HypersensitivityNCT01316952
Coreg and HSRs-Updated Analysis
An observational study of Hypersensitivity, run by GlaxoSmithKline.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypersensitivity
- What is being tested?
- Carvedilol immediate release only, Carvedilol extended release only and Long acting β-blockers
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Jun 2010to Mar 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Derived from the LabRx database from Oct. 1st 2004 to Sep. 30th 2009. The LabRx Database (referred to in publications as the "i3 InVision Data Mart") is provided by Ingenix Pharmaceutical Services, Inc. It is a comprehensive, de-identified U.S. healthcare claims database that contains the aggregated health claims experience of the covered lives managed by United Healthcare. It contains only those covered lives for which there exists a combined benefit structure including medical and prescription coverage. Overall, it is representative of the non-elderly, insurance-carrying population in the U.S., but it also contains information on several hundred thousand Managed Medicaid and Medicare Advantage members. It contains inpatient, outpatient and pharmacy claims, lab results and enrolment information on over 30.5 million lives from October 2004 through September 2009.
Who may be able to join
- 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
Who cannot join
- None
About this study
Official title: A Nested Case-control Study of the Association Between Coreg IR and Coreg CR and Hypersensitivity Reactions: Anaphylactic Reaction/Angioedema-Updated Analysis
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.
- Conditions
- Hypersensitivity
- Being tested
- Carvedilol immediate release only, Carvedilol extended release only, Long acting β-blockers, Other α1/β-adrenergic antagonists, Short acting Non-selective β-blockers and short acting β1-Selective agents
- Keywords
- carvedilol, propranolol, hypersensitivity reactions, beta- blockers, Coreg
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carvedilol immediate release onlyDrug
All dosages of carvedilol immediate release
Carvedilol extended release onlyDrug
All dosages of carvedilol extended release
Long acting β-blockersDrug
All dosages of LA propranolol and SA metoprolol
Other α1/β-adrenergic antagonistsDrug
i.e., labetalol. All dosages. Excluding carvedilol immediate release and carvedilol extended release.
Short acting Non-selective β-blockers and short acting β1-Selective agentsDrug
All dosages of short acting non-selective β-Blockers (Carteolol, Levobunolol, Metipranolol, Nadolol, Penbutolol, Pindolol, Sotalol, Timolol) and short acting β1-Selective agents (Acebutolol, Atenolol, Betaxolol, Bisoprolol, Nebivolol)
No β-blockerOther
No β-blocker within the month prior to the index date
| Study group | Role | What they receive |
|---|---|---|
| LabRx database Oct. 1st 2004 to Sep. 30th 2009 | The study cohort from which cases and controls are drawn is all subjects in the LabRx database between Oct. 1st 2004 to Sep. 30th 2009. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypersensitivity reactions (anaphylactic reaction/ angioedema)
Measured: Hypersensitivity reactions among users in the LabRx database between Oct. 1st 2004 to Sep. 30th 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2011 (estimated)
- Study startJun 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypersensitivityStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01316952
- Sponsor's protocol ID
- 114522
- Other IDs
- WEUSRTP4862
- Status last verified
- Apr 2015
- First submitted
- 15 Mar 2011
- Last updated
- 15 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Koro CE, Sowell MD, 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 Apr;34(4):870-7. doi: 10.1016/j.clinthera.2012.02.027. Epub 2012 Mar 22.
PubMed 22444788
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Nested Case-control Study of the Association Between Coreg IR and Coreg CR and Hypersensitivity Reactions: Anaphylactic Reaction/Angioedema-Updated Analysis
- ClinicalTrials.gov ID
- NCT01316952
- Acronym / sponsor ID
- 114522
- Conditions
- Hypersensitivity
- Keywords
- carvedilol, propranolol, hypersensitivity reactions, beta- blockers, Coreg
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 16 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LabRx database Oct. 1st 2004 to Sep. 30th 2009 | – | 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-blockerThe study cohort from which cases and controls are drawn is all subjects in the LabRx database between Oct. 1st 2004 to Sep. 30th 2009. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Derived from the LabRx database from Oct. 1st 2004 to Sep. 30th 2009. The LabRx Database (referred to in publications as the "i3 InVision Data Mart") is provided by Ingenix Pharmaceutical Services, Inc. It is a comprehensive, de-identified U.S. healthcare claims database that contains the aggregated health claims experience of the covered lives managed by United Healthcare. It contains only those covered lives for which there exists a combined benefit structure including medical and prescription coverage. Overall, it is representative of the non-elderly, insurance-carrying population in the U.S., but it also contains information on several hundred thousand Managed Medicaid and Medicare Advantage members. It contains inpatient, outpatient and pharmacy claims, lab results and enrolment information on over 30.5 million lives from October 2004 through September 2009.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carvedilol immediate release onlyAll dosages of carvedilol immediate release | Drug | LabRx database Oct. 1st 2004 to Sep. 30th 2009 |
| Carvedilol extended release onlyAll dosages of carvedilol extended release | Drug | LabRx database Oct. 1st 2004 to Sep. 30th 2009 |
| Long acting β-blockersAll dosages of LA propranolol and SA metoprolol | Drug | LabRx database Oct. 1st 2004 to Sep. 30th 2009 |
| Other α1/β-adrenergic antagonistsi.e., labetalol. All dosages. Excluding carvedilol immediate release and carvedilol extended release. | Drug | LabRx database Oct. 1st 2004 to Sep. 30th 2009 |
| Short acting Non-selective β-blockers and short acting β1-Selective agentsAll dosages of short acting non-selective β-Blockers (Carteolol, Levobunolol, Metipranolol, Nadolol, Penbutolol, Pindolol, Sotalol, Timolol) and short acting β1-Selective agents (Acebutolol, Atenolol, Betaxolol, Bisoprolol, Nebivolol) | Drug | LabRx database Oct. 1st 2004 to Sep. 30th 2009 |
| No β-blockerNo β-blocker within the month prior to the index date | Other | LabRx database Oct. 1st 2004 to Sep. 30th 2009 |
Primary outcome
Hypersensitivity reactions (anaphylactic reaction/ angioedema)
Time frame: Hypersensitivity reactions among users in the LabRx database between Oct. 1st 2004 to Sep. 30th 2009
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2015.
- Background: PubMed 22444788Koro CE, Sowell MD, 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 Apr;34(4):870-7. doi: 10.1016/j.clinthera.2012.02.027. Epub 2012 Mar 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Hypersensitivity, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypersensitivity reactions (anaphylactic reaction/ angioedema) (time frame: Hypersensitivity reactions among users in the LabRx database between Oct. 1st 2004 to Sep. 30th 2009). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01316952, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2015.