NCT06046196

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 148 (actual)
• Sponsor: Yuhan Corporation · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Arterial Occlusive Diseases
• Intermittent Claudication

Interventions

Type	Name	Description
DRUG	Sarpogrelate SR	Sarpogrelate SR 300mg, once a daily, for 24weeks
DRUG	Sarpogrelate	Sarpogrelate 100mg, 3 times a day, for 24weeks

Timeline

• Start date: 2020-11-18
• Primary completion: 2023-03-09
• Completion: 2023-03-09
• First posted: 2023-09-21
• Last updated: 2023-09-21

Locations

7 sites across 1 country: South Korea