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

NCT06886620 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2025-03-20

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Genovate Biotechnology Co., Ltd.,

    lead INDUSTRY

Principal Investigators

  • Jen-Kuang Lee, M.D. · National Taiwan University Hospital

  • Chern-En Chiang, M.D., Ph.D. · Taipei Veterans General Hospital, Taiwan

  • Jen-Yuan Kuo, M.D. · Mackay Memorail Hospital

  • Ming-Shien Wen, M.D. · Chang Gung Memorial Hospital

  • Yin-Wei Hsian, M.D., Ph.D. · Cheng-Hsin General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-14
Primary Completion
2017-02-08
Completion
2017-02-08

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06886620 on ClinicalTrials.gov