Dose Response of Valsartan on Sitting Systolic Blood Pressure in Children 6 Months - 5 Years of Age With High Blood Pressure

Summary

The purpose of this study is to evaluate the safety and efficacy of three doses of valsartan (0.25, 1.0, and 4.0 mg/kg) on mean sitting systolic blood pressure (MSSBP) and mean sitting diastolic blood pressure (MSDBP) in 6 months - 5 year old children with hypertension (sitting systolic blood pressure \[SSBP\] ≥ 95th percentile ).

Timeline

Start

2007-03

Primary completion

2009-01

Completion

2009-01

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Low Dose vs Medium Dose vs High Dose; p = 0.0990; Slope -1.05 (95% CI -2.31 to 0.20); Regression, Linear NCT00435162 ↗

Drugs

Indications