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

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ClinicalTrials.gov Identifier: NCT02940366
Recruitment Status : Recruiting
First Posted : October 20, 2016
Last Update Posted : February 9, 2017
Sponsor:
Collaborator:
JW Pharmaceutical
Information provided by (Responsible Party):
Hyung-Kwan Kim, Seoul National University Hospital

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

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Drug: Pitavastatin 4 mg orally daily Drug: Atorvastatin 20 mg orally daily Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 1, 2016
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : November 30, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Absolute change in HbA1c level [ Time Frame: baselina and after 24months treatment ]


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02940366


Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Hyung-Kwan Kim, MD    82-2-2072-0243    cardiman73@gmail.com   
Principal Investigator: Hyung-Kwan Kim, MD         
Sponsors and Collaborators
Seoul National University Hospital
JW Pharmaceutical

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hyung-Kwan Kim, Director, Division of Cardiology, Clinical Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02940366     History of Changes
Other Study ID Numbers: 1406-027-584
First Posted: October 20, 2016    Key Record Dates
Last Update Posted: February 9, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
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Metabolic Syndrome
Syndrome
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Atorvastatin
Pitavastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors