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Coreg and HSRs-Updated Analysis

NCT01316952 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1

Last updated 2015-04-15

No results posted yet for this study

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. 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

Interventions

DRUG

Carvedilol immediate release only

All dosages of carvedilol immediate release

DRUG

Carvedilol extended release only

All dosages of carvedilol extended release

DRUG

Long acting β-blockers

All dosages of LA propranolol and SA metoprolol

DRUG

Other α1/β-adrenergic antagonists

i.e., labetalol. All dosages. Excluding carvedilol immediate release and carvedilol extended release.

DRUG

Short acting Non-selective β-blockers and short acting β1-Selective agents

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)

OTHER

No β-blocker

No β-blocker within the month prior to the index date

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2011-03-31
Completion
2011-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01316952 on ClinicalTrials.gov