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

NCT07600385 | Completed Phase 3

• 1 other identifier: KUP-UI022-301
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in KPAQ Summary Score at Week 24

  Baseline and Week 24

Secondary Outcomes (10)

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

  Baseline, Week 4, Week 8, and Week 12

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

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

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

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

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

  Week 4, Week 8, Week 12, and Week 24

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

  Week 4, Week 8, Week 12, and Week 24

Study Arms (2)

Test group

EXPERIMENTAL

UI022+UIC201804 or UI023+UIC201805

Drug: UI022 or UI023 and co-administration of matching placebo

Control group

ACTIVE COMPARATOR

UIC201604+UIC201802 or UIC201801+UIC201803

Drug: UIC201604 or UIC201801 and co-administration of matching placebo

Interventions

UI022 or UI023 and co-administration of matching placebo DRUG

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

Test group

UIC201604 or UIC201801 and co-administration of matching placebo DRUG

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

Control group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must meet all of the following 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.
• 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.
• 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

You may not qualify if:

• 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:
• \) Myocardial infarction, unstable angina, transient ischemic attack, stroke, coronary artery bypass graft, or coronary angioplasty within 12 weeks.
• \) Deep vein thrombosis within 12 weeks. However, subjects with isolated calf vein thrombosis may participate.
• \) 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:
• 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.
• \. 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:

Sponsors & Collaborators

• Korea United Pharm. Inc.: lead

Study Sites (1)

Yonsei University College of Medicine, Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: May 20, 2026
• Study Start: March 12, 2019
• Primary Completion: May 3, 2022
• Study Completion: May 3, 2022
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)