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

• Status: Withdrawn
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To define the relationship between Cardene I.V. dose, serum concentrations, and blood pressure reduction in pediatric subjects with hypertension.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Facet Biotech
• Treatments: Nicardipine

Criteria

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.