Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00129363
Status:
COMPLETED
Last Update Posted:
2008-12-25
First Post:
2005-08-08
Brief Title:
Study to Evaluate the Safety of Twice Daily Oral Carvedilol
Sponsor:
Shaddy Robert MD
Organization:
Shaddy Robert MD
Study Overview
Official Title:
A Multicenter Open Label Extension Study to Evaluate the Safety of Twice Daily Oral Carvedilol in Pediatric Patients With Chronic Heart Failure
Status:
COMPLETED
Status Verified Date:
2008-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 dba GlaxoSmithKline GSK or the University Sponsor
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None