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

Yuhan

Status and phase

Completed

Phase 4

Conditions

Intermittent Claudication

Arterial Occlusive Diseases

Treatments

Drug: Sarpogrelate SR

Drug: Sarpogrelate

Study type

Interventional

Funder types

Industry

Identifiers

NCT06046196

YMC044

Details and patient eligibility

About

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).

Full 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).

Enrollment

148 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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