Dyslipidemia in Cardiovascular Disease (KoLipilou)
Primary Purpose
Dyslipidemia
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Atorvastatin (Lipilou)
Atorvastatin (Lipitor)
Sponsored by
About this trial
This is an interventional treatment trial for Dyslipidemia focused on measuring Dyslipidemia
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
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
NCT ID
NCT01029522
First Posted
November 16, 2009
Last Updated
August 8, 2012
Sponsor
Chong Kun Dang Pharmaceutical
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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