Phase 4
Completed N=4,595
Study To Evaluate Cardiac Assessments Following Different Treatments Of Smoking Cessation Medications In Subjects With And Without Psychiatric Disorders.
Source: ClinicalTrials.gov NCT01574703 ↗Enrolled (actual)
4,595
Serious AEs
3.4%
Results posted
Dec 2016
Primary outcomePrimary: Time to Occurrence of Major Adverse Cardiovascular Event (MACE) During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936. — 0.29; 0.50; 0.29; NA Unitless — p=0.37
◆ Published Evidence
Highly cited
149citations · ~19 / year
Cardiovascular Safety of Varenicline, Bupropion, and Nicotine Patch in Smokers: A Randomized Clinical Trial.
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.
Linked Publications
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Cardiovascular Safety of Varenicline, Bupropion, and Nicotine Patch in Smokers: A Randomized Clinical Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Occurrence of Major Adverse Cardiovascular Event (MACE) During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936. |
0.29; 0.50; 0.29; NA | 0.37 |
| SECONDARY Time to MACE up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936. |
0.29; 0.51; 0.50; NA | 0.53 |
| SECONDARY Time to MACE Until the End of Study NCT01574703. |
0.39; 1.09; 0.75; NA | 0.34 |
| SECONDARY Incidence of MACE Assessed During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936. |
0.05; 0.10; 0.05; 0.20 | 0.8375 |
| SECONDARY Incidence of MACE + Assessed During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936. |
0.25; 0.20; 0.10; 0.25 | 0.9687 |
| SECONDARY Incidence of MACE Assessed up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936. |
0.05; 0.10; 0.10; 0.20 | 0.8117 |
| SECONDARY Incidence of MACE+ Assessed up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936. |
0.25; 0.20; 0.15; 0.35 | 0.8932 |
| SECONDARY Incidence of MACE Assessed Until End of Study NCT01574703. |
0.15; 0.45; 0.30; 0.40 | 0.6441 |
| SECONDARY Incidence of MACE+ Assessed Until End of Study NCT01574703. |
0.50; 0.75; 0.49; 0.60 | 0.6105 |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01574703) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.