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Efficacy and Safety of Varenicline in Smokers With Cardiovascular Disease Who Wish to Quit Smoking

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00282984
Recruitment Status : Completed
First Posted : January 27, 2006
Results First Posted : April 29, 2009
Last Update Posted : April 5, 2017
Sponsor:
Information provided by:
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Smoking Cessation
Interventions Drug: placebo
Drug: Varenicline
Enrollment 714
Recruitment Details The study was conducted in outpatients. The target population was cigarette smokers with cardiovascular disease drawn from the communities surrounding the participating clinics.
Pre-assignment Details 714 smokers were randomized (ie, assigned to study treatment), 11 participants were randomized, but not treated. The reasons for participants being randomized, not treated included no longer willing to participate in the study (5 participants), protocol violation (3 participants), lost to follow-up (1 participant), and other (2 participants).
Arm/Group Title Varenicline (Var) Placebo (Pbo)
Hide Arm/Group Description 1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52. 1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
Period Title: Overall Study
Started 353 350
Completed 302 289
Not Completed 51 61
Reason Not Completed
Death             2             5
Adverse Event             8             5
Lack of Efficacy             0             2
Lost to Follow-up             14             10
Withdrawal by Participant             22             34
Participant stopped study medication             2             2
Participant only allowed phone follow-up             0             1
Participant used antipsychosis meds             0             1
lack of motivation             1             0
in prison             0             1
Protocol Violation             2             0
Arm/Group Title Varenicline (Var) Placebo (Pbo) Total
Hide Arm/Group Description 1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52. 1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52. Total of all reporting groups
Overall Number of Baseline Participants 353 350 703
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 353 participants 350 participants 703 participants
57.0  (8.6) 56.0  (8.4) 56.5  (8.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 353 participants 350 participants 703 participants
Female
87
  24.6%
63
  18.0%
150
  21.3%
Male
266
  75.4%
287
  82.0%
553
  78.7%
1.Primary Outcome
Title Number of Responders With Carbon Monoxide (CO) Confirmed 4-week Continuous Quit Rate (CQR) for Last 4 Weeks of Treatment (Trtmt)
Hide Description Participants considered Responders (4-week CQR <=10 parts per million <ppm>) through reports of cigarette or other nicotine use since last study visit, confirmed by measurement of end-expiratory exhaled carbon monoxide (CO). If any CO measurement at a particular timepoint was >10 ppm, subject was considered to be Non-Responder at that timepoint.
Time Frame weeks 9 through 12
Hide Outcome Measure Data
Hide Analysis Population Description
Primary analysis population (Modified Intent-to-Treat) included all participants who took at least 1 dose randomized study medication. Participants who discontinued study were assumed smokers from timepoint of discontinuation through end of study. Modified Intent-to-Treat population is referred to as "All Participants" population in this report.
Arm/Group Title Varenicline (Var) Placebo (Pbo)
Hide Arm/Group Description:
1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
Overall Number of Participants Analyzed 353 350
Measure Type: Number
Unit of Measure: participants
responders 167 50
non-responders 186 300
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Varenicline (Var), Placebo (Pbo)
Comments Estimates for expected & clinically meaningful var & pbo 4-week CQR for Week 9 - 12 of trtmt based on response rates & corresponding 95% OR confidence interval (CI) from A30510285 & A30510366 study results. Total n=700 randomized var or pbo 1:1 should have provided at least 99% power to detect difference in primary endpoint (endpt) between (b/w) var & pbo, assuming true 4-week CQR of 0.18 for pbo & 0.40 for var (OR of at least 3.04), and 84% power for 2 key secondary endpts.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments To preserve type I family-wise error rate of 0.05, used step-down procedure to analyze primary & 2 key secondary endpoints. Hierarchy of comparisons: 1) 4-week CQR for Weeks 9 thru 12, 2) CA at Week 52, 3) the Long Term Quit Rate (LTQR) thru Week 52.
Method Regression, Logistic
Comments Logistic regression model fitted to primary endpoint & key secondary endpoints; included main effects of trtmt group and center as independent var.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 6.05
Confidence Interval 95%
4.13 to 8.86
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Responders With Continuous Abstinence (CA) Through Week 52
Hide Description Responders: participants who remained abstinent based on 'since the last contact' question in Nicotine Use Inventory 1) "Has participant smoked any cigarettes (even a puff) since last contact?" = No AND 2) "Has participant used any other tobacco products… since last contact?" = No. Participant a non-responder if expired CO > 10 ppm.
Time Frame Week 9 through Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
All participants population
Arm/Group Title Varenicline (Var) Placebo (Pbo)
Hide Arm/Group Description:
1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
Overall Number of Participants Analyzed 353 350
Measure Type: Number
Unit of Measure: participants
responders 70 26
non-responders 283 324
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Varenicline (Var), Placebo (Pbo)
Comments Estimates for expected and clinically meaningful var & pbo 4-week CQR for Weeks 9 - 12 of trtmt were based on response rates & corresponding 95% odds ratio CI from A30510285 and A30510366 study results. Total n=700 randomized var or pbo 1:1 should have provided at least 99% power to detect difference in primary endpt b/w var & pbo, assuming true 4-week CQR of 0.18 for pbo & 0.40 for var (odds ratio of at least 3.04) & a power of 84% for the 2 key secondary endpts.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments To preserve type I family-wise error rate of 0.05, a step-down procedure was used for the analysis of primary & 2 key secondary endpts. Hierarchy of comparisons: 1) 4-week CQR for Weeks 9 through 12, 2) CA at Week 52, 3) LTQR through Week 52.
Method Regression, Logistic
Comments Logistic regression model fitted to primary endpoint & key secondary endpoints; included main effects of treatment group & center as independent var.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.19
Confidence Interval 95%
1.97 to 5.18
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Long-Term Quit Responders
Hide Description Responders: participants were considered Long Term Quit responders if 1) they were responders for the primary endpoint (the 4-week CQR for Weeks 9-12) and 2) had no more than 6 days of smoking from Week 12 through the given visit.
Time Frame Week 9 through Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
All participants population
Arm/Group Title Varenicline (Var) Placebo (Pbo)
Hide Arm/Group Description:
1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
Overall Number of Participants Analyzed 353 350
Measure Type: Number
Unit of Measure: participants
responders 80 34
non-responders 273 316
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Varenicline (Var), Placebo (Pbo)
Comments Estimates for expected and clinically meaningful varenicline (var) & pbo 4-week CQR for Weeks 9 - 12 of treatment were based on response rates & corresponding 95% odds ratio CI from A30510285 and A30510366 study results. Total n=700 randomized var or pbo 1:1 should have provided at least 99% power to detect difference in primary endpt b/w varenicline & pbo, assuming true 4-week CQR of 0.18 for pbo & 0.40 for var (odds ratio of at least 3.04), and a power of 84% for the 2 key secondary endpts.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments To preserve type I family-wise error rate of 0.05, a step-down procedure was used for the analysis of primary & 2 key secondary endpoints. Hierarchy of comparisons: 1) 4-week CQR for Weeks 9 through 12, 2) CA at Week 52, 3) the LTQR through Week 52.
Method Regression, Logistic
Comments Logistic regression model fitted to primary endpoint & key secondary endpoints; included main effects of trtmt group and center as independent var.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.82
Confidence Interval 95%
1.82 to 4.38
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 12
Hide Description Responders: abstinence in previous seven days, defined in the non-treatment follow-up as: 1) "Has the participant smoked any cigarettes in the last 7 days?" = No AND 2) "Has the participant used any other tobacco products in the last 7 days?" = No. Participant a non-responder if expired CO > 10 ppm.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All Participants population
Arm/Group Title Varenicline (Var) Placebo (Pbo)
Hide Arm/Group Description:
1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
Overall Number of Participants Analyzed 353 350
Measure Type: Number
Unit of Measure: participants
responders 192 65
non-responders 161 285
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Varenicline (Var), Placebo (Pbo)
Comments Week 12 analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 5.97
Confidence Interval 95%
4.17 to 8.56
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 24
Hide Description Responders: abstinence in previous seven days, defined in the non-treatment follow-up as: 1) "Has the participant smoked any cigarettes in the last 7 days?" = No AND 2) "Has the participant used any other tobacco products in the last 7 days?" = No. Participant a non-responder if expired CO > 10 ppm.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Varenicline (Var) Placebo (Pbo)
Hide Arm/Group Description:
1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
Overall Number of Participants Analyzed 353 350
Measure Type: Number
Unit of Measure: participants
responders 124 57
non-responders 229 293
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Varenicline (Var), Placebo (Pbo)
Comments 24 Week analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.93
Confidence Interval 95%
2.03 to 4.23
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 52
Hide Description Responders: abstinence in previous seven days, defined in the non-treatment follow-up as: 1) "Has the participant smoked any cigarettes in the last 7 days?" = No AND 2) "Has the participant used any other tobacco products in the last 7 days?" = No. Participant a non-responder if expired CO > 10 ppm.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Varenicline (Var) Placebo (Pbo)
Hide Arm/Group Description:
1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
Overall Number of Participants Analyzed 353 350
Measure Type: Number
Unit of Measure: participants
responders 102 62
non-responders 251 288
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Varenicline (Var), Placebo (Pbo)
Comments 52 Week analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.93
Confidence Interval 95%
1.34 to 2.77
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Number of Participants With a 4 Week Point Prevalence of Smoking Cessation
Hide Description Responders: participants with abstinence during the last 4 weeks of non-treatment based on answering 'no' to both of the two 'last 4 week' questions in the Nicotine Use Inventory (NUI). NUI collected information of cigarette or other nicotine use during the study.
Time Frame Week 48 through Week 52 (final 4 weeks of non-treatment period [pd])
Hide Outcome Measure Data
Hide Analysis Population Description
All Participants population
Arm/Group Title Varenicline (Var) Placebo (Pbo)
Hide Arm/Group Description:
1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
Overall Number of Participants Analyzed 353 350
Measure Type: Number
Unit of Measure: participants
99 57
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Varenicline (Var), Placebo (Pbo)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.05
Confidence Interval 95%
1.41 to 2.97
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Number of Responders With Continuous Abstinence (CA) Through Week 24
Hide Description Responders: participants who remained abstinent based on 'since the last contact' question in Nicotine Use Inventory 1) "Has participant smoked any cigarettes (even a puff) since the last contact?" = No AND 2) "Has participant used any other tobacco products… since the last contact?" = No. Non- responder if the expired CO > 10 ppm at any given timepoint.
Time Frame Week 9 through Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All Participants population
Arm/Group Title Varenicline (Var) Placebo (Pbo)
Hide Arm/Group Description:
1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
Overall Number of Participants Analyzed 353 350
Measure Type: Number
Unit of Measure: participants
100 34
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Varenicline (Var), Placebo (Pbo)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.86
Confidence Interval 95%
2.51 to 5.93
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Cigarettes Smoked Per Day
Hide Description Cigarettes smoked each day during the first 3 weeks of the treatment phase.
Time Frame Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
All Participants population
Arm/Group Title Varenicline (Var) Placebo (Pbo)
Hide Arm/Group Description:
1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
Overall Number of Participants Analyzed 353 350
Mean (Standard Deviation)
Unit of Measure: cigarettes per day
Baseline 22.2  (10.0) 22.9  (10.9)
Day 1 17.6  (9.4) 19.1  (10.0)
Day 2 16.8  (8.8) 18.4  (9.6)
Day 3 15.8  (9.2) 18.0  (10.0)
Day 4 15.7  (8.9) 17.1  (9.6)
Day 5 15.1  (8.8) 16.3  (8.9)
Day 6 14.4  (8.4) 16.0  (8.9)
Day 7 13.8  (8.6) 15.1  (8.8)
Day 8 11.7  (9.2) 12.3  (10.5)
Day 9 9.5  (7.5) 10.9  (9.5)
Day 10 8.9  (7.2) 10.6  (8.6)
Day 11 8.9  (7.3) 10.4  (8.4)
Day 12 8.7  (7.5) 10.5  (8.3)
Day 13 8.8  (7.1) 10.3  (8.2)
Day 14 9.3  (7.4) 10.7  (8.6)
Day 15 8.9  (7.6) 11.2  (9.1)
Day 16 8.8  (7.1) 11.0  (8.7)
Day 17 8.3  (6.4) 10.6  (8.2)
Day 18 8.2  (6.9) 10.3  (8.8)
Day 19 7.8  (6.7) 10.3  (8.4)
Day 20 7.9  (6.1) 10.6  (8.3)
Day 21 7.2  (6.3) 9.3  (8.1)
10.Secondary Outcome
Title Number of Long-Term Quit Responders From Week 9 Through Week 24
Hide Description Responders: participants were considered Long Term Quit Responders if 1) they were responders for the primary endpoint (the 4-week CQR for Weeks 9-12) and 2) had no more than 6 days of smoking from Week 12 through the given visit.
Time Frame Week 9 through Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All Participants population
Arm/Group Title Varenicline (Var) Placebo (Pbo)
Hide Arm/Group Description:
1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
Overall Number of Participants Analyzed 353 350
Measure Type: Number
Unit of Measure: participants
responders 117 42
non-responders 236 308
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Varenicline (Var), Placebo (Pbo)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.85
Confidence Interval 95%
2.58 to 5.75
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Varenicline (Var) Placebo (Pbo)
Hide Arm/Group Description 1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52. 1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
All-Cause Mortality
Varenicline (Var) Placebo (Pbo)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Varenicline (Var) Placebo (Pbo)
Affected / at Risk (%) Affected / at Risk (%)
Total   23   21 
Blood and lymphatic system disorders     
Anaemia † 1  0/353 (0.00%)  1/350 (0.29%) 
Cardiac disorders     
Acute coronary syndrome † 1  0/353 (0.00%)  1/350 (0.29%) 
Acute myocardial infarction † 1  2/353 (0.57%)  1/350 (0.29%) 
Angina pectoris † 1  1/353 (0.28%)  2/350 (0.57%) 
Arrhythmia † 1  1/353 (0.28%)  0/350 (0.00%) 
Atrial fibrillation † 1  1/353 (0.28%)  2/350 (0.57%) 
Cardiac failure † 1  1/353 (0.28%)  1/350 (0.29%) 
Cardiac failure congestive † 1  0/353 (0.00%)  1/350 (0.29%) 
Myocardial infarction † 1  1/353 (0.28%)  1/350 (0.29%) 
Angina unstable † 1  1/353 (0.28%)  0/350 (0.00%) 
Cardiogenic shock † 1  0/353 (0.00%)  1/350 (0.29%) 
Coronary artery disease † 1  1/353 (0.28%)  0/350 (0.00%) 
Ventricular tachycardia † 1  0/353 (0.00%)  1/350 (0.29%) 
Gastrointestinal disorders     
Gingival bleeding † 1  1/353 (0.28%)  0/350 (0.00%) 
Gingival recession † 1  1/353 (0.28%)  0/350 (0.00%) 
Inguinal hernia † 1  0/353 (0.00%)  1/350 (0.29%) 
Periodontal disease † 1  1/353 (0.28%)  0/350 (0.00%) 
Gastrointestinal haemorrhage † 1  0/353 (0.00%)  1/350 (0.29%) 
General disorders     
Chest pain † 1  2/353 (0.57%)  2/350 (0.57%) 
Infections and infestations     
Cellulitis † 1  1/353 (0.28%)  0/350 (0.00%) 
Infected cyst † 1  1/353 (0.28%)  0/350 (0.00%) 
Infected skin ulcer † 1  0/353 (0.00%)  1/350 (0.29%) 
Pneumonia † 1  0/353 (0.00%)  1/350 (0.29%) 
Injury, poisoning and procedural complications     
Road traffic accident † 1  1/353 (0.28%)  0/350 (0.00%) 
Stent occlusion † 1  0/353 (0.00%)  1/350 (0.29%) 
Tibia fracture † 1  1/353 (0.28%)  0/350 (0.00%) 
Ankle fracture † 1  0/353 (0.00%)  1/350 (0.29%) 
Metabolism and nutrition disorders     
Diabetes mellitus † 1  1/353 (0.28%)  1/350 (0.29%) 
Ketoacidosis † 1  0/353 (0.00%)  1/350 (0.29%) 
Hypovolaemia † 1  0/353 (0.00%)  1/350 (0.29%) 
Musculoskeletal and connective tissue disorders     
Back pain † 1  1/353 (0.28%)  1/350 (0.29%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Oesophageal squamous cell carcinoma † 1  0/353 (0.00%)  1/350 (0.29%) 
Nervous system disorders     
Cerebrovascular accident † 1  2/353 (0.57%)  0/350 (0.00%) 
Cervical root pain † 1  1/353 (0.28%)  0/350 (0.00%) 
Complex partial seizures † 1  1/353 (0.28%)  0/350 (0.00%) 
Syncope † 1  1/353 (0.28%)  1/350 (0.29%) 
Diabetic coma † 1  0/353 (0.00%)  1/350 (0.29%) 
Renal and urinary disorders     
Renal failure acute † 1  0/353 (0.00%)  1/350 (0.29%) 
Reproductive system and breast disorders     
Menorrhagia † 1  1/353 (0.28%)  0/350 (0.00%) 
Testicular torsion † 1  1/353 (0.28%)  0/350 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease † 1  1/353 (0.28%)  0/350 (0.00%) 
Dyspnoea † 1  1/353 (0.28%)  0/350 (0.00%) 
Skin and subcutaneous tissue disorders     
Hyperhidrosis † 1  1/353 (0.28%)  0/350 (0.00%) 
Surgical and medical procedures     
Percutaneous coronary intervention † 1  0/353 (0.00%)  1/350 (0.29%) 
Vascular disorders     
Circulatory collapse † 1  0/353 (0.00%)  1/350 (0.29%) 
Intermittent claudication † 1  0/353 (0.00%)  1/350 (0.29%) 
Thrombosis † 1  1/353 (0.28%)  0/350 (0.00%) 
Arteriosclerosis † 1  1/353 (0.28%)  0/350 (0.00%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (v11.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Varenicline (Var) Placebo (Pbo)
Affected / at Risk (%) Affected / at Risk (%)
Total   253   179 
Cardiac disorders     
Angina pectoris † 1  12/353 (3.40%)  5/350 (1.43%) 
Gastrointestinal disorders     
Abdominal distension † 1  7/353 (1.98%)  3/350 (0.86%) 
Abdominal pain upper † 1  15/353 (4.25%)  9/350 (2.57%) 
Constipation † 1  23/353 (6.52%)  7/350 (2.00%) 
Diarrhoea † 1  22/353 (6.23%)  18/350 (5.14%) 
Dry mouth † 1  13/353 (3.68%)  7/350 (2.00%) 
Dyspepsia † 1  19/353 (5.38%)  12/350 (3.43%) 
Flatulence † 1  8/353 (2.27%)  7/350 (2.00%) 
Nausea † 1  104/353 (29.46%)  30/350 (8.57%) 
Vomiting † 1  29/353 (8.22%)  4/350 (1.14%) 
General disorders     
Chest pain † 1  7/353 (1.98%)  6/350 (1.71%) 
Fatigue †  25/353 (7.08%)  14/350 (4.00%) 
Irritability †  6/353 (1.70%)  9/350 (2.57%) 
Oedema peripheral †  7/353 (1.98%)  4/350 (1.14%) 
Infections and infestations     
Influenza †  15/353 (4.25%)  17/350 (4.86%) 
Nasopharyngitis †  23/353 (6.52%)  30/350 (8.57%) 
Upper respiratory tract infection †  11/353 (3.12%)  12/350 (3.43%) 
Musculoskeletal and connective tissue disorders     
Back pain †  13/353 (3.68%)  8/350 (2.29%) 
Nervous system disorders     
Dizziness †  22/353 (6.23%)  16/350 (4.57%) 
Dysgeusia †  16/353 (4.53%)  8/350 (2.29%) 
Headache †  45/353 (12.75%)  39/350 (11.14%) 
Somnolence †  2/353 (0.57%)  7/350 (2.00%) 
Psychiatric disorders     
Abnormal dreams †  28/353 (7.93%)  6/350 (1.71%) 
Anxiety †  8/353 (2.27%)  13/350 (3.71%) 
Insomnia †  42/353 (11.90%)  23/350 (6.57%) 
Nicotine dependence †  9/353 (2.55%)  5/350 (1.43%) 
Sleep disorder †  12/353 (3.40%)  5/350 (1.43%) 
Respiratory, thoracic and mediastinal disorders     
Cough †  7/353 (1.98%)  13/350 (3.71%) 
Dyspnoea †  9/353 (2.55%)  4/350 (1.14%) 
Vascular disorders     
Hypertension †  5/353 (1.42%)  9/350 (2.57%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (v11.1)
[Not Specified]
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 <60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), <12 months (mo) from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.
Results Point of Contact
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Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.govCallCenter@pfizer.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer
ClinicalTrials.gov Identifier: NCT00282984    
Other Study ID Numbers: A3051049
First Submitted: January 26, 2006
First Posted: January 27, 2006
Results First Submitted: February 13, 2009
Results First Posted: April 29, 2009
Last Update Posted: April 5, 2017