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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
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

Further study details as provided by Chong Kun Dang Pharmaceutical:

Primary Outcome Measures:
  • LDL-C [ Time Frame: after taken medicine for 8 weeks ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01029522

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

No publications provided

Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT01029522     History of Changes
Other Study ID Numbers: 224CHL08F
Study First Received: November 16, 2009
Last Updated: August 8, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Chong Kun Dang Pharmaceutical:
Dyslipidemia

Additional relevant MeSH terms:
Cardiovascular Diseases
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013