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

NCT ID: NCT00861861

Last Updated: 2013-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2013-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hypercholesterolemia Coronary Artery Disease

Keywords

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Pitavastatin Atorvastatin CAD HDL-C Adiponectin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

pitavastatin group

Group Type ACTIVE_COMPARATOR

Pitavastatin

Intervention Type DRUG

comparison of two drugs in increasing HDL-C and adiponectin

2

atorvastatin group

Group Type ACTIVE_COMPARATOR

Atorvastatin

Intervention Type DRUG

comparison of two drugs in increasing HDL-C and adiponectin

Interventions

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Pitavastatin

comparison of two drugs in increasing HDL-C and adiponectin

Intervention Type DRUG

Atorvastatin

comparison of two drugs in increasing HDL-C and adiponectin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kumamoto University

OTHER

Sponsor Role lead

Responsible Party

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Hisao Ogawa

Kumamoto University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hisao Ogawa, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Kumamoto University Graduate School of Medical Sciences

Locations

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Kumamoto University Graduate School of Medical Sciences Department of Cardiocascular Medicine

Kumamoto, Kumamoto, Japan

Site Status

Countries

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Japan

Other Identifiers

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Kumamoto-746

Identifier Type: -

Identifier Source: org_study_id