Clinical Trials Directory

Trials / Unknown

UnknownNCT03403556

High-intensity Rosuvastatin vs. Moderate-intensity Rosuvastatin/Ezetimibe in High Atherosclerotic Cardiovascular Disease Risk Patients With Type 2 Diabetes

A Randomized, Multicenter, Open, Parallel, Phase 4 Study to Compare the Efficacy and Safety Between High-intensity Rosuvastatin and Moderate-intensity Rosuvastatin/Ezetimibe in High ASCVD Risk Patients With Type 2 diabEtes (CREATE Study)

Status
Unknown
Phase
Phase 4
Study type
Interventional
Enrollment
140 (estimated)
Sponsor
Yuhan Corporation · Industry
Sex
All
Age
40 Years – 74 Years
Healthy volunteers
Not accepted

Summary

To assess the efficacy and safety of moderate-intensity rosuvastatin/ezetimibe compared to high-intensity rosuvastatin in high atherosclerotic cardiovascular disease risk patients with type 2 diabetes

Detailed description

This study is to assess the efficacy and safety of Rosuvamibe® (rosuvastatin 10mg/ezetimibe 10mg) vs. rosuvastatin 20mg treated for 24 weeks in atherosclerotic cardiovascular disease risk (≥ 7.5%) patients with type 2 diabetes

Conditions

Interventions

TypeNameDescription
DRUGRosuvamibeRosuvastatin 10mg/Ezetimibe10mg qd for 24 weeks
DRUGMonorovaRosuvastatin 20mg qd for 24 weeks

Timeline

Start date
2018-03-27
Primary completion
2021-10-01
Completion
2021-12-01
First posted
2018-01-18
Last updated
2020-12-14

Locations

6 sites across 1 country: South Korea

Source: ClinicalTrials.gov record NCT03403556. Inclusion in this directory is not an endorsement.