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Ezetimibe Coadministration with Simvastatin in Middle Eastern Patients
NCT00652444Phase 4
Key facts
- Status
- Completed
- Start
- Sep 2003
- Primary completion
- Aug 2004
- Sponsor
- Organon & Co.
- Modality
- Small Molecules
- Drugs
- ezetimibe
- Conditions
- hypercholesterolemia
01
Overview
Phase 4, randomised, double-blind trial of ezetimibe in hypercholesterolemia (2 arms), sponsored by Organon & Co. Primary endpoint: Percentage reduction of LDL-C at 6 weeks. Started Sep 2003; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Coadministration Arm
Simvastatin 20mg + Ezetimibe 10mg
Monotherapy Arm
Simvastatin 20mg + Placebo
03
Who it enrols
Adult patients aged 18-75 with known Coronary Artery Disease (CAD) and primary hypercholesterolemia, currently treated with simvastatin 20mg daily. Patients must have calculated LDL-C between 2.6 and 4.1 mmol/L and triglycerides < 3.99 mmol/L. Excludes patients with severe heart failure, uncontrolled arrhythmias, recent acute coronary syndrome, uncontrolled hypertension or diabetes, and active liver disease.
04
Endpoints
Primary
Percentage reduction of LDL-C
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