Dyslipidemia in Cardiovascular Disease (KoLipilou)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01029522
Recruitment Status : Completed
First Posted : December 10, 2009
Last Update Posted : August 9, 2012
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical

November 16, 2009
December 10, 2009
August 9, 2012
August 2008
October 2008   (Final data collection date for primary outcome measure)
LDL-C [ Time Frame: after taken medicine for 8 weeks ]
Same as current
Complete list of historical versions of study NCT01029522 on Archive Site
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Dyslipidemia in Cardiovascular Disease
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
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.
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Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Drug: Atorvastatin (Lipilou)
    treatment of dyslipidemia administration : PO, qod
  • Drug: Atorvastatin (Lipitor)
    treatment of dyslipidemia administration : PO, qod
    Other Name: Lipitor
  • Experimental: Lipilou 20mg
    Intervention: Drug: Atorvastatin (Lipilou)
  • Active Comparator: Lipitor 20mg
    Intervention: Drug: Atorvastatin (Lipitor)
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
November 2009
October 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years to 85 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Chong Kun Dang Pharmaceutical
Chong Kun Dang Pharmaceutical
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Principal Investigator: KIM hyo soo, ph D yongon-dong, jong-ro gu, Seoul National University Hospital, South of Korea
Chong Kun Dang Pharmaceutical
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP