307B - Safety, Tolerability and Pharmacokinetics Study of TOPROL-XL® in Hypertensive Pediatric Subjects
Public ClinicalTrials.gov record NCT00255502. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Safety, Tolerability and Pharmacokinetics Study of TOPROL-XL® (Metoprolol Succinate) Extended-release Tablets (Metoprolol CR/XL) in Hypertensive Pediatric Subjects: A Multicenter, Open-Label Extension of Protocol 307A
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT00255502
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 100 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 6 Years to 16 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 2002 (Type not available)
- Primary completion
- Not listed
- Completion
- Not listed
- Last update posted
- Jan 18, 2020
Started 2002
United States locations
- U.S. sites
- 30
- U.S. states
- 17
- U.S. cities
- 30
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Little Rock | Arkansas | — | — |
| Research Site | Bellflower | California | — | — |
| Research Site | Beverly Hills | California | — | — |
| Research Site | Los Angeles | California | — | — |
| Research Site | Orange | California | — | — |
| Research Site | Hartford | Connecticut | — | — |
| Research Site | Wilmington | Delaware | — | — |
| Research Site | Gainesville | Florida | — | — |
| Research Site | Miami | Florida | — | — |
| Research Site | Orlando | Florida | — | — |
| Research Site | Tampa | Florida | — | — |
| Research Site | Honolulu | Hawaii | — | — |
| Research Site | Chicago | Illinois | — | — |
| Research Site | Louisville | Kentucky | — | — |
| Research Site | Livingston | New Jersey | — | — |
| Research Site | New Hyde Park | New York | — | — |
| Research Site | The Bronx | New York | — | — |
| Research Site | Durham | North Carolina | — | — |
| Research Site | Winston-Salem | North Carolina | — | — |
| Research Site | Cincinnati | Ohio | — | — |
| Research Site | Cleveland | Ohio | — | — |
| Research Site | Columbus | Ohio | — | — |
| Research Site | Lansdale | Pennsylvania | — | — |
| Research Site | Philadelphia | Pennsylvania | — | — |
| Research Site | Greenville | South Carolina | — | — |
| Research Site | Beaumont | Texas | — | — |
| Research Site | Houston | Texas | — | — |
| Research Site | San Antonio | Texas | — | — |
| Research Site | Salt Lake City | Utah | — | — |
| Research Site | Norfolk | Virginia | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00255502, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 18, 2020 · Synced Oct 28, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00255502 live on ClinicalTrials.gov.