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Impact of Pitavastatin in Hypercholesterolemic Patients With Metabolic Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00444717
Recruitment Status : Completed
First Posted : March 8, 2007
Last Update Posted : July 13, 2011
Information provided by:
Aichi Gakuin University

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

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Oxidative Stress Inflammation Drug: pitavastatin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Study for Anti-oxidative and Anti-inflammatory Effects of Pitavastatin in Hypercholesterolemic Patients With Metabolic Syndrome
Study Start Date : April 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: pitavastatin
    Pitavastatin (2mg/day) was administered for 12 weeks
    Other Name: livalo

Primary Outcome Measures :
  1. Thiobarbituric acid reactive substance; high sensitive C-reactive protein [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Total cholesterol; LDL-cholesterol; HDL-cholesterol; triglyceride; [ Time Frame: 12 weeks ]
  2. Homeostasis model assessment for insulin resistance; adiponectin; [ Time Frame: 12 weeks ]
  3. Soluble intercellular adhesion molecule-1 [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Hypercholesterolemic patients

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00444717

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Tatsuaki Matsubara
Nagoya, Aichi, Japan, 464-8651
Sponsors and Collaborators
Aichi Gakuin University
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Principal Investigator: Tatsuaki Matsubara, MD, PhD Department of Internal Medicine, School of Dentistry, Aichi Gakuin University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Tatsuaki Matsubara, Department of Internal Medicine, School of Dentistry, Aichi Gakuin University Identifier: NCT00444717    
Other Study ID Numbers: AGU-64
First Posted: March 8, 2007    Key Record Dates
Last Update Posted: July 13, 2011
Last Verified: October 2008
Keywords provided by Aichi Gakuin University:
metabolic syndrome
oxidative stress
Additional relevant MeSH terms:
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Metabolic Syndrome
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents