Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis
Age
6–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | A Study to Evaluate the Safety/Tolerability and Pharmacokinetics of Aliskiren in Hypertensive Pediatric and Adolescent Patients 6-17 Years of Age
