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

February 8, 2017 updated by: Hyung-Kwan Kim, Seoul National University Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Hospital
        • Principal Investigator:
          • Hyung-Kwan Kim, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pitavastatin 4 mg orally daily
Drug: Pitavastatin 4 mg orally daily
Pitavastatin 4 mg orally daily for 24months
Placebo Comparator: Atorvastatin 20 mg orally daily
Drug: Atorvastatin 20 mg orally daily
Atorvastatin 20 mg orally daily for 24months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Absolute change in HbA1c level
Time Frame: baselina and after 24months treatment
baselina and after 24months treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

JW Pharmaceutical

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Anticipated)

November 30, 2019

Study Completion (Anticipated)

November 30, 2019

Study Registration Dates

First Submitted

October 19, 2016

First Submitted That Met QC Criteria

October 19, 2016

First Posted (Estimate)

October 20, 2016

Study Record Updates

Last Update Posted (Estimate)

February 9, 2017

Last Update Submitted That Met QC Criteria

February 8, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1406-027-584

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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