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NCT02940366 Clinical Trial

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

Metabolic Syndrome Clinical Trial

Official title:
the Long-term Effects of High-doSe pitavaStatin on Diabetogenicity in Comparison With Atorvastatin in Patients With Metabolic Syndrome (LESS-DM) Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02940366
Other study ID # 1406-027-584
Secondary ID
Status Recruiting
Phase Phase 4
First received October 19, 2016
Last updated February 8, 2017
Start date December 1, 2016
Est. completion date November 30, 2019

Study information
Verified date February 2017
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date November 30, 2019
Est. primary completion date November 30, 2019
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Pitavastatin 4 mg orally daily
Pitavastatin 4 mg orally daily for 24months
• Atorvastatin 20 mg orally daily
Atorvastatin 20 mg orally daily for 24months

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (2)
Lead Sponsor Collaborator
Seoul National University Hospital JW Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Absolute change in HbA1c level baselina and after 24months treatment
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