307B - Safety, Tolerability and Pharmacokinetics Study of TOPROL-XL® in Hypertensive Pediatric Subjects
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
This was a 52-week, multicenter, open-label study to determine the safety, tolerability and
pharmacokinetics 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 12 years < Tanner Stage 3) and adolescents (> 12 years old or > Tanner Stage 3 to
16 years old) of both genders. Because response to some therapies in adult hypertension
appears to be different in black and non-black populations, the recruitment will have a
mixture of black and non-black subjects. Pharmacokinetic measurements were performed on a
subset of patients. Thirty subjects (15 subjects each in the 6 to 12 year age group and the
13 to 16 year age group) had a series of blood samples drawn. All subjects had a trough
plasma level taken 24 hours after the last dose of open-label metoprolol CR/XL (Visit 18)
with the exception of those subjects who completed Protocol 307B (16 week open-label
treatment).