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

NCT06886620 | Terminated Phase 3 DMC

• 1 other identifier: GBL14-001
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 5

Brief 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

Keywords

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

Outcome Measures

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.

  At baseline (day 0) and week 24

Secondary Outcomes (4)

• Geometric mean percent change in initial claudication distance (ICD)

  At baseline (day 0) and week 12

• Geometric mean percent change in absolute claudication distance (ACD)

  At baseline (day 0) and week 12

• Geometric mean percent change in absolute claudication distance (ACD)

  At baseline (day 0) and week 24

• Subject assessment of treatment response

  At week 24

Study Arms (2)

PMR

EXPERIMENTAL

Cilostazol 200 mg, tablet, PO, QN

Drug: Cilostazol 200 mg

Pletaal®

ACTIVE COMPARATOR

Cilostazol 100 mg, tablet, PO, BID

Drug: Cilostazol 100 mg

Interventions

Cilostazol 200 mg DRUG

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

PMR

Cilostazol 100 mg DRUG

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

Also known as: Pletaal®

Pletaal®

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Genovate Biotechnology Co., Ltd.,: lead

Study Sites (5)

National Taiwan University Hospital

Taipei, 10016, Taiwan

Location

Mackay Memorial Hospital

Taipei, 10449, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Cheng Hsin General Hospital

Taipei, 112, Taiwan

Location

Chang Gung Memorial Hospital Linkou

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

Intermittent Claudication; Peripheral Arterial Disease

Interventions

Cilostazol

Condition Hierarchy (Ancestors)

Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Jen-Kuang Lee, M.D.

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

• Chern-En Chiang, M.D., Ph.D.

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

• Jen-Yuan Kuo, M.D.

  Mackay Memorail Hospital

  PRINCIPAL INVESTIGATOR

• Ming-Shien Wen, M.D.

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

• Yin-Wei Hsian, M.D., Ph.D.

  Cheng-Hsin General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: March 20, 2025
• Study Start: March 14, 2016
• Primary Completion: February 8, 2017
• Study Completion: February 8, 2017
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (5)