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The primary purpose of this study is to determine whether or not varenicline will help people with cardiovascular disease quit smoking and to confirm it is safe in these patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator |
| |
| varenicline | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Drug | 1 mg placebo twice daily by mouth for 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Responders With Carbon Monoxide (CO) Confirmed 4-week Continuous Quit Rate (CQR) for Last 4 Weeks of Treatment (Trtmt) | Participants considered Responders (4-week CQR <=10 parts per million <ppm>) through reports of cigarette or other nicotine use since last study visit, confirmed by measurement of end-expiratory exhaled carbon monoxide (CO). If any CO measurement at a particular timepoint was >10 ppm, subject was considered to be Non-Responder at that timepoint. | weeks 9 through 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Responders With Continuous Abstinence (CA) Through Week 52 | Responders: participants who remained abstinent based on 'since the last contact' question in Nicotine Use Inventory 1) "Has participant smoked any cigarettes (even a puff) since last contact?" = No AND 2) "Has participant used any other tobacco products… since last contact?" = No. Participant a non-responder if expired CO > 10 ppm. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Hartford | Connecticut | 06102-5037 | United States | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37142273 | Derived | Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8. | |
| 20048210 | Derived | Rigotti NA, Pipe AL, Benowitz NL, Arteaga C, Garza D, Tonstad S. Efficacy and safety of varenicline for smoking cessation in patients with cardiovascular disease: a randomized trial. Circulation. 2010 Jan 19;121(2):221-9. doi: 10.1161/CIRCULATIONAHA.109.869008. Epub 2010 Jan 4. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
714 smokers were randomized (ie, assigned to study treatment), 11 participants were randomized, but not treated. The reasons for participants being randomized, not treated included no longer willing to participate in the study (5 participants), protocol violation (3 participants), lost to follow-up (1 participant), and other (2 participants).
The study was conducted in outpatients. The target population was cigarette smokers with cardiovascular disease drawn from the communities surrounding the participating clinics.
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| ID | Title | Description |
|---|---|---|
| FG000 | Varenicline (Var) | 1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52. |
| FG001 | Placebo (Pbo) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Varenicline |
| Drug |
1 mg twice daily by mouth for 12 weeks |
|
|
| Week 9 through Week 52 |
| Number of Long-Term Quit Responders | Responders: participants were considered Long Term Quit responders if 1) they were responders for the primary endpoint (the 4-week CQR for Weeks 9-12) and 2) had no more than 6 days of smoking from Week 12 through the given visit. | Week 9 through Week 52 |
| Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 12 | Responders: abstinence in previous seven days, defined in the non-treatment follow-up as: 1) "Has the participant smoked any cigarettes in the last 7 days?" = No AND 2) "Has the participant used any other tobacco products in the last 7 days?" = No. Participant a non-responder if expired CO > 10 ppm. | Week 12 |
| Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 24 | Responders: abstinence in previous seven days, defined in the non-treatment follow-up as: 1) "Has the participant smoked any cigarettes in the last 7 days?" = No AND 2) "Has the participant used any other tobacco products in the last 7 days?" = No. Participant a non-responder if expired CO > 10 ppm. | Week 24 |
| Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 52 | Responders: abstinence in previous seven days, defined in the non-treatment follow-up as: 1) "Has the participant smoked any cigarettes in the last 7 days?" = No AND 2) "Has the participant used any other tobacco products in the last 7 days?" = No. Participant a non-responder if expired CO > 10 ppm. | Week 52 |
| Number of Participants With a 4 Week Point Prevalence of Smoking Cessation | Responders: participants with abstinence during the last 4 weeks of non-treatment based on answering 'no' to both of the two 'last 4 week' questions in the Nicotine Use Inventory (NUI). NUI collected information of cigarette or other nicotine use during the study. | Week 48 through Week 52 (final 4 weeks of non-treatment period [pd]) |
| Number of Responders With Continuous Abstinence (CA) Through Week 24 | Responders: participants who remained abstinent based on 'since the last contact' question in Nicotine Use Inventory 1) "Has participant smoked any cigarettes (even a puff) since the last contact?" = No AND 2) "Has participant used any other tobacco products… since the last contact?" = No. Non- responder if the expired CO > 10 ppm at any given timepoint. | Week 9 through Week 24 |
| Cigarettes Smoked Per Day | Cigarettes smoked each day during the first 3 weeks of the treatment phase. | Day 21 |
| Number of Long-Term Quit Responders From Week 9 Through Week 24 | Responders: participants were considered Long Term Quit Responders if 1) they were responders for the primary endpoint (the 4-week CQR for Weeks 9-12) and 2) had no more than 6 days of smoking from Week 12 through the given visit. | Week 9 through Week 24 |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| Pfizer Investigational Site | Madison | Wisconsin | 53711 | United States |
| Pfizer Investigational Site | Capital Federal | Buenos Aires | 1181 | Argentina |
| Pfizer Investigational Site | Ciudad de Buenos Aires | Buenos Aires | 1221 | Argentina |
| Pfizer Investigational Site | Concord | New South Wales | 2139 | Australia |
| Pfizer Investigational Site | Herston | Queensland | 4029 | Australia |
| Pfizer Investigational Site | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Pfizer Investigational Site | São Paulo | São Paulo | 05403-904 | Brazil |
| Pfizer Investigational Site | London | Ontario | N6C 5J1 | Canada |
| Pfizer Investigational Site | Ottawa | Ontario | K1Y 4W7 | Canada |
| Pfizer Investigational Site | Drummondville | Quebec | J2B 7T1 | Canada |
| Pfizer Investigational Site | Québec | Quebec | G1V 4M6 | Canada |
| Pfizer Investigational Site | Brno | 625 00 | Czechia |
| Pfizer Investigational Site | Prague | 120 00 | Czechia |
| Pfizer Investigational Site | Aarhus C | DK-8000 | Denmark |
| Pfizer Investigational Site | Hellerup | DK-2900 | Denmark |
| Pfizer Investigational Site | Caen | 14033 | France |
| Pfizer Investigational Site | Marseille | 13015 | France |
| Pfizer Investigational Site | Toulouse | 31059 | France |
| Pfizer Investigational Site | Berlin | 10787 | Germany |
| Pfizer Investigational Site | Göttingen | 37075 | Germany |
| Pfizer Investigational Site | Tübingen | 72076 | Germany |
| Pfizer Investigational Site | Athens | 11528 | Greece |
| Pfizer Investigational Site | Pireaus | 18526 | Greece |
| Pfizer Investigational Site | Tlalpan | Mexico City | 14080 | Mexico |
| Pfizer Investigational Site | Monterrey | Nuevo León | Mexico |
| Pfizer Investigational Site | Amsterdam | 1066 EC | Netherlands |
| Pfizer Investigational Site | Zuthpen | 7207 BA | Netherlands |
| Pfizer Investigational Site | Seoul | Korea | 152-703 | South Korea |
| Pfizer Investigational Site | Seoul | 110-799 | South Korea |
| Pfizer Investigational Site | Seoul | 135-720 | South Korea |
| Pfizer Investigational Site | Seoul | 138-736 | South Korea |
| Pfizer Investigational Site | Taipei | Taiwan | 11217 | Taiwan |
| Pfizer Investigational Site | Tau-Yuan Hsien | 333 | Taiwan |
| Pfizer Investigational Site | Carshalton | Surrey | SM5 1AA | United Kingdom |
| Pfizer Investigational Site | Bradford | West Yorkshire | BD9 6RJ | United Kingdom |
| Pfizer Investigational Site | Leicester | LE1 5WW | United Kingdom |
| Pfizer Investigational Site | Paisley | PA2 9PN | United Kingdom |
1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Varenicline (Var) | 1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52. |
| BG001 | Placebo (Pbo) | 1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 Responders With Carbon Monoxide (CO) Confirmed 4-week Continuous Quit Rate (CQR) for Last 4 Weeks of Treatment (Trtmt) | Participants considered Responders (4-week CQR <=10 parts per million <ppm>) through reports of cigarette or other nicotine use since last study visit, confirmed by measurement of end-expiratory exhaled carbon monoxide (CO). If any CO measurement at a particular timepoint was >10 ppm, subject was considered to be Non-Responder at that timepoint. | Primary analysis population (Modified Intent-to-Treat) included all participants who took at least 1 dose randomized study medication. Participants who discontinued study were assumed smokers from timepoint of discontinuation through end of study. Modified Intent-to-Treat population is referred to as "All Participants" population in this report. | Posted | Number | participants | weeks 9 through 12 |
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Responders With Continuous Abstinence (CA) Through Week 52 | Responders: participants who remained abstinent based on 'since the last contact' question in Nicotine Use Inventory 1) "Has participant smoked any cigarettes (even a puff) since last contact?" = No AND 2) "Has participant used any other tobacco products… since last contact?" = No. Participant a non-responder if expired CO > 10 ppm. | All participants population | Posted | Number | participants | Week 9 through Week 52 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Long-Term Quit Responders | Responders: participants were considered Long Term Quit responders if 1) they were responders for the primary endpoint (the 4-week CQR for Weeks 9-12) and 2) had no more than 6 days of smoking from Week 12 through the given visit. | All participants population | Posted | Number | participants | Week 9 through Week 52 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 12 | Responders: abstinence in previous seven days, defined in the non-treatment follow-up as: 1) "Has the participant smoked any cigarettes in the last 7 days?" = No AND 2) "Has the participant used any other tobacco products in the last 7 days?" = No. Participant a non-responder if expired CO > 10 ppm. | All Participants population | Posted | Number | participants | Week 12 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 24 | Responders: abstinence in previous seven days, defined in the non-treatment follow-up as: 1) "Has the participant smoked any cigarettes in the last 7 days?" = No AND 2) "Has the participant used any other tobacco products in the last 7 days?" = No. Participant a non-responder if expired CO > 10 ppm. | Posted | Number | participants | Week 24 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 52 | Responders: abstinence in previous seven days, defined in the non-treatment follow-up as: 1) "Has the participant smoked any cigarettes in the last 7 days?" = No AND 2) "Has the participant used any other tobacco products in the last 7 days?" = No. Participant a non-responder if expired CO > 10 ppm. | Posted | Number | participants | Week 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With a 4 Week Point Prevalence of Smoking Cessation | Responders: participants with abstinence during the last 4 weeks of non-treatment based on answering 'no' to both of the two 'last 4 week' questions in the Nicotine Use Inventory (NUI). NUI collected information of cigarette or other nicotine use during the study. | All Participants population | Posted | Number | participants | Week 48 through Week 52 (final 4 weeks of non-treatment period [pd]) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Responders With Continuous Abstinence (CA) Through Week 24 | Responders: participants who remained abstinent based on 'since the last contact' question in Nicotine Use Inventory 1) "Has participant smoked any cigarettes (even a puff) since the last contact?" = No AND 2) "Has participant used any other tobacco products… since the last contact?" = No. Non- responder if the expired CO > 10 ppm at any given timepoint. | All Participants population | Posted | Number | participants | Week 9 through Week 24 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Cigarettes Smoked Per Day | Cigarettes smoked each day during the first 3 weeks of the treatment phase. | All Participants population | Posted | Mean | Standard Deviation | cigarettes per day | Day 21 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Long-Term Quit Responders From Week 9 Through Week 24 | Responders: participants were considered Long Term Quit Responders if 1) they were responders for the primary endpoint (the 4-week CQR for Weeks 9-12) and 2) had no more than 6 days of smoking from Week 12 through the given visit. | All Participants population | Posted | Number | participants | Week 9 through Week 24 |
|
|
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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 (Var) | 1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52. | 23 | 253 | ||||
| EG001 | Placebo (Pbo) | 1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52. | 21 | 179 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Gingival recession | Gastrointestinal disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Periodontal disease | Gastrointestinal disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (v11.1) | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (v11.1) | Systematic Assessment |
| |
| Stent occlusion | Injury, poisoning and procedural complications | MedDRA (v11.1) | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA (v11.1) | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Ketoacidosis | Metabolism and nutrition disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Oesophageal squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (v11.1) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Cervical root pain | Nervous system disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Complex partial seizures | Nervous system disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Testicular torsion | Reproductive system and breast disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Percutaneous coronary intervention | Surgical and medical procedures | MedDRA (v11.1) | Systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Intermittent claudication | Vascular disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Infected cyst | Infections and infestations | MedDRA (v11.1) | Systematic Assessment |
| |
| Infected skin ulcer | Infections and infestations | MedDRA (v11.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (v11.1) | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (v11.1) | Systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Diabetic coma | Nervous system disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA (v11.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (v11.1) | Systematic Assessment |
| |
| Fatigue | General disorders | Systematic Assessment |
| ||
| Irritability | General disorders | Systematic Assessment |
| ||
| Oedema peripheral | General disorders | Systematic Assessment |
| ||
| Influenza | Infections and infestations | Systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Dysgeusia | Nervous system disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Somnolence | Nervous system disorders | Systematic Assessment |
| ||
| Abnormal dreams | Psychiatric disorders | Systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Systematic Assessment |
| ||
| Nicotine dependence | Psychiatric disorders | Systematic Assessment |
| ||
| Sleep disorder | Psychiatric disorders | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of <60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), <12 months (mo) from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.govCallCenter@pfizer.com |
| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068580 | Varenicline |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011810 | Quinoxalines |
Not provided
Not provided
| Male |
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| Superiority or Other |
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