Trial · NCT00282984
Efficacy and Safety of Varenicline in Smokers With Cardiovascular Disease Who Wish to Quit Smoking
NCT00282984, Phase 3, Completed, Pfizer; results first posted 2009-04-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Varenicline in Smokers With Cardiovascular Disease Who Wish to Quit Smoking. Trials, record NCT00282984. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00282984
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Varenicline in Smokers With Cardiovascular Disease Who Wish to Quit Smoking
- NCT number
- NCT00282984
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 714 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Smoking Cessation
- Interventions
- placebo, Varenicline
- First posted
- 2006-01-27
- Last updated
- 2017-04-05
- Results first posted
- 2009-04-29
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Responders With Carbon Monoxide (CO) Confirmed 4-week Continuous Quit Rate (CQR) for Last 4 Weeks of Treatment (Trtmt) | weeks 9 through 12 | Participants considered Responders (4-week CQR \<=10 parts per million \<ppm\>) through reports of cigarette or other nicotine use since last study visit, confirmed by measurement of end-expiratory exhaled carbon monoxide (CO). If any CO measurement at a particular timepoint was \>10 ppm, subject was considered to be Non-Responder at that timepoint. |
| Secondary | Number of Responders With Continuous Abstinence (CA) Through Week 52 | Week 9 through Week 52 | Responders: participants who remained abstinent based on 'since the last contact' question in Nicotine Use Inventory 1) "Has participant smoked any cigarettes (even a puff) since last contact?" = No AND 2) "Has participant used any other tobacco products… since last contact?" = No. Participant a non-responder if expired CO \> 10 ppm. |
| Secondary | Number of Long-Term Quit Responders | Week 9 through Week 52 | Responders: participants were considered Long Term Quit responders if 1) they were responders for the primary endpoint (the 4-week CQR for Weeks 9-12) and 2) had no more than 6 days of smoking from Week 12 through the given visit. |
| Secondary | Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 12 | Week 12 | Responders: abstinence in previous seven days, defined in the non-treatment follow-up as: 1) "Has the participant smoked any cigarettes in the last 7 days?" = No AND 2) "Has the participant used any other tobacco products in the last 7 days?" = No. Participant a non-responder if expired CO \> 10 ppm. |
| Secondary | Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 24 | Week 24 | Responders: abstinence in previous seven days, defined in the non-treatment follow-up as: 1) "Has the participant smoked any cigarettes in the last 7 days?" = No AND 2) "Has the participant used any other tobacco products in the last 7 days?" = No. Participant a non-responder if expired CO \> 10 ppm. |
| Secondary | Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 52 | Week 52 | Responders: abstinence in previous seven days, defined in the non-treatment follow-up as: 1) "Has the participant smoked any cigarettes in the last 7 days?" = No AND 2) "Has the participant used any other tobacco products in the last 7 days?" = No. Participant a non-responder if expired CO \> 10 ppm. |
| Secondary | Number of Participants With a 4 Week Point Prevalence of Smoking Cessation | Week 48 through Week 52 (final 4 weeks of non-treatment period [pd]) | Responders: participants with abstinence during the last 4 weeks of non-treatment based on answering 'no' to both of the two 'last 4 week' questions in the Nicotine Use Inventory (NUI). NUI collected information of cigarette or other nicotine use during the study. |
| Secondary | Number of Responders With Continuous Abstinence (CA) Through Week 24 | Week 9 through Week 24 | Responders: participants who remained abstinent based on 'since the last contact' question in Nicotine Use Inventory 1) "Has participant smoked any cigarettes (even a puff) since the last contact?" = No AND 2) "Has participant used any other tobacco products… since the last contact?" = No. Non- responder if the expired CO \> 10 ppm at any given timepoint. |
| Secondary | Cigarettes Smoked Per Day | Day 21 | Cigarettes smoked each day during the first 3 weeks of the treatment phase. |
| Secondary | Number of Long-Term Quit Responders From Week 9 Through Week 24 | Week 9 through Week 24 | Responders: participants were considered Long Term Quit Responders if 1) they were responders for the primary endpoint (the 4-week CQR for Weeks 9-12) and 2) had no more than 6 days of smoking from Week 12 through the given visit. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Responders With Carbon Monoxide (CO) Confirmed 4-week Continuous Quit Rate (CQR) for Last 4 Weeks of Treatment (Trtmt) | weeks 9 through 12 | Primary analysis population (Modified Intent-to-Treat) included all participants who took at least 1 dose randomized study medication. Participants who discontinued study were assumed smokers from timepoint of discontinuation through end of study. Modified Intent-to-Treat population is referred to as All Participants population in this report. | participants | NUMBER |
| SECONDARY | Number of Responders With Continuous Abstinence (CA) Through Week 52 | Week 9 through Week 52 | All participants population | participants | NUMBER |
| SECONDARY | Number of Long-Term Quit Responders | Week 9 through Week 52 | All participants population | participants | NUMBER |
| SECONDARY | Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 12 | Week 12 | All Participants population | participants | NUMBER |
| SECONDARY | Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 24 | Week 24 | participants | NUMBER | |
| SECONDARY | Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 52 | Week 52 | participants | NUMBER | |
| SECONDARY | Number of Participants With a 4 Week Point Prevalence of Smoking Cessation | Week 48 through Week 52 (final 4 weeks of non-treatment period [pd]) | All Participants population | participants | NUMBER |
| SECONDARY | Number of Responders With Continuous Abstinence (CA) Through Week 24 | Week 9 through Week 24 | All Participants population | participants | NUMBER |
| SECONDARY | Cigarettes Smoked Per Day | Day 21 | All Participants population | cigarettes per day | MEAN |
| SECONDARY | Number of Long-Term Quit Responders From Week 9 Through Week 24 | Week 9 through Week 24 | All Participants population | participants | NUMBER |
Source ClinicalTrials.gov
Results by group76
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Responders With Carbon Monoxide (CO) Confirmed 4-week Continuous Quit Rate (CQR) for Last 4 Weeks of Treatment (Trtmt) | Varenicline (Var) | responders | 167 | participants | |
| Number of Responders With Carbon Monoxide (CO) Confirmed 4-week Continuous Quit Rate (CQR) for Last 4 Weeks of Treatment (Trtmt) | Placebo (Pbo) | responders | 50 | participants | |
| Number of Responders With Carbon Monoxide (CO) Confirmed 4-week Continuous Quit Rate (CQR) for Last 4 Weeks of Treatment (Trtmt) | Varenicline (Var) | non-responders | 186 | participants | |
| Number of Responders With Carbon Monoxide (CO) Confirmed 4-week Continuous Quit Rate (CQR) for Last 4 Weeks of Treatment (Trtmt) | Placebo (Pbo) | non-responders | 300 | participants | |
| Number of Responders With Continuous Abstinence (CA) Through Week 52 | Varenicline (Var) | responders | 70 | participants | |
| Number of Responders With Continuous Abstinence (CA) Through Week 52 | Placebo (Pbo) | responders | 26 | participants | |
| Number of Responders With Continuous Abstinence (CA) Through Week 52 | Varenicline (Var) | non-responders | 283 | participants | |
| Number of Responders With Continuous Abstinence (CA) Through Week 52 | Placebo (Pbo) | non-responders | 324 | participants | |
| Number of Long-Term Quit Responders | Varenicline (Var) | responders | 80 | participants | |
| Number of Long-Term Quit Responders | Placebo (Pbo) | responders | 34 | participants |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Varenicline (Var) | 353 | |
| Overall Study | STARTED | Placebo (Pbo) | 350 | |
| Overall Study | COMPLETED | Varenicline (Var) | 302 | |
| Overall Study | COMPLETED | Placebo (Pbo) | 289 | |
| Overall Study | NOT COMPLETED | Varenicline (Var) | 51 | |
| Overall Study | NOT COMPLETED | Placebo (Pbo) | 61 |
Source ClinicalTrials.gov
Adverse events156
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 | Angina pectoris | Cardiac disorders | Varenicline (Var) | 12 | 353 | |
| other | Angina pectoris | Cardiac disorders | Placebo (Pbo) | 5 | 350 | |
| other | Abdominal distension | Gastrointestinal disorders | Varenicline (Var) | 7 | 353 | |
| other | Abdominal distension | Gastrointestinal disorders | Placebo (Pbo) | 3 | 350 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Varenicline (Var) | 15 | 353 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo (Pbo) | 9 | 350 | |
| other | Constipation | Gastrointestinal disorders | Varenicline (Var) | 23 | 353 | |
| other | Constipation | Gastrointestinal disorders | Placebo (Pbo) | 7 | 350 | |
| other | Diarrhoea | Gastrointestinal disorders | Varenicline (Var) | 22 | 353 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo (Pbo) | 18 | 350 |
1 to 10 of 156Source ClinicalTrials.gov
See all 156 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Varenicline (Var) | ||
| Total, all-cause mortality | Placebo (Pbo) | ||
| Total, other adverse events | Varenicline (Var) | 253 | |
| Total, other adverse events | Placebo (Pbo) | 179 | |
| Total, serious adverse events | Varenicline (Var) | 23 | |
| Total, serious adverse events | Placebo (Pbo) | 21 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Varenicline (Var) vs Placebo (Pbo): Number of Responders With Continuous Abstinence (CA) Through Week 24 | Trial comparisons |
| Varenicline (Var) vs Placebo (Pbo): Number of Participants With a 4 Week Point Prevalence of Smoking Cessation | Trial comparisons |
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/NCT00282984
GET https://conductscience.org/api/trials/v1/NCT00282984/results?page=2