Study to Evaluate the Safety of Twice Daily Oral Carvedilol

December 24, 2008 updated by: Shaddy, Robert, M.D.

A Multicenter, Open Label Extension Study to Evaluate the Safety of Twice Daily Oral Carvedilol in Pediatric Patients With Chronic Heart Failure

The objective of this study is to evaluate the long-term safety of carvedilol in pediatric patients with chronic heart failure, who completed the Pediatric Carvedilol Study 321. Carvedilol will be provided as open-label therapy for a period of at least 6 months (or until termination of the study) by SmithKline Beecham Corporation d/b/a GlaxoSmithKline (GSK) or the University Sponsor.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This open-label, uncontrolled, extension study is designed to assess the long-term safety of carvedilol in pediatric patients with heart failure and includes the following phases:

  1. Screening Phase (coincides with the final maintenance Month 6 Visit in the 321 study
  2. Down-/Up-titration Phase
  3. Maintenance Phase
  4. Down-titration
  5. Follow-up

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90027
        • Children's Hospital Los Angeles
      • Los Angeles, California, United States, 90025
        • Mattel Children's Hospital at UCLA
      • Palo Alto, California, United States, 94303
        • Stanford University
    • Colorado
      • Denver, Colorado, United States, 80218
        • University of Colorado
    • Florida
      • Miami, Florida, United States, 33101
        • University of Miami
    • Illinois
      • Chicago, Illinois, United States, 60614
        • Children's Memorial Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Children's Hospital, Boston
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • C.S. Mott Children's Hospital
      • Detroit, Michigan, United States, 48201-2196
        • Children's Hospital of Michigan
    • Missouri
      • St. Louis, Missouri, United States, 63110-1014
        • Washington University
    • New York
      • New York, New York, United States, 10032-1537
        • Columbia University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia
    • Tennessee
      • Nashville, Tennessee, United States, 37332
        • Vanderbilt Children's Hospital
    • Texas
      • Dallas, Texas, United States, 75235-7794
        • UT Southwestern Medical Center
      • Houston, Texas, United States, 77030
        • Texas Children's Hospital
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah
    • Washington
      • Seattle, Washington, United States, 98105
        • Seattle Childrens Hospital and Regional Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 17 years (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female patients with chronic symptomatic congestive heart failure (CHF) due to systemic ventricular systolic dysfunction, who are receiving standard heart failure therapy and have successfully completed the maintenance phase of the Pediatric Carvedilol Study 321.
  • Parent or guardian of patient able and willing to give written informed consent. The written assent from children > 9 years of age is also required.

Exclusion Criteria:

  • A patient who, in the opinion of the investigator, would not benefit from open-label carvedilol.
  • A patient who, in the opinion of the investigator, is incapable of cooperating with the requirements of this study.

  • A patient treated with the following medications at the time of entry in the study:

    • Monoamine oxidase (MAO) inhibitors;
    • Calcium entry blockers;
    • α- blockers, or labetalol;
    • Disopyramide, flecainide, encainide, moricizine, propafenone;
    • Intravenous inotropes such as dobutamine or intravenous vasodilator agents such as amrinone or milrinone;
    • Intravenous CHF medications (e.g. diuretics, digoxin);
    • Beta-blockers, other than double-blind carvedilol.
  • Uncorrected primary obstructive or severe regurgitative valvular disease, nondilated (restrictive) or hypertrophic cardiomyopathy, or significant systemic ventricular outflow obstruction.

  • A patient with any of the following contra-indications to beta-blocker therapy:

    • Heart rate < 2nd percentile for age;
    • Unacceptable blood pressure. Sitting (supine in infants) systolic blood pressure must be > 85 mm Hg in teens; >75 mm Hg in school-aged children; and >65 mm Hg in infants;
    • Sick sinus syndrome, second or third degree atrioventricular (AV) block, unless treated with a permanent pacemaker;
    • History or current clinical evidence of moderate-to-severe obstructive pulmonary disease or reactive airway diseases (e.g., asthma) requiring therapy;
    • Unstable insulin-dependent diabetes mellitus.
  • Renovascular hypertension or evidence of pulmonary hypertension (pulmonary vascular resistance index > 6 Wood units m2) unresponsive to vasodilator agents such as oxygen, nitroprusside, or nitric oxide

  • A patient with any one of these general exclusion criteria:

    • Significant renal (serum creatinine > 2.0), hepatic (serum AST and/or ALT > 3 times upper limit of normal), gastrointestinal, or biliary disorders that could impair absorption, metabolism, or excretion of orally administered medications;
    • Endocrine disorders such as pheochromocytoma, active hyperthyroidism and untreated hypothyroidism;
    • Any illness other than heart failure that may limit survival within 1 year (e.g. neoplasm);
    • Girls of childbearing potential who are pregnant or sexually active and not taking adequate contraceptive precautions (e.g., intrauterine device [IUD] or oral contraceptives).
  • A patient who received any investigational drug within the preceding 30 days except blinded medication in Pediatric Carvedilol Study 321. An investigational drug is defined as any agent (placebo or drug) dispensed as part of a research study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
dose tolerability
growth and development
physical exam (PE) including cardiopulmonary examination
blood pressure (BP), heart rate (HR), height (Ht) and weight [Wt] (including %)
laboratory safety assessments
pregnancy test, if applicable
an echocardiographic measurement
reporting of all adverse events [AEs] (serious and non-serious)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shaddy, Robert, M.D.

Collaborators

GlaxoSmithKline

Investigators

  • Principal Investigator: Robert E Shaddy, MD, University of Utah

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Primary Completion (Actual)

January 1, 2006

Study Completion (Actual)

January 1, 2006

Study Registration Dates

First Submitted

August 8, 2005

First Submitted That Met QC Criteria

August 8, 2005

First Posted (Estimate)

August 11, 2005

Study Record Updates

Last Update Posted (Estimate)

December 25, 2008

Last Update Submitted That Met QC Criteria

December 24, 2008

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SB 105517-396

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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