Clinical Trial: Dose Ranging, Safety and Tolerability of TOPROL-XL® Extended-Release Tablets in Hypertensive Pediatric Subjects

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Dose Ranging, Safety and Tolerability of TOPROL-XL® (Metoprolol Succinate) Extended-Release Tablets (Metoprolol CR/XL) in Hypertensive Pediatric Subjects: A Multicenter, Double-Blind, Placebo-Con

Brief 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.

Detailed Summary:
Sponsor: AstraZeneca

Current Primary Outcome: 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.

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome: Same as current

Information By: AstraZeneca

Dates:
Date Received: November 17, 2005
Date Started: July 2002
Date Completion:
Last Updated: March 19, 2007
Last Verified: March 2007