1. Previous, documented diagnosis of hypertension, or newly diagnosed hypertension
according to the fourth report on the diagnosis, evaluation and treatment of high
blood pressure in children and adolescents (United States). SiSBP greater than or
equal to the 95th percentile for age, gender, and height.
2. The subject can be safely withdrawn from antihypertensive medications during the
screening period, and if given placebo during the treatment period in the judgment of
3. The subject is male or female age 6 to 16 years (inclusive), and weighs greater than
or equal to 20 kg.
4. Female subjects greater than or equal to 12 years of age, or who have had greater
than or equal to 1 menstruation must: (a) have a negative serum pregnancy test at
screening (i.e., subject is not pregnant), (b) not be lactating, and (c) use an
acceptable method of contraception.
5. Parents/guardians are able to demonstrate their ability to (a) use a home blood
pressure monitor supplied for the study to monitor their child's blood pressure, and
(2) mix and administer a liquid dose of study drug if needed.
1. Bilateral renal artery stenosis.
2. Uncorrected coarctation of the aorta or corrected coarctation with a right arm/right
leg blood pressure gradient greater than 10 mmHg.
3. Severe hypertension.
4. Renal transplantation or other previous solid organ transplantation less than 6
months prior to entering the study.
5. Subjects with nephrotic syndrome not on stable maintenance therapy of prednisone or
6. A history of cardiomyopathy, clinically significant structural heart disease, or
atrioventricular conduction disturbance, sick sinus syndrome, atrial flutter, atrial
fibrillation, clinically significant bradycardia or an accessory bypass tract, or
clinical symptoms of congestive heart failure.
7. Clinically significant hematologic, hepatobiliary, or renal disease including a
Schwartz formula GFR less than 40 mL/min/1.73 m2, and/or serum potassium (K+) greater
than 5.5 mEq/L.
8. History of pancreatitis (active or inactive).
9. Known sensitivity to angiotensin converting enzyme inhibitors or a history of