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NCT00255502 · ClinicalTrials.gov registry record · Phase 3

307B - Safety, Tolerability and Pharmacokinetics Study of TOPROL-XL® in Hypertensive Pediatric Subjects

A Phase 3 study of Hypertension, sponsored by AstraZeneca.

Completed
Registry status
Phase 3
Development phase
100
Enrollment target
20
Study locations

NCT00255502 is a Phase 3 study of Hypertension that has completed, run by AstraZeneca. The registered enrollment target is 100 participants, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (97% lower). The trial reports 20 study locations across 12 states.

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The verdict

NCT00255502, a Phase 3 study of Hypertension, has completed, sponsored by AstraZeneca.

COMPLETED
Registry status
Phase 3
Development phase
100 participants
Enrollment target
20
Study locations

Study 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).

Conditions Studied

Hypertension

Interventions

  • DRUG metoprolol succinate

Study Locations (20)

California

  • Research Site - Bellflower
  • Research Site - Beverly Hills
  • Research Site - Los Angeles
  • Research Site - Orange

Florida

  • Research Site - Gainesville
  • Research Site - Miami
  • Research Site - Orlando
  • Research Site - Tampa

New York

  • Research Site - New Hyde Park
  • Research Site - The Bronx

North Carolina

  • Research Site - Durham
  • Research Site - Winston-Salem

Arkansas

  • Research Site - Little Rock

Connecticut

  • Research Site - Hartford

Delaware

  • Research Site - Wilmington

Hawaii

  • Research Site - Honolulu

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2002-07
Phase Phase 3

Sponsor

AstraZeneca

1,285 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00255502

The ClinicalTrials.gov registry entry for NCT00255502 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (97% lower). The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Hypertension appearing as the primary indexed condition, and to 1 intervention - of which metoprolol succinate is the first listed.

NCT00255502 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, Florida, New York.

Frequently Asked Questions

What is clinical trial NCT00255502 about?

NCT00255502 is a clinical study titled "307B - Safety, Tolerability and Pharmacokinetics Study of TOPROL-XL® in Hypertensive Pediatric Subjects". 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 \< Tan...

What is the current status of trial NCT00255502?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 100 participants. The study started on 2002-07.

What conditions does trial NCT00255502 study?

This clinical trial studies the following conditions: Hypertension.

What interventions are being tested in trial NCT00255502?

The interventions under investigation include: metoprolol succinate (DRUG).

Who is sponsoring clinical trial NCT00255502?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00255502 being conducted?

This trial has 20 study locations across Arkansas, California, Connecticut, Delaware, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.