Impact of Pitavastatin in Hypercholesterolemic Patients With Metabolic Syndrome - Full Text View

Sponsored by:	Aichi Gakuin University
Information provided by:	Aichi Gakuin University
ClinicalTrials.gov Identifier:	NCT00444717

Purpose

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

Condition	Intervention	Phase
Metabolic Syndrome Oxidative Stress Inflammation	Drug: pitavastatin	Phase IV

Drug Information available for: Pitavastatin NK 104

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Multicenter Study for Anti-Oxidative and Anti-Inflammatory Effects of Pitavastatin in Hypercholesterolemic Patients With Metabolic Syndrome

Further study details as provided by Aichi Gakuin University:

Primary Outcome Measures:

Thiobarbituric acid reactive substance; high sensitive C-reactive protein

Secondary Outcome Measures:

Total cholesterol; LDL-cholesterol; HDL-cholesterol; triglyceride;
Homeostasis model assessment for insulin resistance; adiponectin;
Soluble intercellular adhesion molecule-1

Enrollment:	100
Study Start Date:	April 2007
Study Completion Date:	September 2008

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Hypercholesterolemic patients

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00444717

Locations

Japan, Aichi
Tatsuaki Matsubara
Nagoya, Aichi, Japan, 464-8651

Sponsors and Collaborators

Aichi Gakuin University

Investigators

Principal Investigator:

Tatsuaki Matsubara, MD, PhD

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

More Information

Study ID Numbers:	AGU-64
Study First Received:	March 7, 2007
Last Updated:	October 27, 2008
ClinicalTrials.gov Identifier:	NCT00444717
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Aichi Gakuin University:

statin
metabolic syndrome
oxidative stress
inflammation

Study placed in the following topic categories:

NK 104
Stress
Inflammation

Additional relevant MeSH terms:

Disease
Pathologic Processes
Molecular Mechanisms of Pharmacological Action

Syndrome
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009