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NCT00244621 · ClinicalTrials.gov registry record · Phase 3
Atacand Dose Ranging in Hypertensive Pediatric Subjects 1 Year to Less Than 6 Years of Age
A Phase 3 study of Hypertension, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 95
- Enrollment target
- 20
- Study locations
NCT00244621: Completed Phase 3 study of Hypertension, sponsored by AstraZeneca.
NCT00244621 is a Phase 3 study of Hypertension that has completed, run by AstraZeneca. The registered enrollment target is 95 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 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00244621, a Phase 3 study of Hypertension, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 95 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a dose ranging study of candesartan cilexetil in hypertensive pediatric subjects ages 1 to less than 6 years of age. It employs a double blind, randomized, dose ranging design intended for conduct as a multicenter trial. There are 3 study 'periods': a 1-week placebo run-in, a 4-week double blind treatment, and a 52-week open-label, long-term treatment period. 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 (0.05 mg/kg, or 0.20 mg /kg or 0.40 mg /kg), liquid formulation, in a 1:1:1 ratio for 4-weeks. At the end of randomized dose allocation (Day 28), blood pressure assessment will be performed and subjects may begin the 52-week, open-label treatment period of the study.
Conditions Studied
Interventions
- DRUG candesartan cilexetil (Atacand)
Study Locations (20)
Other
- Research Site - Edegem
- Research Site - Ghent
- Research Site - Aarhus
- Research Site - Strasbourg
Texas
- Research Site - Beaumont
- Research Site - Houston
- Research Site - San Antonio
California
- Research Site - Los Angeles
- Research Site - San Francisco
Florida
- Research Site - Miami
- Research Site - Orlando
Alabama
- Research Site - Birmingham
Arkansas
- Research Site - Little Rock
Idaho
- Research Site - Boise
Michigan
- Research Site - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2004-11 |
| Est. Completion | 2008-08 |
| Phase | Phase 3 |
What the finished NCT00244621 record still lists
NCT00244621 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, 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 candesartan cilexetil (Atacand) is the first listed.
NCT00244621 names 20 study sites across 13 states, led by Other, Texas, California.
Frequently Asked Questions
What is clinical trial NCT00244621 about?
NCT00244621 is a clinical study titled "Atacand Dose Ranging in Hypertensive Pediatric Subjects 1 Year to Less Than 6 Years of Age". This is a dose ranging study of candesartan cilexetil in hypertensive pediatric subjects ages 1 to less than 6 years of age. It employs a double blind, randomized, dose ranging design intended for conduct as a multicenter trial. There are 3 study 'periods': a 1-week placebo run-in, a 4-week double b...
What is the current status of trial NCT00244621?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 95 participants. The study started on 2004-11. Estimated completion is 2008-08.
What conditions does trial NCT00244621 study?
This clinical trial studies the following conditions: Hypertension.
What interventions are being tested in trial NCT00244621?
The interventions under investigation include: candesartan cilexetil (Atacand) (DRUG).
Who is sponsoring clinical trial NCT00244621?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00244621 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Florida, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00244621's enrollment target sits among peer trials
95 303rd of 470 higher than 167 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.
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