Assess the Safety and Effectiveness of Once Daily PMR Compared to Twice Daily Pletaal® in Patient… (NCT06886620) | Clinical Trial Compass
TerminatedPhase 3
Assess the Safety and Effectiveness of Once Daily PMR Compared to Twice Daily Pletaal® in Patients With Intermittent Claudication
Taiwan14 participantsStarted 2016-03-14
Plain-language 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.
Who can participate
Age range20 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
Geometric mean percent change in initial claudication distance (ICD)