Status:
COMPLETED
A Study to Evaluate the Safety/Tolerability and Pharmacokinetics of Aliskiren in Hypertensive Pediatric and Adolescent Patients 6-17 Years of Age
Lead Sponsor:
Novartis
Conditions:
Hypertension
Eligibility:
All Genders
6-17 years
Phase:
PHASE1
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00834041
Start Date
April 1 2009
End Date
January 1 2010
Last Update
May 9 2011
Active Locations (5)
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1
Investigative Site
Louisville, Kentucky, United States
2
Investigative Site
Brussels, Belgium
3
Investigative Site
Brasília, Brazil
4
Investigative Site
Budapest, Hungary