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

Completed · Phase 1/Phase 2

Conditions studied: Hypertension

In brief

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.

Key facts

Study ID

NCT00834041

Run by

Novartis

People needed

39

Starts

2009-04-01

Expected to finish

2010-01-01

Last updated by the study team

2011-05-09

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, 6-17 years of age
• Documented history of hypertension as defined in National High Blood Pressure Education Program Working Group on High Blood Pressure in Children and Adolescents (2004)
• Must be ≥ 21.0 kg and ≤ 100.0 kg at randomization
• Able to safely wash out previous antihypertensive therapy for 1-2 weeks

You may not qualify if…

• Body weight of < 21 kg (45 lbs) or > 100 kg (220 lbs)
• Inability to discontinue prior antihypertensive medication as required during the washout period
• Any clinically significant abnormalities or clinically noteworthy abnormal laboratory values
• Renal artery stenosis
• Current diagnosis of heart failure (NYHA Class II-IV)
• msSBP ≥ 25% above the 95th percentile for age, gender, and height at Visit 2
• Second or third degree heart block with or without a pacemaker
• Atrial fibrillation or atrial flutter at Visit 1, or potentially life threatening or any symptomatic arrhythmia during the 12 months prior to Visit 1
• Evidence of current symptomatic valvular disease
• Other protocol-defined inclusion/exclusion criteria applied to the study.

Where it is running

• Investigative Site — Louisville, Kentucky, United States
• Investigative Site — Brussels, Belgium
• Investigative Site — Brasília, Brazil
• Investigative Site — Budapest, Hungary
• Investigative Site — Warsaw, Poland

Full record on ClinicalTrials.gov

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