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

Yuhan

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus and Hypercholesterolemia

Treatments: Drug: Rosuvastatin+Ezetimibe; Drug: Rosuvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03217409

YMC022

Details and patient eligibility

About

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

Full description

This trial is conducted to compare the efficacy and safety between Rosuvastatin/Ezetimibe combination and Rosuvastatin monotherapy in patients with Diabetes Mellitus and Hypercholesterolemia for 8 weeks.

Enrollment: 85 patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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85 participants in 2 patient groups

Rosuvastatin+Ezetimibe

Experimental group

Description:

Rosuvastatin 5mg+Ezetimibe 10mg Rosuvamibe ® Tablet, 1T, Once a day/8week

Treatment:

Drug: Rosuvastatin+Ezetimibe

Rosuvastatin

Active Comparator group

Description:

Rosuvastatin 5mg Monorova ® Tablet, 1T, Once a day/8week

Treatment:

Drug: Rosuvastatin