Efficacy/Safety of DP-R207 Tablet Versus CRESTOR Tablet in Patients With Primary Hypercholesterolemia

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate efficacy and safety of DP-R207 in patients with primary hypercholesterolemia.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alvogen Korea
• Treatments: Ezetimibe; Rosuvastatin Calcium

Criteria

Inclusion Criteria:

• Aged over 19 years

• Signed informed consent form

• At visit 1 and visit 2, LDL-Cholesterol ≤ 250mg/dL and Triglyderide ≤ 350mg/dL

Exclusion Criteria:

• Has a history of hypersensitivity to HMG-CoA reductase inhibitor and component of ezeimibe

• Liver transaminases > 2 x upper limit of normal