Trial · NCT00691483
Randomized Study Comparing the Efficacy and Safety of Varenicline Tartrate to Placebo in Smoking Cessation When Subjects Are Allowed to Set Their Own Quit Date
NCT00691483, Phase 4, Completed, Pfizer; results first posted 2010-09-30
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Randomized Study Comparing the Efficacy and Safety of Varenicline Tartrate to Placebo in Smoking Cessation When Subjects Are Allowed to Set Their Own Quit Date. Trials, record NCT00691483. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00691483
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Randomized Study Comparing the Efficacy and Safety of Varenicline Tartrate to Placebo in Smoking Cessation When Subjects Are Allowed to Set Their Own Quit Date
- NCT number
- NCT00691483
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 659 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Smoking Cessation
- Interventions
- placebo, varenicline
- First posted
- 2008-06-05
- Last updated
- 2015-11-20
- Results first posted
- 2010-09-30
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With 4-week Continuous Abstinence (CA) | Week 9 through Week 12 | The percentage of participants who reported complete abstinence from cigarette smoking and other nicotine use (on the Nicotine Use Inventory) and who did not have carbon monoxide (CO) \>10 parts per million (ppm) at any visits Week 9 through Week 12. A participant was considered a responder if they met the following criterion: said they had not smoked or used nicotine products 'since the last visit' and did not have CO \>10 ppm. |
| Secondary | Percentage of Participants With Continuous Abstinence (CA) From Smoking Weeks 9-24 | Week 9 through Week 24 | Percentage of participants with CA from cigarette smoking and other nicotine-containing (treatment phase) or tobacco (non-treatment phase) products use, who did not have CO \>10 ppm at any visits Week 9 through Week 24. A participant was considered a responder if they met the following criterion: said they had not smoked or used nicotine products 'since the last visit' and did not have CO \>10 ppm. |
| Secondary | Percentage of Participants With Long Term Quit Through Week 24 | Week 9 through Week 24 | Responder for the primary endpoint of CA from Week 9 through Week 12 and who had no more than 6 days of smoking during the non-treatment phase of the study. For Weeks 13, 16, 20, and 24, long term quit was determined by CO-confirmed in-clinic visit. |
| Secondary | Percentage of Participants With 7-day Point Prevalence of Nonsmoking (Smoking Cessation) | Week 12 and Week 24 | Percentage of participants with complete abstinence from cigarette smoking or other nicotine-containing (treatment phase) or tobacco (non-treatment phase) products use for the 7 days prior to Week 12 and Week 24, respectively, who did not have CO \>10 ppm at any visits. CO-confirmed in-clinic visit. |
| Secondary | Percentage of Participants With 4-week Point Prevalence of Nonsmoking | Week 24 | Percentage of participants with complete abstinence from cigarette smoking or use of tobacco products for the 4 weeks prior to Week 24 who did not have CO \>10 ppm at any visits. |
| Other | Change From Baseline in Fagerström Test for Nicotine Dependence (FTND) to Day of First Quit Attempt (FQA) Through Week 5 by Smoking Status at Weeks 9-12 | Baseline through Week 5 | Change in nicotine dependence from baseline to the date of the FQA within the first 5 weeks. FTND was designed to provide an ordinal measure of nicotine dependence related to cigarette smoking. It contains items that evaluate the quantity of cigarette consumption, the compulsion to use, and dependence. The FTND contains 4 yes-no and 2 multiple choice questions and can be used in a self-report format. The items on FTND are scored 0 to 3 for multiple choice items, the items are summed to yield a total score of 0-10 (0=minimum nicotine dependence; 10=maximum nicotine dependence). |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With 4-week Continuous Abstinence (CA) | Week 9 through Week 12 | Full analysis set (FAS): took at least 1 dose, including partial doses, of randomized study drug. Missing CO measurements imputed as =\<10 ppm. Missing visit(s) imputed based on next available visit. Subjects who discontinued study and were lost to follow up were assumed smokers. Missing data not imputed from other weekly interview questions. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Continuous Abstinence (CA) From Smoking Weeks 9-24 | Week 9 through Week 24 | FAS. Missing CO measurements imputed as =\<10 ppm. Missing visit(s) imputed based on next available visit. Subjects who discontinued study and were lost to follow up were assumed smokers. Missing data not imputed from other weekly interview questions. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Long Term Quit Through Week 24 | Week 9 through Week 24 | FAS. If the number of days smoked was missing for a subject visit, the CA responder status of the subject at that visit determined the imputation. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With 7-day Point Prevalence of Nonsmoking (Smoking Cessation) | Week 12 and Week 24 | FAS. Missing weekly interview questions of whether the subject had smoked in the last 7 days were not imputed; missing CO was imputed as =\<10 ppm. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With 4-week Point Prevalence of Nonsmoking | Week 24 | FAS. Missing inventory interview questions of whether the subject had smoked or used any other tobacco products in the last 4 weeks were not imputed. Missing CO was imputed as =\<10 ppm. | Percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Change From Baseline in Fagerström Test for Nicotine Dependence (FTND) to Day of First Quit Attempt (FQA) Through Week 5 by Smoking Status at Weeks 9-12 | Baseline through Week 5 | Number of participants analyzed = participants with FQA through Week 5, excluding 157 participants for whom FTND was not done at the time of FQA (1 participant also had inconsistent FQA date with first dosing date). Analysis done by smoking status at Week 12 (Responder for the primary endpoint of CA Weeks 9-12). | Units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With 4-week Continuous Abstinence (CA) | Varenicline | 53.9 | Percentage of participants | ||
| Percentage of Participants With 4-week Continuous Abstinence (CA) | Placebo | 19.4 | Percentage of participants | ||
| Percentage of Participants With Continuous Abstinence (CA) From Smoking Weeks 9-24 | Varenicline | 35.2 | Percentage of participants | ||
| Percentage of Participants With Continuous Abstinence (CA) From Smoking Weeks 9-24 | Placebo | 12.7 | Percentage of participants | ||
| Percentage of Participants With Long Term Quit Through Week 24 | Varenicline | 40.7 | Percentage of participants | ||
| Percentage of Participants With Long Term Quit Through Week 24 | Placebo | 14.6 | Percentage of participants | ||
| Percentage of Participants With 7-day Point Prevalence of Nonsmoking (Smoking Cessation) | Varenicline | Week 12 | 59.5 | Percentage of participants | |
| Percentage of Participants With 7-day Point Prevalence of Nonsmoking (Smoking Cessation) | Placebo | Week 12 | 24.2 | Percentage of participants | |
| Percentage of Participants With 7-day Point Prevalence of Nonsmoking (Smoking Cessation) | Varenicline | Week 24 | 43.0 | Percentage of participants | |
| Percentage of Participants With 7-day Point Prevalence of Nonsmoking (Smoking Cessation) | Placebo | Week 24 | 17.6 | Percentage of participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Varenicline | 493 | |
| Overall Study | STARTED | Placebo | 166 | |
| Overall Study | Received Treatment | Varenicline | 486 | |
| Overall Study | Received Treatment | Placebo | 165 | |
| Overall Study | COMPLETED | Varenicline | 425 | |
| Overall Study | COMPLETED | Placebo | 141 | |
| Overall Study | NOT COMPLETED | Varenicline | 68 | |
| Overall Study | NOT COMPLETED | Placebo | 25 |
Source ClinicalTrials.gov
Adverse events80
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 | Abdominal pain | Gastrointestinal disorders | Varenicline | 6 | 486 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 4 | 165 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Varenicline | 14 | 486 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo | 0 | 165 | |
| other | Constipation | Gastrointestinal disorders | Varenicline | 23 | 486 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 5 | 165 | |
| other | Diarrhoea | Gastrointestinal disorders | Varenicline | 11 | 486 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 3 | 165 | |
| other | Dry mouth | Gastrointestinal disorders | Varenicline | 18 | 486 | |
| other | Dry mouth | Gastrointestinal disorders | Placebo | 3 | 165 |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Varenicline | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Varenicline | 297 | 486 |
| Total, other adverse events | Placebo | 79 | 165 |
| Total, serious adverse events | Varenicline | 6 | 486 |
| Total, serious adverse events | Placebo | 1 | 165 |
Source ClinicalTrials.gov
Papers3
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Varenicline vs Placebo: serious adverse events |
Source 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/NCT00691483
GET https://conductscience.org/api/trials/v1/NCT00691483/events?page=2