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Impact of Pitavastatin in Hypercholesterolemic Patients With Metabolic Syndrome

This study has been completed.
Sponsor:
Information provided by:
Aichi Gakuin University
ClinicalTrials.gov Identifier:
NCT00444717
First received: March 7, 2007
Last updated: July 12, 2011
Last verified: October 2008
History of Changes
  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
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:

U.S. FDA Resources

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.

  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
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

No publications provided by Aichi Gakuin University

Additional 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
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:
statin
metabolic syndrome
oxidative stress
inflammation

Additional relevant MeSH terms:
Inflammation
Metabolic Syndrome X
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
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013