Dyslipidemia in Cardiovascular Disease

NCT01029522 | Completed Phase 4

• 1 other identifier: 224CHL08F
• Study Type: interventional
• Target: 244
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dyslipidemia

Keywords

Dyslipidemia

Outcome Measures

Primary Outcomes (1)

• LDL-C

  after taken medicine for 8 weeks

Study Arms (2)

Lipilou 20mg

EXPERIMENTAL

Drug: Atorvastatin (Lipilou)

Lipitor 20mg

ACTIVE COMPARATOR

Drug: Atorvastatin (Lipitor)

Interventions

Atorvastatin (Lipilou) DRUG

treatment of dyslipidemia administration : PO, qod

Lipilou 20mg

Atorvastatin (Lipitor) DRUG

treatment of dyslipidemia administration : PO, qod

Also known as: Lipitor

Lipitor 20mg

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

MeSH Terms

Conditions

Dyslipidemias

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• KIM hyo soo, ph D

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2009
• First Posted: December 10, 2009
• Study Start: August 1, 2008
• Primary Completion: October 1, 2008
• Study Completion: November 1, 2009
• Last Updated: August 9, 2012

Record last verified: 2012-08