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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
144
Research Site
Little Rock, Arkansas, United States
Research Site
Bellflower, California, United States
Research Site
Beverly Hills, California, United States
Research Site
Los Angeles, California, United States
Research Site
Orange, California, United States
Research Site
Hartford, Connecticut, United States
Research Site
Wilmington, Delaware, United States
Research Site
Gainsville, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Orlando, Florida, United States
...and 21 more locations
To evaluate the dose range, safety, and tolerability of metoprolol CR/XL in hypertensive pediatric subjects, based on the change in sitting SBP from baseline to the end of treatment.
Slope of placebo-corrected changes in sitting DBP: baseline to end of treatment as a function of target dose. Differences in mean change: baseline to end of treatment comparing each active group to placebo for sitting SBP and DBP.
Safety profile
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