None listed
Conditions
Interventions
Drug : This clinical trial consists of a 4-week run-in period followed by a 24-week treatment period. During the run-in period, all participants will receive UIC201802 1 tablet/day plus UIC201604 1 ta
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria: Subjects must meet all of the following criteria. Screening Inclusion Criteria 1) Subjects aged 19 years or older. 2) Subjects with lower limb ischemic symptoms persisting for at least 24 weeks before screening. 3) Subjects who have been taking a statin according to dyslipidemia treatment guidelines for at least 12 weeks before screening. 4) Subjects with stable symptoms without significant improvement during the 12 weeks before screening, with a response of 3 or less to Korean Peripheral Artery Questionnaire (KPAQ) Question 3 and a KPAQ summary score of 60 or less. 5) Subjects with ankle-brachial index (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. 6) Subjects with Fontaine Stage II, including Stage IIa or IIb. 7) Subjects who voluntarily provide written informed consent to participate in the clinical trial. Randomization Inclusion Criteria 1) Subjects whose Korean Peripheral Artery Questionnaire (KPAQ) summary score differs by no more than 10% between the screening visit and baseline visit. 2) Subjects who are able to maintain the dose of rosuvastatin, the run-in medication, during the treatment period. 3) Subjects with compliance of 70% or higher with the run-in medication during the run-in period.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: Subjects who meet any of the following criteria are not eligible to participate in this clinical trial. 1. 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. 2. 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: 1) Moderate or severe lower limb pain caused by spinal disease, such as spinal stenosis. 2) Congestive heart failure. 3) 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. 4) Severe renal impairment, defined as creatinine clearance (CLcr) 9%. 6) Uncontrolled hypertension, defined as systolic blood pressure (SBP) > 180 mmHg or diastolic blood pressure (DBP) > 110 mmHg. 7) Abnormal muscle enzyme level, defined as creatine kinase (CK) > 3 times the upper limit of normal. 8) Active liver disease, including unexplained persistent elevation of serum transaminases, alanine aminotransferase (ALT) or aspartate aminotransferase (AST), or elevation of serum transaminases greater than 3 times the upper limit of normal, defined as 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: 1) 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. 2) 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. 3) Anticoag
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Korean Peripheral Artery Questionnaire (KPAQ) summary score at Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in Korean Peripheral Artery Questionnaire (KPAQ) summary score at Weeks 4, 8, and 12;Change from baseline in Korean Peripheral Artery Questionnaire (KPAQ) domain scores [physical limitation, symptom, symptom stability, social limitation, treatment satisfaction, and quality of life] at Weeks 4, 8, 12, and 24;Change from baseline in 100 mm Visual Analogue Scale (VAS) score for lower extremity pain at Weeks 4, 8, 12, and 24;Improvement rate of lower extremity ischemic symptoms at Weeks 4, 8, 12, and 24 [defined as a decrease of at least 10 mm in Visual Analogue Scale (VAS) score];Improvement in lower extremity ischemic symptoms based on the subject’s global assessment at Weeks 4, 8, 12, and 24;Change from baseline in initial claudication distance (ICD) measured by treadmill test at Weeks 12 and 24;Change from baseline in functional claudication distance (FCD) measured by treadmill test at Weeks 12 and 24;Change from baseline in absolute claudication distance (ACD) measured by treadmill test at Weeks 12 and 24;Change from baseline in ankle-brachial index (ABI) at Weeks 12 and 24;Percent change from baseline in lipid parameters at Weeks 12 and 24: total cholesterol (TC), triglyceride (TG), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), non-HDL-C, apolipoprotein A-1 (Apo A-1), and apolipoprotein B (Apo B) | — |
Countries
Korea, Republic of
Contacts
Public ContactJi-Hwan Lee
Korea United Pharm
Outcome results
None listed