Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
Age
6–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | Safety and Tolerability of Valsartan in Children 6 to 17 Years of Age
