Impact of Pitavastatin in Hypercholesterolemic Patients With Metabolic Syndrome

July 12, 2011 updated by: Aichi Gakuin University

Multicenter Study for Anti-oxidative and Anti-inflammatory Effects 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Drug: pitavastatin

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Japan
- Aichi
  - Nagoya, Aichi, Japan, 464-8651
    - Tatsuaki Matsubara

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Hypercholesterolemic patients

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Thiobarbituric acid reactive substance; high sensitive C-reactive protein Time Frame: 12 weeks	12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aichi Gakuin University

Investigators

Principal Investigator: Tatsuaki Matsubara, MD, PhD, Department of Internal Medicine, School of Dentistry, Aichi Gakuin University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Matsubara T, Naruse K, Arakawa T, Nakao M, Yokoi K, Oguri M, Marui N, Amano T, Ichimiya S, Ohashi T, Imai K, Sakai S, Sugiyama S, Ishii H, Murohara T. Impact of pitavastatin on high-sensitivity C-reactive protein and adiponectin in hypercholesterolemic patients with the metabolic syndrome: the PREMIUM Study. J Cardiol. 2012 Nov;60(5):389-94. doi: 10.1016/j.jjcc.2012.07.012. Epub 2012 Aug 11.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)