CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 267 enrolled
Drug / intervention
Aliskiren (6.25/12.5/25 mg) +2 moredrug
Likely dose
Aliskiren (6.25/12.5/25 mg)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01150357
NCT01150357Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Double-blind, 8 Week Study to Evaluate the Dose Response, Efficacy and Safety of Aliskiren in Pediatric Hypertensive Patients 6-17 Years of Age

Novartis Pharmaceuticals·interventional·Posted Jun 24, 2010·Updated Oct 15, 2015

In Brief

A Phase 3 clinical trial evaluating Aliskiren (6.25/12.5/25 mg), Aliskiren (37.5/75/150 mg), and 1 other intervention for Hypertension. Completed, enrolled 267 participants across 48 sites in 9 countries.

Detailed Summary

This double-blind 8 week study will evaluate dose response, efficacy (blood pressure lowering effect) and safety of aliskiren in children 6 - 17 years old with hypertension at low, mid and high weight-based doses. The low dose ranges from 6.25 mg to 25 mg of aliskiren, the mid dose ranges from 37.5 mg to 150 mg of aliskiren and the high dose ranges from 150 mg to 600 mg of aliskiren. This study is being conducted to support monotherapy registration of aliskiren for the treatment of hypertension in children 6-17 years of age.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension
CountriesBelgium, Germany, Guatemala, Hungary, Poland, Puerto Rico, Slovakia, Turkey (Türkiye), United States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 24, 2010
Enrollment StartJun 1, 2010
Primary CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 16.0 years ago

Interventions

Aliskiren (6.25/12.5/25 mg)drug

Aliskiren dispensing capsules containing minitablets (3.125 mg per minitablet). For the low dose arm, participants used one or more of the 6.25 mg capsule (containing 2 minitablets) once daily to reach the body-weight stratified dose of aliskiren.

Aliskiren (37.5/75/150 mg)drug

Aliskiren dispensing capsules containing minitablets (3.125 mg per minitablet). For the medium dose arm, participants used one or more of the 37.5 mg capsule (containing 12 minitablets) once daily to reach the body- weight stratified dose of aliskiren.

Aliskiren (150/300/600 mg)drug

Aliskiren dispensing capsules containing minitablets (3.125 mg per minitablet). For the high dose arm, participants used one or more of the 150 mg capsule (containing 48 minitablets) once daily to reach the body- weight stratified dose of aliskiren.