drugset / Trial / NCT03446261

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

NCT03446261 ↗

Phase 4 Completed 140 enrolled Yuhan Corporation
RandomizedParallel-groupOpen-labelTreatment

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

Timeline

Start
2018-02-23
Primary completion
2019-03-05
Completion
2019-03-05

Outcome

Met primary endpoint

paper percentage change (least-square means ± standard error) in the apoB/A1 ratio in the rosuvastatin/ezetimibe group was significantly decreased compared to the rosuvastatin group (- 46.14 ± 1.58% vs. - 41.30 ± 1.58%, respectively; P = 0.03). PMID 32065359 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Ezetimibe Unknown 10 mg —
Subject Rosuvastatin Small molecule 5 mg —
Subject Rosuvastatin Small molecule 10 mg —