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The purpose

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.

Provided treatments

  • 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

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01316952. The sponsor of the trial is GlaxoSmithKline and it is looking for 1 volunteers for the current phase.
Official trial title:
A Nested Case-control Study of the Association Between Coreg IR and Coreg CR and Hypersensitivity Reactions: Anaphylactic Reaction/Angioedema-Updated Analysis