Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01709513 | Study of Alirocumab (REGN727/SAR236553) in Patients With Primary Hypercholesterolemia and Moderate, High, or Very High Cardiovascular (CV) Risk, Who Are Intolerant to Statins (ODYSSEY ALTERNATIVE) | PHASE3 | COMPLETED | 314 | — | — | Sep 30, 2012 | May 31, 2017 | Jun 23, 2020 | 70 | United States, Austria +6 |
Calculated LDL-C values were obtained from Friedewald formula. Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis).
| Arm | Type | Description |
|---|---|---|
| Atorvastatin (statin rechallenge arm) | OTHER | Atorvastatin 20 mg over-encapsulated tablets orally once daily (QD) for 24 weeks and placebo (for alirocumab) subcutaneous (SC) injection every two weeks (Q2W) for 24 weeks added to stable lipid-modifying therapy (LMT). |
| Ezetimibe | ACTIVE_COMPARATOR | Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT. |
| Alirocumab 75 mg/ up to 150 mg | EXPERIMENTAL | Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk. |
| Name | Type | Description |
|---|---|---|
| Atorvastatin | DRUG | Atorvastatin over-encapsulated tablets. |
| Ezetimibe | DRUG | Ezetimibe over-encapsulated tablet. |
| Alirocumab | DRUG | Alirocumab SC injection of 1 mL into the abdomen, thigh, or outer area of the upper arm. |
| Placebo | DRUG | Placebo for alirocumab, ezitimibe and atorvastatin. |
Inclusion: 1. Patients with primary hypercholesterolemia \[Heterozygous Familial Hypercholesterolemia (heFH) or non-FH\] with moderate, high or very high CV risk and a history of statin intolerance 2. Provide signed informed consent Exclusion: 1. Calculated serum LDL-C \<70 mg/dL (1.81 mmol/L) an...