Sanofi Hypercholestrolemia 1569
A Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of SAR236553/REGN727 Versus Ezetimibe in High Cardiovascular Risk Patients With Hypercholesterolemia Not Adequately Controlled With Their Statin Therapy
| Protocol | EFC11569 |
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| Identifier | EFC11569 Site Number 840933 |
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| UID | 1f1a8708-5aee-4325-a94c-a3bb0f807821 |
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| Status | Done - Archived |
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| Phase | 3 |
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| Category | High Cholesterol / Adult |
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| Launch Year | 2014 |
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| NCT Number | - |
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| Created | 2012-06-01 13:38 |
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| Last Updated | 2012-06-01 13:38 |
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Description
Key Elements:
• Study purpose: To demonstrate the reduction of LDL cholesterol by study medication as add-on therapy to statin in comparison to ezetimibe after 24 weeks of treatment in patients with hypercholesterolemia at high cardiovascular risk
• Study drug: SAR236553 is a type of protein that blocks a substance called PCSK9. PCSK9 is secreted from the liver and causes higher LDL-cholesterol (bad cholesterol) levels in the blood. Therefore, blocking PCSK9 through the use of the study medication can potentially decrease the levels of LDL-C in patients with high cholesterol
• Study Drug Administration: A subcutaneous injection every two weeks in addition to a capsule orally once-daily. There is a 2-in-3 chance of getting SAR236553 and about a 1-in-3 chance of getting ezetimibe. There is placebo in this study; however everyone will receive an active drug.
• 15 visits (104 weeks/24 months)
• Stipend: $40 for each completed visit
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