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Dyslipidemia in Cardiovascular Disease (KoLipilou)

This study has been completed.
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical Identifier:
First received: November 16, 2009
Last updated: August 8, 2012
Last verified: August 2012
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 Intervention Phase
Dyslipidemia Drug: Atorvastatin (Lipilou) Drug: Atorvastatin (Lipitor) Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Chong Kun Dang Pharmaceutical:

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

Enrollment: 244
Study Start Date: August 2008
Study Completion Date: November 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   20 Years to 85 Years   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Responsible Party: Chong Kun Dang Pharmaceutical Identifier: NCT01029522     History of Changes
Other Study ID Numbers: 224CHL08F
Study First Received: November 16, 2009
Last Updated: August 8, 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 processed this record on September 21, 2017