Pediatric trials of antihypertensive agents: impact of trial design and unique pediatric factors on efficacy end points

Author(s): Kevin D Hill, Patricia Y Chu, Jennifer S Li & Christoph P Hornik

There is an increasing prevalence of pediatric hypertension worldwide due to the growing epidemic of childhood obesity. Recent regulatory changes in the USA and Europe have stimulated major pediatric clinical trials of 16 different antihypertensive agents, leading to US FDA labeling of 10 of these drugs. With increased pediatric hypertension trial experience, trial designs have been refined and we now better understand factors associated with trial success, including the ability to differentiate a dose–response relationship. The use of weight-based dosing and liquid formulation of study drug, selection of an appropriate dose range and appropriate blood pressure end points all increase the likelihood of pediatric trial success.