Trial · NCT01370356
A Study To Evaluate The Efficacy And Safety Of Varenicline Compared To Placebo For Smoking Cessation Through Reduction
NCT01370356, Phase 4, Completed, Pfizer; results first posted 2014-09-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study To Evaluate The Efficacy And Safety Of Varenicline Compared To Placebo For Smoking Cessation Through Reduction. Trials, record NCT01370356. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01370356
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study To Evaluate The Efficacy And Safety Of Varenicline Compared To Placebo For Smoking Cessation Through Reduction
- NCT number
- NCT01370356
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 1,510 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Smoking Cessation
- Interventions
- Varenicline Tartrate, Placebo
- First posted
- 2011-06-09
- Last updated
- 2014-09-01
- Results first posted
- 2014-09-01
- Limitations and caveats
Two cases of fetal exposure during pregnancy occurred but are not included in the SAE section as they did not meet the criteria of serious in the safety database. One of them relates to a non-study participant who was the study participant's partner.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Carbon Monoxide (CO) Confirmed 10-Week Continuous Abstinence (CA) From Smoking | Week 15 - 24 | Percentage of participants who remained abstinent from Week 15 to Week 24, inclusive, reporting no smoking and no use of nicotine-containing products since the last study visit or contact on the Nicotine Use Inventory (NUI) and confirmed by expired CO \< 10 ppm at any time point (CO measurements conducted at the clinic visits) during Weeks 15 through 24, inclusive. Missing CO was imputed as negative (CO ≤ 10 ppm). |
| Secondary | Percentage of Participants With CO Confirmed 4-Week CA From Smoking | Week 21 - 24 | Percentage of participants who remained abstinent from Week 21 to Week 24, inclusive, reporting no smoking and no use of nicotine-containing products since the last study visit or contact on the NUI and confirmed by expired CO \< 10 ppm at any time point (CO measurements conducted at the clinic visits) during Weeks 21 through 24, inclusive. Missing CO was imputed as negative (CO ≤ 10 ppm). |
| Secondary | Percentage of Participants With CO Confirmed Long Term CA From Smoking | Weeks 21 - 52 | Percentage of participants who remained abstinent from Week 21 to Week 52, inclusive, reporting no smoking and no use of nicotine-containing products since the last study visit or contact on the NUI and confirmed by expired CO \< 10 ppm at any time point (CO measurements conducted at the clinic visits) during Weeks 21 through 52, inclusive. Missing CO was imputed as negative (CO ≤ 10 ppm). |
| Secondary | Percentage of Participants With 7-Day Point Prevalence of Smoking Cessation | Week 12, 24, and 52 | The 7-day point prevalence of abstinence was defined as being abstinent from smoking and using tobacco products during the last 7 days at Week 12, 24, and 52. The participant's smoking status and other nicotine use was evaluated based on the "last 7 days" questions on the NUI and confirmed by CO expiration. Responders were defined as those, who answered "no" to both questions ("Has the subject smoked any cigarettes (even a puff) in the last 7 days?"; and "Has the subject used any nicotine products and/or other tobacco.... in the last 7 days?") and whose expired CO \< 10 ppm. Missing CO was imputed as negative (CO ≤ 10 ppm). |
| Secondary | Percentage of Participants With 4-Week Point Prevalence of Smoking Cessation | Week 52 | The 4-week point prevalence of abstinence was defined as being abstinent from smoking and using tobacco products during the last 4 weeks of the study. The participant's smoking status and other nicotine use was evaluated based on the "last 4 weeks" questions on the NUI and confirmed by CO expiration. Responders were defined as those, who answered "no" to both questions ("Has the subject smoked any cigarettes (even a puff) in the last 4 weeks?"; and "Has the subject used any nicotine products and/or other tobacco.... in the last 4 weeks?") and whose expired CO \< 10 ppm. Missing CO was imputed as negative (CO ≤ 10 ppm). |
Source ClinicalTrials.gov
Outcomes5
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 Carbon Monoxide (CO) Confirmed 10-Week Continuous Abstinence (CA) From Smoking | Week 15 - 24 | The Full Analysis Set was referred to as the Intent-to-Treat (ITT) population and was defined as all randomized participants. The ITT population was the primary analysis set for the efficacy analyses in this study. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With CO Confirmed 4-Week CA From Smoking | Week 21 - 24 | The Full Analysis Set was referred to as the ITT population and was defined as all randomized participants. The ITT population was the primary analysis set for the efficacy analyses in this study. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With CO Confirmed Long Term CA From Smoking | Weeks 21 - 52 | The Full Analysis Set was referred to as the ITT population and was defined as all randomized participants. The ITT population was the primary analysis set for the efficacy analyses in this study. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With 7-Day Point Prevalence of Smoking Cessation | Week 12, 24, and 52 | The Full Analysis Set was referred to as the ITT population and was defined as all randomized participants. The ITT population was the primary analysis set for the efficacy analyses in this study. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With 4-Week Point Prevalence of Smoking Cessation | Week 52 | The Full Analysis Set was referred to as the ITT population and was defined as all randomized participants. The ITT population was the primary analysis set for the efficacy analyses in this study. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group14
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 Carbon Monoxide (CO) Confirmed 10-Week Continuous Abstinence (CA) From Smoking | Varenicline | 32.1 | percentage of participants | ||
| Percentage of Participants With Carbon Monoxide (CO) Confirmed 10-Week Continuous Abstinence (CA) From Smoking | Placebo | 6.9 | percentage of participants | ||
| Percentage of Participants With CO Confirmed 4-Week CA From Smoking | Varenicline | 37.8 | percentage of participants | ||
| Percentage of Participants With CO Confirmed 4-Week CA From Smoking | Placebo | 12.5 | percentage of participants | ||
| Percentage of Participants With CO Confirmed Long Term CA From Smoking | Varenicline | 27.0 | percentage of participants | ||
| Percentage of Participants With CO Confirmed Long Term CA From Smoking | Placebo | 9.9 | percentage of participants | ||
| Percentage of Participants With 7-Day Point Prevalence of Smoking Cessation | Varenicline | Week 12 | 31.2 | percentage of participants | |
| Percentage of Participants With 7-Day Point Prevalence of Smoking Cessation | Placebo | Week 12 | 6.7 | percentage of participants | |
| Percentage of Participants With 7-Day Point Prevalence of Smoking Cessation | Varenicline | Week 24 | 43.2 | percentage of participants | |
| Percentage of Participants With 7-Day Point Prevalence of Smoking Cessation | Placebo | Week 24 | 17.5 | percentage of participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 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 | 751 | |
| Overall Study | STARTED | Placebo | 742 | |
| Overall Study | COMPLETED | Varenicline | 559 | |
| Overall Study | COMPLETED | Placebo | 515 | |
| Overall Study | NOT COMPLETED | Varenicline | 192 | |
| Overall Study | NOT COMPLETED | Placebo | 227 |
Source ClinicalTrials.gov
Adverse events126
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 | Constipation | Gastrointestinal disorders | Varenicline | 38 | 751 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 13 | 742 | |
| other | Nausea | Gastrointestinal disorders | Varenicline | 209 | 751 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 67 | 742 | |
| other | Fatigue | General disorders | Varenicline | 46 | 751 | |
| other | Fatigue | General disorders | Placebo | 34 | 742 | |
| other | Irritability | General disorders | Varenicline | 39 | 751 | |
| other | Irritability | General disorders | Placebo | 30 | 742 | |
| other | Nasopharyngitis | Infections and infestations | Varenicline | 98 | 751 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 89 | 742 |
1 to 10 of 126Source ClinicalTrials.gov
See all 126 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 | 467 | 751 |
| Total, other adverse events | Placebo | 339 | 742 |
| Total, serious adverse events | Varenicline | 28 | 751 |
| Total, serious adverse events | Placebo | 16 | 742 |
Source ClinicalTrials.gov
Papers4
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/NCT01370356
GET https://conductscience.org/api/trials/v1/NCT01370356/events?page=2