drugset / Trial / NCT01592240
Monthly And Twice Monthly Subcutaneous Dosing Of PF-04950615 (RN316) In Hypercholesterolemic Subjects On A Statin
RandomizedParallel-groupTriple-blindTreatment
Summary
To evaluate the Low Density Lipoprotein-Cholesterol (LDL-C) lowering effect of PF-04950615 administered subcutaneously at monthly intervals, or twice monthly intervals in subjects with high cholesterol whose LDL-cholesterol is \>/=80 mg/dL on background treatment with a statin.
Timeline
- Start
- 2012-07
- Primary completion
- 2013-04
- Completion
- 2013-05
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.
- Ballantyne CM, Neutel J, Cropp A, Duggan W, Wang EQ, Plowchalk D, Sweeney K, Kaila N, Vincent J, Bays H. Results of bococizumab, a monoclonal antibody against proprotein convertase subtilisin/kexin type 9, from a randomized, placebo-controlled, dose-ranging study in statin-treated subjects with hypercholesterolemia. Am J Cardiol. 2015 May 1;115(9):1212-21. doi: 10.1016/j.amjcard.2015.02.006. Epub 2015 Feb 12.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bococizumab | Monoclonal antibody | 50 mg | Subcutaneous |
| Subject | Bococizumab | Monoclonal antibody | 100 mg | Subcutaneous |
| Subject | Bococizumab | Monoclonal antibody | 150 mg | Subcutaneous |
| Subject | Bococizumab | Monoclonal antibody | 200 mg | Subcutaneous |
| Subject | Bococizumab | Monoclonal antibody | 300 mg | Subcutaneous |