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To monitor use in real practice including safety and efficacy of Champix tablets 0.5mg, 1mg medication for 12 weeks in smokers
No sampling method will be applied to this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy smokers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| varenicline | Drug | As prescribed by physician in usual clinical practice. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With 7-day Point Prevalence From Week 3 to Less Than 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). | Week 3 through Week 7 |
| Percentage of Participants With 7-day Point Prevalence From Week 7 to Less Than 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). | Week 7 through Week 11 |
| Percentage of Participants With 7-day Point Prevalence for 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). | At least Week 11 |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy smokers
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35210758 | Derived | Ock M, Shin JS, Ra SW. Safety and Effectiveness of Varenicline in Korean Smokers: A Nationwide Post-Marketing Surveillance Study. Patient Prefer Adherence. 2022 Feb 15;16:413-426. doi: 10.2147/PPA.S344757. eCollection 2022. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Varenicline | Varenicline tartrate tablets 0.5 milligram (mg) or 1 mg administered as per investigator's discretion for 12 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Varenicline | Varenicline tartrate tablets 0.5 milligram (mg) or 1 mg administered as per investigator's discretion for 12 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | Percentage of Participants With 7-day Point Prevalence From Week 3 to Less Than 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). | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 3 through Week 7 |
|
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The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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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 | Varenicline tartrate tablets 0.5 milligram (mg) or 1 mg administered as per investigator's discretion for 12 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appetite decreased/anorexia | General disorders | MedDRA 14.1 | Non-systematic Assessment |
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.
| 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 |
| 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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| Other |
|
| Other |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | Percentage of Participants With 7-day Point Prevalence From Week 7 to Less Than 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). | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 7 through Week 11 |
|
|
|
| Primary | Percentage of Participants With 7-day Point Prevalence for 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). | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | At least Week 11 |
|
|
|
| 4 |
| 3,719 |
| 342 |
| 3,719 |
| Cerebral artery stenosis | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Neuritis | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Thinking abnormal | Psychiatric disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Fatigue/malaise/adynamia | General disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Epigastric discomfort | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Gingival oedema | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 14.1 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 14.1 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Increased appetite | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Dreamy state | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Mental impairment | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Abnormal dreams | Psychiatric disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Hallucination | Psychiatric disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Nightmare | Psychiatric disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Nipple pain | Reproductive system and breast disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
|
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 |