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

J Pediatr. 2004 Sep;145(3):353-9. doi: 10.1016/j.jpeds.2004.04.009.


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 > or =0.06 mg/kg per day. Systolic BP < or =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 Amlodipine was well tolerated, with just 6 children withdrawn from treatment because of drug-related adverse events.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.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Amlodipine / administration & dosage
  • Amlodipine / adverse effects
  • Amlodipine / therapeutic use*
  • Blood Pressure / drug effects
  • Calcium Channel Blockers / administration & dosage
  • Calcium Channel Blockers / adverse effects
  • Calcium Channel Blockers / therapeutic use*
  • Child
  • Double-Blind Method
  • Drug Administration Schedule
  • Female
  • Humans
  • Hypertension / drug therapy*
  • Male


  • Calcium Channel Blockers
  • Amlodipine