| Study To Evaluate Cardiac Assessments Following Different Treatments Of Smoking Cessation Medications In Subjects With And Without Psychiatric Disorders.
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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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| Non-treatment extension to study A3051123, aimed at collecting data on 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.
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| This study is an extension protocol for study A3051123. No treatment is provided during this study. This study is to monitor for cardiovascular events 28 weeks after completion of A3051123. This study is an extension protocol for study A3051123. No treatment is provided during this study. This study is to monitor for cardiovascular events 28 weeks after completion of A3051123.
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| Interventional
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| Phase 4
|
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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| Smoking Cessation
|
- Drug: placebo
All dosing to have taken place per study A3051123
- Drug: varenicline tartrate
All dosing to have taken place per study A3051123
Other Name: Chantix; Champix
- Drug: bupropion hydrochloride
All dosing to have taken place per study A3051123
Other Name: Zyban
- Drug: Nicotine Replacement Therapy Patch
All dosing to have taken place per study A3051123
Other Name: NRT
|
- Experimental: placebo
Intervention: Drug: placebo
- Experimental: varenicline
Intervention: Drug: varenicline tartrate
- Experimental: bupropion
Intervention: Drug: bupropion hydrochloride
- Experimental: Nicotine Replacement Therapy Patch
Intervention: Drug: Nicotine Replacement Therapy Patch
|
|
Benowitz NL, Pipe A, West R, Hays JT, Tonstad S, McRae T, Lawrence D, St Aubin L, Anthenelli RM. Cardiovascular Safety of Varenicline, Bupropion, and Nicotine Patch in Smokers: A Randomized Clinical Trial. JAMA Intern Med. 2018 May 1;178(5):622-631. doi: 10.1001/jamainternmed.2018.0397.
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| |
| Completed
|
| 4595
|
| 8000
|
| July 2015
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| July 2015 (Final data collection date for primary outcome measure)
|
|
Inclusion Criteria:
- Subjects will be eligible if they were randomized to study A3051123.
Exclusion Criteria:
- Participation in study A3051123 ceased (ie, withdrew consent, lost to follow-up, etc) prior to final visit of study A3051123.
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| Sexes Eligible for Study: |
All |
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| 18 Years to 75 Years (Adult, Older Adult)
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| Yes
|
|
Contact information is only displayed when the study is recruiting subjects
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| Argentina, Australia, Brazil, Bulgaria, Canada, Chile, Denmark, Finland, Germany, Mexico, New Zealand, Russian Federation, Slovakia, South Africa, Spain, United States
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|
|
| |
| NCT01574703
|
A3051148
2011-005513-37 ( EudraCT Number )
CATS ( Other Identifier: Alias Study Number )
|
| Yes
|
| Not Provided
|
| Not Provided
|
| Pfizer
|
| Pfizer
|
| Not Provided
|
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
| Pfizer
|
| October 2016
|
