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

Novartis

Status and phase: Completed; Phase 2; Phase 1

Conditions: Hypertension

Treatments: Drug: Aliskiren 3.125 mini-tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT00834041

CSPP100A2256

Details and patient eligibility

About

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.

Enrollment: 39 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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39 participants in 2 patient groups

Aliskiren 2 mg/kg

Experimental group

Description:

Oral mini-tablets (3.125 mg) of aliskiren dosed at 2 mg/kg body weight once each morning

Treatment:

Drug: Aliskiren 3.125 mini-tablets

Aliskiren 6 mg/kg

Experimental group

Description:

Oral mini-tablets (3.125 mg) of aliskiren dosed at 6 mg/kg body weight once each morning

Treatment:

Drug: Aliskiren 3.125 mini-tablets