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

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02940366
• Collaborator: JW Pharmaceutical (Industry)
• Enrollment: 500
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 35.9
• Patients Per Site Per Month: 13.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Metabolic Syndrome	Drug: Pitavastatin 4 mg orally daily; Drug: Atorvastatin 20 mg orally daily	Phase 4

Study Design

• Study Type: Interventional
• Anticipated 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: Dec 1, 2016
• Anticipated Primary Completion Date: Nov 30, 2019
• Anticipated Study Completion Date: Nov 30, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Absolute change in HbA1c level [baselina and after 24months treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Seoul National University Hospital
• JW Pharmaceutical

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hyung-Kwan Kim, Director, Division of Cardiology, Clinical Professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT02940366
• Other Study ID Numbers: 1406-027-584
• First Posted: Oct 20, 2016
• Last Update Posted: Feb 9, 2017
• Last Verified: Feb 1, 2017

• Additional relevant MeSH terms: Metabolic Syndrome; Syndrome; Atorvastatin; Pitavastatin

Study Results

No Results Posted as of Feb 9, 2017