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I-ROSETTE: Ezetimibe/Rosuvastatin vs Rosuvastatin in Hypercholesterolemia
NCT02749994Phase 3
Key facts
- Status
- Completed
- Start
- Apr 2016
- Primary completion
- Feb 2017
- Countries
- 1
- Sponsor
- Ildong Pharmaceutical Co Ltd
- Modality
- Small Molecules
- Drugs
- ezetimibe
- Conditions
- hypercholesterolemia
01
Overview
Phase 3, randomised, double-blind trial of ezetimibe in hypercholesterolemia (6 arms), sponsored by Ildong Pharmaceutical Co Ltd. Primary endpoint: Percent change from baseline in LDL-Cholesterol at 8 weeks. Started Apr 2016; status: completed.
02
Design
6 arms- Study design
- RandomizedDouble-blind
Rosuvastatin 5mg
Rosuvastatin 5mg daily
Rosuvastatin 10mg
Rosuvastatin 10mg daily
Rosuvastatin 20mg
Rosuvastatin 20mg daily
Rosuvastatin 5mg/Ezetimibe 10mg
Rosuvastatin 5mg + Ezetimibe 10mg daily
Rosuvastatin 10mg/Ezetimibe 10mg
Rosuvastatin 10mg + Ezetimibe 10mg daily
Rosuvastatin 20mg/Ezetimibe 10mg
Rosuvastatin 20mg + Ezetimibe 10mg daily
03
Who it enrols
Adult patients aged 19-79 with confirmed hypercholesterolemia requiring drug therapy, excluding those with severe renal or active liver disease, uncontrolled hypertension, or recent use of lipid regulators.
04
Endpoints
Primary
Percent change from baseline in LDL-Cholesterol
Secondary
Percent change from baseline in Total Cholesterol
Percent change from baseline in Triglyceride
Percent change from baseline in HDL-Cholesterol
Percent change from baseline in non-HDL-Cholesterol
Percent change from baseline in Apolipoprotein B
Percent change from baseline in Apolipoprotein A1
Percent change from baseline in LDL-Cholesterol at 4 weeks
Percent change from baseline in hs-CRP
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