A Study to Compare Rosuvastatin/Ezetimibe and Rosuvastatin in Patients With Diabetes Mellitus and Hypercholesterolemia

• Status: Completed
• Trial end date: 2019-05-23
• Target enrollment: 0
• Participant gender: All

Summary

A Study to Compare Rosuvastatin/Ezetimibe Combination and Monotherapy in Patients with Diabetes Mellitus and Hypercholesterolemia.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yuhan Corporation
• Collaborator: Linical Korea
• Treatments: Ezetimibe; Rosuvastatin Calcium

Criteria

Inclusion Criteria:

• Subjects ≥ 19 or ≤ 75 years of age

• Subjects undergoing treatment for type 2 diabetes

• Subjects undergoing treatment of statin for hypercholesterolemia

• Fasting LDL-C ≤ 250mg/dL at the screening visit

• Fasting LDL-C ≥70mg/dL or ≤ 160mg/dL at the randomization visit

• Fasting TG<500mg/dL

Exclusion Criteria:

• Subjects with hypersensitivity reaction to Statin and Ezetimibe

• Subjects with severe kidney disease

• Subjects with HIV positive result at the screening

• Pregnant or breast-feeding subjects

• Subjects with taking any medication affecting level of LDL (Fenofibrate, Omega 3 fatty aicd etc.)

• Insulin-treated Subjects

• Other exclusions applied