limb Pain Visual Analogue Scale (VAS)(from baseline to the 12-week and 24-week timepoints)
- Change in Walking Impairment Questionnaire (WIQ)(from baseline to the 12-week and 24-week timepoints)