A randomized, placebo-controlled trial of amlodipine in children with hypertension

Abstract

Objectives Evaluation of the efficacy and safety of amlodipine in hypertensive children. Study design A randomized, double blinded, placebo-controlled, parallel-group, dose-ranging study was conducted at 49 centers in North and South America. The primary end point was the effect of amlodipine on systolic blood pressure (BP); secondary end points included the effect of amlodipine on diastolic BP, the effect of amlodipine as a function of dose and body size, and evaluation of safety. Results We enrolled 268 hypertensive children (mean age, 12.1 ± 3.3 years); 84 (31.3%) had primary hypertension, and 177 (66%) were boys. Amlodipine produced significantly greater reductions in systolic BP than placebo; these were −6.9 mm Hg for 2.5 mg daily ( P = .045 vs placebo) and −8.7 mm Hg for 5 mg daily ( P = .005 vs placebo). The underlying cause of hypertension had no effect on the response to amlodipine. There was a significant dose-response effect of amlodipine on both systolic and diastolic BP beginning at doses ≥0.06 mg/kg per day. Systolic BP ≤95 th percentile was achieved in 34.6% of subjects with systolic hypertension. Amlodipine was well tolerated, with just 6 children withdrawn from treatment because of drug-related adverse events. Conclusions Amlodipine effectively lowers systolic BP in a dose-dependent manner in hypertensive children who require drug treatment.