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The primary objective of this protocol is to evaluate 12 weeks of treatment of varenicline compared to placebo for smoking cessation. Abstinence from cigarette smoking and other tobacco products (e.g., pipe, cigars, chew, snuff.) use during non-treatment follow-up period will also be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| varenicline | Active Comparator |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| varenicline tartrate (CP-526, 555-18) | Drug | 1 mg twice a day for 12 weeks, starting with a 1-week titration period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With 4-week Continuous Abstinence | The number of participants who, at each visit from Week 9 through 12 (inclusive), reported no smoking and no use of other nicotine-containing products since the last study visit (on the Nicotine Use Inventory) and who did not have carbon monoxide (CO) > 10 parts per milion (ppm) at any of these visits | Weeks 9 through 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Continuous Abstinence | The number of participants who, at each contact from Week 9 through the given timepoint, reported no smoking and no use of other nicotine-containing products (Treatment Phase) or tobacco products (Nontreatment Phase) since the last study contact(on the Nicotine Use Inventory) and who did not have CO > 10 ppm | Weeks 9 through 24 |
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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 | Fortaleza | Ceará | 60864-190 | Brazil | ||
| 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. | |
| 21635992 | Derived | Bolliger CT, Issa JS, Posadas-Valay R, Safwat T, Abreu P, Correia EA, Park PW, Chopra P. Effects of varenicline in adult smokers: a multinational, 24-week, randomized, double-blind, placebo-controlled study. Clin Ther. 2011 Apr;33(4):465-77. doi: 10.1016/j.clinthera.2011.04.013. |
| 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 | 0.5 mg once daily (QD) for 3 days + 0.5 mg twice a day (BID) for 4 days, and then 1 mg BID for 11 weeks |
| FG001 | Placebo | matching placebo following the same treatment schema as the varenicline group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | matching placebo 1 tablet twice a day for 12 weeks |
|
| Number of Participants With Seven-day Point Prevalence of Abstinence | Number of participants who, at the given visit or telephone contact, reported no smoking and no use of other nicotine-containing products (treatment phase) or tobacco products (non-treatment phase) in the last 7 days and who did not have CO >10 ppm on that day | Week 12 and 24 |
| Porto Alegre |
| Centro |
| RS |
| Brazil |
| Pfizer Investigational Site | Juiz de Fora | Minas Gerais | 36036-110 | Brazil |
| Pfizer Investigational Site | Botucatu | São Paulo | 18618-000 | Brazil |
| Pfizer Investigational Site | São Paulo | São Paulo | 04012-909 | Brazil |
| Pfizer Investigational Site | São Paulo | São Paulo | 04032-060 | Brazil |
| Pfizer Investigational Site | São Paulo | São Paulo | 05019-010 | Brazil |
| Pfizer Investigational Site | MedellÃn | Antioquia | 0 | Colombia |
| Pfizer Investigational Site | Barranquilla | Atlántico | 0 | Colombia |
| Pfizer Investigational Site | San Pedro | Provincia de San José | Costa Rica |
| Pfizer Investigational Site | Cairo | Egypt | Egypt |
| Pfizer Investigational Site | Amman | Jordan | Jordan |
| Pfizer Investigational Site | Beirut | Lebanon | Lebanon |
| Pfizer Investigational Site | Beirut Lebanon | Lebanon | 00000 | Lebanon |
| Pfizer Investigational Site | México | D.f. | 14000 | Mexico |
| Pfizer Investigational Site | Morelia | Michoacán | 58249 | Mexico |
| Pfizer Investigational Site | Monterrey | Nuevo León | 64460 | Mexico |
| Pfizer Investigational Site | Jeddah | 21499 | Saudi Arabia |
| Pfizer Investigational Site | Riyadh | 11211 | Saudi Arabia |
| Pfizer Investigational Site | Tygerberg | Cape Town | 7505 | South Africa |
| Pfizer Investigational Site | Bloemfontein | Free State | 9300 | South Africa |
| Pfizer Investigational Site | Benoni | Gauteng | 1501 | South Africa |
| Pfizer Investigational Site | Midrand | Gauteng | 1685 | South Africa |
| Pfizer Investigational Site | Pretoria | Gauteng | South Africa |
| Pfizer Investigational Site | Soweto | Johannesburg | South Africa |
| Pfizer Investigational Site | Durban | KwaZulu-Natal | 4001 | South Africa |
| Pfizer Investigational Site | Sydenham, Durban | KwaZulu-Natal | 4091 | South Africa |
| Pfizer Investigational Site | Hillcrest | Pretoria | 0083 | South Africa |
| Pfizer Investigational Site | Cape Town | Western Cape | 7764 | South Africa |
| Pfizer Investigational Site | Paarl, Cape Town | Western Cape | 7647 | South Africa |
| Pfizer Investigational Site | Durban | 4091 | South Africa |
| Pfizer Investigational Site | Lyttelton | 0140 | South Africa |
| Pfizer Investigational Site | Dubai | United Arab Emirates | 0 | United Arab Emirates |
| Pfizer Investigational Site | Abu Dhabi | United Arab Emirates |
| Pfizer Investigational Site | Al Ain City | 0 | United Arab Emirates |
| Pfizer Investigational Site | Dubai | 0 | United Arab Emirates |
| Pfizer Investigational Site | Jumeirah/Dubai | 0 | United Arab Emirates |
| Pfizer Investigational Site | Ras Al Khaima | 0 | United Arab Emirates |
| Pfizer Investigational Site | Caracas | Distrito Federal | 1011 | Venezuela |
| Pfizer Investigational Site | Barquisimeto | Lara | 3002 | Venezuela |
| Pfizer Investigational Site | Gran Caracas | Miranda | 1060 | Venezuela |
| Pfizer Investigational Site | Caracas | Venezuela |
| Received Treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Varenicline | 0.5 mg once daily (QD) for 3 days + 0.5 mg twice a day (BID) for 4 days, and then 1 mg BID for 11 weeks |
| BG001 | Placebo | matching placebo following the same treatment schema as the varenicline group |
| 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, Customized | Number | 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Number of Participants With Continuous Abstinence | The number of participants who, at each contact from Week 9 through the given timepoint, reported no smoking and no use of other nicotine-containing products (Treatment Phase) or tobacco products (Nontreatment Phase) since the last study contact(on the Nicotine Use Inventory) and who did not have CO > 10 ppm | ITT | Posted | Number | participants | Weeks 9 through 24 |
|
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Seven-day Point Prevalence of Abstinence | Number of participants who, at the given visit or telephone contact, reported no smoking and no use of other nicotine-containing products (treatment phase) or tobacco products (non-treatment phase) in the last 7 days and who did not have CO >10 ppm on that day | ITT | Posted | Number | participants | Week 12 and 24 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With 4-week Continuous Abstinence | The number of participants who, at each visit from Week 9 through 12 (inclusive), reported no smoking and no use of other nicotine-containing products since the last study visit (on the Nicotine Use Inventory) and who did not have carbon monoxide (CO) > 10 parts per milion (ppm) at any of these visits | Intent-to-treat (ITT) | Posted | Number | participants | Weeks 9 through 12 |
|
|
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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 | 0.5 mg once daily (QD) for 3 days + 0.5 mg twice a day (BID) for 4 days, and then 1 mg BID for 11 weeks | 11 | 390 | 224 | 390 | ||
| EG001 | Placebo | matching placebo following the same treatment schema as the varenicline group | 2 | 198 | 82 | 198 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Peritonitis | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Thyroid neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| Abortion | Pregnancy, puerperium and perinatal conditions | MedDRA (12.0) | Systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Nasal septum deviation | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Appendicectomy | Surgical and medical procedures | MedDRA (12.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Irritability | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Increased appetite | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Abnormal dreams | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Drug dependence | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | 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 from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information 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 |
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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 |
| D011810 | Quinoxalines |
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| Title | Measurements |
|---|---|
|
| > 65 |
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| Male |
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