Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00044265
Status:
COMPLETED
Last Update Posted:
2012-06-07
First Post:
2002-08-23
Brief Title:
Treatment of Pediatric Hypertension With Altace Trial
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A Dose Escalation Randomized Double-blind Withdrawal Study of the Efficacy Dose-response and Safety of Ramipril for the Treatment of Hypertension in Children and Adolescents
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Ramipril is an ACE inhibitor that has been marketed in the US for the treatment of hypertension since 1991 It has been shown to be effective in reducing both systolic and diastolic blood pressure in adults when used once daily ACE inhibitors are frequently used to treat hypertension in children however ramipril has not been extensively tested in children and information regarding the efficacy and safety would therefore be of benefit to children This study is designed to demonstrate the efficacy and safety of ramipril in the treatment of hypertension in children ages 6 through 16 years
Detailed Description:
In adults common side effects include persistent dry mouth dizziness fatigue and headache Rare cases of angioedema have been reported When used in pregnancy during the second and third trimesters ACE inhibitors can cause injury and even death to the developing fetus When pregnancy is detected ramipril should be discontinued as soon as possible Ramipril is contraindicated in patients who are hypersensitive to the product or have a history of angioedema related to previous treatment with an ACE inhibitor
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