Dyslipidemia in Cardiovascular Disease

Phase 4

Completed

• Conditions: Dyslipidemia
• Interventions: Drug: Atorvastatin (Lipilou); Drug: Atorvastatin (Lipitor)

• Registration Number: NCT01029522
• Lead Sponsor: Chong Kun Dang Pharmaceutical

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Primary Completion: 2008-10
• Study Completion: 2009-11
• Study First Submitted: 2009-11-16
• Study First Submitted QC: 2009-12-09
• Study First Posted: 2009-12-10
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-08
• Last Update Posted: 2012-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 244

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lipilou 20mg	Atorvastatin (Lipilou)	-
Lipitor 20mg	Atorvastatin (Lipitor)	-

Primary Outcome Measures

Name	Time	Method
LDL-C	after taken medicine for 8 weeks