safety and tolerability of valsartan in children 6 to 17 years of age

Conditions: Hypertension; Chronic Kidney Disease

Summary: the purpose of this study is to assess the long-term safety and tolerability profile of valsartan and valsartan-based treatments in children with hypertension, with or without chronic kidney disease.


Eligibility criteria:
inclusion criteria: * documented diagnosis of hypertension * able to swallow a tablet * body weight ≥18 kg and ≤160 kg at baseline * mssbp must be ≥ 95th percentile and ≤25% above the 95th percentile for age, gender and height. 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. other protocol-defined inclusion/exclusion criteria may apply

Keywords: hypertension, pediatric hypertension with or without chronic kidney disease