high cholesterol primary hypercholesterolemia
Conditions
Interventions
Study drug: Dose/Route/Schedule: REGN727 75 mg SC Q2W for 24 weeks, or 75 mg SC
Q2W for 12 weeks followed by 150 mg SC Q2W for 12 weeks
Study Drug: Dose/Route/Schedule: Ezetimibe 10 mg PO QD for 24 w
Sponsors
Regeneron Pharmaceuticals Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients with primary hypercholesterolemia (familiaal of niet familiaal) with moderate, high or very high CV risk and a history of statin intolerance *** Definition of statin intolerance: Inability to tolerate at least 2 previous statins at the lowest approved daily dose due to skeletal muscle-related symptoms, other than those due to strain or trauma, such as pain, aches, weakness, or cramping, that began or increased during statin therapy and stopped when statin therapy was discontinued.
Exclusion criteria
Exclusion criteria: - Calculated serum LDL-C
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint is the percent change in calculated LDL-C from baseline to week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| * The percent change in calculated LDL-C from baseline to week 12 * The percent change in ApoB from baseline to week 24. * The percent change in non-HDL-C from baseline to week 24. * The percent change in total-C from baseline to week 24. * The percent change in ApoB from baseline to week 12. * The percent change in non-HDL-C from baseline to week 12. * The percent change in total-C from baseline to week 12. * The proportion of patients reaching LDL-C goal at week 24, ie, LDL-C | — |
Countries
Netherlands
Outcome results
None listed