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Chronic Occlusive Arterial DiseasePhase 4NCT01711333

A Study to Evaluate the Efficacy and Safety of Pletaal SR Capsule (Cilostazol) in Subjects With Peripheral Arterial Disease Symptom Due to Chronic Occlusive Arterial Disease

A Phase 4 study testing Pletaal SR capsule in people with Chronic Occlusive Arterial Disease, run by Korea Otsuka Pharmaceutical Co., Ltd. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is to evaluate symptomatic changes and safety before and after the administration of Pletaal® SR Capsules based on Peripheral Artery Questionnaire (PAQ) in subjects with peripheral arterial disease symptom due to chronic occlusive arterial disease (COAD). Read more about this study

Who is it for?
Ages 40 to 75 years
Conditions the study is for
Chronic Occlusive Arterial Disease
What is being tested?
Pletaal SR capsule
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
101 participants
Where
1 siteSouth Korea
Study dates
26 Oct 2012to 18 Aug 2014
Phase
Phase 4
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 40 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or Female outpatients between 40 and 75 years of age,
  • Patients confirmed to have symptoms of peripheral arterial disease (including intermittent claudication, pain, coldness and fatigue) in the lower extremities,
  • Patients who have a steady symptom without significant improvement within 12 weeks prior to screening visit and whose PAQ score of the question number 3 is 3 or less at enrollment visit,
  • Ankle Branchial Index (ABI) ≤0.90 when measuring the pressure in a supine position after resting for 10 minutes,
  • Patients who are equal to or less than 10% of the difference in PAQ summary scores at between screening and enrollment,
  • Patients who have been fully explained about this study, voluntarily decided to participate in this study, and provided written informed consent.

Who cannot join

  • Patients with ischemic pain at rest or having ischemic ulcer or gangrene,
  • Patients with Ankle Branchial Index (ABI) ≤ 0.40
  • Patients who underwent sympathectomy or lower extremity arterial reparative surgery including endovascular procedures within 12 weeks prior to screening visit,
  • Patients diagnosed of deep vein thrombosis within 12 weeks prior to screening visit, (provided that patients with isolated calf vein thrombosis may be enrolled)
  • Patients with the following disease:
  • Patients who is on or needs the treatment for Congestive heart failure
Show all 17Show fewer
  • Myocardial infarction which occurred within 24 weeks prior to screening visit
  • Patients who is on or needs the treatment for unstable angina pectoris,
  • Patients with hemorrhage (hemophilia, capillary fragility, intracranial hemorrhage, upper gastrointestinal hemorrhage, urinary hemorrhage, hemoptysis, vitreous hemorrhage, etc.) and predisposition to hemorrhage (active peptic ulcer, hemorrhagic stroke within the recent 24 weeks, suspected hemorrhage when administering cilostazol for wound due to surgery within the recent 12 weeks, and proliferative diabetic retinopathy),
  • PT, aPTT level greater than 1.5 times the upper limit of normal at screening visit,
  • Uncontrolled hypertension defined as ≥ 160 mmHg of systolic blood pressure or ≥ 100 mmHg of diastolic blood pressure,
  • Creatinine clearance(Ccr)a ≤ 25mL/min at screening a. Creatinine clearance (Ccr) is calculated by the following modified Cockcroft-Gault formula using the serum creatinine as determined by the site laboratory.
  • Ccr(mL/min)=[260-age(year)] x Body weight(kg) / 160 x Serum creatinine(mg/dL) (male) Ccr(mL/min)=[236-age(year)] x Body weight(kg) / 180 x Serum creatinine(mg/dL) (female), 10) AST or ALT level greater than 3 times the upper limit of normal at screening, 11) Total bilirubin level greater than 2 times the upper limit of normal at screening, 12) Type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus (HbA1c greater than 9%), 13) Patients determined ineligible to participate in this clinical trial at the discretion of Investigator due to critical diabetic complications (diabetic foot ulcer, foot deformity, etc.), 14) Female patients whose serum pregnancy test at screening or urine pregnancy test at enrollment is positive in case of childbearing potential and breastfeeding women,
  • For female patients, those who have been at their postmenopause at least for one year or longer, who have no potential to be pregnant by surgery or procedure, or who agreed to use acceptable contraceptive methods (intrauterine device [loop or Mirena], double barrier method [diaphragm or condom/femidom + spermicide], vasectomy in spouse, oral contraceptives or non-oral contraceptives) throughout the entire study period,Female patients whose pregnancy test at screening is positive in case of childbearing potential or breastfeeding women 15) History of malignant disease (excluding treated basal cell or squamous cell carcinoma of skin) within 5 years prior to Screening. Resolution of a prior malignancy more than 5 years prior to Screening must be deemed as cured by the investigator, 16) Patients who have history of taking or plan to take the following medications:
  • Cilostazol-containing medications within 12 weeks prior to screening visit,
  • Antiplatelets (such as aspirin and ticlopidine), anticoagulants (such as warfarin), thrombolytics (such as urokinase and alteplase), prostaglandin E1 and its derivatives (such as alprostadil and limaprost), pentoxyfylline, beraprost, sarpogrelate and statin within 4 weeks prior to screening visit. However, aspirin (≤ 100 mg) or statin being taken for more than 4 weeks prior to screening visit may be administered at the same dose.
  • Nitrates, papaverine, isoxsuprine, and NSAIDs within 4 weeks prior to screening visit. However, NSAIDs being taken for more than 4 weeks prior to screening visit may be administered at the same dose, 17) Patients with a history of hypersensitivity to cilostazol, 18) Patients who have received an investigational product or biological agent within 12 weeks prior to screening visit, 19) Patients who plans to enroll in another clinical trial (excluding observational studies) during this study, 20) Patients who needs to stop the Investigational Product because of scheduled operation, extraction of tooth or endoscopy, 21) Patients who are otherwise judged by the investigator to be inappropriate for inclusion in the study.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • KYUNG-HEE UNIVERSITY HOSPITAL at GANGDONG

    Seoul

Other trials in South Korea

About this study

Official title: A Multicenter, Therapeutic Used Study to Evaluate the Efficacy and Safety of Pletaal SR Capsule (Cilostazol) in Subjects With Peripheral Arterial Disease Symptom Due to Chronic Occlusive Arterial Disease

This study is to evaluate symptomatic changes and safety before and after the administration of Pletaal® SR Capsules based on Peripheral Artery Questionnaire (PAQ) in subjects with peripheral arterial disease symptom due to chronic occlusive arterial disease (COAD).

Read the detailed description

This is a multinational, single-arm, therapeutic used clinical trial. After screening in subjects with peripheral arterial disease symptom due to chronic occlusive arterial disease, the eligible subjects will be enrolled, followed by the administration of the study drug (two capsules qd of Pletaal SR 100mg Capsules) for 12 weeks.

Being tested
Pletaal SR capsule

What participants receive

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

  • Pletaal SR capsuleDrug

    two capsules once a day of Pletaal SR 100mg Capsules

Study groups in NCT01711333
Study groupRoleWhat they receive
Pletaal SR capsuleExperimentalNot described
Receives: Drug: Pletaal SR capsule

What is being measured

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

  1. Summary score based on PAQ (Peripheral artery questionnaire)

    Measured: Change from Baseline in PAQ summary score at Week 12

Secondary outcomes (7)

  1. Score of domain (physical limitation) based on PAQ

    Measured: Change from Baseline in PAQ domain (physical limitation) at Week 12

  2. Assessement based on HAQ-DI

    Measured: Change from Baseline in HAQ-DI at Week 12

  3. Score of domain(symptom) based on PAQ

    Measured: Change from Baseline in PAQ domain(symptom) at Week 12

  4. Score of domain(symptom stability) based on PAQ

    Measured: Change from Baseline in PAQ domain(symptom stability) at Week 12

  5. Score ofdomain(social limitation) based on PAQ

    Measured: Change from Baseline in PAQ domain (social limitation) at Week 12

  6. Score of domain(treatment satisfaction) based on PAQ

    Measured: Change from Baseline in PAQ domain (treatment satisfaction) at Week 12

  7. Score of domain(quality of life) based on PAQ

    Measured: Change from Baseline in PAQ domain (quality of life) at Week 12

Timeline

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

  1. First posted22 Oct 2012 (estimated)
  2. Study start26 Oct 2012
  3. Primary completion20 May 2014
  4. Study completion18 Aug 2014

Resources

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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
101 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01711333
Sponsor's protocol ID
021-KOA-1102i
Status last verified
Jun 2022
First submitted
18 Oct 2012
Last updated
10 Jun 2022
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Pletaal SR capsule in people with Chronic Occlusive Arterial Disease, run by Korea Otsuka Pharmaceutical Co., Ltd. at 1 site in South Korea.

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

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. 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: finished, as of the sponsor's last update on 10 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Summary score based on PAQ (Peripheral artery questionnaire) (time frame: Change from Baseline in PAQ summary score at Week 12). 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 NCT01711333.

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 10 Jun 2022.

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