Dyslipidemia
Conditions
Keywords
Dyslipidemia
Brief summary
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.
Interventions
DRUGAtorvastatin (Lipilou)
treatment of dyslipidemia administration : PO, qod
treatment of dyslipidemia administration : PO, qod
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Dyslipidemic patients with high-risk cardiovascular disease meeting more than 1 requirement below (LDL-C ≥ 100mg/dL) 1) Coronary artery disease * diagnosed with atheroma in Coronary CT or Angiography, or SPECT positive or Treadmill test positive 2) Diabetes Mellitus 3) intervened with stent in coronary artery disease more than 1 year before 4) diagnosed with atheroma in carotid artery 5) Peripheral artery disease 2. Aged 20\ 85 years 3. Volunteers consented with participating clinical trial and submitted consent paper
Exclusion criteria
1. 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 2. intervened with stent in coronary artery disease less than 1 year before 3. Hyper-sensitive or resistant to other HMG-CoA reductase inhibitors, or experienced serious adverse events 4. Patients taking dyslipidemic treatments within 4 weeks (HMG-CoA reductase inhibitors, fibrates, nicotinic acids or bile acid resins, etc.) 5. As uncontrolled DM patients, HbA1c≥11% or fasting plasma glucose ≥200mg/dL 6. DBP \> 100mmHg, SBP \> 160mmHg 7. Diagnosed with myopathy 8. Appear to be a risk of myopathy below * renal impairment or prior renal dysfunction * hypothyroidism * genetic defects or family history of myopathy * experienced prior muscle toxicity with taking statins or fibrates * prior liver disease or higher intakes of alcohol * aged over 70, and a risk of myopathy 9. Women pregnant or breast-feeding 10. Women capable of pregnancy without using contraceptives 11. contra-indicated medically or mentally, or forbidden legally 12. Enrolled to other clinical trial within 4 weeks 13. Impossible to participate clinical trial according to investigator's decision
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| LDL-C | after taken medicine for 8 weeks |
Outcome results
None listed