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
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.
309 studies on the registry are indexed under Intermittent Claudication; 46 are open to participants now.
This study's enrollment of 14 is below the median of 74 across 242 interventional studies indexed under Intermittent Claudication.
Browse Intermittent Claudication studies →Genovate Biotechnology Co., Ltd., is the lead sponsor of 13 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Main Inclusion Criteria:
Main Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cilostazol 200 mg, tablet, PO, QN
Drug: Cilostazol 200 mg
Cilostazol 100 mg, tablet, PO, BID
Drug: Cilostazol 100 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
Provided as 1# Pletaal® 100 mg/tablet, orally twice a day, for 24 weeks.
Also known as: Pletaal®
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
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
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
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
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
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2016 to primary completion in Feb 2017, 10 months.
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This study is terminated, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cilostazol
Genovate Biotechnology Co., Ltd.,