Effect of High-dose Pitavastatin on Glucose Control in Patients With Metabolic Syndrome
the Long-term Effects of High-doSe pitavaStatin on Diabetogenicity in Comparison With Atorvastatin in Patients With Metabolic Syndrome (LESS-DM) Randomized Clinical Trial
1 other identifier
interventional
500
1 country
1
Brief Summary
This purpose of this study is to evaluate effect of high-dose Pitavastatin on glucose control in patients with metabolic syndrome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2016
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2016
CompletedFirst Posted
Study publicly available on registry
October 20, 2016
CompletedStudy Start
First participant enrolled
December 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2019
CompletedFebruary 9, 2017
February 1, 2017
3 years
October 19, 2016
February 8, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Absolute change in HbA1c level
baselina and after 24months treatment
Study Arms (2)
Pitavastatin 4 mg orally daily
EXPERIMENTALAtorvastatin 20 mg orally daily
PLACEBO COMPARATORInterventions
Pitavastatin 4 mg orally daily for 24months
Atorvastatin 20 mg orally daily for 24months
Eligibility Criteria
You may qualify if:
- Patients diagnosed as metabolic syndrome according to National cholesterol Education Program criteria
- Patients with hypercholesterolemia who required to start statin therapy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seoul National University Hospitallead
- JW Pharmaceuticalcollaborator
Study Sites (1)
Seoul National University Hospital
Seoul, South Korea
Related Publications (1)
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.
PMID: 29078817DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Division of Cardiology, Clinical Professor
Study Record Dates
First Submitted
October 19, 2016
First Posted
October 20, 2016
Study Start
December 1, 2016
Primary Completion
November 30, 2019
Study Completion
November 30, 2019
Last Updated
February 9, 2017
Record last verified: 2017-02