CompletedPhase 3

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

South Korea260 participantsStarted 2019-03-12

Plain-language 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

Who can participate

Age range

19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.
. 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.

Exclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change From Baseline in KPAQ Summary Score at Week 24

Timeframe: Baseline and Week 24

Trial details

NCT IDNCT07600385

SponsorKorea United Pharm. Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-05-03

View on ClinicalTrials.gov More Peripheral Arterial Disease trials