A Study of the Effectiveness and Safety of Ramipril in the Treatment of Hypertension in Children and Adolescents

• Change From Baseline to 4 Weeks in Trough Sitting Systolic Blood Pressure [ Time Frame: Baseline to 4 weeks ] [ Designated as safety issue: No ]
  Value at end of treatment minus value at baseline, comparing the high-dose ramipril group with placebo
  
  

• Change From Baseline to 4 Weeks in Trough Sitting Diastolic Blood Pressure [ Time Frame: Baseline to 4 weeks ] [ Designated as safety issue: No ]
  Value at end of treatment minus value at baseline, comparing the high-dose ramipril group with placebo
  
  
• Change From Baseline to 4 Weeks in Serum Creatinine [ Time Frame: Baseline up to 4 weeks ] [ Designated as safety issue: Yes ]
  Value at end of treatment (up to 4 weeks) minus value at baseline
  
  
• Change From Baseline to 4 Weeks in Serum Potassium [ Time Frame: Baseline up to 4 weeks ] [ Designated as safety issue: Yes ]
  Value at end of treatment (up to 4 weeks) minus value at baseline
  
  
• Change From Baseline to 4 Weeks in Schwartz Formula Glomerular Filtration Rate (GFR) [ Time Frame: Baseline up to 4 weeks ] [ Designated as safety issue: Yes ]
  Value at end of treatment (up to 4 weeks) minus value at baseline; GFR is a measure of kidney function.
  
  

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.