Trial · NCT01574703
Study To Evaluate Cardiac Assessments Following Different Treatments Of Smoking Cessation Medications In Subjects With And Without Psychiatric Disorders.
NCT01574703, Phase 4, Completed, Pfizer; results first posted 2016-12-29
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Study To Evaluate Cardiac Assessments Following Different Treatments Of Smoking Cessation Medications In Subjects With And Without Psychiatric Disorders. Trials, record NCT01574703. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01574703
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study To Evaluate Cardiac Assessments Following Different Treatments Of Smoking Cessation Medications In Subjects With And Without Psychiatric Disorders.
- NCT number
- NCT01574703
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 4,595 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Smoking Cessation
- Interventions
- placebo, varenicline tartrate, bupropion hydrochloride, Nicotine Replacement Therapy Patch
- First posted
- 2012-04-10
- Last updated
- 2016-12-29
- Other registries' IDs
- eudract:2011-005513-37
- Results first posted
- 2016-12-29
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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. | Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks). | This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug). The measure type mentioned in the outcome data table is Hazard Ratio relative to Placebo. |
| Secondary | Time to MACE up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936. | Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days. | This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug) plus 30 days follow-up. The measure type mentioned in the outcome data table is Hazard Ratio. |
| Secondary | Time to MACE Until the End of Study NCT01574703. | Baseline until end of study (end of study is defined as last visit in study NCT01574703 [up to Week 52], or in study NCT01456936 [up to 24 Weeks] for those participants not enrolled into study NCT01574703). | This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated until end of study. The measure type mentioned in the outcome data table is Hazard Ratio. |
| Secondary | Incidence of MACE Assessed During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936. | Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks). | This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug). |
| Secondary | Incidence of MACE + Assessed During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936. | Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks). | This is an adjudicated endpoint. MACE + is defined as any MACE or a new onset or worsening peripheral vascular disease (PVD) requiring intervention, a need for coronary revascularization, or hospitalization for unstable angina. |
| Secondary | Incidence of MACE Assessed up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936. | Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days follow-up. | This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug) plus 30 days follow-up. |
| Secondary | Incidence of MACE+ Assessed up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936. | Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days follow-up. | This is an adjudicated endpoint. MACE + is defined as any MACE or a new onset or worsening PVD requiring intervention, a need for coronary revascularization, or hospitalization for unstable angina. |
| Secondary | Incidence of MACE Assessed Until End of Study NCT01574703. | Baseline until end of study (end of study is defined as last visit in study NCT01574703 [up to Week 52], or in study NCT01456936 [up to 24 Weeks] for those participants not enrolled into study NCT01574703). | This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated until end of study. |
| Secondary | Incidence of MACE+ Assessed Until End of Study NCT01574703. | Baseline until end of study (end of study is defined as last visit in study NCT01574703 [up to Week 52], or in study NCT01456936 [up to 24 Weeks] for those participants not enrolled into study NCT01574703). | This is an adjudicated endpoint. MACE+ is defined as any MACE or a new onset or worsening PVD requiring intervention, a need for coronary revascularization, or hospitalization for unstable angina. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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. | Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks). | The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936. | Unitless | NUMBER |
| SECONDARY | Time to MACE up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936. | Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days. | The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936. | Unitless | NUMBER |
| SECONDARY | Time to MACE Until the End of Study NCT01574703. | Baseline until end of study (end of study is defined as last visit in study NCT01574703 [up to Week 52], or in study NCT01456936 [up to 24 Weeks] for those participants not enrolled into study NCT01574703). | The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936. | Unitless | NUMBER |
| SECONDARY | Incidence of MACE Assessed During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936. | Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks). | The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936. | percentage of participants | NUMBER |
| SECONDARY | Incidence of MACE + Assessed During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936. | Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks). | The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936. | percentage of participants | NUMBER |
| SECONDARY | Incidence of MACE Assessed up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936. | Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days follow-up. | The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936. | percentage of participants | NUMBER |
| SECONDARY | Incidence of MACE+ Assessed up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936. | Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days follow-up. | The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936. | percentage of participants | NUMBER |
| SECONDARY | Incidence of MACE Assessed Until End of Study NCT01574703. | Baseline until end of study (end of study is defined as last visit in study NCT01574703 [up to Week 52], or in study NCT01456936 [up to 24 Weeks] for those participants not enrolled into study NCT01574703). | The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936. | percentage of participants | NUMBER |
| SECONDARY | Incidence of MACE+ Assessed Until End of Study NCT01574703. | Baseline until end of study (end of study is defined as last visit in study NCT01574703 [up to Week 52], or in study NCT01456936 [up to 24 Weeks] for those participants not enrolled into study NCT01574703). | The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Occurrence of Major Adverse Cardiovascular Event (MACE) During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936. | Varenicline | 0.29 | 95% Confidence Interval 0.05 to 1.68 | Unitless | |
| Time to Occurrence of Major Adverse Cardiovascular Event (MACE) During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936. | Bupropion | 0.50 | 95% Confidence Interval 0.10 to 2.50 | Unitless | |
| Time to Occurrence of Major Adverse Cardiovascular Event (MACE) During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936. | NRT Patch | 0.29 | 95% Confidence Interval 0.05 to 1.70 | Unitless | |
| Time to Occurrence of Major Adverse Cardiovascular Event (MACE) During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936. | Placebo | NA | 95% Confidence Interval NA to NA | Unitless | |
| Time to MACE up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936. | Varenicline | 0.29 | 95% Confidence Interval 0.05 to 1.70 | Unitless | |
| Time to MACE up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936. | Bupropion | 0.51 | 95% Confidence Interval 0.10 to 2.51 | Unitless | |
| Time to MACE up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936. | NRT Patch | 0.50 | 95% Confidence Interval 0.10 to 2.48 | Unitless | |
| Time to MACE up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936. | Placebo | NA | 95% Confidence Interval NA to NA | Unitless | |
| Time to MACE Until the End of Study NCT01574703. | Varenicline | 0.39 | 95% Confidence Interval 0.12 to 1.27 | Unitless | |
| Time to MACE Until the End of Study NCT01574703. | Bupropion | 1.09 | 95% Confidence Interval 0.42 to 2.83 | Unitless |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Varenicline | 1,192 | |
| Overall Study | STARTED | Bupropion | 1,166 | |
| Overall Study | STARTED | Nicotine Replacement Therapy (NRT) Patch | 1,116 | |
| Overall Study | STARTED | Placebo | 1,121 | |
| Overall Study | COMPLETED | Varenicline | 1,067 | |
| Overall Study | COMPLETED | Bupropion | 1,054 | |
| Overall Study | COMPLETED | Nicotine Replacement Therapy (NRT) Patch | 1,011 | |
| Overall Study | COMPLETED | Placebo | 1,007 | |
| Overall Study | NOT COMPLETED | Varenicline | 125 | |
| Overall Study | NOT COMPLETED | Bupropion | 112 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events540
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | Varenicline | 103 | 1,192 | |
| other | Nasopharyngitis | Infections and infestations | Bupropion | 78 | 1,166 | |
| other | Nasopharyngitis | Infections and infestations | NRT Patch | 69 | 1,116 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 81 | 1,121 | |
| other | Upper respiratory tract infection | Infections and infestations | Varenicline | 63 | 1,192 | |
| other | Upper respiratory tract infection | Infections and infestations | Bupropion | 84 | 1,166 | |
| other | Upper respiratory tract infection | Infections and infestations | NRT Patch | 48 | 1,116 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 63 | 1,121 | |
| serious | Acute myocardial infarction | Cardiac disorders | Varenicline | 0 | 1,192 | |
| serious | Acute myocardial infarction | Cardiac disorders | Bupropion | 4 | 1,166 |
1 to 10 of 540Source ClinicalTrials.gov
See all 540 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Varenicline | ||
| Total, all-cause mortality | Bupropion | ||
| Total, all-cause mortality | NRT Patch | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Varenicline | 165 | 1,192 |
| Total, other adverse events | Bupropion | 160 | 1,166 |
| Total, other adverse events | NRT Patch | 116 | 1,116 |
| Total, other adverse events | Placebo | 143 | 1,121 |
| Total, serious adverse events | Varenicline | 34 | 1,192 |
| Total, serious adverse events | Bupropion | 39 | 1,166 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29630702 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01574703
GET https://conductscience.org/api/trials/v1/NCT01574703/results?page=2