- Males or females age 6 to 16 years. All female subjects ≥ 8 years of age must have a
negative urine pregnancy test and must use an acceptable method of contraception,
including abstinence, a barrier method (diaphragm or condom), Depo-Provera, or an oral
contraceptive, for the duration of the study.
- Weight ≥ 20 kg.
- Parents/guardians must be able to demonstrate their ability to use the home blood
pressure device to monitor blood pressure.
- Sitting systolic blood pressure or sitting diastolic blood pressure ≥ the 95th
percentile for age, gender and height; or diabetes mellitus or chronic renal
insufficiency (as evidenced by GFR 40-70 mL/min/1.73 m2) and a sitting systolic blood
pressure or sitting diastolic blood pressure ≥ the 90th percentile for age, gender,
and height.
- Severe hypertension documented by (1) Sitting systolic blood pressure or sitting
diastolic blood pressure more than 20 mmHg above the 95th percentile for age, gender,
and height without antihypertensive therapy, (2) Sitting systolic blood pressure or
sitting diastolic blood pressure more than 12 mmHg above the 95th percentile for age,
gender, and height while receiving active therapy, or (3) hypertensive encephalopathy
within the previous 5 months.
- Currently receiving more than one antihypertensive medication including: ACE
inhibitors, angiotensin receptor inhibitors, beta blockers, calcium channel blockers,
diuretics.
- Receiving lithium, potassium supplements, monoamine oxidase inhibitors, or major
tranquilizers (Note: Stimulant medications for behavioral disorders, corticosteroids,
and non-steroidal anti-inflammatory agents for chronic pain management are permitted
during the trial provided the subject's dosage is anticipated to remain unchanged
throughout the duration of the study.)
- 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.