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

Primary Purpose

Metabolic Syndrome

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Pitavastatin 4 mg orally daily
Atorvastatin 20 mg orally daily
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pitavastatin 4 mg orally daily

Atorvastatin 20 mg orally daily

Arm Description

Outcomes

Primary Outcome Measures

Absolute change in HbA1c level

Secondary Outcome Measures

Full Information

First Posted
October 19, 2016
Last Updated
February 8, 2017
Sponsor
Seoul National University Hospital
Collaborators
JW Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT02940366
Brief Title
Effect of High-dose Pitavastatin on Glucose Control in Patients With Metabolic Syndrome
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2016 (Actual)
Primary Completion Date
November 30, 2019 (Anticipated)
Study Completion Date
November 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
JW Pharmaceutical

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pitavastatin 4 mg orally daily
Arm Type
Experimental
Arm Title
Atorvastatin 20 mg orally daily
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Pitavastatin 4 mg orally daily
Intervention Description
Pitavastatin 4 mg orally daily for 24months
Intervention Type
Drug
Intervention Name(s)
Atorvastatin 20 mg orally daily
Intervention Description
Atorvastatin 20 mg orally daily for 24months
Primary Outcome Measure Information:
Title
Absolute change in HbA1c level
Time Frame
baselina and after 24months treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyung-Kwan Kim, MD
Phone
82-2-2072-0243
Email
cardiman73@gmail.com
First Name & Middle Initial & Last Name & Degree
Hyung-Kwan Kim, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
29078817
Citation
Park JB, Jung JH, Yoon YE, Kim HL, Lee SP, Kim HK, Kim YJ, Cho GY, Sohn DW. Long-term Effects of high-doSe pitavaStatin on Diabetogenicity in comparison with atorvastatin in patients with Metabolic syndrome (LESS-DM): study protocol for a randomized controlled trial. Trials. 2017 Oct 27;18(1):501. doi: 10.1186/s13063-017-2229-4.
Results Reference
derived

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

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