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.
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
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
75
Mattel Children's Hospital at UCLA
Los Angeles, California, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
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)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Stanford University
Palo Alto, California, United States
University of Colorado
Denver, Colorado, United States
University of Miami
Miami, Florida, United States
Children's Memorial Hospital
Chicago, Illinois, United States
Children's Hospital, Boston
Boston, Massachusetts, United States
C.S. Mott Children's Hospital
Ann Arbor, Michigan, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
Washington University
St Louis, Missouri, United States
...and 7 more locations