Dose Ranging, Safety and Tolerability of TOPROL-XL® Extended-Release Tablets in Hypertensive Pediatric Subjects
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
This was a 4-week, multicenter, double-blind, placebo-controlled, randomized, parallel-group
study to determine the antihypertensive dose range, efficacy, safety and tolerability of
TOPROL-XL ® (metoprolol succinate) extended-release tablets (metoprolol CR/XL) in
hypertensive pediatric subjects. The study population included school age children (age 6 to
< Tanner Stage 3) and adolescents (> Tanner Stage 3 to age 16) of both genders. No more than
50% of the randomized subjects could be adolescents (> Tanner Stage 3 to 16 years old). Since
response to some therapies in adult hypertension appears to be different in black and
non-black populations, recruitment was aimed at a mixture of black and non-black children.
The design included a 1-week screening period (for treatment naive subjects), a 1-week
single-blind placebo run-in period, and a 4-week double-blind treatment period. Eligible
subjects were randomized to the double-blind period with a once daily oral dose of metoprolol
CR/XL to one of three target doses: 0.2, 1.0 and 2.0 mg/kg, or placebo. Dosing was weight
adjusted. The dose range for this study was 12.5 to 200 mg daily. Subjects were closely
monitored and evaluated at the end of Weeks 1, 2, 3 and 4 during the double-blind treatment
period.