Study to Evaluate the Safety of Twice Daily Oral Carvedilol
A Multicenter, Open Label Extension Study to Evaluate the Safety of Twice Daily Oral Carvedilol in Pediatric Patients With Chronic Heart Failure
1 other identifier
interventional
75
1 country
17
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2002
Typical duration for phase_3
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2002
CompletedFirst Submitted
Initial submission to the registry
August 8, 2005
CompletedFirst Posted
Study publicly available on registry
August 11, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2006
CompletedDecember 25, 2008
December 1, 2008
4 years
August 8, 2005
December 24, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
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)
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shaddy, Robert, M.D.lead
- GlaxoSmithKlinecollaborator
Study Sites (17)
Mattel Children's Hospital at UCLA
Los Angeles, California, 90025, United States
Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
Stanford University
Palo Alto, California, 94303, United States
University of Colorado
Denver, Colorado, 80218, United States
University of Miami
Miami, Florida, 33101, United States
Children's Memorial Hospital
Chicago, Illinois, 60614, United States
Children's Hospital, Boston
Boston, Massachusetts, 02115, United States
C.S. Mott Children's Hospital
Ann Arbor, Michigan, 48109, United States
Children's Hospital of Michigan
Detroit, Michigan, 48201-2196, United States
Washington University
St Louis, Missouri, 63110-1014, United States
Columbia University
New York, New York, 10032-1537, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Vanderbilt Children's Hospital
Nashville, Tennessee, 37332, United States
UT Southwestern Medical Center
Dallas, Texas, 75235-7794, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
University of Utah
Salt Lake City, Utah, 84132, United States
Seattle Childrens Hospital and Regional Medical Center
Seattle, Washington, 98105, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert E Shaddy, MD
University of Utah
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDIV
Study Record Dates
First Submitted
August 8, 2005
First Posted
August 11, 2005
Study Start
January 1, 2002
Primary Completion
January 1, 2006
Study Completion
January 1, 2006
Last Updated
December 25, 2008
Record last verified: 2008-12