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
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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
Observational study model:
Other
Primary completion date:
Not applicable
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)
No location data available.
Study documents
Statistical analysis plan
Available language(s): English
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
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
Participate in clinical trial
Access to clinical trial data by researchers
Visit website