- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02940366
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
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-
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Seoul, Korea, Republic of
- Recruiting
- Seoul National University Hospital
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Principal Investigator:
- Hyung-Kwan Kim, MD
-
Contact:
- Hyung-Kwan Kim, MD
- Phone Number: 82-2-2072-0243
- Email: cardiman73@gmail.com
-
-
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
|
Pitavastatin 4 mg orally daily for 24months
|
Placebo Comparator: 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.
Collaborators
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.
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
- Pathologic Processes
- Glucose Metabolism Disorders
- Metabolic Diseases
- Disease
- Insulin Resistance
- Hyperinsulinism
- Syndrome
- Metabolic Syndrome
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Atorvastatin
- Pitavastatin
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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