A randomized, placebo-controlled trial of amlodipine in children with hypertension.
OBJECTIVE
Evaluation of the efficacy and safety of amlodipine in hypertensive children.


METHODS
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 Amlodipine was well tolerated, with just 6 children withdrawn from treatment because of drug-related adverse events.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.
Flynn
Joseph T
JT
Division of Pediatric Nephrology, Children's Hospital at Montefiore, Albert Einstein College of Medicine, 111 East 210th Street, Bronx, NY 10467, USA.
Newburger
Jane W
JW
Daniels
Stephen R
SR
Sanders
Stephen P
SP
Portman
Ronald J
RJ
Hogg
Ronald J
RJ
Saul
J Philip
JP
D000293:Adolescent; D017311:Amlodipine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects; D002121:Calcium Channel Blockers / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D008297:Male
D002121:Calcium Channel Blockers; D017311:Amlodipine