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Peripheral Arterial DiseasePhase 3NCT07600385

A Study to Evaluate the Efficacy and Safety of UI022/UI023

A Phase 3 study of Peripheral Arterial Disease, run by Korea United Pharm. Inc. 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

Efficacy and Safety of Combined Cilostazol and Rosuvastatin Therapy Versus Rosuvastatin Alone in Patients with Chronic Lower Extremity Peripheral Artery Disease: A Multicenter, Double-Blind, Randomized Controlled Trial Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Peripheral Arterial Disease
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
260 participants
Where
1 siteSouth Korea
Study dates
12 Mar 2019to 3 May 2022
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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must meet all of the following criteria.
  • Screening Inclusion Criteria
  • Subjects aged 19 years or older.
  • Subjects with lower limb ischemic symptoms persisting for at least 24 weeks before screening.
  • Subjects who have been taking a statin according to dyslipidemia treatment guidelines for at least 12 weeks before screening.
  • Subjects with stable symptoms without significant improvement during the 12 weeks before screening, with a response of 3 or less to KPAQ Question 3 and a KPAQ summary score of 60 or less.
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  • Subjects with ABI ≤ 0.9 at screening.Subjects with 0.9 < ABI ≤ 1.0 may participate if arterial stenosis of 50% or more is confirmed by vascular imaging.
  • Subjects with Fontaine Stage II, including Stage IIa or IIb.
  • Subjects who voluntarily provide written informed consent to participate in the clinical trial.
  • Randomization Inclusion Criteria
  • Subjects whose KPAQ summary score differs by no more than 10% between the screening visit and baseline visit.
  • Subjects who are able to maintain the dose of rosuvastatin, the run-in medication, during the treatment period.
  • Subjects with compliance of 70% or higher with the run-in medication during the run-in period

Who cannot join

  • Subjects who meet any of the following criteria are not eligible to participate in this clinical trial.
  • Subjects who underwent an endovascular procedure, surgery, or reconstruction within 24 weeks before the screening visit, or who are expected to require such a procedure, surgery, or reconstruction during the clinical trial.
  • Subjects with any of the following medical histories at the screening visit:
  • 1) Myocardial infarction, unstable angina, transient ischemic attack, stroke, coronary artery bypass graft, or coronary angioplasty within 12 weeks.
  • 2) Deep vein thrombosis within 12 weeks. However, subjects with isolated calf vein thrombosis may participate.
  • 3) Intolerance to statins, such as myopathy including rhabdomyolysis. 4) Malignant tumor within 5 years. 5) Alcohol or drug abuse. 3. Subjects with any of the following concomitant diseases at the screening visit:
Show all 34Show fewer
  • Moderate or severe lower limb pain caused by spinal disease, such as spinal stenosis.
  • Congestive heart failure.
  • Bleeding, including hemophilia, capillary fragility, intracranial hemorrhage, upper gastrointestinal bleeding, urinary tract bleeding, hemoptysis, or vitreous hemorrhage, or a bleeding tendency, including active peptic ulcer, hemorrhagic stroke within 24 weeks before screening, surgery within 12 weeks before screening, or proliferative diabetic retinopathy.
  • Severe renal impairment, defined as Clcr < 30 mL/min.
  • Uncontrolled diabetes mellitus, defined as HbA1c > 9%.
  • Uncontrolled hypertension, defined as SBP > 180 mmHg or DBP > 110 mmHg.
  • Abnormal muscle enzyme level, defined as CK > 3 times the upper limit of normal.
  • Active liver disease, including unexplained persistent elevation of serum transaminases, ALT or AST, or elevation of serum transaminases greater than 3 times the upper limit of normal, ALT or AST > 3 times the upper limit of normal.
  • 4. Subjects who have received cilostazol within 12 weeks before screening. 5. Subjects who are expected to require any of the following medications during the clinical trial:
  • Lipid-modifying agents other than rosuvastatin administered in this clinical trial, including statins, ezetimibe, bile acid sequestrants, nicotinic acid and its derivatives, and fibrates.
  • However, lipid-modifying agents other than statins are permitted if they have been administered at a stable dose without dose changes for at least 8 weeks from screening, or at least 12 weeks including the run-in period, and no dose change is expected during the clinical trial.
  • Antiplatelet agents, including aspirin, clopidogrel, dipyridamole, indobufen, prasugrel, sarpogrelate, triflusal, ticagrelor, and ticlopidine.
  • However, except for sarpogrelate and ticlopidine, antiplatelet agents are permitted if they have been administered at a stable dose without dose changes for at least 8 weeks from screening, or at least 12 weeks including the run-in period, and no dose change is expected during the clinical trial. Up to two antiplatelet agents other than the investigational product are permitted. If the investigator determines, based on the benefit-risk assessment of the treatment, that monotherapy with one antiplatelet agent or discontinuation is necessary in subjects receiving one or two antiplatelet agents, this may be permitted.
  • Anticoagulants, including heparin, low molecular weight heparin, warfarin, apixaban, dabigatran, edoxaban, and rivaroxaban.
  • However, non-vitamin K oral anticoagulants may be permitted if they have been administered at a stable dose without dose changes for at least 8 weeks from screening, or at least 12 weeks including the run-in period, and no dose change is expected during the clinical trial. Subjects receiving both a non-vitamin K oral anticoagulant and an antiplatelet agent are not eligible to participate.
  • Thrombolytic agents, including streptokinase, tenecteplase, and urokinase.
  • Prostaglandin E1 or I2 and their derivatives, including alprostadil, beraprost, iloprost, and limaprost.
  • Other medications used for peripheral arterial disease, including pentoxifylline and Ginkgo biloba extract.
  • Cyclosporine.
  • Analgesics, including NSAIDs. However, concomitant use is permitted if analgesics are used transiently for the treatment of diseases other than the target clinical disease or for the treatment of adverse events.
  • 6. Pregnant or lactating women, and women of childbearing potential or men who do not agree to use any of the following reliable contraceptive methods from screening until 30 days after the last dose of the investigational product:
  • Implantation of an intrauterine device or intrauterine system.
  • Sterilization of the subject or the subject's partner.
  • Double-barrier method, including spermicide with condom and contraceptive diaphragm, vaginal sponge, or cervical cap.
  • 7. Subjects who participated in another clinical trial and received or were treated with an investigational drug or medical device within 12 weeks before screening.
  • 8. Subjects with known hypersensitivity or allergy to any component of the investigational product or to drugs of a similar class.
  • 9. Subjects with hereditary problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
  • 10. Subjects who are judged by the investigator to be ineligible to participate in the clinical trial for any other reason.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Yonsei University College of Medicine, Severance Hospital

    Seoul

Other trials in South Korea

About this study

Official title: A Multi-Center, Randomized, Double-Blind, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of UI022/UI023

Efficacy and Safety of Combined Cilostazol and Rosuvastatin Therapy Versus Rosuvastatin Alone in Patients with Chronic Lower Extremity Peripheral Artery Disease: A Multicenter, Double-Blind, Randomized Controlled Trial

Being tested
UI022 or UI023 and co-administration of matching placebo, UIC201604 or UIC201801 and co-administration of matching placebo
Medical subject headings
Peripheral Arterial Disease

What participants receive

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

  • UI022 or UI023 and co-administration of matching placeboDrug

    Run-in period: UIC201802 1 Tab/day + UIC201604 1 Tab/day, or UIC201803 1 Tab/day + UIC201801 1 Tab/day, for 4 weeks Treatment period: UI022 1 Tab/day + UIC201804 1 Tab/day, or UI023 1 Tab/day + UIC201805 1 Tab/day, for 24 weeks

  • UIC201604 or UIC201801 and co-administration of matching placeboDrug

    Run-in period: UIC201802 1 Tab/day + UIC201604 1 Tab/day, or UIC201803 1 Tab/day + UIC201801 1 Tab/day, for 4 weeks Treatment period: UIC201604 1 Tab/day + UIC201802 1 Tab/day, or UIC201801 1 Tab/day + UIC201803 1 Tab/day, for 24 weeks

Study groups in NCT07600385
Study groupRoleWhat they receive
Test groupExperimentalUI022+UIC201804 or UI023+UIC201805
Receives: Drug: UI022 or UI023 and co-administration of matching placebo
Control groupActive comparatorUIC201604+UIC201802 or UIC201801+UIC201803
Receives: Drug: UIC201604 or UIC201801 and co-administration of matching placebo

What is being measured

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

  1. Change From Baseline in KPAQ Summary Score at Week 24

    Measured: Baseline and Week 24

Secondary outcomes (10)

  1. Change From Baseline in KPAQ Summary Score at Weeks 4, 8, and 12

    Measured: Baseline, Week 4, Week 8, and Week 12

  2. Change From Baseline in KPAQ Domain Scores at Weeks 4, 8, 12, and 24

    Measured: Baseline, Week 4, Week 8, Week 12, and Week 24

  3. Change From Baseline in 100-mm VAS Score for Lower Limb Pain at Weeks 4, 8, 12, and 24

    Measured: Baseline, Week 4, Week 8, Week 12, and Week 24

  4. Improvement Rate of Lower Limb Ischemic Symptoms at Weeks 4, 8, 12, and 24

    Measured: Week 4, Week 8, Week 12, and Week 24

  5. Improvement of Lower Limb Ischemic Symptoms Based on Participant Global Assessment at Weeks 4, 8, 12, and 24

    Measured: Week 4, Week 8, Week 12, and Week 24

  6. Change From Baseline in Initial Claudication Distance Using the Treadmill Test at Weeks 12 and 24

    Measured: Baseline, Week 12, and Week 24

  7. Change From Baseline in Functional Claudication Distance Using the Treadmill Test at Weeks 12 and 24

    Measured: Baseline, Week 12, and Week 24

  8. Change From Baseline in Absolute Claudication Distance Using the Treadmill Test at Weeks 12 and 24

    Measured: Baseline, Week 12, and Week 24

  9. Change From Baseline in Ankle-Brachial Index at Weeks 12 and 24

    Measured: Baseline, Week 12, and Week 24

  10. Percent Change From Baseline in Lipid Parameters at Weeks 12 and 24

    Measured: Baseline, Week 12, and Week 24

Timeline

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

  1. First posted20 May 2026
  2. Study start12 Mar 2019
  3. Primary completion3 May 2022
  4. Study completion3 May 2022

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
260 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07600385
Sponsor's protocol ID
KUP-UI022-301
Status last verified
May 2026
First submitted
14 May 2026
Last updated
20 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kemalasari AD, Suh DW, Jin IT, Lee SJ, Ahn CM, Choi D, Jang JY, Yu CW, Kwon O, Ryu HY, Kim U, Park JK, Park KH, Kim JY, Ko YG; KUP-UI022-301 investigators. Efficacy and Safety of Fixed-Dose Combination Therapy with Cilostazol and Rosuvastatin in Patients with Symptomatic Lower Extremity Peripheral Artery Disease: A Multicenter Randomized Controlled Trial. Cardiovasc Drugs Ther. 2026 Sep 7. doi: 10.1007/s10557-026-07951-x. Online ahead of print.

    PubMed 42704575

Questions about this trial

What is this clinical trial studying?

A Phase 3 study of Peripheral Arterial Disease, run by Korea United Pharm. Inc. 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 13 inclusion and 34 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 20 May 2026. 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 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 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?

Change From Baseline in KPAQ Summary Score at Week 24 (time frame: Baseline 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 NCT07600385, which also lists 1 linked publication.

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 May 2026.

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