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.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)