A Randomized, Double-Blinded, Placebo-Controlled, Dose-Ranging Study of Cardene® I.V. in Pediatric Subjects With Hypertension - Full Text View

Sponsored by:	PDL BioPharma, Inc.
Information provided by:	PDL BioPharma, Inc.
ClinicalTrials.gov Identifier:	NCT00528827

Purpose

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

Condition	Intervention	Phase
Hypertension	Drug: Cardene® I.V.	Phase II

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Nicardipine Nicardipine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Pharmacokinetics/Dynamics Study
Official Title:	A Randomized, Double-Blinded, Placebo-Controlled, Dose-Ranging Study of Cardene® I.V. in Pediatric Subjects With Hypertension

Further study details as provided by PDL BioPharma, Inc.:

Primary Outcome Measures:

Mean percent change in SBP (Systolic Blood Pressure) from baseline during the 30-minute Randomized, Placebo-controlled Infusion Phase for each dose level of Cardene I.V. compared to placebo. [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

1) Mean percent change in SBP and DBP between various phases of dosing. 2) Proportion of subjects requiring additional antihypertensive medications during the treatment period. 3) Mean effective dose of Cardene I.V. [ Time Frame: 72 ] [ Designated as safety issue: No ]

Estimated Enrollment:	140
Study Start Date:	September 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator	Drug: 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.
2: Experimental 5 mcg	Drug: 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.
3: Experimental 2.5	Drug: 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.
4: Experimental 0.5	Drug: 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.

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.

Eligibility

Ages Eligible for Study:	2 Years to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00528827

Locations

United States, California

Beverly Hills, California, United States, 90211
United States, Florida

Miami, Florida, United States, 33145

Sponsors and Collaborators

PDL BioPharma, Inc.

More Information

Responsible Party:	None for this trial ( None for this trial )
Study ID Numbers:	Cardene® I.V. 1406
Study First Received:	September 10, 2007
Last Updated:	August 2, 2008
ClinicalTrials.gov Identifier:	NCT00528827
Health Authority:	United States: Food and Drug Administration

Keywords provided by PDL BioPharma, Inc.:

Hypertension, High Blood Pressure, Pediatric Hypertension, High blood pressure in children

Study placed in the following topic categories:

Calcium, Dietary
Vascular Diseases
Nicardipine
Hypertension

Additional relevant MeSH terms:

Membrane Transport Modulators
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Calcium Channel Blockers

Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009