ABSTRACT
This chapter presents a case study in which simulation was used to evaluate candidate population pharmacokinetic (PPK) substudy designs for a phase III clinical trial in black/Caucasian hypertensive patients. The primary endpoint of the clinical trial was to compare the antihypertensive effect of orally administered eplerenone, an aldosterone antagonist, with placebo and an active control. A sparse sampling strategy was desirable in this outpatient setting to facilitate patient recruitment by eliminating lengthy clinic visits that burden the patient and study sites.
