Status and phase
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Treatments
About
A multi-center, randomized, double-blinded equivalence clinical trial to evaluate efficacy and safety of LipiLou 20 mg versus Lipitor 20 mg in hypercholesterolemic patients with higher risk cardiovascular disease in Korea.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Dyslipidemic patients with high-risk cardiovascular disease meeting more than 1 requirement below (LDL-C ≥ 100mg/dL) 1) Coronary artery disease
Aged 20~85 years
Volunteers consented with participating clinical trial and submitted consent paper
Exclusion criteria
Experimental examination at screening 1) Active liver disease or more than 2 x ULN of AST/ALT 2) Creatine Kinase > 2 x ULN 3) Creatinine > 2.5mg/dL 4) Triglycerides > 500mg/dL
intervened with stent in coronary artery disease less than 1 year before
Hyper-sensitive or resistant to other HMG-CoA reductase inhibitors, or experienced serious adverse events
Patients taking dyslipidemic treatments within 4 weeks (HMG-CoA reductase inhibitors, fibrates, nicotinic acids or bile acid resins, etc.)
As uncontrolled DM patients, HbA1c≥11% or fasting plasma glucose ≥200mg/dL
DBP > 100mmHg, SBP > 160mmHg
Diagnosed with myopathy
Appear to be a risk of myopathy below
Women pregnant or breast-feeding
Women capable of pregnancy without using contraceptives
contra-indicated medically or mentally, or forbidden legally
Enrolled to other clinical trial within 4 weeks
Impossible to participate clinical trial according to investigator's decision
Primary purpose
Allocation
Interventional model
Masking
244 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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