Hypertension Clinical Trial
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
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.
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 drug(s), 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 (U.S.
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 child's parents/guardians will be instructed to measure their
child's 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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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