Dyslipidemia in Cardiovascular Disease

Dyslipidemia Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01029522
• Other study ID #: 224CHL08F
• Status: Completed
• Phase: Phase 4
• First received: November 16, 2009
• Last updated: August 8, 2012
• Start date: August 2008
• Est. completion date: November 2009

Study information

• Verified date: August 2012
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 244
• Est. completion date: November 2009
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Dyslipidemia
• Dyslipidemias

Intervention

Drug:
• Atorvastatin (Lipilou)
treatment of dyslipidemia administration : PO, qod
• Atorvastatin (Lipitor)
treatment of dyslipidemia administration : PO, qod

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDL-C		after taken medicine for 8 weeks	No