Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00389519
Status:
TERMINATED
Last Update Posted:
2012-06-11
First Post:
2006-10-17
Brief Title:
A Study of the Effectiveness and Safety of Ramipril in the Treatment of Hypertension in Children and Adolescents
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Multicenter Parallel-Arm Study Assessing the Efficacy Safety and Dose-Response of Ramipril for the Treatment of Hypertension in Children and Adolescents
Status:
TERMINATED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
A planned interim analysis was performed after approx 240 subjects completed the trial The study was stopped as permitted by protocol after the analysis
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary purpose of this study is to evaluate the blood pressure lowering effects of ramipril an FDA-approved drug for the treatment of hypertension in adults in children and adolescents aged 6 to 16 years with hypertension
Detailed Description:
Information is needed on the treatment of hypertension in children and adolescents with antihypertensive drugs like ramipril The study will assess the safety and blood pressure effects of several doses of the antihypertensive drug ramipril in children and adolescents age 6-16 years Approximately 450 children will be given placebo or 1 of the 3 doses of ramipril The treatment assigned will be done by chance like flipping a coin Approximately 120 study centers throughout the world will participate in the trial
Each child will complete a 1- to 4-week Screening Period where they will stop taking their current blood pressure lowering drugs a 4-week Treatment Period where they will receive placebo or one of the ramipril doses and a Follow-up visit 1 week after completion of the Treatment Period Children diagnosed with hypertension according to the fourth report on the diagnosis evaluation and treatment of high blood pressure in children and adolescents US report will be included in the study if their blood pressure meets certain values
Each child will complete a minimum of 6 and up to 9 clinic visits over the course of the study during which procedures and assessments of blood pressure and safety will be performed In addition a childs parentsguardians will be instructed to measure their childs blood pressure at home between clinic visits
A planned interim analysis was performed after approximately 240 subjects completed the trial The study was stopped as permitted by protocol after the analysis
Each child will complete a 1- to 4-week Screening Period where they will stop taking their current blood pressure lowering drugs a 4-week Treatment Period where they will receive placebo or one of the ramipril doses and a Follow-up visit 1 week after completion of the Treatment Period Children diagnosed with hypertension according to the fourth report on the diagnosis evaluation and treatment of high blood pressure in children and adolescents US report will be included in the study if their blood pressure meets certain values
Each child will complete a minimum of 6 and up to 9 clinic visits over the course of the study during which procedures and assessments of blood pressure and safety will be performed In addition a childs parentsguardians will be instructed to measure their childs blood pressure at home between clinic visits
A planned interim analysis was performed after approximately 240 subjects completed the trial The study was stopped as permitted by protocol after the analysis
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