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 range19 Years
SexALL
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.
✓. 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):