Study to Assess the Tolerability and Efficacy of Anacetrapib (MK-0859) Co-Administered With Statin in Participants With Heterozygous Familial Hypercholesterolemia (MK-0859-020)

Phase 3 Completed 306 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupDouble-blindTreatment

Summary

The objective of this study is to evaluate the efficacy and tolerability of adding anacetrapib to ongoing statin therapy in participants with heterozygous familial hypercholesterolemia (HeFH).

Timeline

Start: 2012-02-03
Primary completion: 2014-02-12
Completion: 2018-11-13

Outcome

Met primary endpoint

registry analysis (superiority test); Anacetrapib 100 mg vs Placebo; p <0.001; Difference in Least Squares (LS) Means -39.7 (95% CI -45.7 to -33.7) NCT01524289 ↗

Publications

Background Kastelein JJ, Besseling J, Shah S, Bergeron J, Langslet G, Hovingh GK, Al-Saady N, Koeijvoets M, Hunter J, Johnson-Levonas AO, Fable J, Sapre A, Mitchel Y. Anacetrapib as lipid-modifying therapy in patients with heterozygous familial hypercholesterolaemia (REALIZE): a randomised, double-blind, placebo-controlled, phase 3 study. Lancet. 2015 May 30;385(9983):2153-61. doi: 10.1016/S0140-6736(14)62115-2. Epub 2015 Mar 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Anacetrapib	Small molecule	100 mg	Oral