Study To Evaluate Cardiac Assessments Following Different Treatments Of Smoking Cessation Medications In Subjects With And Without Psychiatric Disorders.

Phase 4 Completed 4595 enrolled Pfizer

RandomizedSingle-groupOpen-label

Summary

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.

Timeline

Start: 2012-05
Primary completion: 2015-07
Completion: 2015-07

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

paper There was no significant difference in time to onset of MACE for either varenicline or bupropion treatment vs placebo. PMID 29630702 ↗

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bupropion	Small molecule	150 mg	—
Subject	Nicotine	Unknown	21 mg	Other
Subject	Varenicline	Small molecule	1 mg	—

Indications

No indication recorded.