Efficacy, Safety and Tolerability of Multiple Doses of Valsartan in Children With Hypertension With or Without CKD
Condition: Pediatric Hypertension With or Without CKD
MeSH terms: Hypertension
Intervention: VAL489; VAL489 matching placebo
Intervention description: Valsartan 3mg/kg oral solution; Valsartan 3 mg/kg oral solution
Intervention MeSH terms: Valsartan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 127.0
Sex: All
Minimum age: 1 Year
Maximum age: 5 Years
Healthy volunteers: No
Keywords: Hypertension; CKD; Pediatric

Summary:

      To assess efficacy, safety and tolerability of valsartan when comparing two doses of
      valsartan in reducing and controlling blood pressure in children with hypertension with or
      without CKD.
    

Eligibility criteria:

        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.