Clinical Trial to Evaluate Efficacy and Safety of DP-R202 and Anplag in Patients With Artery Occlusive Disease

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Sarpogrelate hydrochloride, a selective 5-HT2A antagonist, has been widely used as an anti-platelet agent for the treatment of PAD. DP-R202 is a new Sarpogrelate hydrochloride product improved patient's convenience and disadvantage of dosage regimen of previous drug. The aim of this study was to compare the efficacy and safety of DP-R202 and Anplag® Tab in patients with PAD

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alvogen Korea
• Treatments: Sarpogrelate

Criteria

Inclusion Criteria:

• Lower limb pain degree is over 40 mm evaluated by VAS at screening

• ABI (ankle-brachial index) ≤0.9

Exclusion Criteria:

• Patients with peripheral related surgery within 1 month of clinical study participation

• Fontaine stage 4, NYHA class 3-4