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NCT00244595 · ClinicalTrials.gov registry record · Phase 3
Efficacy, Safety, & Pharmacokinetics of Candesartan Cilexetil in Hypertensive Paediatric Subjects 6 to < 17 Years of Age
A Phase 3 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 235
- Enrollment target
NCT00244595 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 235 participants.
The verdict
NCT00244595, a Phase 3 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 235 participants
- Enrollment target
Study Summary
The objectives of this study are to describe candesartan cilexetil antihypertensive effects in terms of achieved blood pressure and hypertension control rates and the relationship between subject characteristics and antihypertensive efficacy, and between antihypertensive therapy (candesartan cilexetil dose and add-on treatments) and efficacy over a 1 year treatment period in hypertensive children ages 6 to \< 17 years; to describe growth in terms of height and weight in the study population; to describe change in neurocognition as assessed by the Full Scaled IQ score in a subset of study subjects; to determine the pharmacokinetics of candesartan in hypertensive paediatric subjects ages 6 to \< 17 years; and to describe safety including adverse events and adverse events necessitating study drug discontinuation including dose level and dose duration relationships and growth over a 1 year period in hypertensive children age 6 to \< 17 years.
Interventions
- DRUG candsartan cilexetil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 235 participants |
| Start Date | 2003-09 |
| Est. Completion | 2006-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00244595
The ClinicalTrials.gov registry entry for NCT00244595 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 235 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 0 conditions, and to 1 intervention - of which candsartan cilexetil is the first listed.
NCT00244595 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00244595 about?
NCT00244595 is a clinical study titled "Efficacy, Safety, & Pharmacokinetics of Candesartan Cilexetil in Hypertensive Paediatric Subjects 6 to < 17 Years of Age". The objectives of this study are to describe candesartan cilexetil antihypertensive effects in terms of achieved blood pressure and hypertension control rates and the relationship between subject characteristics and antihypertensive efficacy, and between antihypertensive therapy (candesartan cilexet...
What is the current status of trial NCT00244595?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 235 participants. The study started on 2003-09. Estimated completion is 2006-11.
What interventions are being tested in trial NCT00244595?
The interventions under investigation include: candsartan cilexetil (DRUG).
Who is sponsoring clinical trial NCT00244595?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
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