A Randomized, Double-blinded, Placebo-controlled, Dose-ranging Study of Cardene® I.V. in Pediatric Subjects With Hypertension

Inclusion Criteria:

• Evidence of Stage 1 or Stage 2 systolic hypertension at the time of screening.
• Male or female subjects, ages ≥2 to ≤16 years.

• Females who meet either of the following criteria:

  • Non-childbearing potential , as documented by:

    1. a medical history of non-menstruation or
    2. surgical sterility from oophorectomy and/or hysterectomy. * A history of tubal ligation or evidence of a sterile sexual partner is insufficient evidence of non-childbearing potential.
  • Childbearing potential: provide a negative urine pregnancy test within 24 hours of administration of study drug and agree to utilize effective contraception or remain abstinent during the entire treatment and follow-up periods of the study.
• Signed informed consent provided by an authorized subject representative and assent from subject, if feasible (based on local Institutional Review Board (IRB)/ethics panel requirements).

Exclusion Criteria:

• Subjects with seizures, altered state of consciousness, chest pain, facial palsy or intracranial hemorrhage at the time of screening.
• Receiving antihypertensive medication within a duration specified prior to screening.
• Treatment with cimetidine within 10 hours prior to dosing with study drug.
• Any known or suspected allergy to nicardipine hydrochloride.
• A calculated Glomerular Filtration Rate (GFR) under 30 mL/min/ 1.73 m2 as calculated using the Schwartz formula and the associated K values.
• Known history of severe aortic stenosis.
• Known history of severe left ventricular dysfunction.
• Known history of severely impaired hepatic function with portal hypertension.
• Liver function test (AST or ALT) results greater than or equal to twice the upper limit of normal.
• Receiving maintenance hemodialysis at screening or anticipated to require hemodialysis within 12 hours following initiation of treatment with study drug.
• Receiving a blood transfusion at screening or anticipated to require blood transfusions within 12 hours following initiation of treatment with study drug.
• Lack of appropriate intravenous (I.V.) access.
• Inability to tolerate a large-volume I.V. infusion.
• Any other condition or prior therapy, which, in the opinion of the investigator, would make the subject unsuitable for this study.
• Participation in any phase of another clinical research study involving the evaluation of another investigational drug or device within 30 days before randomization.