Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00244621
Status:
COMPLETED
Last Update Posted:
2011-08-31
First Post:
2005-10-25
Brief Title:
Atacand Dose Ranging in Hypertensive Pediatric Subjects 1 Year to Less Than 6 Years of Age
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Dose-ranging Safety and Pharmacokinetics Study of Candesartan Cilexetil in Hypertensive Pediatric Subjects 1 to Less That 6 Years of Age A 4-week Multicenter Randomized Double-blind Study With a 1-year Open-label Follow-up Period
Status:
COMPLETED
Status Verified Date:
2011-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 005 mgkg or 020 mg kg or 040 mg kg liquid formulation in a 111 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 328 | None | None | None |