Impact of Pitavastatin in Hypercholesterolemic Patients With Metabolic Syndrome

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00444717
• Other study ID #: AGU-64
• Status: Completed
• Phase: Phase 4
• First received: March 7, 2007
• Last updated: July 12, 2011
• Start date: April 2007
• Est. completion date: September 2008

Study information

• Verified date: October 2008
• Source: Aichi Gakuin University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Inflammation
• Metabolic Syndrome
• Metabolic Syndrome X
• Oxidative Stress
• Syndrome

Intervention

Drug:
• pitavastatin
Pitavastatin (2mg/day) was administered for 12 weeks

Locations

Country	Name	City	State
Japan	Tatsuaki Matsubara	Nagoya	Aichi

Sponsors (1)

Lead Sponsor	Collaborator
Aichi Gakuin University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thiobarbituric acid reactive substance; high sensitive C-reactive protein		12 weeks	Yes
Secondary	Total cholesterol; LDL-cholesterol; HDL-cholesterol; triglyceride;		12 weeks	Yes
Secondary	Homeostasis model assessment for insulin resistance; adiponectin;		12 weeks	Yes
Secondary	Soluble intercellular adhesion molecule-1		12 weeks	Yes