Status and phase
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About
A multicenter, double-blind, parallel-group, active-controlled, dose-ranging study to assess the safety and efficacy of the novel cholesteryl ester transfer protein (CETP) inhibitor CKD-519 in combination with atorvastatin or rosuvastatin in subjects with dyslipidemia.
Full description
The purpose of this study is to assess the safety, efficacy, and tolerability of CKD-519, administered with HMG-CoA reductase inhibitors in subjects with dyslipidemia
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Age 18 to 80 years.
Dyslipidemia with LDL-C
HDL-C <45 mg/dL (males) or <50 mg/dL (females).
Fasting TG <400 mg/dL.
Presence of the following conditions is permitted but not mandatory, at the discretion of the investigator:
Willing and able to sign the informed consent form (ICF).
Exclusion criteria
Chronic heart failure as defined by New York Heart Association classes III and IV.
Uncontrolled cardiac arrhythmias.
Myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft, or unstable angina in past 3 months before Visit 1.
Stroke or transient ischemic attack within 3 months before Visit 1.
Uncontrolled hypertension.
Clinically significant laboratory abnormalities
Any active nephropathy or estimated glomerular filtration rate <60 mL/min/1.73m2 or on kidney dialysis.
Poorly controlled (thyroid-stimulating hormone [TSH] >2 times upper limit of normal) hyperthyroidism.
Homozygous familial hypercholesterolemia.
Intolerance or hypersensitivity to atorvastatin or rosuvastatin.
Prior treatment with any CETP inhibitor.
Positive for human immunodeficiency virus (HIV) positive, hepatitis B or hepatitis C.
Primary purpose
Allocation
Interventional model
Masking
62 participants in 6 patient groups
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Data sourced from clinicaltrials.gov
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