Phase 2
Completed N=92
Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) When Co-administered With High Dose of Atorvastatin in Patients With Primary Hypercholesterolemia
Source: ClinicalTrials.gov NCT01288469 ↗Enrolled (actual)
92
Serious AEs
1.1%
Results posted
Sep 2015
Primary outcomePrimary: Percent Change From Baseline in Calculated LDL-C at Week 8 - On-treatment Analysis — -17.3; -66.2; -73.2 percent change — p=<0.0001
Summary
Primary Objective:
To evaluate the effect of alirocumab (SAR236553/REGN727) on low-density lipoprotein cholesterol (LDL-C) levels compared with placebo when co-administered with 80 mg of atorvastatin after 8 weeks of treatment in participants with LDL-C ≥ 100mg/dL (≥ 2.59 mmol/L) on atorvastatin 10 mg.
Secondary Objectives:
* To evaluate the effects of alirocumab on other lipid levels in comparison with placebo, when co-administered with 80 mg of atorvastatin after 8 weeks of treatment.
* To evaluate the efficacy of alirocumab when co-administered with a high dose of atorvastatin (80 mg) versus atorvastatin 10 mg.
* To evaluate the safety and tolerability of alirocumab when co-administered with 2 different doses of atorvastatin.
* To evaluate the development of anti-alirocumab antibodies.
* To evaluate the pharmacokinetics of alirocumab.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Calculated LDL-C at Week 8 - On-treatment Analysis |
-17.3; -66.2; -73.2 | <0.0001 sig |
| SECONDARY Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Week 8 - On-treatment Analysis |
-0.56; -2.09; -2.31 | — |
| SECONDARY Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Week 8 - On-treatment Analysis |
-21.5; -80.7; -89.3 | — |
| SECONDARY Percentage of Participants Achieving Calculated LDL-C <100 mg/dL (2.59 mmol/L) and < 70 mg/dL (1.81 mmol/L) at Week 8 - On-treatment Analysis |
51.7; 100.0; 100.0; 17.2; 96.6; 90.0 | — |
| SECONDARY Percent Change From Baseline in Total Cholesterol, Fasting Triglycerides, Non-high-Density Lipoprotein Cholesterol (Non-HDL-C), Apolipoprotein B (Apo-B) and Lipoprotein(a) at Week 8 - On-treatment Analysis |
-16.6; -40.5; -47.2; -11.9; -4.0; -24.7 | — |
| SECONDARY Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Week 8 - On-treatment Analysis |
-3.6; 2.6; 5.8 | — |
| SECONDARY Absolute Change in the Ratio Apolipoprotein B/Apolipoprotein A-1 (ApoB/ApoA-1) From Baseline to Week 8 - On-treatment Analysis |
-0.03; -0.34; -0.36 | — |
Eligibility Criteria
Inclusion criteria
- Participants receiving a lipid-lowering treatment other than atorvastatin/ or not at stable dose of atorvastatin 10 mg for at least 6 weeks prior to screening, or drug naive participants with primary hypercholesterolemia if they are likely to have low-density lipoprotein cholesterol (LDL-C) ≥ 100 mg/dL (≥ 2.59 mmol/L) at the end of the 6-week run-in treatment period on atorvastatin therapy
OR
- Participants with primary hypercholesterolemia treated with stable dose of atorvastatin 10 mg for at least 6 weeks prior to screening and likely to have low-density lipoprotein cholesterol (LDL-C) ≥ 100 mg/dL (≥ 2.59 mmol/L) at the screening visit.
Exclusion criteria
- LDL-C 350 mg/dL (> 3.95 mmol/L) at screening visit.
- Positive serum or urine pregnancy test in females of childbearing potential.
- Pregnant or breast-feeding women.
- Women of childbearing potential with no effective contraceptive method.
The above information is not intended to contain all considerations relevant to a Participant's potential participation in a clinical trial.
Data sourced from ClinicalTrials.gov (NCT01288469). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.