drugset / Trial / NCT01350141
A Multiple Dose Study Of PF-04950615 (RN316) In Subjects On Maximum Doses Of Statins
RandomizedParallel-groupDouble-blindTreatment
Summary
PF-04950615 is a new investigational hypercholesterolemic agent that is being tested in this study to evaluate if it can lower LDL cholesterol.
Timeline
- Start
- 2011-06
- Primary completion
- 2012-04
- Completion
- 2012-06
Outcome
Met primary endpoint
registry Placebo vs PF-04950615 (RN316) 1 mg/kg; p = 0.0137; Least Squares (LS) Mean Difference -21.81 (95% CI -38.85 to -4.77) NCT01350141 ↗
registry Placebo vs PF-04950615 (RN316) 3 mg/kg; p <0.0001; LS Mean Difference -46.42 (95% CI -63.62 to -29.22) NCT01350141 ↗
Publications
- Wang EQ, Kaila N, Plowchalk D, Gibiansky L, Yunis C, Sweeney K. Population PK/PD modeling of low-density lipoprotein cholesterol response in hypercholesterolemic participants following administration of bococizumab, a potent anti-PCSK9 monoclonal antibody. CPT Pharmacometrics Syst Pharmacol. 2023 Dec;12(12):2013-2026. doi: 10.1002/psp4.13050. Epub 2023 Nov 22.
- Wan H, Gumbiner B, Joh T, Riel T, Udata C, Forgues P, Garzone PD. Effects of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition with Bococizumab on Lipoprotein Particles in Hypercholesterolemic Subjects. Clin Ther. 2017 Nov;39(11):2243-2259.e5. doi: 10.1016/j.clinthera.2017.09.009. Epub 2017 Oct 14.
- Udata C, Garzone PD, Gumbiner B, Joh T, Liang H, Liao KH, Williams JH, Meng X. A Mechanism-Based Pharmacokinetic/Pharmacodynamic Model for Bococizumab, a Humanized Monoclonal Antibody Against Proprotein Convertase Subtilisin/Kexin Type 9, and Its Application in Early Clinical Development. J Clin Pharmacol. 2017 Jul;57(7):855-864. doi: 10.1002/jcph.867. Epub 2017 Feb 9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bococizumab | Monoclonal antibody | — | Intravenous |