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

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.