Efficacy, Safety and Tolerability of Multiple Doses of Valsartan in Children With Hypertension With or Without CKD

Inclusion Criteria:

Patients eligible for inclusion in this study have to fulfill all of the following
criteria:

Have the ability to provide written informed consent; Have at baseline , a documented
diagnosis of hypertension (as defined in the National High Blood Pressure Education
Program 2004); MSBP (mean of 3 measurements) must be ≥95th percentile, and ≤25% above the
95th percentile, for age, gender and height, at baseline; CKD patients must be defined as
any of the following criteria: Kidney damage for ≥3 months, as defined by structural or
functional abnormalities of the kidney, with or without decreased GFR, manifested by one
or more of the following features: Abnormalities in the composition of urine,
Abnormalities in imaging tests, Abnormalities on kidney biopsy, Estimated eGFR <60
mL/min/1.73m2 for ≥3 months, with or without the other signs of kidney damage described
above; Able to swallow the valsartan solution; Body weight must be ≥8 kg and ≤40 kg at
baseline; Must be able to safely washout from other antihypertensive therapy (if
applicable) Exclusion criteria AST/SGOT or ALT/SGPT >3 times the upper limit of the
reference range; Estimated Glomerular Filtration Rate [eGFR] <30 mL/min/1.73m² (calculated
using Modified Schwartz Formula); Serum potassium >5.3 mmol/L; Uncontrolled diabetes
mellitus, as defined by the investigator; Unilateral, bilateral and graft renal artery
stenosis; Current diagnosis of heart failure (NYHA Class II-IV); Patients taking any of
the following concomitant medications following screening: RAAS blockers other than study
drug, Lithium, Potassium-sparing diuretics, potassium supplements, salt substitutes
containing potassium and other substances that may increase potassium levels;
Non-steroidal anti-inflammatory drugs (NSAIDS), including selective COX-2 inhibitors,
acetylsalicylic acid >3g/day, and non-selective NSAIDs (paracetamol/acetaminophen is
permitted); Antidepressant drugs in the class of MAO inhibitors (e.g. phenelzine); Chronic
use of stimulant therapy for ADD/ADHD; patients who have coarctation of the aorta with a
gradient of ≥30 mmHg; Previous solid organ transplantation except renal transplantation.
Renal transplant must have occurred at least 1 year prior to enrollment; Patient must be
on stable doses of immunosuppressive therapy and deemed clinically stable by the
investigator; Patients known to be positive for the human immunodeficiency virus (HIV)
Other protocol defined inclusion/exclusion criteria may apply.