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Dyslipidemia in Cardiovascular Disease (KoLipilou)

Primary Purpose

Dyslipidemia

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Atorvastatin (Lipilou)
Atorvastatin (Lipitor)
Sponsored by
Chong Kun Dang Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemia focused on measuring Dyslipidemia

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Lipilou 20mg

    Lipitor 20mg

    Arm Description

    Outcomes

    Primary Outcome Measures

    LDL-C

    Secondary Outcome Measures

    Full Information

    First Posted
    November 16, 2009
    Last Updated
    August 8, 2012
    Sponsor
    Chong Kun Dang Pharmaceutical
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01029522
    Brief Title
    Dyslipidemia in Cardiovascular Disease
    Acronym
    KoLipilou
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2008 (undefined)
    Primary Completion Date
    October 2008 (Actual)
    Study Completion Date
    November 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Chong Kun Dang Pharmaceutical

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dyslipidemia
    Keywords
    Dyslipidemia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    244 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Lipilou 20mg
    Arm Type
    Experimental
    Arm Title
    Lipitor 20mg
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Atorvastatin (Lipilou)
    Intervention Description
    treatment of dyslipidemia administration : PO, qod
    Intervention Type
    Drug
    Intervention Name(s)
    Atorvastatin (Lipitor)
    Other Intervention Name(s)
    Lipitor
    Intervention Description
    treatment of dyslipidemia administration : PO, qod
    Primary Outcome Measure Information:
    Title
    LDL-C
    Time Frame
    after taken medicine for 8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Aged 20~85 years Volunteers consented with participating clinical trial and submitted consent paper Exclusion Criteria: 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 intervened with stent in coronary artery disease less than 1 year before Hyper-sensitive or resistant to other HMG-CoA reductase inhibitors, or experienced serious adverse events Patients taking dyslipidemic treatments within 4 weeks (HMG-CoA reductase inhibitors, fibrates, nicotinic acids or bile acid resins, etc.) As uncontrolled DM patients, HbA1c≥11% or fasting plasma glucose ≥200mg/dL DBP > 100mmHg, SBP > 160mmHg Diagnosed with myopathy 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 Women pregnant or breast-feeding Women capable of pregnancy without using contraceptives contra-indicated medically or mentally, or forbidden legally Enrolled to other clinical trial within 4 weeks Impossible to participate clinical trial according to investigator's decision
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    KIM hyo soo, ph D
    Organizational Affiliation
    yongon-dong, jong-ro gu, Seoul National University Hospital, South of Korea
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Dyslipidemia in Cardiovascular Disease

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