Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy of DW5421A/DW5421B Comp… (NCT07444762) | Clinical Trial Compass
CompletedPhase 3
Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy of DW5421A/DW5421B Compared to Monotherapy of DW5421A
South Korea184 participantsStarted 2025-04-21
Plain-language summary
This is a multicenter, randomized, double-blind, active-controlled, parallel, phase III clinical trial to evaluate the efficacy and safety of combination therapy of DW5421A/DW5421B versus monotherapy of DW5421A in patients with primary hypercholesterolemia or mixed dyslipidemia.
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
. Male or female aged ≥19 years
. Subjects diagnosed with primary hypercholesterolemia or mixed dyslipidemia
. Subjects who satisfy both of the following criteria at Visit 1: (1) Triglyceride (TG) \< 400 mg/dL; (2) Low-density lipoprotein cholesterol (LDL-C) ≤ 250 mg/dL
. At Visit 1, for subjects who are receiving hypercholesterolemia treatment, those who, in the investigator's judgment, can medically and appropriately discontinue their existing hypercholesterolemia treatment for the duration of the clinical trial.
. Subjects who voluntarily provided written informed consent to participate in this clinical trial.
. If currently receiving hypercholesterolemia treatment, subjects who have undergone a washout period of at least 4 weeks prior to Visit 2.
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.
. Subjects who have implemented TLC for at least 4 weeks prior to Visit 2 and have continued TLC through Visit 3.
. Subjects whose RIP IP compliance during the run-in period is between 70% and 130%.
Exclusion criteria
. Presence of any of the following medical histories or past surgical histories:
. Acute arterial disease-related history (as of Visit 1, within the 12-week period preceding the visit including: Unstable angina, myocardial infarction, transient ischemic attack (TIA), cerebrovascular disease, coronary artery bypass graft (CABG), or percutaneous coronary intervention (PCI)) Exception: Subjects whose events occurred more than 12 weeks before Visit 1, have been adjudicated as cured, or are in a stable state (ex: managed with a stable drug dosage for at least 12 weeks prior to Visit 1) may be eligible.
. Hypersensitivity or prior exposure to the investigational product's active ingredients (pitavastatin, ezetimibe) or to any dyslipidemia-treating agents.
. History of fibromyalgia, myopathy, rhabdomyolysis, or other hereditary myopathies, or a family history of such conditions.
. Severe heart failure (NYHA functional class III or IV).
. Any surgical or internal medical condition that could affect the absorption, distribution, metabolism, or excretion of the investigational drug (excluding uncomplicated appendectomy or hernia repair).
. A history of drug or alcohol abuse within 1 year prior to Visit 1.
. A history of malignancy (however, the following cases are eligible for participation):