Expired Study
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Daytona Beach, Florida


Purpose:

This first open-label study in a pediatric population is designed to evaluate aliskiren safety and pharmacokinetics after single and multiple dosing in 6 - 17 year old children (includes children 6 to less than 18 years of age) with hypertension. The study includes doses (2 mg/kg and 6 mg/kg) that span the dose range researched in adults. The total dose of aliskiren will be calculated based on body weight (maximum 100 kg for inclusion) and will be no greater than 600 mg.


Criteria:

Inclusion Criteria: - Male or female, 6 - 17 years of age (6 to less than 18 years of age at study completion) - Documented history of hypertension - 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 may apply


NCT ID:

NCT00834041


Primary Contact:

Study Chair
Novartis
Novartis


Backup Contact:

N/A


Location Contact:

Daytona Beach, Florida
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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