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

NCT00834041 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2011-05-09

Study results available
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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

Interventions

DRUG

Aliskiren 3.125 mini-tablets

Oral mini-tablets (3.125 mg) of aliskiren once each morning

Sponsors & Collaborators

Principal Investigators

  • Novartis · Novartis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2010-01-31
Completion
2010-01-31

Countries

  • United States
  • Belgium
  • Brazil
  • Hungary
  • Poland

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00834041 on ClinicalTrials.gov