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NCT Number: NCT00444717

Impact of Pitavastatin in Hypercholesterolemic Patients With Metabolic Syndrome

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

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Key information

Conditions

Metabolic Syndrome Glucose Metabolism Disorders Hyperinsulinism Inflammation Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Oxidative Stress Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tatsuaki Matsubara

Nagoya, Aichi-ken, 464-8651, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hypercholesterolemic patients

Exclusion criteria

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

Treatment and study plan

Pitavastatin

Drug

Pitavastatin (2mg/day) was administered for 12 weeks

Other names: livalo

Primary outcomes

  1. Thiobarbituric acid reactive substance; high sensitive C-reactive protein

    Time frame: 12 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Aichi Gakuin University

Other

Registry information

Official study title

Multicenter Study for Anti-oxidative and Anti-inflammatory Effects of Pitavastatin in Hypercholesterolemic Patients With Metabolic Syndrome

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Mar 8, 2007
Registry last updated
Jul 13, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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