NCT06886620

Assess the Safety and Effectiveness of Once Daily PMR Compared to Twice Daily Pletaal® in Patients With Intermittent Claudication

A Phase III Prospective, Randomized, Double Blind, Active Controlled, Multicenter, Parallel Group Study to Assess the Safety and Effectiveness of Once Daily PMR Compared to Twice Daily Pletaal® in Patients With Intermittent Claudication

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Genovate Biotechnology Co., Ltd., · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The study is designed to compare the efficacy and safety of once daily PMR treatment with twice daily Pletaal® treatment in patients with intermittent claudication caused by peripheral arterial disease and are currently treated with cilostazol of any strength and any dosing frequency.

Conditions

• Intermittent Claudication

Interventions

Type	Name	Description
DRUG	Cilostazol 200 mg	Provided as 1# placebo tablet in the morning and 1# PMR 200 mg/tablet in the evening, orally, for 24 weeks.
DRUG	Cilostazol 100 mg	Provided as 1# Pletaal® 100 mg/tablet, orally twice a day, for 24 weeks.

Timeline

• Start date: 2016-03-14
• Primary completion: 2017-02-08
• Completion: 2017-02-08
• First posted: 2025-03-20
• Last updated: 2025-03-20

Locations

5 sites across 1 country: Taiwan