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

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.

Condition or disease Intervention/treatment Phase
Dyslipidemia Drug: Atorvastatin (Lipilou) Drug: Atorvastatin (Lipitor) Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 244 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2008
Actual Primary Completion Date : October 2008
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Lipilou 20mg Drug: Atorvastatin (Lipilou)
treatment of dyslipidemia administration : PO, qod

Active Comparator: Lipitor 20mg Drug: Atorvastatin (Lipitor)
treatment of dyslipidemia administration : PO, qod
Other Name: Lipitor

Primary Outcome Measures :
  1. LDL-C [ Time Frame: after taken medicine for 8 weeks ]

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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01029522

Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Principal Investigator: KIM hyo soo, ph D yongon-dong, jong-ro gu, Seoul National University Hospital, South of Korea

Responsible Party: Chong Kun Dang Pharmaceutical Identifier: NCT01029522     History of Changes
Other Study ID Numbers: 224CHL08F
First Posted: December 10, 2009    Key Record Dates
Last Update Posted: August 9, 2012
Last Verified: August 2012

Keywords provided by Chong Kun Dang Pharmaceutical:

Additional relevant MeSH terms:
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors