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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00255528 |
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.
Condition | Intervention | Phase |
---|---|---|
Hypertension |
Drug: metoprolol succinate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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-Controlled, Randomized, Parallel-Group Study |
Estimated Enrollment: | 144 |
Study Start Date: | July 2002 |
Ages Eligible for Study: | 6 Years to 16 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Have hypertension that is either:
Exclusion Criteria:
Study Director: | AstraZeneca Toprol Medical Science Director, MD | AstraZeneca |
Study ID Numbers: | D4020C00033, 307A, SH-MET-0033 |
Study First Received: | November 17, 2005 |
Last Updated: | March 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00255528 |
Health Authority: | United States: Food and Drug Administration |
Pediatric hypertension |
Metoprolol succinate Vascular Diseases Metoprolol Hypertension |
Neurotransmitter Agents Sympatholytics Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions |
Autonomic Agents Therapeutic Uses Adrenergic beta-Antagonists Cardiovascular Diseases Adrenergic Antagonists Peripheral Nervous System Agents Anti-Arrhythmia Agents |