NCT03446261

Rosuvastatin/Ezetimibe vs Rosuvastatin in Korean Patients With Type 2 Diabetes Mellitus and Hypercholesterolemia

A Randomized, Multicenter, Open, Parallel, Phase 4 Study to Compare the Efficacy and Safety of Rosuvastatin/Ezetimibe Combination Therapy vs Rosuvastatin Monotherapy in Korean Patients With Type 2 Diabetes Mellitus and Hypercholesterolemia

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Yuhan Corporation · Industry
• Sex: All
• Age: 19 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

To assess the efficacy and safety of rosuvastatin/ezetimibe combination therapy compared to rosuvastatin monotherapy in Korean patients with type 2 diabetes mellitus and hypercholesterolemia

Detailed description

This study is to assess the efficacy and safety of Rosuvamibe® (rosuvastatin 5mg/ezetimibe 10mg) vs Monorova® (rosuvastatin 10mg) treated for 8 weeks in Korean patients with type 2 diabetes mellitus and hypercholesterolemia.

Conditions

• Type 2 Diabetes Mellitus
• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	Rosuvamibe® Tab	Rosuvastatin 5mg/ezetimibe 10mg qd for 8 weeks
DRUG	Monorova® Tab	Rosuvastatin 10mg qd for 8 weeks

Timeline

• Start date: 2018-02-23
• Primary completion: 2019-03-05
• Completion: 2019-03-05
• First posted: 2018-02-26
• Last updated: 2019-07-23

Locations

2 sites across 1 country: South Korea