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

Seoul National University

Status and phase: Unknown; Phase 4

Conditions: Metabolic Syndrome

Treatments: Drug: Atorvastatin 20 mg orally daily; Drug: Pitavastatin 4 mg orally daily

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02940366

1406-027-584

Details and patient eligibility

About

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

Enrollment: 500 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups, including a placebo group

Pitavastatin 4 mg orally daily

Experimental group

Treatment:

Drug: Pitavastatin 4 mg orally daily

Atorvastatin 20 mg orally daily

Placebo Comparator group

Treatment:

Drug: Atorvastatin 20 mg orally daily