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NCT00255528 · ClinicalTrials.gov registry record · Phase 3
Dose Ranging, Safety and Tolerability of TOPROL-XL® Extended-Release Tablets in Hypertensive Pediatric Subjects
A Phase 3 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 144
- Enrollment target
NCT00255528 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 144 participants.
The verdict
NCT00255528, a Phase 3 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 144 participants
- Enrollment target
Study 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.
Interventions
- DRUG metoprolol succinate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 144 participants |
| Start Date | 2002-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00255528
The ClinicalTrials.gov registry entry for NCT00255528 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 144 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which metoprolol succinate is the first listed.
NCT00255528 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00255528 about?
NCT00255528 is a clinical study titled "Dose Ranging, Safety and Tolerability of TOPROL-XL® Extended-Release Tablets in Hypertensive Pediatric Subjects". 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...
What is the current status of trial NCT00255528?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 144 participants. The study started on 2002-07.
What interventions are being tested in trial NCT00255528?
The interventions under investigation include: metoprolol succinate (DRUG).
Who is sponsoring clinical trial NCT00255528?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
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