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Impact of Pitavastatin in Hypercholesterolemic Patients With Metabolic Syndrome

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00444717
Enrollment
100
Registered
2007-03-08
Start date
2007-04-30
Completion date
2008-09-30
Last updated
2011-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammation, Metabolic Syndrome, Oxidative Stress

Keywords

statin, metabolic syndrome, oxidative stress, inflammation

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.

Interventions

DRUGpitavastatin

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

Sponsors

Aichi Gakuin University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Thiobarbituric acid reactive substance; high sensitive C-reactive protein12 weeks

Secondary

MeasureTime frame
Total cholesterol; LDL-cholesterol; HDL-cholesterol; triglyceride;12 weeks
Homeostasis model assessment for insulin resistance; adiponectin;12 weeks
Soluble intercellular adhesion molecule-112 weeks

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026