Intermittent ClaudicationPhase 3NCT06886620

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

A Phase 3 study testing Cilostazol 200 mg and Cilostazol 100 mg in people with Intermittent Claudication, run by Genovate Biotechnology Co., Ltd., at 5 sites in Taiwan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Intermittent Claudication
What is being tested?: Cilostazol 200 mg and Cilostazol 100 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 5 sitesTaiwan
Study dates: 14 Mar 2016to 8 Feb 2017
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Taiwan5 sites

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

Other trials in Taiwan

About this study

Official title: A Phase III Prospective, Randomized, Double Blind, Active Controlled, Multicenter, Parallel Group Study to Assess the Safety and Effectiveness of Once Daily PMR Compared to Twice Daily Pletaal® in Patients With Intermittent Claudication

Conditions: Intermittent Claudication
Being tested: Cilostazol 200 mg, Cilostazol 100 mg
Keywords: Peripheral Arterial Disease, Ankle Brachial Index, Absolute Claudication Distance, Initial Claudication Distance, PMR, Cilostazol
Medical subject headings: Intermittent Claudication, Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cilostazol 200 mgDrug
Also called PMR
Provided as 1# placebo tablet in the morning and 1# PMR 200 mg/tablet in the evening, orally, for 24 weeks.
Cilostazol 100 mgDrug
Also called Pletaal®
Provided as 1# Pletaal® 100 mg/tablet, orally twice a day, for 24 weeks.

Study groups in NCT06886620
Study group	Role	What they receive
PMR	Experimental	Cilostazol 200 mg, tablet, PO, QN Receives: Drug: Cilostazol 200 mg
Pletaal®	Active comparator	Cilostazol 100 mg, tablet, PO, BID Receives: Drug: Cilostazol 100 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: At baseline (day 0) and week 24

Secondary outcomes (4)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Mar 20168 Feb 2017

First posted20 Mar 2025
Study start14 Mar 2016
Primary completion8 Feb 2017
Study completion8 Feb 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Intermittent ClaudicationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06886620
Sponsor's protocol ID: GBL14-001
Status last verified: Mar 2025
First submitted: 13 Mar 2025
Last updated: 20 Mar 2025
Results posted: No
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Recruiting
EVERO Drug-coated Balloon (DCB) Randomized Trial
Peripheral Vascular Disease, Peripheral Arterial Disease
Recruiting
Personalised Multicomponent Exercise Programme in Peripheral Arterial Disease
Peripheral Arterial Disease, Intermittent Claudication
Active, not recruitingPhase 4
Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
Peripheral Arterial Disease
RecruitingPhase 3
Improving Mobility After Revascularization in Peripheral Artery Disease
Peripheral Artery Disease, Intermittent Claudication

All Intermittent Claudication trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III Prospective, Randomized, Double Blind, Active Controlled, Multicenter, Parallel Group Study to Assess the Safety and Effectiveness of Once Daily PMR Compared to Twice Daily Pletaal® in Patients With Intermittent Claudication
ClinicalTrials.gov ID: NCT06886620
Acronym / sponsor ID: GBL14-001
Conditions: Intermittent Claudication
Keywords: Peripheral Arterial Disease, Ankle Brachial Index, Absolute Claudication Distance, Initial Claudication Distance, PMR, Cilostazol
Phase: Phase 3
Study type: Interventional
Recruitment status: Terminated
Enrolment: 14 participants (actual)
Lead sponsor: Genovate Biotechnology Co., Ltd.,Industry (pharma, biotech, devices)
Study start: 14 Mar 2016 (actual)
Primary completion: 8 Feb 2017 (actual)
Study completion: 8 Feb 2017 (actual)
First posted: 20 Mar 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
PMR	Experimental	Drug: Cilostazol 200 mgCilostazol 200 mg, tablet, PO, QN
Pletaal®	Active comparator	Drug: Cilostazol 100 mgCilostazol 100 mg, tablet, PO, BID

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cilostazol 200 mgAlso: PMRProvided as 1# placebo tablet in the morning and 1# PMR 200 mg/tablet in the evening, orally, for 24 weeks.	Drug	PMR
Cilostazol 100 mgAlso: Pletaal®Provided as 1# Pletaal® 100 mg/tablet, orally twice a day, for 24 weeks.	Drug	Pletaal®

Primary outcome

Geometric mean percent change in initial claudication distance (ICD)
Time frame: At baseline (day 0) and week 24
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.

4 secondary outcomes

Geometric mean percent change in initial claudication distance (ICD)
Time frame: At baseline (day 0) and week 12
Geometric mean percent change in absolute claudication distance (ACD)
Time frame: At baseline (day 0) and week 12
Geometric mean percent change in absolute claudication distance (ACD)
Time frame: At baseline (day 0) and week 24
Subject assessment of treatment response
Time frame: At week 24

Results and safety

The study was stopped early. Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
Individual participant dataSharing planned: No

Related trials for Intermittent Claudication

Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Recruiting
EVERO Drug-coated Balloon (DCB) Randomized Trial
Peripheral Vascular Disease, Peripheral Arterial Disease
Recruiting
Personalised Multicomponent Exercise Programme in Peripheral Arterial Disease
Peripheral Arterial Disease, Intermittent Claudication
Active, not recruitingPhase 4
Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
Peripheral Arterial Disease
RecruitingPhase 3
Improving Mobility After Revascularization in Peripheral Artery Disease
Peripheral Artery Disease, Intermittent Claudication

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cilostazol 200 mg and Cilostazol 100 mg in people with Intermittent Claudication, run by Genovate Biotechnology Co., Ltd., at 5 sites in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Geometric mean percent change in initial claudication distance (ICD) (time frame: At baseline (day 0) and week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06886620.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.