Treatment of Pediatric Hypertension With Altace Trial
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|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|
|Study Start Date:||July 2002|
|Estimated Study Completion Date:||November 2004|
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.
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