Last updated: 11/03/2018 16:45:31
Coreg and HSRs-Updated Analysis
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: A nested case-control study of the association between Coreg IR and Coreg CR and hypersensitivity reactions: anaphylactic reaction/angioedema-Updated Analysis
Trial description: A cluster of reports of hypersensitivity reactions among patients who switched from carvedilol (immediate release formulation, referred to hereafter as carvedilol) to carvedilol extended release was received during the initial post-launch period of carvedilol extended release. In follow up to this observation, product labeling for both agents was updated and a nested case control study was subsequently conducted to examine the risk of serious hypersensitivity reactions i.e. anaphylactic reaction and/or angioedema among patients who used carvedilol extended release compared to carvedilol and separately compared to other long acting beta(β)-blockers. This proposed analysis is an update to the previously conducted analysis using the same database, LabRx, now containing 2 additional years of data, which should provide a larger number of carvedilol extended release exposed subjects.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Hypersensitivity reactions (anaphylactic reaction/ angioedema)
Timeframe: Hypersensitivity reactions among users in the LabRx database between Oct. 1st 2004 to Sep. 30th 2009
Secondary outcomes:
Not applicable
Interventions:
Drug: Carvedilol immediate release only
Drug: Carvedilol extended release only
Drug: Long acting β-blockers
Drug: Other α1/β-adrenergic antagonists
Drug: Short acting Non-selective β-blockers and short acting β1-Selective agents
Other: No β-blocker
Enrollment:
1
Observational study model:
Case-Control
Primary completion date:
Not applicable
Time perspective:
Retrospective
Clinical publications:
Koro C, Sowell M, Stender M. An assessment of the association between carvedilol exposure and severe hypersensitivity reactions, angioedema, and anaphylactic reactions: a retrospective nested case-control analysis. . [Clin Ther]. 2012;34(4):870-77.
Koro C, Sowell M, Stender M. An assessment of the association between carvedilol exposure and severe hypersensitivity reactions, angioedema, and anaphylactic reactions: a retrospective nested case-control analysis. Clin Ther. 2012;34(4):870-77.
Medical condition
Hypersensitivity
Product
carvedilol, propranolol
Collaborators
Not applicable
Study date(s)
June 2010 to March 2011
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
No
- At least one prescription claim for a β-blocker during follow-up time available in the database.
- At least one month of enrollment in the healthcare plan
- None
Inclusion and exclusion criteria
Inclusion criteria:
- At least one prescription claim for a β-blocker during follow-up time available in the database.
- At least one month of enrollment in the healthcare plan
Exclusion criteria:
- None
Trial location(s)
No location data available.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
Not applicable
Actual study completion date
2011-15-03
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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