Back to resultsImpact of Pitavastatin in Hypercholesterolemic Patients With Metabolic Syndrome
Primary Purpose
Metabolic Syndrome, Oxidative Stress, Inflammation
Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
pitavastatin
Sponsored by
About this trial
This is an interventional treatment trial for Metabolic Syndrome focused on measuring statin, metabolic syndrome, oxidative stress, inflammation
Eligibility 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
Sites / Locations
- Tatsuaki Matsubara
Outcomes
Primary Outcome Measures
Thiobarbituric acid reactive substance; high sensitive C-reactive protein
Secondary Outcome Measures
Total cholesterol; LDL-cholesterol; HDL-cholesterol; triglyceride;
Homeostasis model assessment for insulin resistance; adiponectin;
Soluble intercellular adhesion molecule-1
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00444717
Brief Title
Impact of Pitavastatin in Hypercholesterolemic Patients With Metabolic Syndrome
Official Title
Multicenter Study for Anti-oxidative and Anti-inflammatory Effects of Pitavastatin in Hypercholesterolemic Patients With Metabolic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Aichi Gakuin University
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Oxidative Stress, Inflammation
Keywords
statin, metabolic syndrome, oxidative stress, inflammation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
pitavastatin
Other Intervention Name(s)
livalo
Intervention Description
Pitavastatin (2mg/day) was administered for 12 weeks
Primary Outcome Measure Information:
Title
Thiobarbituric acid reactive substance; high sensitive C-reactive protein
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Total cholesterol; LDL-cholesterol; HDL-cholesterol; triglyceride;
Time Frame
12 weeks
Title
Homeostasis model assessment for insulin resistance; adiponectin;
Time Frame
12 weeks
Title
Soluble intercellular adhesion molecule-1
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tatsuaki Matsubara, MD, PhD
Organizational Affiliation
Department of Internal Medicine, School of Dentistry, Aichi Gakuin University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tatsuaki Matsubara
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
464-8651
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
22884685
Citation
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.
Results Reference
derived
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Impact of Pitavastatin in Hypercholesterolemic Patients With Metabolic Syndrome
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