Dose Ranging, Safety and Tolerability of TOPROL-XL® Extended-Release Tablets in Hypertensive Pediatric Subjects
Public ClinicalTrials.gov record NCT00255528. 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
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00255528
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 144 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
- Mar 20, 2007
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 | Gainsville | 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 | Landsdale | 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 NCT00255528, 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 Mar 20, 2007 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00255528 live on ClinicalTrials.gov.