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Dyslipidemia in Cardiovascular Disease

NCT ID: NCT01029522

Last Updated: 2012-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

244 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Dyslipidemia

Keywords

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Dyslipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Lipilou 20mg

Group Type EXPERIMENTAL

Atorvastatin (Lipilou)

Intervention Type DRUG

treatment of dyslipidemia administration : PO, qod

Lipitor 20mg

Group Type ACTIVE_COMPARATOR

Atorvastatin (Lipitor)

Intervention Type DRUG

treatment of dyslipidemia administration : PO, qod

Interventions

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Atorvastatin (Lipilou)

treatment of dyslipidemia administration : PO, qod

Intervention Type DRUG

Atorvastatin (Lipitor)

treatment of dyslipidemia administration : PO, qod

Intervention Type DRUG

Other Intervention Names

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Lipitor

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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KIM hyo soo, ph D

Role: PRINCIPAL_INVESTIGATOR

yongon-dong, jong-ro gu, Seoul National University Hospital, South of Korea

Other Identifiers

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224CHL08F

Identifier Type: -

Identifier Source: org_study_id