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TerminatedNCT06886620Updated Mar 20, 2025

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

A Phase 3 interventional study of Cilostazol 200 mg and Cilostazol 100 mg in Intermittent Claudication, sponsored by Genovate Biotechnology Co., Ltd.,. Terminated at 5 sites in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2025-03-20.

Sponsored by Genovate Biotechnology Co., Ltd., · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
14
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

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.

02

Conditions studied

  • Intermittent Claudication

Keywords

  • Peripheral Arterial Disease
  • Ankle Brachial Index
  • Absolute Claudication Distance
  • Initial Claudication Distance
  • PMR
  • Cilostazol
03

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Main Inclusion Criteria:

  • Stable use of Cilostazol of any strength and any dosing frequency for at least 3 months prior to screening, for the treatment of peripheral arterial disease.
  • Initial claudication distance ≥ 30 meters at the constant workload treadmill test.

Main Exclusion Criteria:

  • Presence of limb-threatening chronic limb ischemia, manifested by ischemic rest pain, ulceration or gangrene.
  • History of lower-extremity surgical or endovascular arterial reconstructions or sympathectomy within 3 months prior to screening.
  • Presence of illness(es) (such as angina pectoris, respiratory disease, orthopaedic disease, or neurological disorders, except the study disease) limiting the exercise capacity.
  • Presence of uncontrolled hypertension (based on physician's judgment) or other unstable cardiovascular disease such as congestive heart failure of any severity and myocardial infarction within 6 months prior to screening.
  • History of coronary artery bypass graft (CABG) or major cardiovascular surgical procedures within 6 months prior to screening.
  • History of Buerger's disease or deep vein thrombosis within 3 months prior to screening.
  • Presence of haemostatic disorders or active pathologic bleeding, such as bleeding peptic ulcer and intracranial bleeding.
  • Presence or history of ventricular tachycardia, ventricular fibrillation or multifocal ventricular tachycardia with or without adequate treatment, QTc prolongation associated with cardiac disorders, or severe tachyarrhythmia within 6 months prior to screening, which is considered not suitable for this study by Investigator.
  • History of type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus.
  • Use of anticoagulant agent(s) within 6 months prior to screening.
  • Use of two or more than two anti-platelet agents within 3 months prior to screening.
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
14 participants (actual)

Study arms

  • Experimental
    PMR

    Cilostazol 200 mg, tablet, PO, QN

    Drug: Cilostazol 200 mg

  • Active comparator
    Pletaal®

    Cilostazol 100 mg, tablet, PO, BID

    Drug: Cilostazol 100 mg

Interventions

  • DrugCilostazol 200 mg

    Provided as 1# placebo tablet in the morning and 1# PMR 200 mg/tablet in the evening, orally, for 24 weeks.

    Also known as: PMR

  • DrugCilostazol 100 mg

    Provided as 1# Pletaal® 100 mg/tablet, orally twice a day, for 24 weeks.

    Also known as: Pletaal®

05

What researchers measure

Primary outcomes

  1. Geometric mean percent change in initial claudication distance (ICD)

    The standardized workload treadmill test will be conducted for evaluation of walking performance. ICD is defined as the distance walked to the point of the onset of claudication symptoms.

    Time frame: At baseline (day 0) and week 24

Secondary outcomes

  1. Geometric mean percent change in initial claudication distance (ICD)

    The standardized workload treadmill test will be conducted for evaluation of walking performance. ICD is defined as the distance walked to the point of the onset of claudication symptoms.

    Time frame: At baseline (day 0) and week 12

  2. Geometric mean percent change in absolute claudication distance (ACD)

    The standardized workload treadmill test will be conducted for evaluation of walking performance. ACD is defined as the maximal distance walked to the point where severe claudication pain forced cessation of exercise.

    Time frame: At baseline (day 0) and week 12

  3. Geometric mean percent change in absolute claudication distance (ACD)

    The standardized workload treadmill test will be conducted for evaluation of walking performance. ACD is defined as the maximal distance walked to the point where severe claudication pain forced cessation of exercise.

    Time frame: At baseline (day 0) and week 24

  4. Subject assessment of treatment response

    Participants will subjectively evaluate the treatment response of study drug on claudication symptoms which will be categorized into: * Much Better * Better * Unchanged * Worse * Much Worse Participants rating their improvement on claudication symptoms as "Much Better" or "Better" are classified as responders.

    Time frame: At week 24

06

Study locations

5 sites
  • National Taiwan University Hospital
    Taipei, 10016, Taiwan
  • Mackay Memorial Hospital
    Taipei, 10449, Taiwan
  • Taipei Veterans General Hospital
    Taipei, 11217, Taiwan
  • Cheng Hsin General Hospital
    Taipei, 112, Taiwan
  • Chang Gung Memorial Hospital Linkou
    Taoyuan, 333, Taiwan
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06886620
Lead sponsor
Genovate Biotechnology Co., Ltd.,
Responsible party
Sponsor
First posted
Mar 20, 2025
Start date
Mar 14, 2016
Primary completion
Feb 8, 2017
Completion
Feb 8, 2017
Last update
Mar 20, 2025

Study contacts

Jen-Kuang Lee, M.D.
principal investigator · National Taiwan University Hospital
Chern-En Chiang, M.D., Ph.D.
principal investigator · Taipei Veterans General Hospital, Taiwan
Jen-Yuan Kuo, M.D.
principal investigator · Mackay Memorail Hospital
Ming-Shien Wen, M.D.
principal investigator · Chang Gung Memorial Hospital
Yin-Wei Hsian, M.D., Ph.D.
principal investigator · Cheng-Hsin General Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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