A Phase 4, Randomized, Double Blind, Active And Placebo Controlled Multicenter Study Evaluating The Neuropsychiatric Safety And Efficacy Of 12 Weeks Varenicline Tartrate 1MG BID And Bupropion Hydrochloride 150MG BID For Smoking Cessation In Subjects With And Without A History of Psychiatric Disorders

Trial Profile

A Phase 4, Randomized, Double Blind, Active And Placebo Controlled Multicenter Study Evaluating The Neuropsychiatric Safety And Efficacy Of 12 Weeks Varenicline Tartrate 1MG BID And Bupropion Hydrochloride 150MG BID For Smoking Cessation In Subjects With And Without A History of Psychiatric Disorders

Completed
Phase of Trial: Phase IV

Latest Information Update: 24 May 2017

At a glance

  • Drugs Bupropion (Primary) ; Varenicline (Primary) ; Nicotine replacement therapy
  • Indications Smoking withdrawal
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms EAGLES
  • Sponsors Pfizer
  • Most Recent Events

    • 16 Dec 2016 According to a Pfizer media release, based on the outcomes of this study, company announced that the U.S. Food and Drug Administration (FDA) approved updates to the CHANTIX (varenicline) labeling, including removal of the boxed warning regarding serious neuropsychiatric events.
    • 14 Sep 2016 According to a Pfizer media release, the US FDA's Psychopharmacologic Drugs Advisory Committee and Drug Safety Risk Management Advisory Committee recommended by a majority vote to remove the boxed warning regarding serious neuropsychiatric adverse events from the CHANTIX labeling after review of data from this trial.
    • 26 Apr 2016 Results published in The Lancet
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