CLINICAL TRIALS PROFILE FOR ALIROCUMAB
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All Clinical Trials for alirocumab
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT01266876 ↗ | Study of the Safety and Efficacy of REGN727/SAR236553 in Patients With HeFH Hypercholesterolemia | Completed | Sanofi | Phase 2 | 2011-01-01 | The purpose of this study is to assess the efficacy and safety of REGN727/SAR236553 in participants diagnosed with heterozygous familial hypercholesterolemia (heFH) |
| NCT01266876 ↗ | Study of the Safety and Efficacy of REGN727/SAR236553 in Patients With HeFH Hypercholesterolemia | Completed | Regeneron Pharmaceuticals | Phase 2 | 2011-01-01 | The purpose of this study is to assess the efficacy and safety of REGN727/SAR236553 in participants diagnosed with heterozygous familial hypercholesterolemia (heFH) |
| NCT01288443 ↗ | Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) in Patients With Primary Hypercholesterolemia on Stable Atorvastatin Therapy | Completed | Regeneron Pharmaceuticals | Phase 2 | 2011-01-01 | Primary Objective: - To evaluate the effect of alirocumab (SAR236553/REGN727) on low-density lipoprotein cholesterol (LDL-C) levels after 12 weeks of treatment in comparison with placebo in participants with LDL-C ≥ 100 mg/dL (≥ 2.59 mmol/L) on ongoing stable atorvastatin therapy. Secondary Objectives: - To evaluate the effects of alirocumab on other lipid levels after 12 weeks of treatment in comparison with placebo - To evaluate the safety and tolerability of alirocumab - To evaluate the development of anti-alirocumab antibodies - To evaluate the pharmacokinetics of alirocumab |
| NCT01288443 ↗ | Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) in Patients With Primary Hypercholesterolemia on Stable Atorvastatin Therapy | Completed | Sanofi | Phase 2 | 2011-01-01 | Primary Objective: - To evaluate the effect of alirocumab (SAR236553/REGN727) on low-density lipoprotein cholesterol (LDL-C) levels after 12 weeks of treatment in comparison with placebo in participants with LDL-C ≥ 100 mg/dL (≥ 2.59 mmol/L) on ongoing stable atorvastatin therapy. Secondary Objectives: - To evaluate the effects of alirocumab on other lipid levels after 12 weeks of treatment in comparison with placebo - To evaluate the safety and tolerability of alirocumab - To evaluate the development of anti-alirocumab antibodies - To evaluate the pharmacokinetics of alirocumab |
| NCT01288469 ↗ | Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) When Co-administered With High Dose of Atorvastatin in Patients With Primary Hypercholesterolemia | Completed | Regeneron Pharmaceuticals | Phase 2 | 2011-01-01 | 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. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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