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Search / Trial NCT06886620

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

Launched by GENOVATE BIOTECHNOLOGY CO., LTD., · Mar 19, 2025

Trial Information

Current as of July 15, 2025

Terminated

Keywords

Peripheral Arterial Disease Ankle Brachial Index Absolute Claudication Distance Initial Claudication Distance Pmr Cilostazol

ClinConnect Summary

No description provided

Gender

ALL

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.

About Genovate Biotechnology Co., Ltd.,

Genovate Biotechnology Co., Ltd. is a leading biopharmaceutical company dedicated to the development of innovative therapies that address unmet medical needs. With a strong focus on research and development, Genovate harnesses advanced biotechnological methodologies to create effective solutions in areas such as oncology, autoimmune diseases, and infectious diseases. Committed to improving patient outcomes, the company emphasizes rigorous clinical trials, regulatory compliance, and collaboration with global healthcare partners. Through its dedication to scientific excellence and patient-centric approaches, Genovate aims to contribute significantly to the future of medicine.

Locations

Taipei, , Taiwan

Taipei, , Taiwan

Taipei, , Taiwan

Taipei, , Taiwan

Taipei, , Taiwan

Taoyuan, , Taiwan

Patients applied

0 patients applied

Trial Officials

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

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported