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The purpose of this study is to collect the efficacy and safety information in subjects who have been retreated with varenicline (Champix®) within 52 weeks of initial treatment for their appropriate use in daily practice and are participants for varenicline Drug Use Investigation protocol A3051109 ((NCT# NCT00772941).
The subjects have been retreated with varenicline within 52 weeks, and subjects have been enrolled to varenicline Drug Use Investigation protocol A3051109.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| varenicline (Champix®) | Subjects who have been retreated with varenicline within 52 weeks and have been enrolled to varenicline protocol A3051109. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| varenicline | Drug | Dosage form: tablet 0.5mg, tablet 1mg. The usual adult dosage for oral use is 0.5 mg once daily after eating on Days 1 to 3; 0.5 mg twice daily after eating in the morning and evening on Days 4 to 7, and 1 mg twice daily after eating in the morning and evening on Day 8 and thereafter. The drug should be administered to subjects for 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Related Adverse Events (AEs) | An AE was any untoward medical occurrence attributed to veranicline in a participant who received veranicline. Treatment related adverse events were evaluated in company with the causal relationship to veranicline. | 24 weeks |
| Number of Responders to Varenicline Treatment | Number of participants who succeeded in smoking cessation from 12 weeks through 24 weeks of the observation period. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Treatment-Related Adverse Events (AEs) Unlisted in Japanese Package Insert | An AE was any untoward medical occurrence attributed to varenicline in a participant who received varenicline. Treatment related adverse events were evaluated in company with the causal relationship to veranicline. | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Non-participants of varenicline (Champix®) Drug use Investigation protocol A3051109.
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The subjects who have been retreated with varenicline in A3051109 (NCT# NCT00772941) within 52 weeks of initial treatment.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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This survey enrolled those who participated in preceding varenicline Drug Use Investigation protocol A3051109 (NCT00772941) and retreated with varenicline within 52 weeks of initial treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Varenicline (Champix®) | The usual adult dosage for oral use is as follows: Day 1 through Day 3, 0.5 mg once daily after eating; Day 4 through Day 7, 0.5 mg twice daily after eating in the morning and evening; and Day 8 and thereafter, 1 mg twice daily after eating in the morning and evening. Treatment period was 12 weeks. Participants were retreated within 52 weeks of initial treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
A total of 20 participants were enrolled in this survey. Of the 20 participants, 14 participants were excluded from the baseline analysis due to a protocol violation.
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| ID | Title | Description |
|---|---|---|
| BG000 | Varenicline (Champix®) | The usual adult dosage for oral use is as follows: Day 1 through Day 3, 0.5 mg once daily after eating; Day 4 through Day 7, 0.5 mg twice daily after eating in the morning and evening; and Day 8 and thereafter, 1 mg twice daily after eating in the morning and evening. Treatment period was 12 weeks. Participants were retreated within 52 weeks of initial treatment. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment-Related Adverse Events (AEs) | An AE was any untoward medical occurrence attributed to veranicline in a participant who received veranicline. Treatment related adverse events were evaluated in company with the causal relationship to veranicline. | The safety analysis population comprised participants who had been enrolled in varenicline protocol A3051109 and retreated with varenicline within 52 weeks of initial treatment. | Posted | Number | Participants | 24 weeks |
|
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The frequency of adverse events during the survey.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Varenicline (Champix®) | The usual adult dosage for oral use is as follows: Day 1 through Day 3, 0.5 mg once daily after eating; Day 4 through Day 7, 0.5 mg twice daily after eating in the morning and evening; and Day 8 and thereafter, 1 mg twice daily after eating in the morning and evening. Treatment period was 12 weeks. Participants were retreated within 52 weeks of initial treatment. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000068580 | Varenicline |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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|
|
| Number of Participants With Risk Factors Likely to Affect the Frequency of Treatment-Related Adverse Events (AEs) |
| 24 weeks |
| Number of Participants With Risk Factors Likely to Affect the Proportion of Responders | 24 weeks |
| participants |
|
| Sex/Gender, Customized | Number | participants |
|
|
|
| Primary | Number of Responders to Varenicline Treatment | Number of participants who succeeded in smoking cessation from 12 weeks through 24 weeks of the observation period. | The efficacy analysis population comprised the participants who had at least one post-baseline efficacy measurement among the safety analysis population. | Posted | Number | Participants | 24 weeks |
|
|
|
| Secondary | Number of Treatment-Related Adverse Events (AEs) Unlisted in Japanese Package Insert | An AE was any untoward medical occurrence attributed to varenicline in a participant who received varenicline. Treatment related adverse events were evaluated in company with the causal relationship to veranicline. | The safety analysis population comprised participants who had been enrolled in varenicline protocol A3051109 and retreated with varenicline within 52 weeks of initial treatment. | Posted | Number | Participants | 24 weeks |
|
|
|
| Secondary | Number of Participants With Risk Factors Likely to Affect the Frequency of Treatment-Related Adverse Events (AEs) | The safety analysis population comprised participants who had been enrolled in varenicline protocol A3051109 and retreated with varenicline within 52 weeks of initial treatment. Because of the small population size, no risk analyses were performed. | Posted | 24 weeks |
|
|
| Secondary | Number of Participants With Risk Factors Likely to Affect the Proportion of Responders | The efficacy analysis population comprised the participants who had at least one post-baseline efficacy measurement among the safety analysis population. Because of the small population size, no risk analyses were performed. | Posted | 24 weeks |
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| 0 |
| 6 |
| 0 |
| 6 |
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D011810 | Quinoxalines |