Overview

Phase IV Study to Evaluate the Effects of Statin Monotherapy or Statin / Ezetimibe Combination Therapy on Hepatic Steatosis in Patients With Hyperlipidemia and Nonalcoholic Fatty Liver Disease

Status:
Completed

Trial end date:
2019-09-11

Target enrollment:

Participant gender:

Summary

To investigate the therapeutic effect of ezetimibe on nonalcoholic fatty liver disease, the effect of rosuvastatin 5mg monotherapy and rosuvastatin 5mg / ezetimibe 10mg combination therapy n patients with hyperlipidemia and fatty liver will be compared and analyzed. This study included a total of 70 patients (35 per subgroup) for randomized controlled trials with prospective, open label, randomized, single-institution clinical trials. The drug will be maintained for a total of six months. The primary endpoint is the difference of liver fat change measured by MRI-PDFF in colocalized regions of interest within nine liver segments between two groups.

Phase:

Phase 4

Details

Lead Sponsor:

Yonsei University

Treatments:

Ezetimibe
Rosuvastatin Calcium