Ignite Creation Date:
2025-12-24 @ 11:51 AM
Ignite Modification Date:
2025-12-28 @ 1:18 PM
Study NCT ID:
NCT01244061
Status:
COMPLETED
Last Update Posted:
2014-06-09
First Post:
2010-11-17
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Multi-National Study To Assess How Effective And Safe The Smoking Cessation Medicine Varenicline Is In Smokers Who Have Already Tried Varenicline In The Past As A Prescription Medicine From Their Usual Healthcare Provider
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068580', 'term': 'Varenicline'}], 'ancestors': [{'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011810', 'term': 'Quinoxalines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': '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.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': "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."}}, 'adverseEventsModule': {'timeFrame': '2 years', 'description': '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.', 'eventGroups': [{'id': 'EG000', 'title': 'Varenicline', 'description': '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.', 'otherNumAtRisk': 249, 'otherNumAffected': 145, 'seriousNumAtRisk': 249, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Placebo', 'description': '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.', 'otherNumAtRisk': 245, 'otherNumAffected': 70, 'seriousNumAtRisk': 245, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 245, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 245, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 87, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 245, 'numEvents': 24, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 245, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 245, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 21, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 245, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 34, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 245, 'numEvents': 32, 'numAffected': 24}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Abnormal dreams', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 39, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 245, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 19, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 245, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Sleep disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 17, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 245, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'seriousEvents': [{'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 245, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 245, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Allergy to chemicals', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 245, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 245, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 245, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 245, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Ligament rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 245, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 245, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hyperventilation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 245, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Knee arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 245, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Continuous Abstinence Rate (CAR) From Week 9 Through Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '245', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Varenicline', 'description': '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.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '45.0', 'groupId': 'OG000'}, {'value': '11.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.08', 'ciLowerLimit': '4.34', 'ciUpperLimit': '11.55', 'pValueComment': 'The statistical significance was declared for each hypothesis firstly for CAR Weeks 9-12, and then secondly for CAR Weeks 9-52 until a p-value \\> 0.05 was obtained, at which point the hypothesis would be declared to be not statistically significant.', 'groupDescription': 'The study was conducted on a sample size to achieve at least 90% power for the treatment comparison in the primary efficacy endpoint assuming an odds ratio of 3.36 with a placebo abstinence rate of 12% and varenicline abstinence rate of 31%. The intent of the primary efficacy analysis was to evaluate the hypothesis that varenicline is superior to placebo for smoking cessation after 12 weeks of treatment.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The analysis model included main effect of treatment and pooled center.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 9 through Week 12', 'description': '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.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'CAR From Week 9 Through Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '245', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Varenicline', 'description': '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.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.1', 'groupId': 'OG000'}, {'value': '3.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.00', 'ciLowerLimit': '3.97', 'ciUpperLimit': '20.41', 'pValueComment': 'Statistical significance was declared for each hypothesis in the order above until a p-value \\>0.05 was obtained, at which point the hypothesis was declared to be not statistically significant.', 'groupDescription': 'The sample size was sufficient to achieve 80% power for the treatment comparison in the key secondary end point for an odds ratio of 2.55 with a placebo abstinence rate of 6% and varenicline abstinence rate of 14%. The intent of the key secondary efficacy analysis was to evaluate the hypothesis that varenicline is superior to placebo for smoking cessation from Week 9 to the end of non-treatment follow up period at Week 52.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The analysis model included main effect of treatment and pooled center.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 9 through Week 52', 'description': '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.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'CAR From Week 9 Through Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '245', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Varenicline', 'description': '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.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.9', 'groupId': 'OG000'}, {'value': '7.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.83', 'ciLowerLimit': '3.25', 'ciUpperLimit': '10.44', 'pValueComment': 'The statistical test was two-sided and at a 0.05 level of significance. No adjustment was made for the analysis of multiple secondary endpoints.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The analysis model included main effect of treatment and pooled center.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 9 through Week 24', 'description': '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.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': '7-day Point Prevalence (PP) of Abstinence at Weeks 12, 24, and 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '245', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Varenicline', 'description': '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.'}, {'id': 'OG001', 'title': 'Placebo', 'description': '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.'}], 'classes': [{'title': 'Week 12', 'categories': [{'measurements': [{'value': '53.0', 'groupId': 'OG000'}, {'value': '14.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '32.9', 'groupId': 'OG000'}, {'value': '15.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '28.9', 'groupId': 'OG000'}, {'value': '12.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.85', 'ciLowerLimit': '4.92', 'ciUpperLimit': '12.51', 'pValueComment': 'The statistical test was two-sided and at a 0.05 level of significance. No adjustment was made for the analysis of multiple secondary endpoints.', 'groupDescription': 'Week 12 assessment', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The analysis model included main effect of treatment and pooled center.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.94', 'ciLowerLimit': '1.86', 'ciUpperLimit': '4.64', 'pValueComment': 'The statistical test was two-sided and at a 0.05 level of significance. No adjustment was made for the analysis of multiple secondary endpoints.', 'groupDescription': 'Week 24 assessment', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The analysis model included main effect of treatment and pooled center.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.06', 'ciLowerLimit': '1.88', 'ciUpperLimit': '4.97', 'pValueComment': 'The statistical test was two-sided and at a 0.05 level of significance. No adjustment was made for the analysis of multiple secondary endpoints.', 'groupDescription': 'Week 52 assessment', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The analysis model included main effect of treatment and pooled center.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 12, 24 and 52', 'description': '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.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Varenicline', 'description': '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.'}, {'id': 'FG001', 'title': 'Placebo', 'description': '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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '251'}, {'groupId': 'FG001', 'numSubjects': '247'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '169'}, {'groupId': 'FG001', 'numSubjects': '144'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}, {'groupId': 'FG001', 'numSubjects': '103'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Did not meet entrance criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Randomized but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'BG000'}, {'value': '245', 'groupId': 'BG001'}, {'value': '494', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Varenicline', 'description': '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.'}, {'id': 'BG001', 'title': 'Placebo', 'description': '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.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '< 18 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': '18-44 years', 'categories': [{'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '188', 'groupId': 'BG002'}]}]}, {'title': '45-64 years', 'categories': [{'measurements': [{'value': '135', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '274', 'groupId': 'BG002'}]}]}, {'title': '>= 65 years', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'number of participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '125', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '249', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '124', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '245', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 498}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-20', 'studyFirstSubmitDate': '2010-11-17', 'resultsFirstSubmitDate': '2013-10-30', 'studyFirstSubmitQcDate': '2010-11-18', 'lastUpdatePostDateStruct': {'date': '2014-06-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-05-20', 'studyFirstPostDateStruct': {'date': '2010-11-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-06-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Continuous Abstinence Rate (CAR) From Week 9 Through Week 12', 'timeFrame': 'Week 9 through Week 12', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'CAR From Week 9 Through Week 52', 'timeFrame': 'Week 9 through Week 52', 'description': '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.'}, {'measure': 'CAR From Week 9 Through Week 24', 'timeFrame': 'Week 9 through Week 24', 'description': '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.'}, {'measure': '7-day Point Prevalence (PP) of Abstinence at Weeks 12, 24, and 52', 'timeFrame': 'Weeks 12, 24 and 52', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Smoking Cessation']}, 'referencesModule': {'references': [{'pmid': '37142273', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '24911368', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3051139&StudyName=A%20Multi-National%20Study%20To%20Assess%20How%20Effective%20And%20Safe%20The%20Smoking%20Cessation%20Medicine%20Varenicline%20Is%20In%20Smokers%20Who%20Have%20Already%20Trie', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Smokers aged 18 years or above and wanting to stop smoking\n* Smokers who have smoked an average of at least 10 cigarettes per day over the last 4 weeks\n* Smokers who have tried before to stop smoking at least once with varenicline, and who took varenicline for at least 2 weeks\n* The last attempt to stop smoking must be at least 3 months before entering the study\n\nExclusion Criteria:\n\n* Individuals who have not tolerated varenicline well previously, or who have a current or prior medical or psychiatric history that would make entry into the trial inadvisable\n* Individuals who have previously participated in clinical trials of varenicline\n* Individuals who have been participating in another smoking cessation trial within the last 3 months, or other drug trial within the last 30 days'}, 'identificationModule': {'nctId': 'NCT01244061', 'briefTitle': 'A Multi-National Study To Assess How Effective And Safe The Smoking Cessation Medicine Varenicline Is In Smokers Who Have Already Tried Varenicline In The Past As A Prescription Medicine From Their Usual Healthcare Provider', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 4 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating The Efficacy And Safety Of Re-Treatment With Varenicline In Subjects Who Are Currently Smoking, And Who Have Previously Taken Varenicline', 'orgStudyIdInfo': {'id': 'A3051139'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Varenicline', 'interventionNames': ['Drug: Varenicline']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: 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