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Impact of Pitavastatin in Hypercholesterolemic Patients With Metabolic Syndrome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00444717
First Posted: March 8, 2007
Last Update Posted: July 13, 2011
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.
Information provided by:
Aichi Gakuin University
  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 4

Study Type: Interventional
Study Design: 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

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 ]

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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT00444717


Locations
Japan
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tatsuaki Matsubara, Department of Internal Medicine, School of Dentistry, Aichi Gakuin University
ClinicalTrials.gov Identifier: NCT00444717     History of Changes
Other Study ID Numbers: AGU-64
First Submitted: March 7, 2007
First Posted: March 8, 2007
Last Update Posted: July 13, 2011
Last Verified: October 2008

Keywords provided by Aichi Gakuin University:
statin
metabolic syndrome
oxidative stress
inflammation

Additional relevant MeSH terms:
Syndrome
Inflammation
Metabolic Syndrome X
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Pitavastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents