Trial · NCT00483002
Post Marketing Surveillance Study To Observe Safety And Efficacy Of Champix® Tablets
NCT00483002, Completed, Pfizer; results first posted 2012-05-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Post Marketing Surveillance Study To Observe Safety And Efficacy Of Champix® Tablets. Trials, record NCT00483002. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00483002
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Post Marketing Surveillance Study To Observe Safety And Efficacy Of Champix® Tablets
- NCT number
- NCT00483002
- Status
- Completed
- Enrollment
- 3,719 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Smoking Cessation
- Interventions
- varenicline
- First posted
- 2007-06-06
- Last updated
- 2012-05-11
- Results first posted
- 2012-05-11
- Limitations and caveats
Planned observation time points at 4, 8 and 12 weeks were reported as from week 3 to less than week 7, from week 7 to less than week 11, at least week 11. As this is non-interventional study it is likely that adverse events had been under reported.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With 7-day Point Prevalence From Week 3 to Less Than Week 7 | Week 3 through Week 7 | Treatment effectiveness was measured by 7-day point prevalence of smoking abstinence status. The smoking status was categorized as smoking or abstained smoking based on 2 parameters: if participant smoked any cigarettes (even a puff) in the last 7 days (Yes/No); if participant used any other nicotine-containing products in the last 7 days (Yes/No). |
| Primary | Percentage of Participants With 7-day Point Prevalence From Week 7 to Less Than Week 11 | Week 7 through Week 11 | Treatment effectiveness was measured by 7-day point prevalence of smoking abstinence status. The smoking status was categorized as smoking or abstained smoking based on 2 parameters: if participant smoked any cigarettes (even a puff) in the last 7 days (Yes/No); if participant used any other nicotine-containing products in the last 7 days (Yes/No). |
| Primary | Percentage of Participants With 7-day Point Prevalence for at Least Week 11 | At least Week 11 | Treatment effectiveness was measured by 7-day point prevalence of smoking abstinence status. The smoking status was categorized as smoking or abstained smoking based on 2 parameters: if participant smoked any cigarettes (even a puff) in the last 7 days (Yes/No); if participant used any other nicotine-containing products in the last 7 days (Yes/No). |
Source ClinicalTrials.gov
Outcomes3
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 7-day Point Prevalence From Week 3 to Less Than Week 7 | Week 3 through Week 7 | Study population included all those participants who received the study medication more than once and were available for follow up. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With 7-day Point Prevalence From Week 7 to Less Than Week 11 | Week 7 through Week 11 | Study population included all those participants who received the study medication more than once and were available for follow up. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With 7-day Point Prevalence for at Least Week 11 | At least Week 11 | Study population included all those participants who received the study medication more than once and were available for follow up. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group3
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 7-day Point Prevalence From Week 3 to Less Than Week 7 | Varenicline | 59.55 | 95% Confidence Interval 57.77 to 61.33 | Percentage of participants | |
| Percentage of Participants With 7-day Point Prevalence From Week 7 to Less Than Week 11 | Varenicline | 73.29 | 95% Confidence Interval 71.07 to 75.51 | Percentage of participants | |
| Percentage of Participants With 7-day Point Prevalence for at Least Week 11 | Varenicline | 77.02 | 95% Confidence Interval 74.85 to 79.18 | Percentage of participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Varenicline | 3,719 | |
| Overall Study | COMPLETED | Varenicline | 1,165 | |
| Overall Study | NOT COMPLETED | Varenicline | 2,554 |
Source ClinicalTrials.gov
Adverse events51
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 | Appetite decreased/anorexia | General disorders | Varenicline | 7 | 3,719 | |
| other | Fatigue/malaise/adynamia | General disorders | Varenicline | 17 | 3,719 | |
| other | Abdominal pain | Gastrointestinal disorders | Varenicline | 13 | 3,719 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Varenicline | 2 | 3,719 | |
| other | Constipation | Gastrointestinal disorders | Varenicline | 12 | 3,719 | |
| other | Dry mouth | Gastrointestinal disorders | Varenicline | 4 | 3,719 | |
| other | Dyspepsia | Gastrointestinal disorders | Varenicline | 30 | 3,719 | |
| other | Epigastric discomfort | Gastrointestinal disorders | Varenicline | 1 | 3,719 | |
| other | Flatulence | Gastrointestinal disorders | Varenicline | 2 | 3,719 | |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Varenicline | 1 | 3,719 |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Varenicline | ||
| Total, other adverse events | Varenicline | 342 | 3,719 |
| Total, serious adverse events | Varenicline | 4 | 3,719 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35210758 | 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/NCT00483002
GET https://conductscience.org/api/trials/v1/NCT00483002/events?page=2