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  • Title: A randomized, placebo-controlled trial of amlodipine in children with hypertension.
    Author: Flynn JT, Newburger JW, Daniels SR, Sanders SP, Portman RJ, Hogg RJ, Saul JP, PATH-1 Investigators.
    Journal: J Pediatr; 2004 Sep; 145(3):353-9. PubMed ID: 15343191.
    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 > 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 Amlodipine was well tolerated, with just 6 children withdrawn from treatment because of drug-related adverse events.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.
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