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A Phase 4, Non-treatment Follow-up For Cardiac Assessments Following Use Of Smoking Cessation Treatments In Subjects With And Without A History Of Psychiatric Disorders

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Trial Profile

A Phase 4, Non-treatment Follow-up For Cardiac Assessments Following Use Of Smoking Cessation Treatments In Subjects With And Without A History Of Psychiatric Disorders

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 13 Apr 2018

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At a glance

  • Drugs Bupropion (Primary) ; Varenicline (Primary) ; Nicotine replacement therapy
  • Indications Smoking withdrawal
  • Focus Adverse reactions
  • Sponsors Pfizer

Most Recent Events

  • 09 Apr 2018 Primary endpoint (Time to Occurrence of Major Adverse Cardiovascular Event (MACE) During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936.) has not been met, according to results published in the JAMA Internal Medicine.
  • 09 Apr 2018 Results (n=4595) assessing cardiovascular safety for all participants in the A3051123 trial for an additional 28 weeks, allowing for a total of 52 weeks of cardiovascular safety data collection, were published in the JAMA Internal Medicine.
  • 13 Aug 2015 Status changed from active, no longer recruiting to completed as per ClinicalTrials.gov record.

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