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

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.

Timeline

Start

2006-10

Primary completion

2007-11

Completion

2007-11

Outcome

Met primary endpoint

Stopped: “A planned interim analysis was performed after approx. 240 subjects completed the trial. The study was stopped, as permitted by protocol, after the analysis.”

registry analysis (superiority or other test); Placebo vs Ramipril High Dose; p = 0.044; ANCOVA; note: two-sided test NCT00389519 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ramipril	Small molecule	0.3125 mg	Oral
Subject	Ramipril	Small molecule	0.625 mg	Oral
Subject	Ramipril	Small molecule	1.25 mg	Oral
Subject	Ramipril	Small molecule	2.5 mg	Oral
Subject	Ramipril	Small molecule	5 mg	Oral
Subject	Ramipril	Small molecule	10 mg	Oral
Subject	Ramipril	Small molecule	20 mg	Oral

Indications