Trial · NCT00808015
ASIA CHOICES CHampix (Varenicline) Observational Investigation in the CEssation of Smoking
NCT00808015, Completed, Pfizer; results first posted 2011-07-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. ASIA CHOICES CHampix (Varenicline) Observational Investigation in the CEssation of Smoking. Trials, record NCT00808015. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00808015
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ASIA CHOICES CHampix (Varenicline) Observational Investigation in the CEssation of Smoking
- NCT number
- NCT00808015
- Status
- Completed
- Enrollment
- 1,373 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Smoking Cessation
- Interventions
- varenicline
- First posted
- 2008-12-15
- Last updated
- 2015-05-12
- Results first posted
- 2011-07-28
- Limitations and caveats
- Outcome measures were not designated as primary or secondary measures as this study was a post-marketing, prospective, non-comparative and non-interventional study.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Smoking Abstinence at Week 12 | Week 12 | Four criteria used for derivation of smoking abstinence status: if participant smoked any cigarettes (even a puff) in last 7 days (Yes/No); if participant used any other tobacco products in last 7 days (Yes/No); average number of cigarettes smoked per day over last 7 days (in cigarettes/day); CO level (positive: if more than 10 ppm; negative : if 0-10 ppm).Smoking abstinence status was determined as: smoking: if participant responded positively to at least 1 of above 4; quit: if participant responded negatively to all 4; unknown: if participant had missing information for all 4. |
| Secondary | Percentage of Participants With Smoking Abstinence Before Last Observed Study Visit | Last observed study visit (Week 12 or early termination [ET]) | Four criteria used for derivation of smoking abstinence status: if participant smoked any cigarettes (even a puff) in last 7 days (Yes/No); if participant used any other tobacco products in last 7 days (Yes/No); average number of cigarettes smoked per day over last 7 days (in cigarettes/day); CO level (positive: if more than 10 ppm; negative : if 0-10 ppm).Smoking abstinence status was determined as: smoking: if participant responded positively to at least 1 of above 4; quit: if participant responded negatively to all 4; unknown: if participant had missing information for all 4. |
| Secondary | Percentage of Participants With Smoking Abstinence Status From Week 3 to Week 11 | Week 3 through Week 11 | Four criteria used for derivation of smoking abstinence status: if participant smoked any cigarettes (even a puff) in last 7 days (Yes/No); if participant used any other tobacco products in last 7 days (Yes/No); average number of cigarettes smoked per day over last 7 days (in cigarettes/day); CO level (positive: if more than 10 ppm; negative : if 0-10 ppm).Smoking abstinence status was determined as: smoking: if participant responded positively to at least 1 of above 4; quit: if participant responded negatively to all 4; unknown: if participant had missing information for all 4. |
| Secondary | CO Level at Last Observed Study Visit | Last observed study visit (Week 12 or ET) | The CO level was measured from exhaled air of the participant using CO analyzer at the last observed study visit which was the last available CO level recorded after baseline. The CO level was only measured if it was a part of the usual practice at the site. |
| Secondary | Average Weekly Number of Cigarettes Smoked at Last Observed Study Visit | Last observed study visit (Week 12 or ET) | The average number of cigarettes smoked per day over the last 7 days was collected as a part of nicotine use inventory assessment through consent record form module which included a questionnaire: Did the participant smoke any cigarettes (even a puff) in last 7 days (Yes/No) and Did the participant use any other tobacco products (example- pipe, cigars, chew, snuff) in last 7 days (Yes/No). |
| Other | Varenicline Prescription Status | After last observed study visit (Week 12 or ET) | Prescribed status was assessed using the following question in consent record form: Would a maintenance period of the drug be prescribed to the participant after this study ends (Yes/No). Missing values were recorded as 'unknown'. |
| Other | Average Daily Dose of Varenicline | Days 1-3, Days 4-7, Day 8 through last observed study visit (Week 12 or ET) | |
| Other | Median Duration of Treatment of Varenicline | Baseline through last observed study visit (Week 12 or ET) | The duration was defined as the total number of dosing days from first to last day of each study treatment. |
| Other | Concomitant Drug Treatments | Baseline through Last observed study visit (Week 12 or ET) |
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 | Percentage of Participants With Smoking Abstinence at Week 12 | Week 12 | Full analysis set (FAS) included all participants who received at least 1 dose of study medication | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Smoking Abstinence Before Last Observed Study Visit | Last observed study visit (Week 12 or early termination [ET]) | FAS included all participants who received at least 1 dose of study medication. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Smoking Abstinence Status From Week 3 to Week 11 | Week 3 through Week 11 | At Week t (t = 3 to 11), the analysis population was Observed Cases minus Week t (OC minus Week t), that is (i-e), participants in FAS excluding missing values at the time point in question where OC was the subset of participants in FAS with observed (not missing) values. | percentage of participants | NUMBER |
| SECONDARY | CO Level at Last Observed Study Visit | Last observed study visit (Week 12 or ET) | FAS population included all participants who received at least 1 dose of study medication during study. Missing observations were not imputed and hence the participants analyzed were those without missing values (N=115). | ppm | MEAN |
| SECONDARY | Average Weekly Number of Cigarettes Smoked at Last Observed Study Visit | Last observed study visit (Week 12 or ET) | FAS population included all participants who received at least 1 dose of study medication during study. Missing observations were not imputed and hence the participants analyzed were those without missing values (N=518). | cigarettes | MEDIAN |
| OTHER_PRE_SPECIFIED | Varenicline Prescription Status | After last observed study visit (Week 12 or ET) | FAS population included all participants who received at least 1 dose of study medication. | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Average Daily Dose of Varenicline | Days 1-3, Days 4-7, Day 8 through last observed study visit (Week 12 or ET) | FAS population included all participants who received at least 1 dose of study treatment. Missing values were excluded from analysis. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively. | mg | MEDIAN |
| OTHER_PRE_SPECIFIED | Median Duration of Treatment of Varenicline | Baseline through last observed study visit (Week 12 or ET) | FAS population included all participants who received at least 1 dose of study treatment. Missing values were excluded from analysis. | Days | MEDIAN |
| OTHER_PRE_SPECIFIED | Concomitant Drug Treatments | Baseline through Last observed study visit (Week 12 or ET) | FAS included all participants who received at least 1 dose of study medication. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group525
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 Smoking Abstinence at Week 12 | Varenicline | 46.40 | 95% Confidence Interval 43.73 to 49.07 | percentage of participants | |
| Percentage of Participants With Smoking Abstinence Before Last Observed Study Visit | Varenicline | 50.30 | 95% Confidence Interval 47.58 to 52.93 | percentage of participants | |
| Percentage of Participants With Smoking Abstinence Status From Week 3 to Week 11 | Varenicline | Week 3 (n= 677) | 31.3 | percentage of participants | |
| Percentage of Participants With Smoking Abstinence Status From Week 3 to Week 11 | Varenicline | Week 4 (n= 799) | 38.2 | percentage of participants | |
| Percentage of Participants With Smoking Abstinence Status From Week 3 to Week 11 | Varenicline | Week 5 (n= 988) | 45.4 | percentage of participants | |
| Percentage of Participants With Smoking Abstinence Status From Week 3 to Week 11 | Varenicline | Week 6 (n= 959) | 47.8 | percentage of participants | |
| Percentage of Participants With Smoking Abstinence Status From Week 3 to Week 11 | Varenicline | Week 7 (n= 888) | 49.5 | percentage of participants | |
| Percentage of Participants With Smoking Abstinence Status From Week 3 to Week 11 | Varenicline | Week 8 (n= 812) | 51.6 | percentage of participants | |
| Percentage of Participants With Smoking Abstinence Status From Week 3 to Week 11 | Varenicline | Week 9 (n= 765) | 55.2 | percentage of participants | |
| Percentage of Participants With Smoking Abstinence Status From Week 3 to Week 11 | Varenicline | Week 10 (n= 702) | 55.4 | percentage of participants |
1 to 10 of 525Source ClinicalTrials.gov
See all 525 results by groupParticipant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Varenicline | 1,377 | |
| Overall Study | Treated | Varenicline | 1,373 | |
| Overall Study | COMPLETED | Varenicline | 1,033 | |
| Overall Study | NOT COMPLETED | Varenicline | 344 |
Source ClinicalTrials.gov
Adverse events115
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 | Lymphadenopathy | Blood and lymphatic system disorders | Varenicline | 1 | 1,373 | |
| other | Coronary artery disease | Cardiac disorders | Varenicline | 1 | 1,373 | |
| other | Palpitations | Cardiac disorders | Varenicline | 7 | 1,373 | |
| other | Hearing impaired | Ear and labyrinth disorders | Varenicline | 1 | 1,373 | |
| other | Vision blurred | Eye disorders | Varenicline | 1 | 1,373 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Varenicline | 11 | 1,373 | |
| other | Abdominal distension | Gastrointestinal disorders | Varenicline | 6 | 1,373 | |
| other | Abdominal pain | Gastrointestinal disorders | Varenicline | 3 | 1,373 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Varenicline | 12 | 1,373 | |
| other | Constipation | Gastrointestinal disorders | Varenicline | 5 | 1,373 |
1 to 10 of 115Source ClinicalTrials.gov
See all 115 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 | 379 | 1,373 |
| Total, serious adverse events | Varenicline | 11 | 1,373 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT00808015
GET https://conductscience.org/api/trials/v1/NCT00808015/results?page=2