NCT03434613

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

A Randomized, Prospective, Open Label, Active Control, 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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nonalcoholic Fatty Liver Disease
• Dyslipidemias

Interventions

Type	Name	Description
DRUG	Rosuvastatin	Rosuvastatin 5mg 1T daily for 6 months
DRUG	Rosuvastatin/ezetimibe combination	Rosuvastatin 5mg / Ezetimibe 10mg combination 1T daily for 6 months

Timeline

• Start date: 2018-05-14
• Primary completion: 2019-09-11
• Completion: 2019-09-11
• First posted: 2018-02-15
• Last updated: 2021-07-09

Locations

1 site across 1 country: South Korea