Impact of Pitavastatin in Hypercholesterolemic Patients With Metabolic Syndrome

This study has been completed.
Information provided by:
Aichi Gakuin University Identifier:
First received: March 7, 2007
Last updated: July 12, 2011
Last verified: October 2008
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
Drug: pitavastatin
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter Study for Anti-oxidative and Anti-inflammatory Effects of Pitavastatin in Hypercholesterolemic Patients With Metabolic Syndrome

Resource links provided by NLM:

Further study details as provided by Aichi Gakuin University:

Primary Outcome Measures:
  • Thiobarbituric acid reactive substance; high sensitive C-reactive protein [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Total cholesterol; LDL-cholesterol; HDL-cholesterol; triglyceride; [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Homeostasis model assessment for insulin resistance; adiponectin; [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Soluble intercellular adhesion molecule-1 [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 100
Study Start Date: April 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: pitavastatin
    Pitavastatin (2mg/day) was administered for 12 weeks
    Other Name: livalo
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.

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its identifier: NCT00444717

Tatsuaki Matsubara
Nagoya, Aichi, Japan, 464-8651
Sponsors and Collaborators
Aichi Gakuin University
Principal Investigator: Tatsuaki Matsubara, MD, PhD Department of Internal Medicine, School of Dentistry, Aichi Gakuin University
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Tatsuaki Matsubara, Department of Internal Medicine, School of Dentistry, Aichi Gakuin University Identifier: NCT00444717     History of Changes
Other Study ID Numbers: AGU-64 
Study First Received: March 7, 2007
Last Updated: July 12, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Aichi Gakuin University:
metabolic syndrome
oxidative stress

Additional relevant MeSH terms:
Metabolic Syndrome X
Glucose Metabolism Disorders
Insulin Resistance
Metabolic Diseases
Pathologic Processes
Anticholesteremic Agents
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses processed this record on May 02, 2016