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

NCT00861861 | Completed Phase 4

• 1 other identifier: Kumamoto-746
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypercholesterolemia; Coronary Artery Disease

Keywords

Pitavastatin; Atorvastatin; CAD; HDL-C; Adiponectin

Outcome Measures

Primary Outcomes (1)

• HDL-cholesterol (HDL-C); Adiponectin; High-Molecular- Weight Adiponectin(HMW Adiponectin)

  start, 6 months, 12 months, 30 months

Secondary Outcomes (1)

• 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

  start, 6 months, 12 months, 30 months

Study Arms (2)

1

ACTIVE COMPARATOR

pitavastatin group

Drug: Pitavastatin

2

ACTIVE COMPARATOR

atorvastatin group

Drug: Atorvastatin

Interventions

Pitavastatin DRUG

comparison of two drugs in increasing HDL-C and adiponectin

1

Atorvastatin DRUG

comparison of two drugs in increasing HDL-C and adiponectin

2

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kumamoto University: lead

Study Sites (1)

Kumamoto University Graduate School of Medical Sciences Department of Cardiocascular Medicine

Kumamoto, Kumamoto, 860-8556, Japan

Location

MeSH Terms

Conditions

Hypercholesterolemia; Coronary Artery Disease

Interventions

pitavastatin; Atorvastatin

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Hisao Ogawa, MD,PhD

  Kumamoto University Graduate School of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Kumamoto University

Study Record Dates

• First Submitted: March 12, 2009
• First Posted: March 16, 2009
• Study Start: September 1, 2008
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: October 14, 2013

Record last verified: 2013-10

Locations

JP (1)