Conditions: Hypertension
Keywords: Hypertension/*etiology Blood Pressure Pediatric Adolescent Child
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 422
Healthy volunteers: no

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 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.

Arms:
arm 1: once per day arm 2: 0.3125, 0.625, or 1.25 mg once a day, based on subject weight arm 3: 1.25, 2.5, or 5 mg once a day, based on subject weight arm 4: 5, 10, or 20 mg once a day, based on subject weight

Interventions: intervention 1: ramipril intervention 2: placebo
Intervention descriptions: intervention 1: once a day oral ramipril capsules given for 4 weeks intervention 2: once a day oral placebo capsule for 4 weeks

Protocol document: