Last updated: 11/07/2018 11:26:57

Plan to Assess the incidence of cardiovascular related adverse events in controlled clinical trials of bupropion for the treatment of smoking cessationMACE

GSK study ID
117211
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Plan to Assess the incidence of cardiovascular related adverse events in controlled clinical trials of bupropion for the treatment of smoking cessation
Trial description: The objective of this investigation is to compare the incidence of adverse cardiovascular events in ZYBAN™ treated groups versus control groups in previously completed randomized clinical trials of smoking cessation treatment. All GSK sponsored studies meeting the criteria given below will be included. In addition, external studies will be included for a subsequent separate sensitivity analysis if they meet the appropriate criteria.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

The primary endpoint is the time to an on-treatment MACE event.

Timeframe: n/a

Secondary outcomes:
Not applicable
Interventions:
  • Drug: ZYBAN (bupropion hydrochloride)
    • Enrollment:
    1
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Retrospective
    Clinical publications:
    Kittle J, Lopes R, Huang M, Marquess M, Wilson M, Ascher J, Krishen A, Hasselblad V, Kolls B, Roe M, McGuire D, Russell S, Mahaffey KW. Cardiovascular Adverse Events in the Drug Development Program of Bupropion for Smoking Cessation: A Systematic Retrospective Adjudication Effort. Clin Cardiol. 2017;40(10):899-906
    Medical condition
    Smoking Cessation
    Product
    bupropion
    Collaborators
    Not applicable
    Study date(s)
    February 2013 to May 2014
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 85 Year
    Accepts healthy volunteers
    none
    • N/A
    • N/A
    Inclusion and exclusion criteria
    Inclusion criteria:
    • N/A
    Exclusion criteria:
    • N/A

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Statistical analysis plan
    Available language(s): English
    Download document(s)
    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2014-23-05

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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