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Sponsored by: |
Aichi Gakuin University |
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Information provided by: | Aichi Gakuin University |
ClinicalTrials.gov Identifier: | NCT00444717 |
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 |
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 |
Enrollment: | 100 |
Study Start Date: | April 2007 |
Study Completion Date: | September 2008 |
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.
Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Japan, Aichi | |
Tatsuaki Matsubara | |
Nagoya, Aichi, Japan, 464-8651 |
Principal Investigator: | Tatsuaki Matsubara, MD, PhD | Department of Internal Medicine, School of Dentistry, Aichi Gakuin University |
Study ID Numbers: | AGU-64 |
Study First Received: | March 7, 2007 |
Last Updated: | October 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00444717 History of Changes |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
statin metabolic syndrome oxidative stress inflammation |
NK 104 Stress Hydroxymethylglutaryl-CoA Reductase Inhibitors Inflammation |
Disease Pathologic Processes Molecular Mechanisms of Pharmacological Action NK 104 |
Syndrome Enzyme Inhibitors Pharmacologic Actions Inflammation |