Dyslipidemia in Cardiovascular Disease (KoLipilou)

Chong Kun Dang

Status and phase: Completed; Phase 4

Conditions: Dyslipidemia

Treatments: Drug: Atorvastatin (Lipitor); Drug: Atorvastatin (Lipilou)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01029522

224CHL08F

Details and patient eligibility

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: 244 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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244 participants in 2 patient groups

Lipilou 20mg

Experimental group

Treatment:

Drug: Atorvastatin (Lipilou)

Lipitor 20mg

Active Comparator group

Treatment:

Drug: Atorvastatin (Lipitor)