Effect of High-dose Pitavastatin on Glucose Control in Patients With Metabolic Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-01

Study Completion Date

2019-11-30

Brief Summary

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This purpose of this study is to evaluate effect of high-dose Pitavastatin on glucose control in patients with metabolic syndrome.

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Detailed Description

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Conditions

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Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pitavastatin 4 mg orally daily

Group Type EXPERIMENTAL

Pitavastatin 4 mg orally daily

Intervention Type DRUG

Pitavastatin 4 mg orally daily for 24months

Atorvastatin 20 mg orally daily

Group Type PLACEBO_COMPARATOR

Atorvastatin 20 mg orally daily

Intervention Type DRUG

Atorvastatin 20 mg orally daily for 24months

Interventions

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Pitavastatin 4 mg orally daily

Pitavastatin 4 mg orally daily for 24months

Intervention Type DRUG

Atorvastatin 20 mg orally daily

Atorvastatin 20 mg orally daily for 24months

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed as metabolic syndrome according to National cholesterol Education Program criteria
* Patients with hypercholesterolemia who required to start statin therapy

Exclusion Criteria

* overt diabetes
* acute coronary syndrome within 2 months
* acute cerebrovascular event within 2 months
* recent treatment of statin within 1month
* recent diagnosed neoplasm
* recent diagnosed liver disease
* chronic kidney disease
* patients with myopathy
* pregnant women, nursing mothers, women with possibility of pregnant
* patients being adminstered cyclosporine
* patients with genetic disease such as galactose intolerance, lactose intolerance, glucose-galactose malabsorption
* patients with treatment cyclosporin

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No