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

NCT ID: NCT00528827

Last Updated: 2012-03-16

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2008-12-31

Brief Summary

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

Detailed Description

Children with acute hypertensive episodes are frequently treated with the same marketed drugs as adults. Few drugs are specifically indicated for use in children with severe hypertension. Cardene I.V. has been widely used in children with severe hypertension without specific dosing recommendations for children in the labeling. This study is designed to examine the pharmacokinetics, pharmacodynamics, safety, and efficacy of using Cardene I.V. to reduce blood pressure (BP) in children with hypertension and will provide important information to guide use in pediatric patients.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Group Type: PLACEBO_COMPARATOR

Cardene® I.V.

Intervention Type: DRUG

• 5 mcg/kg/min Cardene I.V.
• 2.5 mcg/kg/min Cardene I.V.
• 0.5 mcg/kg/min Cardene I.V.

2

5 mcg

Group Type: EXPERIMENTAL

Cardene® I.V.

Intervention Type: DRUG

• 5 mcg/kg/min Cardene I.V.
• 2.5 mcg/kg/min Cardene I.V.
• 0.5 mcg/kg/min Cardene I.V.

3

2.5

Group Type: EXPERIMENTAL

Cardene® I.V.

Intervention Type: DRUG

• 5 mcg/kg/min Cardene I.V.
• 2.5 mcg/kg/min Cardene I.V.
• 0.5 mcg/kg/min Cardene I.V.

4

0.5

Group Type: EXPERIMENTAL

Cardene® I.V.

Intervention Type: DRUG

• 5 mcg/kg/min Cardene I.V.
• 2.5 mcg/kg/min Cardene I.V.
• 0.5 mcg/kg/min Cardene I.V.

Interventions

Cardene® I.V.

• 5 mcg/kg/min Cardene I.V.
• 2.5 mcg/kg/min Cardene I.V.
• 0.5 mcg/kg/min Cardene I.V.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Facet Biotech

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beverly Hills, California, United States

Miami, Florida, United States

Countries

United States

Other Identifiers

Cardene® I.V. 1406

Identifier Type: -

Identifier Source: org_study_id