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Drug Use Investigation Of Varenicline (Regulatory Post Marketing Commitment Plan)

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: NCT00772941
Recruitment Status : Completed
First Posted : October 15, 2008
Results First Posted : January 24, 2014
Last Update Posted : February 28, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Condition Smoking Cessation
Intervention Drug: Varenicline
Enrollment 3939
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Varenicline
Hide Arm/Group Description Participants taking Varenicline according to Japanese Package Insert.
Period Title: Overall Study
Started 3939
Completed 3257
Not Completed 682
Reason Not Completed
CRFs not available             195
Study not completed             16
Missed Visits             374
Poor Compliance             7
GPSP Violation             90
Arm/Group Title Varenicline
Hide Arm/Group Description Participants taking Varenicline according to Japanese Package Insert.
Overall Number of Baseline Participants 3257
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3257 participants
<65 years 2768
>=65 years 489
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3257 participants
Female
1078
  33.1%
Male
2179
  66.9%
1.Primary Outcome
Title Risk Factors for the Frequency of Treatment Related Adverse Events – Gender.
Hide Description Number of participants with Treatment Related Adverse Events of Varenicline to determine whether gender is a significant risk factor.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.
Arm/Group Title Male Female
Hide Arm/Group Description:
Male participants taking Varenicline according to Japanese Package Insert.
Female participants taking Varenicline according to Japanese Package Insert.
Overall Number of Participants Analyzed 2179 1078
Measure Type: Number
Unit of Measure: participants
377 336
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Male, Female
Comments The risk factor tested was "Gender". The null hypothesis is that there is no difference between "Male and Female" in the frequency of Treatment Related Adverse Events.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
2.Primary Outcome
Title Risk Factors for the Frequency of Treatment Related Adverse Events – Age.
Hide Description Number of participants with Treatment Related Adverse Events of Varenicline to determine whether age is a significant risk factor.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.
Arm/Group Title <65 Years >=65 Years
Hide Arm/Group Description:
Participants with <65 years taking Varenicline according to Japanese Package Insert.
Participants with >=65 years taking Varenicline according to Japanese Package Insert.
Overall Number of Participants Analyzed 2768 489
Measure Type: Number
Unit of Measure: participants
571 142
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection <65 Years, >=65 Years
Comments The risk factor tested was "Age". The null hypothesis is that there is no difference between "<65 years and >=65 years" in the frequency of Treatment Related Adverse Events.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
3.Primary Outcome
Title Risk Factors for the Frequency of Treatment Related Adverse Events - Chronic Obstructive Pulmonary Disease as a Complication.
Hide Description Number of participants with Treatment Related Adverse Events of Varenicline to determine whether Chronic obstructive pulmonary disease as a complication is a significant risk factor.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.
Arm/Group Title Varenicline - With Chronic Obstructive Pulmonary Disease Varenicline - Without Chronic Obstructive Pulmonary Disease
Hide Arm/Group Description:
Participants with chronic obstructive pulmonary disease as a complication taking Varenicline according to Japanese Package Insert.
Participants without chronic obstructive pulmonary disease as a complication taking Varenicline according to Japanese Package Insert.
Overall Number of Participants Analyzed 46 3211
Measure Type: Number
Unit of Measure: participants
23 690
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Varenicline - With Chronic Obstructive Pulmonary Disease, Varenicline - Without Chronic Obstructive Pulmonary Disease
Comments The risk factor tested was "Chronic obstructive pulmonary disease as a complication". The null hypothesis is that there is no difference between "Varenicline with and without Chronic obstructive pulmonary disease as a complication" in the frequency of Treatment Related Adverse Events.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
4.Primary Outcome
Title Risk Factors for the Frequency of Treatment Related Adverse Events – Concomitant Drugs.
Hide Description Number of participants with Treatment Related Adverse Events of Varenicline to determine whether taking concomitant drugs is a significant risk factor.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.
Arm/Group Title Varenicline - With Concomitant Drugs Varenicline - Without Concomitant Drugs
Hide Arm/Group Description:
Participants taking concomitant drugs while taking Varenicline according to Japanese Package Insert.
Participants taking no concomitant drugs while taking Varenicline according to Japanese Package Insert.
Overall Number of Participants Analyzed 738 2519
Measure Type: Number
Unit of Measure: participants
289 424
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Varenicline - With Concomitant Drugs, Varenicline - Without Concomitant Drugs
Comments The risk factor tested was "concomitant drugs". The null hypothesis is that there is no difference between "Varenicline with and without concomitant drugs" in the frequency of Treatment Related Adverse Events.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
5.Primary Outcome
Title Risk Factors for the Frequency of Treatment Related Adverse Events – Concomitant Therapies.
Hide Description Number of participants with Treatment Related Adverse Events of Varenicline to determine whether receiving concomitant therapies is a significant risk factor.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.
Arm/Group Title Varenicline - With Concomitant Therapies Varenicline - Without Concomitant Therapies
Hide Arm/Group Description:
Participants receiving concomitant therapies while taking Varenicline according to Japanese Package Insert.
Participants receiving no concomitant therapies while taking Varenicline according to Japanese Package Insert.
Overall Number of Participants Analyzed 101 3156
Measure Type: Number
Unit of Measure: participants
45 668
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Varenicline - With Concomitant Therapies, Varenicline - Without Concomitant Therapies
Comments The risk factor tested was "concomitant therapies". The null hypothesis is that there is no difference between "Varenicline with and without concomitant therapies" in the frequency of Treatment Related Adverse Events.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
6.Primary Outcome
Title Risk Factors for the Frequency of Treatment Related Adverse Events - Weight at Baseline.
Hide Description Number of participants with Treatment Related Adverse Events to determine whether weight at baseline is a significant risk factor.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed. The number of participants who provided weight data at baseline was 1700.
Arm/Group Title <40 kg at Baseline >=40 kg and <50 kg at Baseline >=50 kg and <60 kg at Baseline >=60 kg and <70 kg at Baseline >=70 kg and <80 kg at Baseline >= 80 kg at Baseline
Hide Arm/Group Description:
Participants whose weights at baseline were less than 40 kg.
Participants whose weights at baseline were more than or equal to 40 kg and less than 50 kg.
Participants whose weights at baseline were more than or equal to 50 kg and less than 60 kg.
Participants whose weights at baseline were more than or equal to 60 kg and less than 70 kg.
Participants whose weights at baseline were more than or equal to 70 kg and less than 80 kg.
Participants whose weights at baseline were more than or equal to 80 kg.
Overall Number of Participants Analyzed 13 215 453 497 342 180
Measure Type: Number
Unit of Measure: participants
6 98 135 110 61 31
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection <40 kg at Baseline, >=40 kg and <50 kg at Baseline, >=50 kg and <60 kg at Baseline, >=60 kg and <70 kg at Baseline, >=70 kg and <80 kg at Baseline, >= 80 kg at Baseline
Comments The risk factor tested was "Weight at Baseline". The null hypothesis is that there is no association between "Weight at Baseline and the frequency of Treatment Related Adverse Events".
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection <40 kg at Baseline, >=40 kg and <50 kg at Baseline, >=50 kg and <60 kg at Baseline, >=60 kg and <70 kg at Baseline, >=70 kg and <80 kg at Baseline, >= 80 kg at Baseline
Comments The risk factor tested was "Weight at Baseline". The null hypothesis is that there is no linear trend in the frequency of Treatment Related Adverse Events across increasing levels of Weight at Baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Armitage
Comments [Not Specified]
7.Primary Outcome
Title Risk Factors for the Proportion of Responders - Tobacco Consumption Per Day.
Hide Description The primary analysis item was "the number of participants succeeding with continuous smoking cessation for the previous 4 weeks/the number of participants for efficacy evaluation excluding drop-out participants.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis population basically consists of the evaluable participants in accordance with the separately prepared analysis plan (participants judged to have been evaluated appropriately). The number of participants who provided data on daily tobacco consumption was 2827.
Arm/Group Title <=20 Cigarettes Per Day >=21 and <=40 Cigarettes Per Day >=41 Cigarettes Per Day
Hide Arm/Group Description:
Participants with <=20 cigarettes per day during treatment with Varenicline according to Japanese Package Insert.
Participants with >=21 and <=40 cigarettes per day during treatment with Varenicline according to Japanese Package Insert.
Participants with >=41 cigarettes per day during treatment with Varenicline according to Japanese Package Insert.
Overall Number of Participants Analyzed 1637 1082 108
Measure Type: Number
Unit of Measure: participants
1299 817 66
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection <=20 Cigarettes Per Day, >=21 and <=40 Cigarettes Per Day, >=41 Cigarettes Per Day
Comments The risk factor tested was "Tobacco consumption per day". The null hypothesis is that there is no association between "Tobacco consumption per day and the efficacy of Varenicline".
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection <=20 Cigarettes Per Day, >=21 and <=40 Cigarettes Per Day, >=41 Cigarettes Per Day
Comments The risk factor tested was "Tobacco consumption per day". The null hypothesis is that there is no linear trend in the efficacy of Varenicline across increasing levels of tobacco consumption per day.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Armitage
Comments [Not Specified]
8.Primary Outcome
Title Risk Factors for the Proportion of Responders – Prolonged Administration After 12 Weeks.
Hide Description The primary analysis item was "the number of participants succeeding with continuous smoking cessation for the previous 4 weeks/the number of participants for efficacy evaluation excluding drop-out participants.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis population basically consists of the evaluable participants in accordance with the separately prepared analysis plan (participants judged to have been evaluated appropriately). The number of participants in whom the prolonged administration of Varenicline after 12 weeks was confirmed was 2598.
Arm/Group Title Administration Prolonged After 12 Weeks Administration Not Prolonged After 12 Weeks
Hide Arm/Group Description:
Participants with prolonged administration of Varenicline after 12 weeks according to Japanese Package Insert.
Participants without prolonged administration of Varenicline after 12 weeks according to Japanese Package Insert.
Overall Number of Participants Analyzed 64 2534
Measure Type: Number
Unit of Measure: participants
39 1993
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Administration Prolonged After 12 Weeks, Administration Not Prolonged After 12 Weeks
Comments The risk factor tested was "prolonged administration after 12 weeks". The null hypothesis is that there is no difference between "administration prolonged after 12 weeks and administration not prolonged after 12 weeks" in the efficacy of Varenicline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
9.Primary Outcome
Title Risk Factors for the Proportion of Responders - Antipsychotics as a Concomitant Drug.
Hide Description The primary analysis item was "the number of participants succeeding with continuous smoking cessation for the previous 4 weeks/the number of participants for efficacy evaluation excluding drop-out participants.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis population basically consists of the evaluable participants in accordance with the separately prepared analysis plan (participants judged to have been evaluated appropriately). The number of participants who provided data on concomitant administration of antipsychotics was 2842.
Arm/Group Title Varenicline - With Antipsychotics as a Concomitant Drug Varenicline - Without Antipsychotics as a Concomitant Drug
Hide Arm/Group Description:
Varenicline with Antipsychotics as a Concomitant Drug
Varenicline without Antipsychotics as a Concomitant Drug
Overall Number of Participants Analyzed 140 2702
Measure Type: Number
Unit of Measure: participants
85 2111
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Varenicline - With Antipsychotics as a Concomitant Drug, Varenicline - Without Antipsychotics as a Concomitant Drug
Comments The risk factor tested was "antipsychotics as a concomitant drug". The null hypothesis is that there is no difference between "Varenicline with and without antipsychotics as a concomitant drug" in the efficacy of Varenicline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
10.Primary Outcome
Title Number of Participants With Treatment Related Adverse Events.
Hide Description Adverse events mean all unfavorable events that occur in participants after administration of Varenicline, irrespective of causal relationship to Varenicline (including clinically problematic abnormal changes in laboratory test values). Treatment related Adverse Events were evaluated in company with the causal relationship to Varenicline. The safety was evaluated on the first visit after 24 weeks; however, it was evaluated on the last visit for those who had stopped visiting before 24 weeks.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
No statistical analysis provided for the frequency of treatment related adverse events.
Arm/Group Title Varenicline
Hide Arm/Group Description:
Participants taking Varenicline according to Japanese Package Insert.
Overall Number of Participants Analyzed 3257
Measure Type: Number
Unit of Measure: participants
713
11.Primary Outcome
Title Number of Unlisted Treatment Related Adverse Events According to Japanese Package Insert.
Hide Description Adverse events mean all unfavorable events that occur in participants after administration of Varenicline, irrespective of causal relationship to Varenicline (including clinically problematic abnormal changes in laboratory test values). Numbers of Treatment Related Adverse Events were evaluated in company with the causal relationship to Varenicline. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert. The safety was evaluated on the first visit after 24 weeks; however, it was evaluated on the last visit for those who had stopped visiting before 24 weeks.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
No statistical analysis provided for the frequency of unlisted treatment related adverse events.
Arm/Group Title Varenicline
Hide Arm/Group Description:
Participants taking Varenicline according to Japanese Package Insert.
Overall Number of Participants Analyzed 3257
Measure Type: Number
Unit of Measure: events
30
12.Secondary Outcome
Title Number of Participants With Continuous Abstinence Situation by 52 Weeks.
Hide Description Number of participants with dependence on Varenicline by 52 weeks. Varenicline-dependent Treatment Related Adverse Events are Feeling abnormal, Feeling drunk, Feeling jittery, Disturbance in attention, Dizziness, Memory impairment, Mental impairment, Psychomotor hyperactivity, Sedation, Somnolence, Confusional state, Depersonalisation, Disorientation, Dissociation, Euphoric mood, Mood variable, Mood swings, and Hallucination.
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
No statistical analysis provided for the frequency of Varenicline-dependent treatment related adverse events.
Arm/Group Title Varenicline
Hide Arm/Group Description:
Participants taking Varenicline according to Japanese Package Insert.
Overall Number of Participants Analyzed 3257
Measure Type: Number
Unit of Measure: participants
38
Time Frame [Not Specified]
Adverse Event Reporting Description The frequency of treatment related adverse events during the study.
 
Arm/Group Title Varenicline
Hide Arm/Group Description Participants taking Varenicline according to Japanese Package Insert.
All-Cause Mortality
Varenicline
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Varenicline
Affected / at Risk (%) # Events
Total   8/3257 (0.25%)    
Gastrointestinal disorders   
Ileus  1  1/3257 (0.03%)  1
Mallory-Weiss syndrome  1  1/3257 (0.03%)  1
Pancreatitis  1  1/3257 (0.03%)  1
General disorders   
Chest discomfort  1  1/3257 (0.03%)  1
Nervous system disorders   
Lacunar infarction  1  1/3257 (0.03%)  1
Psychiatric disorders   
Depression  1  1/3257 (0.03%)  1
Suicidal ideation  1  1/3257 (0.03%)  1
Insomnia  1  1/3257 (0.03%)  1
Respiratory, thoracic and mediastinal disorders   
Oropharyngeal pain  1  1/3257 (0.03%)  1
Asthma  1  1/3257 (0.03%)  1
Vascular disorders   
Hypertension  1  1/3257 (0.03%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA-J 15.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Varenicline
Affected / at Risk (%) # Events
Total   708/3257 (21.74%)    
Cardiac disorders   
Palpitations  1  2/3257 (0.06%)  2
Ear and labyrinth disorders   
Tinnitus  1  2/3257 (0.06%)  2
Gastrointestinal disorders   
Eructation  1  1/3257 (0.03%)  1
Nausea  1  397/3257 (12.19%)  397
Gastritis  1  49/3257 (1.50%)  49
Gastrooesophageal reflux disease  1  5/3257 (0.15%)  5
Diarrhoea  1  10/3257 (0.31%)  10
Flatulence  1  1/3257 (0.03%)  1
Stomatitis  1  6/3257 (0.18%)  6
Dyspepsia  1  7/3257 (0.21%)  7
Abdominal pain upper  1  22/3257 (0.68%)  22
Glossitis  1  2/3257 (0.06%)  2
Abdominal pain  1  3/3257 (0.09%)  3
Abdominal discomfort  1  18/3257 (0.55%)  18
Abdominal distension  1  12/3257 (0.37%)  12
Constipation  1  91/3257 (2.79%)  91
Vomiting  1  39/3257 (1.20%)  39
General disorders   
Irritability  1  6/3257 (0.18%)  6
Feeling abnormal  1  3/3257 (0.09%)  3
Chest discomfort  1  1/3257 (0.03%)  1
Malaise  1  10/3257 (0.31%)  10
Thirst  1  4/3257 (0.12%)  4
Pyrexia  1  1/3257 (0.03%)  1
Fatigue  1  1/3257 (0.03%)  1
Asthenia  1  1/3257 (0.03%)  1
Pain  1  1/3257 (0.03%)  1
Hepatobiliary disorders   
Liver disorder  1  1/3257 (0.03%)  1
Hepatitis acute  1  1/3257 (0.03%)  1
Cholestasis  1  1/3257 (0.03%)  1
Infections and infestations   
Herpes virus infection  1  1/3257 (0.03%)  1
Gastroenteritis  1  2/3257 (0.06%)  2
Oral herpes  1  2/3257 (0.06%)  2
Investigations   
Blood pressure increased  1  2/3257 (0.06%)  2
Blood creatinine increased  1  1/3257 (0.03%)  1
Weight increased  1  2/3257 (0.06%)  2
Metabolism and nutrition disorders   
Decreased appetite  1  5/3257 (0.15%)  5
Musculoskeletal and connective tissue disorders   
Musculoskeletal stiffness  1  1/3257 (0.03%)  1
Nervous system disorders   
Somnolence  1  23/3257 (0.71%)  23
Headache  1  35/3257 (1.07%)  35
Dementia  1  1/3257 (0.03%)  1
Dizziness  1  13/3257 (0.40%)  13
Migraine  1  1/3257 (0.03%)  1
Dysgeusia  1  3/3257 (0.09%)  3
Psychiatric disorders   
Depression  1  6/3257 (0.18%)  6
Nightmare  1  8/3257 (0.25%)  8
Abnormal dreams  1  9/3257 (0.28%)  9
Decreased activity  1  1/3257 (0.03%)  1
Agitation  1  1/3257 (0.03%)  1
Social avoidant behaviour  1  1/3257 (0.03%)  1
Initial insomnia  1  1/3257 (0.03%)  1
Bulimia nervosa  1  1/3257 (0.03%)  1
Sleep disorder  1  3/3257 (0.09%)  3
Terminal insomnia  1  1/3257 (0.03%)  1
Middle insomnia  1  1/3257 (0.03%)  1
Anger  1  1/3257 (0.03%)  1
Anxiety  1  1/3257 (0.03%)  1
Anxiety disorder  1  2/3257 (0.06%)  2
Dysphoria  1  1/3257 (0.03%)  1
Insomnia  1  51/3257 (1.57%)  51
Apathy  1  1/3257 (0.03%)  1
Depressed mood  1  3/3257 (0.09%)  3
Depressive symptom  1  6/3257 (0.18%)  6
Restlessness  1  1/3257 (0.03%)  1
Renal and urinary disorders   
Pollakiuria  1  1/3257 (0.03%)  1
Renal failure chronic  1  1/3257 (0.03%)  1
Nocturia  1  2/3257 (0.06%)  2
Reproductive system and breast disorders   
Lactation disorder  1  1/3257 (0.03%)  1
Respiratory, thoracic and mediastinal disorders   
Cough  1  1/3257 (0.03%)  1
Skin and subcutaneous tissue disorders   
Pruritus  1  3/3257 (0.09%)  3
Eczema  1  3/3257 (0.09%)  3
Rash generalised  1  1/3257 (0.03%)  1
Rash  1  1/3257 (0.03%)  1
Drug eruption  1  2/3257 (0.06%)  2
Urticaria  1  2/3257 (0.06%)  2
Vascular disorders   
Peripheral coldness  1  1/3257 (0.03%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA-J 15.1
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
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00772941     History of Changes
Other Study ID Numbers: A3051109
First Submitted: October 13, 2008
First Posted: October 15, 2008
Results First Submitted: December 9, 2013
Results First Posted: January 24, 2014
Last Update Posted: February 28, 2014