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A Study To Evaluate The Efficacy And Safety Of Varenicline Compared To Placebo For Smoking Cessation Through Reduction

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ClinicalTrials.gov Identifier: NCT01370356
Recruitment Status : Completed
First Posted : June 9, 2011
Results First Posted : September 1, 2014
Last Update Posted : September 1, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Health Services Research
Condition Smoking Cessation
Interventions Drug: Varenicline Tartrate
Drug: Placebo
Enrollment 1510
Recruitment Details A total of 1747 participants were screened, whereof 1510 were randomized into the study, and of whom 1493 took at least 1 dose of study drug. Overall, 61 centers in 10 countries received study drug: Australia (4), Canada (6), Czech Republic (6), Germany (6), Egypt (3), United Kingdom (7), Japan (6), Mexico (4), Taiwan (7), and USA (12).
Pre-assignment Details  
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description Varenicline was titrated to the full dose during the first week (Day 1 - 3: 0.5 mg/day; Day 4 -7: 0.5 mg twice daily [BID]). From Week 2 to Week 24, the dose was 1 mg BID. Participants who had difficulties with tolerability were permitted to have the dose lowered temporarily or permanently to 0.5 mg BID. Data below are presented for the treated population. Placebo was titrated and administered in the same manner as varenicline and reduction of dosing for difficulties with tolerability was also allowed. Data below are presented for the treated population.
Period Title: Overall Study
Started 751 742
Completed 559 515
Not Completed 192 227
Reason Not Completed
Death             1             0
Lack of Efficacy             6             28
Lost to Follow-up             76             81
Withdrawal by Subject             54             59
Reason not specified             39             43
Protocol Violation             3             3
Adverse event (AE) Related to Study Drug             12             9
AE Not Related to Study Drug             1             4
Arm/Group Title Varenicline Placebo Total
Hide Arm/Group Description Varenicline was titrated to the full dose during the first week (Day 1 - 3: 0.5 mg/day; Day 4 -7: 0.5 mg BID). From Week 2 to Week 24, the dose was 1 mg BID. Participants who had difficulties with tolerability were permitted to have the dose lowered temporarily or permanently to 0.5 mg BID. One participant was assigned to varenicline as a male but is in fact female. Data below are presented for the treated population. Placebo was titrated and administered in the same manner as varenicline and reduction of dosing for difficulties with tolerability was also allowed. Data below are presented for the treated population. Total of all reporting groups
Overall Number of Baseline Participants 751 742 1493
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 751 participants 742 participants 1493 participants
44.7  (11.8) 44.4  (12.0) 44.6  (11.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 751 participants 742 participants 1493 participants
Female
330
  43.9%
321
  43.3%
651
  43.6%
Male
421
  56.1%
421
  56.7%
842
  56.4%
1.Primary Outcome
Title Percentage of Participants With Carbon Monoxide (CO) Confirmed 10-Week Continuous Abstinence (CA) From Smoking
Hide Description Percentage of participants who remained abstinent from Week 15 to Week 24, inclusive, reporting no smoking and no use of nicotine-containing products since the last study visit or contact on the Nicotine Use Inventory (NUI) and confirmed by expired CO < 10 ppm at any time point (CO measurements conducted at the clinic visits) during Weeks 15 through 24, inclusive. Missing CO was imputed as negative (CO ≤ 10 ppm).
Time Frame Week 15 - 24
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set was referred to as the Intent-to-Treat (ITT) population and was defined as all randomized participants. The ITT population was the primary analysis set for the efficacy analyses in this study.
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:
Varenicline was titrated to the full dose during the first week (Day 1 - 3: 0.5 mg/day; Day 4 -7: 0.5 mg BID). From Week 2 to Week 24, the dose was 1 mg BID. Participants who had difficulties with tolerability were permitted to have the dose lowered temporarily or permanently to 0.5 mg BID.
Placebo was titrated and administered in the same manner as varenicline and reduction of dosing for difficulties with tolerability was also allowed.
Overall Number of Participants Analyzed 760 750
Measure Type: Number
Unit of Measure: percentage of participants
32.1 6.9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Varenicline, Placebo
Comments Assuming true CA rate of 6.9% for placebo and 17.2% for varenicline (odds ratio ≥ 2.8), a study randomizing 1404 participants (1:1 ratio) has ≥90% power to detect a difference between the two groups. Analysis was done using a logistic regression model; treatment effect as explanatory variable and investigative center as covariate. The interaction effect was tested using an expanded logistic regression model including treatment-by-center interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Statistical test was 2-sided and a 0.05 level of significance was used. A fixed-sequence procedure was used to adjust for multiplicity. Hierarchy of comparisons: 1) 10-week CA for Weeks 15 - 24, 2) CA for Weeks 21 - 24, 3) CA for Weeks 21 - 52.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 8.74
Confidence Interval (2-Sided) 95%
6.09 to 12.53
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With CO Confirmed 4-Week CA From Smoking
Hide Description Percentage of participants who remained abstinent from Week 21 to Week 24, inclusive, reporting no smoking and no use of nicotine-containing products since the last study visit or contact on the NUI and confirmed by expired CO < 10 ppm at any time point (CO measurements conducted at the clinic visits) during Weeks 21 through 24, inclusive. Missing CO was imputed as negative (CO ≤ 10 ppm).
Time Frame Week 21 - 24
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set was referred to as the ITT population and was defined as all randomized participants. The ITT population was the primary analysis set for the efficacy analyses in this study.
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:
Varenicline was titrated to the full dose during the first week (Day 1 - 3: 0.5 mg/day; Day 4 -7: 0.5 mg BID). From Week 2 to Week 24, the dose was 1 mg BID. Participants who had difficulties with tolerability were permitted to have the dose lowered temporarily or permanently to 0.5 mg BID.
Placebo was titrated and administered in the same manner as varenicline and reduction of dosing for difficulties with tolerability was also allowed.
Overall Number of Participants Analyzed 760 750
Measure Type: Number
Unit of Measure: percentage of participants
37.8 12.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Varenicline, Placebo
Comments Analysis was done using a logistic regression model including treatment effect as the explanatory variable and investigative center as covariate. In addition, the interaction effect was tested using an expanded logistic regression model including the treatment-by-center interaction. However, the inferences reported were based on the logistic regression model including only the main effects of treatment and center, regardless of the significance of the treatment by center interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Statistical test was 2-sided and a 0.05 level of significance was used. A fixed-sequence procedure was used to adjust for multiplicity. Hierarchy of comparisons: 1) 10-week CA for Weeks 15 - 24, 2) CA for Weeks 21 - 24, 3) CA for Weeks 21 - 52.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 5.66
Confidence Interval (2-Sided) 95%
4.21 to 7.61
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With CO Confirmed Long Term CA From Smoking
Hide Description Percentage of participants who remained abstinent from Week 21 to Week 52, inclusive, reporting no smoking and no use of nicotine-containing products since the last study visit or contact on the NUI and confirmed by expired CO < 10 ppm at any time point (CO measurements conducted at the clinic visits) during Weeks 21 through 52, inclusive. Missing CO was imputed as negative (CO ≤ 10 ppm).
Time Frame Weeks 21 - 52
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set was referred to as the ITT population and was defined as all randomized participants. The ITT population was the primary analysis set for the efficacy analyses in this study.
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:
Varenicline was titrated to the full dose during the first week (Day 1 - 3: 0.5 mg/day; Day 4 -7: 0.5 mg BID). From Week 2 to Week 24, the dose was 1 mg BID. Participants who had difficulties with tolerability were permitted to have the dose lowered temporarily or permanently to 0.5 mg BID.
Placebo was titrated and administered in the same manner as varenicline and reduction of dosing for difficulties with tolerability was also allowed.
Overall Number of Participants Analyzed 760 750
Measure Type: Number
Unit of Measure: percentage of participants
27.0 9.9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Varenicline, Placebo
Comments Analysis was done using a logistic regression model including treatment effect as the explanatory variable and investigative center as covariate. In addition, the interaction effect was tested using an expanded logistic regression model including the treatment-by-center interaction. However, the inferences reported were based on the logistic regression model including only the main effects of treatment and center, regardless of the significance of the treatment by center interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Statistical test was 2-sided and a 0.05 level of significance was used. A fixed-sequence procedure was used to adjust for multiplicity. Hierarchy of comparisons: 1) 10-week CA for Weeks 15 - 24, 2) CA for Weeks 21 - 24, 3) CA for Weeks 21 - 52.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.02
Confidence Interval (2-Sided) 95%
2.94 to 5.50
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants With 7-Day Point Prevalence of Smoking Cessation
Hide Description The 7-day point prevalence of abstinence was defined as being abstinent from smoking and using tobacco products during the last 7 days at Week 12, 24, and 52. The participant's smoking status and other nicotine use was evaluated based on the "last 7 days" questions on the NUI and confirmed by CO expiration. Responders were defined as those, who answered "no" to both questions ("Has the subject smoked any cigarettes (even a puff) in the last 7 days?"; and "Has the subject used any nicotine products and/or other tobacco.... in the last 7 days?") and whose expired CO < 10 ppm. Missing CO was imputed as negative (CO ≤ 10 ppm).
Time Frame Week 12, 24, and 52
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set was referred to as the ITT population and was defined as all randomized participants. The ITT population was the primary analysis set for the efficacy analyses in this study.
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:
Varenicline was titrated to the full dose during the first week (Day 1 - 3: 0.5 mg/day; Day 4 -7: 0.5 mg BID). From Week 2 to Week 24, the dose was 1 mg BID. Participants who had difficulties with tolerability were permitted to have the dose lowered temporarily or permanently to 0.5 mg BID.
Placebo was titrated and administered in the same manner as varenicline and reduction of dosing for difficulties with tolerability was also allowed.
Overall Number of Participants Analyzed 760 750
Measure Type: Number
Unit of Measure: percentage of participants
Week 12 31.2 6.7
Week 24 43.2 17.5
Week 52 34.1 18.3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Varenicline, Placebo
Comments Statistical analysis presented above is for Week 12. Analysis was done using logistic regression model with treatment effect as the explanatory variable and investigative center as covariate. The interaction effect was tested using an expanded logistic regression model with treatment-by-center interaction. The inferences reported were based on the logistic regression model including only the main effects of treatment and center, regardless of the significance of treatment by center interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Statistical test was 2-sided and a 0.05 level of significance was used.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 8.69
Confidence Interval (2-Sided) 95%
6.03 to 12.51
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Varenicline, Placebo
Comments Statistical analysis presented above is for Week 24. Analysis was done using logistic regression model with treatment effect as the explanatory variable and investigative center as covariate. The interaction effect was tested using an expanded logistic regression model with treatment-by-center interaction. The inferences reported were based on the logistic regression model including only the main effects of treatment and center, regardless of the significance of treatment by center interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Statistical test was 2-sided and a 0.05 level of significance was used.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.58
Confidence Interval (2-Sided) 95%
3.51 to 5.98
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Varenicline, Placebo
Comments Statistical analysis presented above is for Week 52. Analysis was done using logistic regression model with treatment effect as the explanatory variable and investigative center as covariate. The interaction effect was tested using an expanded logistic regression model with treatment-by-center interaction. The inferences reported were based on the logistic regression model including only the main effects of treatment and center, regardless of the significance of treatment by center interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Statistical test was 2-sided and a 0.05 level of significance was used.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.66
Confidence Interval (2-Sided) 95%
2.05 to 3.44
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants With 4-Week Point Prevalence of Smoking Cessation
Hide Description The 4-week point prevalence of abstinence was defined as being abstinent from smoking and using tobacco products during the last 4 weeks of the study. The participant's smoking status and other nicotine use was evaluated based on the "last 4 weeks" questions on the NUI and confirmed by CO expiration. Responders were defined as those, who answered "no" to both questions ("Has the subject smoked any cigarettes (even a puff) in the last 4 weeks?"; and "Has the subject used any nicotine products and/or other tobacco.... in the last 4 weeks?") and whose expired CO < 10 ppm. Missing CO was imputed as negative (CO ≤ 10 ppm).
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set was referred to as the ITT population and was defined as all randomized participants. The ITT population was the primary analysis set for the efficacy analyses in this study.
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:
Varenicline was titrated to the full dose during the first week (Day 1 - 3: 0.5 mg/day; Day 4 -7: 0.5 mg BID). From Week 2 to Week 24, the dose was 1 mg BID. Participants who had difficulties with tolerability were permitted to have the dose lowered temporarily or permanently to 0.5 mg BID.
Placebo was titrated and administered in the same manner as varenicline and reduction of dosing for difficulties with tolerability was also allowed.
Overall Number of Participants Analyzed 760 750
Measure Type: Number
Unit of Measure: percentage of participants
32.8 17.3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Varenicline, Placebo
Comments Analysis was done using a logistic regression model including treatment effect as the explanatory variable and investigative center as covariate. In addition, the interaction effect was tested using an expanded logistic regression model including the treatment-by-center interaction. However, the inferences reported were based on the logistic regression model including only the main effects of treatment and center, regardless of the significance of the treatment by center interaction.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Statistical test was 2-sided and a 0.05 level of significance was used.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.67
Confidence Interval (2-Sided) 95%
2.05 to 3.47
Estimation Comments [Not Specified]
Time Frame All AEs (serious and nonserious) were recorded from the date of first dose of study drug (Baseline) up to 30 days after the date of last dose of study drug.
Adverse Event Reporting 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.
 
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description Varenicline was titrated to the full dose during the first week (Day 1 - 3: 0.5 mg/day; Day 4 -7: 0.5 mg BID). From Week 2 to Week 24, the dose was 1 mg BID. Participants who had difficulties with tolerability were permitted to have the dose lowered temporarily or permanently to 0.5 mg BID. Placebo was titrated and administered in the same manner as varenicline and reduction of dosing for difficulties with tolerability was also allowed.
All-Cause Mortality
Varenicline Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Varenicline Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   28/751 (3.73%)   16/742 (2.16%) 
Blood and lymphatic system disorders     
Thrombocytopenia * 1  1/751 (0.13%)  0/742 (0.00%) 
Cardiac disorders     
Angina pectoris * 1  1/751 (0.13%)  0/742 (0.00%) 
Myocardial infarction * 1  0/751 (0.00%)  2/742 (0.27%) 
Supraventricular tachycardia * 1  1/751 (0.13%)  0/742 (0.00%) 
Ear and labyrinth disorders     
Vertigo * 1  0/751 (0.00%)  1/742 (0.13%) 
Gastrointestinal disorders     
Gastritis * 1  1/751 (0.13%)  0/742 (0.00%) 
Ileus * 1  0/751 (0.00%)  1/742 (0.13%) 
Pancreatic cyst * 1  1/751 (0.13%)  0/742 (0.00%) 
Vomiting * 1  0/751 (0.00%)  1/742 (0.13%) 
General disorders     
Chest pain * 1  1/751 (0.13%)  1/742 (0.13%) 
Death * 1  1/751 (0.13%)  0/742 (0.00%) 
Infections and infestations     
Acute tonsillitis * 1  1/751 (0.13%)  0/742 (0.00%) 
Cellulitis * 1  0/751 (0.00%)  1/742 (0.13%) 
Laryngitis * 1  1/751 (0.13%)  0/742 (0.00%) 
Lobar pneumonia * 1  0/751 (0.00%)  1/742 (0.13%) 
Lower respiratory tract infection * 1  1/751 (0.13%)  0/742 (0.00%) 
Peritonitis * 1  0/751 (0.00%)  1/742 (0.13%) 
Injury, poisoning and procedural complications     
Contusion * 1  0/751 (0.00%)  1/742 (0.13%) 
Foot fracture * 1  1/751 (0.13%)  0/742 (0.00%) 
Rib fracture * 1  0/751 (0.00%)  1/742 (0.13%) 
Road traffic accident * 1  0/751 (0.00%)  1/742 (0.13%) 
Thermal burn * 1  1/751 (0.13%)  0/742 (0.00%) 
Metabolism and nutrition disorders     
Diabetes mellitus inadequate control * 1  0/751 (0.00%)  1/742 (0.13%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  1/751 (0.13%)  0/742 (0.00%) 
Back pain * 1  1/751 (0.13%)  0/742 (0.00%) 
Costochondritis * 1  0/751 (0.00%)  1/742 (0.13%) 
Intervertebral disc protrusion * 1  1/751 (0.13%)  1/742 (0.13%) 
Musculoskeletal chest pain * 1  1/751 (0.13%)  0/742 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bladder transitional cell carcinoma * 1  1/751 (0.13%)  0/742 (0.00%) 
Breast cancer * 1  1/751 (0.13%)  0/742 (0.00%) 
Prostate cancer * 1  1/751 (0.13%)  0/742 (0.00%) 
Nervous system disorders     
Epilepsy * 1  1/751 (0.13%)  0/742 (0.00%) 
Intercostal neuralgia * 1  1/751 (0.13%)  0/742 (0.00%) 
Migraine * 1  1/751 (0.13%)  0/742 (0.00%) 
Presyncope * 1  1/751 (0.13%)  0/742 (0.00%) 
Ruptured cerebral aneurysm * 1  0/751 (0.00%)  1/742 (0.13%) 
Psychiatric disorders     
Alcohol abuse * 1  1/751 (0.13%)  0/742 (0.00%) 
Alcoholism * 1  0/751 (0.00%)  1/742 (0.13%) 
Delirium tremens * 1  1/751 (0.13%)  0/742 (0.00%) 
Depression suicidal * 1  1/751 (0.13%)  0/742 (0.00%) 
Intentional self-injury * 1  1/751 (0.13%)  0/742 (0.00%) 
Suicidal ideation * 1  1/751 (0.13%)  0/742 (0.00%) 
Renal and urinary disorders     
Calculus ureteric * 1  1/751 (0.13%)  0/742 (0.00%) 
Reproductive system and breast disorders     
Ovarian cyst * 1  2/751 (0.27%)  0/742 (0.00%) 
Ovarian haemorrhage * 1  0/751 (0.00%)  1/742 (0.13%) 
Respiratory, thoracic and mediastinal disorders     
Asthma * 1  1/751 (0.13%)  0/742 (0.00%) 
Pneumothorax * 1  0/751 (0.00%)  1/742 (0.13%) 
Skin and subcutaneous tissue disorders     
Diabetic foot * 1  0/751 (0.00%)  1/742 (0.13%) 
Surgical and medical procedures     
Hospitalisation * 1  1/751 (0.13%)  0/742 (0.00%) 
Vascular disorders     
Aortic aneurysm rupture * 1  1/751 (0.13%)  0/742 (0.00%) 
Hypertension * 1  1/751 (0.13%)  1/742 (0.13%) 
Hypertensive crisis * 1  1/751 (0.13%)  0/742 (0.00%) 
Peripheral arterial occlusive disease * 1  0/751 (0.00%)  1/742 (0.13%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (v16.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Varenicline Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   467/751 (62.18%)   339/742 (45.69%) 
Gastrointestinal disorders     
Constipation * 1  38/751 (5.06%)  13/742 (1.75%) 
Nausea * 1  209/751 (27.83%)  67/742 (9.03%) 
General disorders     
Fatigue * 1  46/751 (6.13%)  34/742 (4.58%) 
Irritability * 1  39/751 (5.19%)  30/742 (4.04%) 
Infections and infestations     
Nasopharyngitis * 1  98/751 (13.05%)  89/742 (11.99%) 
Investigations     
Upper respiratory tract infection * 1  63/751 (8.39%)  63/742 (8.49%) 
Nervous system disorders     
Headache * 1  62/751 (8.26%)  54/742 (7.28%) 
Psychiatric disorders     
Abnormal dreams * 1  86/751 (11.45%)  43/742 (5.80%) 
Anxiety * 1  52/751 (6.92%)  65/742 (8.76%) 
Insomnia * 1  80/751 (10.65%)  51/742 (6.87%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (v16.1)
Two cases of fetal exposure during pregnancy occurred but are not included in the SAE section as they did not meet the criteria of serious in the safety database. One of them relates to a non-study participant who was the study participant's partner.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01370356    
Other Study ID Numbers: A3051075
REDUCE TO QUIT
First Submitted: June 8, 2011
First Posted: June 9, 2011
Results First Submitted: July 2, 2014
Results First Posted: September 1, 2014
Last Update Posted: September 1, 2014