Comparison of Pitavastatin With Atorvastatin in Increasing High Density Lipoprotein – Cholesterol (HDL-C) and Adiponectin in Patients With Dyslipidemia and Coronary Artery Disease (CAD)

Brief Summary

Official Title: “Comparison of Pitavastatin With Atorvastatin in Increasing HDL-C and Adiponectin in Patients With Dyslipidemia and Coronary Artery Disease.”

The purpose of this study is to compare the effects of pitavastatin and atorvastatin on adiponectin percentage change in patients with hypercholesteremia comorbid stable CAD.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: October 2013

Detailed Clinical Trial Description

The efficiency of lipid lowering therapy was already proven by the clinical trials of statins. According to these results, the target value of LDL-C is recommended under 100mg/dL in the Japan Atherosclerosis Society Guidelines. However, the efficiency of intensive therapy to lower LDL-C more than 100mg/dL has not been proven yet.

Interventions Used in this Clinical Trial

  • Drug: Pitavastatin
    • comparison of two drugs in increasing HDL-C and adiponectin
  • Drug: Atorvastatin
    • comparison of two drugs in increasing HDL-C and adiponectin

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: 1
    • pitavastatin group
  • Active Comparator: 2
    • atorvastatin group

Outcome Measures for this Clinical Trial

Primary Measures

  • HDL-cholesterol (HDL-C); Adiponectin; High-Molecular- Weight Adiponectin(HMW Adiponectin)
    • Time Frame: start, 6 months, 12 months, 30 months
      Safety Issue?: Yes

Secondary Measures

  • TC; LDL-C; HDL-C; HDL2-C; HDL3-C; TG; smalldenseLDL; MDA-LDL; FPG; HbA1c; Cr; RLP-C; apoA-I; apoB; apoC-Ⅱ; apoC-Ⅲ
    • Time Frame: start, 6 months, 12 months, 30 months
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

Inclusion Criteria

  • Patients with dyslipidemia as defined by any of the parameters:
  • HDL-C < 50 mg/dL
  • LDL-C ≥ 140 mg/dL
  • LDL-C ≥ 100 mg/dL and cholesterol-lowering treatment is necessary in accordance with the investigator's judgement
  • Patients who passed three months or more after acute myocardial infarction
  • Patients who passed one month or more after unstable angina
  • Patients who passed one month or more after PCI
  • Patients with written consent by their own volition after being provided sufficient explanation for the participation into this clinical trial

Exclusion Criteria

  • Patients with any allergy to pitavastatin or atorvastatin
  • Patients with familial hypercholesterolemia
  • Patients receiving pitavastatin
  • Patients with severe hypertension
  • Patients with renal disorders or undergoing dialysis
  • Patients with hepatobiliary disorders
  • Patients with hepatobiliary disorders
  • Patients with family history of hypothyroidism or muscular dystrophy
  • Patients with history of drug-induced hepatic disorder
  • Drug abuser or dipsomaniac
  • Patients with cardiogenic shock.
  • Patients who hopes for pregnancy during this study
  • Contraindications, Relative Contraindications, Absolute Contraindications for Coadministration and Relative Contraindications for Coadministration for pitavastatin or atorvastatin
  • Patients who are ineligible in the opinion of the investigator

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 85 Years

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Kumamoto University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Hisao Ogawa, Kumamoto University – Kumamoto University
  • Overall Official(s)
    • Hisao Ogawa, MD,PhD, Principal Investigator, Kumamoto University Graduate School of Medical Sciences

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00861861