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NCT00244634 · ClinicalTrials.gov registry record · Phase 3
Atacand Dose Range Finding Study in Pediatric Subjects 6 to <17 Years of Age
A Phase 3 study of Pediatric Hypertension, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 238
- Enrollment target
- 20
- Study locations
NCT00244634: Completed Phase 3 study of Pediatric Hypertension, sponsored by AstraZeneca.
NCT00244634 is a Phase 3 study of Pediatric Hypertension that has completed, run by AstraZeneca. The registered enrollment target is 238 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00244634, a Phase 3 study of Pediatric Hypertension, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 238 participants
- Enrollment target
- 20
- Study locations
Study Summary
Study 261A is a dose-ranging and safety study of candesartan cilexetil. It is a multinational, multicenter, randomized, double-blind, placebo-controlled, parallel-group study with a 4 week treatment period in hypertensive pediatric subjects. Subjects undergo a screening evaluation, then a 1-week, single-blind, placebo run-in after which eligible subjects are allocated to receive 1 of 3 dose levels of candesartan cilexetil or placebo. The study includes 2 panels based on subject weight. The primary efficacy analysis is based on the intent-to-treat population and tests for slope = 0 in a linear regression model with change in sitting systolic blood pressure as the dependent and non-zero dose pooled across weight panels as the independent variable. For subjects without a Double-Blind Week 4 blood pressure determination, carrying the last value forward assigns the value. Additional analyses will include data pooled from a similar dose ranging study conducted in children 1 to \< 6 years of age.
Conditions Studied
Interventions
- DRUG candsartan cilexetil
Study Locations (20)
California
- Research Site - Beverly Hills
- Research Site - Los Angeles
- Research Site - Madera
- Research Site - Yuba City
Delaware
- Research Site - Newark
- Research Site - Wilmington
Georgia
- Research Site - Athens
- Research Site - Augusta
Illinois
- Research Site - Chicago
- Research Site - Park Ridge
Mississippi
- Research Site - Jackson
- Research Site - Port Gibson
New York
- Research Site - Brooklyn
- Research Site - New Hyde Park
Florida
- Research Site - Miami
Kentucky
- Research Site - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 238 participants |
| Start Date | 2003-09 |
| Est. Completion | 2005-11 |
| Phase | Phase 3 |
What the finished NCT00244634 record still lists
NCT00244634 is an interventional study that assigns participants to a tested intervention. The registered 238 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower).
The record links to 1 condition, with Pediatric Hypertension appearing as the primary indexed condition, and to 1 intervention - of which candsartan cilexetil is the first listed.
NCT00244634 names 20 study sites across 12 states, led by California, Delaware, Georgia.
Frequently Asked Questions
What is clinical trial NCT00244634 about?
NCT00244634 is a clinical study titled "Atacand Dose Range Finding Study in Pediatric Subjects 6 to <17 Years of Age". Study 261A is a dose-ranging and safety study of candesartan cilexetil. It is a multinational, multicenter, randomized, double-blind, placebo-controlled, parallel-group study with a 4 week treatment period in hypertensive pediatric subjects. Subjects undergo a screening evaluation, then a 1-week, s...
What is the current status of trial NCT00244634?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 238 participants. The study started on 2003-09. Estimated completion is 2005-11.
What conditions does trial NCT00244634 study?
This clinical trial studies the following conditions: Pediatric Hypertension.
What interventions are being tested in trial NCT00244634?
The interventions under investigation include: candsartan cilexetil (DRUG).
Who is sponsoring clinical trial NCT00244634?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00244634 being conducted?
This trial has 20 study locations across California, Delaware, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00244634's enrollment target sits among peer trials
238 1291st of 2000 higher than 708 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
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