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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

Tracking Information
First Submitted Date  ICMJE October 19, 2016
First Posted Date  ICMJE October 20, 2016
Last Update Posted Date February 9, 2017
Actual Study Start Date  ICMJE December 1, 2016
Estimated Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2017)
Absolute change in HbA1c level [ Time Frame: baselina and after 24months treatment ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 19, 2016)
Absolute change in HbA1c level [ Time Frame: after 24months treatment ]
Change History Complete list of historical versions of study NCT02940366 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of High-dose Pitavastatin on Glucose Control in Patients With Metabolic Syndrome
Official Title  ICMJE the Long-term Effects of High-doSe pitavaStatin on Diabetogenicity in Comparison With Atorvastatin in Patients With Metabolic Syndrome (LESS-DM) Randomized Clinical Trial
Brief Summary This purpose of this study is to evaluate effect of high-dose Pitavastatin on glucose control in patients with metabolic syndrome.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metabolic Syndrome
Intervention  ICMJE
  • Drug: Pitavastatin 4 mg orally daily
    Pitavastatin 4 mg orally daily for 24months
  • Drug: Atorvastatin 20 mg orally daily
    Atorvastatin 20 mg orally daily for 24months
Study Arms  ICMJE
  • Experimental: Pitavastatin 4 mg orally daily
    Intervention: Drug: Pitavastatin 4 mg orally daily
  • Placebo Comparator: Atorvastatin 20 mg orally daily
    Intervention: Drug: Atorvastatin 20 mg orally daily
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 19, 2016)
500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2019
Estimated Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02940366
Other Study ID Numbers  ICMJE 1406-027-584
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hyung-Kwan Kim, Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE JW Pharmaceutical
Investigators  ICMJE Not Provided
PRS Account Seoul National University Hospital
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP