Safety and Tolerability of Valsartan in Children 6 to 17 Years of Age

Exclusion Criteria

• •Any clinically significant physical abnormalities or clinically relevant abnormal laboratory values (other than those relating to renal function) obtained at the screening visit. Including the following:
• •1. AST/SGOT or ALT/SGPT \>3 times the upper limit of the reference range. Patients known to have active or chronic hepatitis were excluded.
• •2. Total bilirubin \>2 times the upper limit of the reference range
• •3. Estimated GFR \<30 mL/min/1.73m² (calculated using Modified Schwartz Formula)
• •4. WBC count \<3000/mm³
• •5. Platelet count \<100,000/mm³
• •6. Serum potassium \>5.3 mmol/L
• •7. Hemoglobin \<8 g/dL
• •Uncontrolled diabetes mellitus
• •Unilateral, bilateral and graft renal artery stenosis
• •Current diagnosis of heart failure (New York Heart Association Class II-IV)
• •Patients taking any of the following concomitant medications following screening: Renin-angiotensin receptor(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, Antidepressant drugs in the class of Monoamine oxidase (MAO) inhibitors (e.g. phenelzine), Chronic use of stimulant therapy for Attention deficit disorder/attention deficit hyperactivity disorder (ADD/ADHD) -Patients who demonstrate clinically significant ECG abnormalities such as concurrent potentially life threatening arrhythmia or symptomatic arrhythmia and patients with second or third degree heart block without a pacemaker.
• •Coarctation of the aorta with a gradient of \>=30 mmHg
• •Previous solid organ transplantation except renal transplantation.
• •Patients known to be positive for the human immunodeficiency virus (HIV)
• •Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of the study drug
• •Known or suspected contraindications to the study drug, including severe hepatic impairment, biliary cirrhosis, cholestasis and history of allergy to ARBs and/or angiotensin-converting enzymes (ACE) and/or Direct Renin Inhibitors (DRIs)
• •History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
• •History or evidence of drug or alcohol abuse within the last 12 months.
• •Female patients of child-bearing potential, defined as all female patients physiologically capable of becoming pregnant, unless they are willing to use highly effective contraception during the study
• •Pregnant or nursing (lactating) female patients
• •Participation in any investigational drug study within 30 days prior to screening or within 5 elimination half-lives of the study drug prior to screening, or whichever is longer.
• •History of hypersensitivity to the study drug or to drugs of similar chemical classes.