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Completed

NCT Number: NCT01316952

Coreg and HSRs-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.

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Key information

Conditions

Hypersensitivity Immune System Diseases

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carvedilol immediate release only

Drug

All dosages of carvedilol immediate release

Carvedilol extended release only

Drug

All dosages of carvedilol extended release

Long acting β-blockers

Drug

All dosages of LA propranolol and SA metoprolol

Other α1/β-adrenergic antagonists

Drug

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

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

Drug

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-blocker

Other

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

Primary outcomes

  1. Hypersensitivity reactions (anaphylactic reaction/ angioedema)

    Time frame: Hypersensitivity reactions among users in the LabRx database between Oct. 1st 2004 to Sep. 30th 2009

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Nested Case-control Study of the Association Between Coreg IR and Coreg CR and Hypersensitivity Reactions: Anaphylactic Reaction/Angioedema-Updated Analysis

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 16, 2011
Registry last updated
Apr 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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