Conditions: Hypertension
Keywords: aliskiren pediatric hypertension pharmacokinetics (PK) pharmacodynamics (PD) plasma renin activity mini-tablet formulation
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 39
Healthy volunteers: no

Brief summary:
This first open-label study in a pediatric population was designed to evaluate aliskiren safety and pharmacokinetics after single and multiple dosing in 6-17 year old children with hypertension.

Detailed description:

Arms:
arm 1: Oral mini-tablets (3.125 mg) of aliskiren dosed at 2 mg/kg body weight once each morning arm 2: Oral mini-tablets (3.125 mg) of aliskiren dosed at 6 mg/kg body weight once each morning

Interventions: intervention 1: Aliskiren 3.125 mini-tablets
Intervention descriptions: intervention 1: Oral mini-tablets (3.125 mg) of aliskiren once each morning

Protocol document: