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Dyslipidemia in Cardiovascular Disease (KoLipilou)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01029522
First received: November 16, 2009
Last updated: August 8, 2012
Last verified: August 2012

November 16, 2009
August 8, 2012
August 2008
October 2008   (final data collection date for primary outcome measure)
LDL-C [ Time Frame: after taken medicine for 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01029522 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Dyslipidemia
  • 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
244
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
Both
20 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01029522
224CHL08F
No
Chong Kun Dang Pharmaceutical
Chong Kun Dang Pharmaceutical
Not Provided
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