NCT00834041

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

An 8-day Open-label, Multiple-dose, Multicenter Study to Evaluate the Safety/Tolerability and Pharmacokinetics of Aliskiren in Hypertensive Pediatric and Adolescent Patients 6-17 Years of Age

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	Aliskiren 3.125 mini-tablets	Oral mini-tablets (3.125 mg) of aliskiren once each morning

Timeline

• Start date: 2009-04-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2009-02-03
• Last updated: 2011-05-09
• Results posted: 2011-05-09

Locations

5 sites across 5 countries: United States, Belgium, Brazil, Hungary, Poland