A Study to Evaluate the Safety/Tolerability and Pharmacokinetics of Aliskiren in Hypertensive Pediatric and Adolescent Patients 6-17 Years of Age

Phase 1/2 Completed 39 enrolled Novartis

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2009-04
Primary completion: 2010-01
Completion: 2010-01

Publications

Sullivan JE, Keefe D, Zhou Y, Satlin L, Fang H, Yan JH. Pharmacokinetics, safety profile, and efficacy of aliskiren in pediatric patients with hypertension. Clin Pediatr (Phila). 2013 Jul;52(7):599-607. doi: 10.1177/0009922813483875. Epub 2013 Apr 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aliskiren	Small molecule	2 mg/kg	Oral
Subject	Aliskiren	Small molecule	6 mg/kg	Oral

A Study to Evaluate the Safety/Tolerability and Pharmacokinetics of Aliskiren in Hypertensive Pediatric and Adolescent Patients 6-17 Years of Age

Summary

Timeline

Publications

Drugs

Indications