A Study to Evaluate the Safety/Tolerability and Pharmacokinetics of Aliskiren in Hypertensive Pediatric and Adolescent Patients 6-17 Years of Age
Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Aliskiren 3.125 mini-tablets (Drug)
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: Novartis Official(s) and/or principal investigator(s): Novartis, Study Chair, Affiliation: Novartis
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.
Clinical Details
Official title: An 8-day Open-label, Multiple-dose, Multicenter Study to Evaluate the Safety/Tolerability and Pharmacokinetics of Aliskiren in Hypertensive Pediatric and Adolescent Patients 6-17 Years of Age
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Maximum Plasma Concentration (Cmax) at Day 1 and Day 8 in 6-11 and 12-17 Year Old PatientsArea Under the Plasma Concentration-time Curve (AUC0-τ) in One Dosing Interval (24 h) at Day 1 and Day 8 in 6-11 and 12-17 Year Old Patients Apparent Plasma Clearance (CL/F) at Day 8 in 6-11 and 12-17 Year Old Patients
Secondary outcome: Change in Plasma Renin Activity From Baseline on Day 1, Day 8, and Day 9Change in Mean Sitting Systolic and Diastolic Blood Pressure (msSBP and msDBP) From Baseline to the End of Treatment (Day 9) in 6-11 and 12-17 Year Old Patients
Eligibility
Minimum age: 6 Years.
Maximum age: 17 Years.
Gender(s): Both.
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.
Locations and Contacts
Investigative Site, Brussels, Belgium
Investigative Site, Brasilia, Brazil
Investigative Site, Budapest, Hungary
Investigative Site, Warsaw, Poland
Investigative Site, Louisville, Kentucky, United States
Additional Information
Starting date: April 2009
Last updated: April 15, 2011
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