Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

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

This study has been withdrawn prior to enrollment.
(Due to the sale of Cardene IV, the sponsor has stopped enrollment and withdrawn the study. No safety issues were identified.)
Sponsor:
Information provided by (Responsible Party):
Facet Biotech
ClinicalTrials.gov Identifier:
NCT00528827
First received: September 10, 2007
Last updated: March 15, 2012
Last verified: March 2012
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blinded, Placebo-controlled, Dose-ranging Study of Cardene® I.V. in Pediatric Subjects With Hypertension

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Facet Biotech:

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 ]
Enrollment: 0
Study Start Date: September 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 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.
Experimental: 2
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.
Experimental: 3
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.
Experimental: 4
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Facet Biotech
  More Information

No publications provided

Responsible Party: Facet Biotech
ClinicalTrials.gov Identifier: NCT00528827     History of Changes
Other Study ID Numbers: Cardene® I.V. 1406
Study First Received: September 10, 2007
Last Updated: March 15, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Facet Biotech:
Hypertension, High Blood Pressure, Pediatric Hypertension, High blood pressure in children

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases
Nicardipine
Antihypertensive Agents
Calcium Channel Blockers
 Cardiovascular Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on March 01, 2015