Impact of Pitavastatin in Hypercholesterolemic Patients With Metabolic Syndrome

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2008-09-30

Brief Summary

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The purpose of this study is to evaluate anti-oxidative and anti-inflammatory effects of pitavastatin in hypercholesterolemic patients with the metabolic syndrome.

Detailed Description

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The metabolic syndrome is defined as a cluster of cardiovascular risk factors including visceral obesity, dyslipidemia, elevated blood pressure and impaired glucose tolerance. Recently, it has been described that oxidative stress and inflammatory reaction, which are important in progression of atherosclerosis, increases in individuals with the metabolic syndrome. Statins might have beneficial effects such as anti-oxidative and anti-inflammatory actions that are independent from their cholesterol-lowering effects. Pitavastatin, a chemically synthesized statin, has potent LDL-cholesterol lowering and also anti-oxidative and anti-inflammatory effects in animal studies. However, the effects of pitavastatin on oxidative stress and inflammatory action in patients with the metabolic syndrome have not been reported.

Conditions

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Metabolic Syndrome Oxidative Stress Inflammation

Keywords

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statin metabolic syndrome oxidative stress inflammation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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pitavastatin

Pitavastatin (2mg/day) was administered for 12 weeks

Intervention Type DRUG

Other Intervention Names

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livalo

Eligibility Criteria

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Inclusion Criteria

* Hypercholesterolemic patients

Exclusion Criteria

* Patients receiving lipid-lowering agents
* Familial hypercholesterolemia
* Renal disease
* Diseases of liver, gallbladder and bile ducts
* Pregnant women

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Department of Internal Medicine, School of Dentistry, Aichi Gakuin University

Principal Investigators

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Tatsuaki Matsubara, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Internal Medicine, School of Dentistry, Aichi Gakuin University

Locations

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Tatsuaki Matsubara

Nagoya, Aichi-ken, Japan

Site Status

Countries

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Japan

References

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Matsubara T, Naruse K, Arakawa T, Nakao M, Yokoi K, Oguri M, Marui N, Amano T, Ichimiya S, Ohashi T, Imai K, Sakai S, Sugiyama S, Ishii H, Murohara T. Impact of pitavastatin on high-sensitivity C-reactive protein and adiponectin in hypercholesterolemic patients with the metabolic syndrome: the PREMIUM Study. J Cardiol. 2012 Nov;60(5):389-94. doi: 10.1016/j.jjcc.2012.07.012. Epub 2012 Aug 11.

Reference Type DERIVED

PMID: 22884685 (View on PubMed)

Other Identifiers

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AGU-64

Identifier Type: -

Identifier Source: org_study_id