Impact of Pitavastatin in Hypercholesterolemic Patients With Metabolic Syndrome

• Sponsor: Aichi Gakuin University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00444717
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Duration (Months): 17.1
• Patients Per Site Per Month: 5.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Metabolic Syndrome; Oxidative Stress; Inflammation	Drug: pitavastatin	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• 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
• Study Start Date: Apr 1, 2007
• Actual Primary Completion Date: Sep 1, 2008
• Actual Study Completion Date: Sep 1, 2008

Outcome Measures

Primary Outcome Measures

1. Thiobarbituric acid reactive substance; high sensitive C-reactive protein [12 weeks]

Secondary Outcome Measures

1. Total cholesterol; LDL-cholesterol; HDL-cholesterol; triglyceride; [12 weeks]

2. Homeostasis model assessment for insulin resistance; adiponectin; [12 weeks]

3. Soluble intercellular adhesion molecule-1 [12 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00444717
• Other Study ID Numbers: AGU-64
• First Posted: Mar 8, 2007
• Last Update Posted: Jul 13, 2011
• Last Verified: Oct 1, 2008

• Keywords provided by , ,: statin; metabolic syndrome; oxidative stress; inflammation
• Additional relevant MeSH terms: Metabolic Syndrome; Syndrome; Inflammation; Pitavastatin

Study Results

No Results Posted as of Jul 13, 2011