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The main purpose of this study is to compare the effectiveness and safety of the re-treatment of smokers with varenicline with placebo for smoking cessation during the last 4 weeks of a 12 week course of treatment. The study will also assess whether smokers remain abstinent at Week 24 (12 weeks after the end of treatment) and Week 52 (40 weeks after the end of treatment).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Varenicline | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Varenicline | Drug | Varenicline 1mg twice daily |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Continuous Abstinence Rate (CAR) From Week 9 Through Week 12 | The percentage of participants who, from Week 9 through Week 12, reported no smoking and no use of other nicotine-containing products since the last study visit/last contact (on the Nicotine Use Inventory) and who did not have carbon monoxide (CO)> 10ppm at any visits during this time frame. | Week 9 through Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| CAR From Week 9 Through Week 52 | The percentage of participants who, from Week 9 through Week 52, reported no smoking (Weeks 9 through 52) and no use of other nicotine-containing products (Weeks 9 through 12), or no use of other tobacco products (Weeks 13 through 52), since the last study visit/last contact (on the Nicotine Use Inventory) and who did not have CO >10 ppm at any of these visits during this time frame. |
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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 |
|---|---|---|---|---|---|---|
| Ronald Reagan University of California Los Angeles Medical Center | Los Angeles | California | 90095-6984 | United States | ||
| 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. | |
| 24911368 | Derived | Gonzales D, Hajek P, Pliamm L, Nackaerts K, Tseng LJ, McRae TD, Treadow J. Retreatment with varenicline for smoking cessation in smokers who have previously taken varenicline: a randomized, placebo-controlled trial. Clin Pharmacol Ther. 2014 Sep;96(3):390-6. doi: 10.1038/clpt.2014.124. Epub 2014 Jun 9. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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This was a Phase 4, randomized, double-blind, placebo-controlled, parallel group, 2-arm, multicenter study. A total of 498 participants were randomized into the study at 36 investigator sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | Varenicline | Participants received 0.5 mg per day of varenicline on Days 1 to 3, 1.0 mg per day on Days 4 to 7, and 2.0 mg per day (1.0 mg twice daily, ie, 2 x 0.5 mg tablets in the morning and 2 x 0.5 mg tablets in the evening) from Weeks 1 to 12. |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
Matched placebo twice daily |
|
| Week 9 through Week 52 |
| CAR From Week 9 Through Week 24 | The percentage of participants who, from Week 9 through Week 24, reported no smoking (Weeks 9 through 24) and no use of other nicotine-containing products (Weeks 9 through 12), or no use of other tobacco products (Weeks 13 through 24), since the last study visit/last contact (on the Nicotine Use Inventory) and who did not have CO >10 ppm at any of these visits during this time frame. | Week 9 through Week 24 |
| 7-day Point Prevalence (PP) of Abstinence at Weeks 12, 24, and 52 | The secondary endpoint of 7-day point prevalence of smoking cessation was determined by evaluating a participant's cigarette smoking status, and other nicotine (and/or other tobacco) use, based on the "last 7 days" questions in the Nicotine Use Inventory. Additionally, a participant was not considered a responder if the expired CO was >10 ppm at the time point being summarized. Participants were considered responders independently at each visit. | Weeks 12, 24 and 52 |
| University of California Los Angeles David Geffen School of Medicine |
| Los Angeles |
| California |
| 90095 |
| United States |
| Avail Clinical Research, LLC | DeLand | Florida | 32720 | United States |
| Central Kentucky Research Associates, Inc. | Lexington | Kentucky | 40509 | United States |
| The University of Maryland | College Park | Maryland | 20742 | United States |
| The Center for Pharmaceutical Research, PC | Kansas City | Missouri | 64114 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239-3098 | United States |
| Clinical Research Associates, Inc. | Nashville | Tennessee | 37203 | United States |
| Australian Clinical Research Network | Maroubra | New South Wales | 2035 | Australia |
| Royal Brisbane and Women's Hospital | Herston | Queensland | 4029 | Australia |
| AusTrials Australia | Sherwood | Queensland | 4075 | Australia |
| Emeritus Research | Malvern | Victoria | 3145 | Australia |
| Universitair Ziekenhuis Antwerpen, Afdeling Pneumologie | Edegem | 2650 | Belgium |
| Universitaire Ziekenhuizen Leuven/Pneumologie | Leuven | 3000 | Belgium |
| Centre Hospitalier Universitaire de Liege | Liège | 4000 | Belgium |
| Cliniques Universitaires U.C.L. de Mont-Godinne/Laboratoire | Yvoir | 5530 | Belgium |
| Office of Dr. Ronald Collette | Burnaby | British Columbia | V5G 1T4 | Canada |
| White Hills Medical Clinic | St. John's | Newfoundland and Labrador | A1A 3R5 | Canada |
| Canadian Phase Onward Inc. | Toronto | Ontario | M3H 5S4 | Canada |
| Clinique des maladies Lipidiques de Quebec | Québec | Quebec | G1V 4M6 | Canada |
| Fakultni nemocnice Brno | Brno | 625 00 | Czechia |
| Krajska nemocnice Liberec a.s., Plicni oddeleni | Liberec | 460 01 | Czechia |
| Mestska nemocnice Ostrava, Plicni oddeleni | Ostrava | 728 80 | Czechia |
| Vseobecna fakultni nemocnice v Praze | Prague | 120 00 | Czechia |
| CHU de la Cavale Blanche | Brest | 29609 | France |
| CHU Côte de Nacre, Unité de Coordination de Tabacologie | Caen | 14033 | France |
| Hopital Arnaud de Villeneuve | Montpellier | 34295 | France |
| Universitaetsklinikum Goettingen Zentrum Innere Medizin Abteilung Kardiologie und Pneumologie | Göttingen | Germany | 37075 | Germany |
| Klinische Forschung Berlin | Berlin | 10787 | Germany |
| Klinische Forschung Hamburg GmbH | Hamburg | 20253 | Germany |
| Ludwig Maximilians-Universitaet Muenchen | München | 80336 | Germany |
| FOCUS Clinical Drug Development GmbH | Neuss | 41460 | Germany |
| Synexus Thames Valley Clinical Research Centre | Reading | Berks | RG2 0TG | United Kingdom |
| Synexus Lancashire Clinical Research Centre | Chorley | Lancashire | PR7 7NA | United Kingdom |
| Synexus Scotland Clinical Research Centre | Glasgow | G20 0SP | United Kingdom |
| Synexus, Merseyside Clinical Research Centre | Liverpool | L22 0LG | United Kingdom |
| William Harvey Research Institute, | London | EC1M 6BQ | United Kingdom |
Participants received 1 tablet per day of placebo from Days 1 to 3, which was titrated up to 2 tablets per day from Days 4 to 7, and then to 4 tablets per day (2 tablets in the morning and 2 tablets in the evening) from Week 1 to Week 12. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Varenicline | Participants received 0.5 mg per day of varenicline on Days 1 to 3, 1.0 mg per day on Days 4 to 7, and 2.0 mg per day (1.0 mg twice daily, ie, 2 x 0.5 mg tablets in the morning and 2 x 0.5 mg tablets in the evening) from Weeks 1 to 12. |
| BG001 | Placebo | Participants received 1 tablet per day of placebo from Days 1 to 3, which was titrated up to 2 tablets per day from Days 4 to 7, and then to 4 tablets per day (2 tablets in the morning and 2 tablets in the evening) from Week 1 to Week 12. |
| 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 | number of participants |
| |||||||||||||||||||
| 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 | Continuous Abstinence Rate (CAR) From Week 9 Through Week 12 | The percentage of participants who, from Week 9 through Week 12, reported no smoking and no use of other nicotine-containing products since the last study visit/last contact (on the Nicotine Use Inventory) and who did not have carbon monoxide (CO)> 10ppm at any visits during this time frame. | The Full Analysis Set (FAS) included all participants as the primary participant population for efficacy analyses in this study and was defined as all participants who had received ≥1 dose, including partial doses, of randomized study drug. | Posted | Number | Percentage of participants | Week 9 through Week 12 |
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| Secondary | CAR From Week 9 Through Week 52 | The percentage of participants who, from Week 9 through Week 52, reported no smoking (Weeks 9 through 52) and no use of other nicotine-containing products (Weeks 9 through 12), or no use of other tobacco products (Weeks 13 through 52), since the last study visit/last contact (on the Nicotine Use Inventory) and who did not have CO >10 ppm at any of these visits during this time frame. | The FAS included all participants as the primary participant population for efficacy analyses in this study and was defined as all participants who had received ≥1 dose, including partial doses, of randomized study drug. | Posted | Number | Percentage of participants | Week 9 through Week 52 |
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| Secondary | CAR From Week 9 Through Week 24 | The percentage of participants who, from Week 9 through Week 24, reported no smoking (Weeks 9 through 24) and no use of other nicotine-containing products (Weeks 9 through 12), or no use of other tobacco products (Weeks 13 through 24), since the last study visit/last contact (on the Nicotine Use Inventory) and who did not have CO >10 ppm at any of these visits during this time frame. | The FAS included all participants as the primary participant population for efficacy analyses in this study and was defined as all participants who had received ≥1 dose, including partial doses, of randomized study drug. | Posted | Number | Percentage of participants | Week 9 through Week 24 |
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| Secondary | 7-day Point Prevalence (PP) of Abstinence at Weeks 12, 24, and 52 | The secondary endpoint of 7-day point prevalence of smoking cessation was determined by evaluating a participant's cigarette smoking status, and other nicotine (and/or other tobacco) use, based on the "last 7 days" questions in the Nicotine Use Inventory. Additionally, a participant was not considered a responder if the expired CO was >10 ppm at the time point being summarized. Participants were considered responders independently at each visit. | The FAS included all participants as the primary participant population for efficacy analyses in this study and was defined as all participants who had received ≥1 dose, including partial doses, of randomized study drug. | Posted | Number | Percentage of participants | Weeks 12, 24 and 52 |
|
2 years
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 | Participants received 0.5 mg per day of varenicline on Days 1 to 3, 1.0 mg per day on Days 4 to 7, and 2.0 mg per day (1.0 mg twice daily, ie, 2 x 0.5 mg tablets in the morning and 2 x 0.5 mg tablets in the evening) from Weeks 1 to 12. | 7 | 249 | 145 | 249 | ||
| EG001 | Placebo | Participants received 1 tablet per day of placebo from Days 1 to 3, which was titrated up to 2 tablets per day from Days 4 to 7, and then to 4 tablets per day (2 tablets in the morning and 2 tablets in the evening) from Week 1 to Week 12. | 4 | 245 | 70 | 245 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute coronary syndrome | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Allergy to chemicals | Immune system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Knee arthroplasty | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Abnormal dreams | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
One SAE, exposure via semen, was not included under the Adverse Events since this event was considered to be experienced by a non-study participant, who was the study participant's partner. This event was coded as nonserious in the safety database.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@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 |
|---|---|
|
| 45-64 years |
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| >= 65 years |
|
| Male |
|
| No |
| Superiority or Other |
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