Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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: Completed Phase 3 study of Hypertension, sponsored by AstraZeneca.

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. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

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
AstraZeneca

1,285 total trials

What the finished NCT00255502 record still lists

NCT00255502 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (97% lower).

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 names 20 study sites across 12 states, led by 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.

Learn More About Clinical Trials

Similar trials for Hypertension

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00255502's enrollment target sits among peer trials

100 292nd of 470 higher than 170 of 470 other Hypertension trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Hypertension trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT01048281 · 100 participants

    Clinical & Pathological Studies of Upper Gastrointestinal Carcinoma

  • NCT01161199 · 100 participants

    The Use of Leukapheresis to Support HIV Pathogenesis Studies

  • NCT01327690 · 100 participants · Early Phase 1

    Mental Health in Veterans and Families After Group Therapies

  • NCT01730781 · 100 participants

    Imaging Cannabinoid Receptors Using Positron Emission Tomography (PET) Scanning

Similar registry start date

  • NCT05988463 · started 2027-01-01 · Phase 1

    Dose-Escalation Study of Artesunate Patients With IPF

  • NCT07219706 · started 2026-12-10 · NA

    Dietary Fiber and Time Restricted Eating

  • NCT02831335 · started 2026-12-01

    Technical Development of Multi-Parametric Renocerebral MRI

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

Related registry views

Source: ClinicalTrials.gov NCT00255502, the US trial registry maintained by the National Library of Medicine. NCT00255502 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.