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OpenTrials
Completed

NCT Number: NCT01029522

Dyslipidemia in Cardiovascular Disease

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.

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Key information

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atorvastatin (Lipilou)

Drug

treatment of dyslipidemia administration : PO, qod

atorvastatin (Lipitor)

Drug

treatment of dyslipidemia administration : PO, qod

Other names: Lipitor

Primary outcomes

  1. LDL-C

    Time frame: after taken medicine for 8 weeks

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study 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

Acronym: KoLipilou

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Dec 10, 2009
Registry last updated
Aug 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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