Study to Evaluate the Safety of Twice Daily Oral Carvedilol

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00129363
Study type	Interventional
Source	Shaddy, Robert, M.D.
Contact
Status	Completed
Phase	Phase 3
Start date	January 2002
Completion date	January 2006

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