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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 is a Phase 3 study of Pediatric Hypertension that has completed, run by AstraZeneca. The registered enrollment target is 238 participants. The trial reports 20 study locations across 12 states.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00244634
The ClinicalTrials.gov registry entry for NCT00244634 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 238 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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.
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