Trial · NCT00772941
Drug Use Investigation Of Varenicline (Regulatory Post Marketing Commitment Plan)
NCT00772941, Completed, Pfizer; results first posted 2014-01-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Drug Use Investigation Of Varenicline (Regulatory Post Marketing Commitment Plan). Trials, record NCT00772941. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00772941
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Drug Use Investigation Of Varenicline (Regulatory Post Marketing Commitment Plan)
- NCT number
- NCT00772941
- Status
- Completed
- Enrollment
- 3,939 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Smoking Cessation
- Interventions
- Varenicline
- First posted
- 2008-10-15
- Last updated
- 2014-02-28
- Results first posted
- 2014-01-24
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Risk Factors for the Frequency of Treatment Related Adverse Events - Gender. | 24 weeks | Number of participants with Treatment Related Adverse Events of Varenicline to determine whether gender is a significant risk factor. |
| Primary | Risk Factors for the Frequency of Treatment Related Adverse Events - Age. | 24 weeks | Number of participants with Treatment Related Adverse Events of Varenicline to determine whether age is a significant risk factor. |
| Primary | Risk Factors for the Frequency of Treatment Related Adverse Events - Chronic Obstructive Pulmonary Disease as a Complication. | 24 weeks | Number of participants with Treatment Related Adverse Events of Varenicline to determine whether Chronic obstructive pulmonary disease as a complication is a significant risk factor. |
| Primary | Risk Factors for the Frequency of Treatment Related Adverse Events - Concomitant Drugs. | 24 weeks | Number of participants with Treatment Related Adverse Events of Varenicline to determine whether taking concomitant drugs is a significant risk factor. |
| Primary | Risk Factors for the Frequency of Treatment Related Adverse Events - Concomitant Therapies. | 24 weeks | Number of participants with Treatment Related Adverse Events of Varenicline to determine whether receiving concomitant therapies is a significant risk factor. |
| Primary | Risk Factors for the Frequency of Treatment Related Adverse Events - Weight at Baseline. | 24 weeks | Number of participants with Treatment Related Adverse Events to determine whether weight at baseline is a significant risk factor. |
| Primary | Risk Factors for the Proportion of Responders - Tobacco Consumption Per Day. | 24 weeks | The primary analysis item was "the number of participants succeeding with continuous smoking cessation for the previous 4 weeks/the number of participants for efficacy evaluation excluding drop-out participants. |
| Primary | Risk Factors for the Proportion of Responders - Prolonged Administration After 12 Weeks. | 24 weeks | The primary analysis item was "the number of participants succeeding with continuous smoking cessation for the previous 4 weeks/the number of participants for efficacy evaluation excluding drop-out participants. |
| Primary | Risk Factors for the Proportion of Responders - Antipsychotics as a Concomitant Drug. | 24 weeks | The primary analysis item was "the number of participants succeeding with continuous smoking cessation for the previous 4 weeks/the number of participants for efficacy evaluation excluding drop-out participants. |
| Primary | Number of Participants With Treatment Related Adverse Events. | 24 weeks | Adverse events mean all unfavorable events that occur in participants after administration of Varenicline, irrespective of causal relationship to Varenicline (including clinically problematic abnormal changes in laboratory test values). Treatment related Adverse Events were evaluated in company with the causal relationship to Varenicline. The safety was evaluated on the first visit after 24 weeks; however, it was evaluated on the last visit for those who had stopped visiting before 24 weeks. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Risk Factors for the Frequency of Treatment Related Adverse Events - Gender. | 24 weeks | The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed. | participants | NUMBER |
| PRIMARY | Risk Factors for the Frequency of Treatment Related Adverse Events - Age. | 24 weeks | The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed. | participants | NUMBER |
| PRIMARY | Risk Factors for the Frequency of Treatment Related Adverse Events - Chronic Obstructive Pulmonary Disease as a Complication. | 24 weeks | The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed. | participants | NUMBER |
| PRIMARY | Risk Factors for the Frequency of Treatment Related Adverse Events - Concomitant Drugs. | 24 weeks | The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed. | participants | NUMBER |
| PRIMARY | Risk Factors for the Frequency of Treatment Related Adverse Events - Concomitant Therapies. | 24 weeks | The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed. | participants | NUMBER |
| PRIMARY | Risk Factors for the Frequency of Treatment Related Adverse Events - Weight at Baseline. | 24 weeks | The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed. The number of participants who provided weight data at baseline was 1700. | participants | NUMBER |
| PRIMARY | Risk Factors for the Proportion of Responders - Tobacco Consumption Per Day. | 24 weeks | The efficacy analysis population basically consists of the evaluable participants in accordance with the separately prepared analysis plan (participants judged to have been evaluated appropriately). The number of participants who provided data on daily tobacco consumption was 2827. | participants | NUMBER |
| PRIMARY | Risk Factors for the Proportion of Responders - Prolonged Administration After 12 Weeks. | 24 weeks | The efficacy analysis population basically consists of the evaluable participants in accordance with the separately prepared analysis plan (participants judged to have been evaluated appropriately). The number of participants in whom the prolonged administration of Varenicline after 12 weeks was confirmed was 2598. | participants | NUMBER |
| PRIMARY | Risk Factors for the Proportion of Responders - Antipsychotics as a Concomitant Drug. | 24 weeks | The efficacy analysis population basically consists of the evaluable participants in accordance with the separately prepared analysis plan (participants judged to have been evaluated appropriately). The number of participants who provided data on concomitant administration of antipsychotics was 2842. | participants | NUMBER |
| PRIMARY | Number of Participants With Treatment Related Adverse Events. | 24 weeks | No statistical analysis provided for the frequency of treatment related adverse events. | participants | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Risk Factors for the Frequency of Treatment Related Adverse Events - Gender. | Male | 377 | participants | ||
| Risk Factors for the Frequency of Treatment Related Adverse Events - Gender. | Female | 336 | participants | ||
| Risk Factors for the Frequency of Treatment Related Adverse Events - Age. | <65 Years | 571 | participants | ||
| Risk Factors for the Frequency of Treatment Related Adverse Events - Age. | >=65 Years | 142 | participants | ||
| Risk Factors for the Frequency of Treatment Related Adverse Events - Chronic Obstructive Pulmonary Disease as a Complication. | Varenicline - With Chronic Obstructive Pulmonary Disease | 23 | participants | ||
| Risk Factors for the Frequency of Treatment Related Adverse Events - Chronic Obstructive Pulmonary Disease as a Complication. | Varenicline - Without Chronic Obstructive Pulmonary Disease | 690 | participants | ||
| Risk Factors for the Frequency of Treatment Related Adverse Events - Concomitant Drugs. | Varenicline - With Concomitant Drugs | 289 | participants | ||
| Risk Factors for the Frequency of Treatment Related Adverse Events - Concomitant Drugs. | Varenicline - Without Concomitant Drugs | 424 | participants | ||
| Risk Factors for the Frequency of Treatment Related Adverse Events - Concomitant Therapies. | Varenicline - With Concomitant Therapies | 45 | participants | ||
| Risk Factors for the Frequency of Treatment Related Adverse Events - Concomitant Therapies. | Varenicline - Without Concomitant Therapies | 668 | participants |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Varenicline | 3,939 | |
| Overall Study | COMPLETED | Varenicline | 3,257 | |
| Overall Study | NOT COMPLETED | Varenicline | 682 |
Source ClinicalTrials.gov
Adverse events86
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 | Herpes virus infection | Infections and infestations | Varenicline | 1 | 3,257 | 1 |
| other | Gastroenteritis | Infections and infestations | Varenicline | 2 | 3,257 | 2 |
| other | Oral herpes | Infections and infestations | Varenicline | 2 | 3,257 | 2 |
| other | Decreased appetite | Metabolism and nutrition disorders | Varenicline | 5 | 3,257 | 5 |
| other | Depression | Psychiatric disorders | Varenicline | 6 | 3,257 | 6 |
| other | Nightmare | Psychiatric disorders | Varenicline | 8 | 3,257 | 8 |
| other | Abnormal dreams | Psychiatric disorders | Varenicline | 9 | 3,257 | 9 |
| other | Decreased activity | Psychiatric disorders | Varenicline | 1 | 3,257 | 1 |
| other | Agitation | Psychiatric disorders | Varenicline | 1 | 3,257 | 1 |
| other | Social avoidant behaviour | Psychiatric disorders | Varenicline | 1 | 3,257 | 1 |
1 to 10 of 86Source ClinicalTrials.gov
See all 86 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 | 708 | 3,257 |
| Total, serious adverse events | Varenicline | 8 | 3,257 |
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 comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Varenicline - With Concomitant Drugs vs Varenicline - Without Concomitant Drugs: Risk Factors for the Frequency of Treatment Related Adverse Events - Concomitant Drugs. | Trial comparisons |
| Varenicline - With Concomitant Therapies vs Varenicline - Without Concomitant Therapies: Risk Factors for the Frequency of Treatment Related Adverse Events - Concomitant Therapies. | Trial comparisons |
| Male vs Female: Risk Factors for the Frequency of Treatment Related Adverse Events - Gender. | Trial comparisons |
| <65 Years vs >=65 Years: Risk Factors for the Frequency of Treatment Related Adverse Events - Age. | Trial comparisons |
Varenicline - With Chronic Obstructive Pulmonary Disease vs Varenicline - Without Chronic Obstructive Pulmonary Disease: Risk Factors for the Frequency of Treatment Related Adverse Events - Chronic Obstructive Pulmonary Disease as a Complication. | Trial comparisons |
| Administration Prolonged After 12 Weeks vs Administration Not Prolonged After 12 Weeks: Risk Factors for the Proportion of Responders - Prolonged Administration After 12 Weeks. | Trial comparisons |
Varenicline - With Antipsychotics as a Concomitant Drug vs Varenicline - Without Antipsychotics as a Concomitant Drug: Risk Factors for the Proportion of Responders - Antipsychotics as a Concomitant Drug. | 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/NCT00772941
GET https://conductscience.org/api/trials/v1/NCT00772941/results?page=2