Changes in pediatric food and drug administration written requests and regulations: Impact on clinical trial of hypertension trials in children
Regulatory changes in the United States and Europe have stimulated major pediatric clinical trials of > 15 different antihypertensive agents over the last decade. With increased pediatric hypertension trial experience, trial designs have been refined and we now have a better understanding of factors associated with trial success or failure. Appropriate dose range, weight-based dosing, use of a liquid formulation, and use of appropriate blood pressure endpoints are all factors that have been associated with improved trial success. These lessons learned and important modifications in trial design templates are reflected in the US Food and Drug Administration written request criteria. The written request provides valuable information that can be used to optimally design future clinical trials of antihypertensive agents as well as other therapeutic agents for use in children.
