Trial Review

ANZCTR is currently experiencing a technical issue. Thank you for your patience while we work on it and apologies for any inconvenience caused.


Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements.
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01456936




Registration number
NCT01456936
Ethics application status
Date submitted
14/10/2011
Date registered
21/10/2011
Date last updated
10/06/2016

Titles & IDs
Public title
Study Evaluating The Safety And Efficacy Of Varenicline and Bupropion For Smoking Cessation In Subjects With And Without A History Of Psychiatric Disorders
Scientific title
A Phase 4, Randomized, Double-blind, Active And Placebo-controlled, Multicenter Study Evaluating The Neuropsychiatric Safety And Efficacy Of 12 Weeks Varenicline Tartrate 1mg Bid And Bupropion Hydrochloride 150mg Bid For Smoking Cessation In Subjects With And Without A History Of Psychiatric Disorders
Secondary ID [1] 0 0
2010-022914-15
Secondary ID [2] 0 0
A3051123
Universal Trial Number (UTN)
Trial acronym
EAGLES
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking Cessation 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - varenicline tartrate
Treatment: Drugs - bupropion hydrochloride
Treatment: Drugs - Nicotine Replacement Therapy Patch

Placebo comparator: placebo - Subjects randomized to placebo will receive placebo treatments for all three study drugs. Blinded placebo will be provided for varenicline, bupropion hydrochloride and transdermal nicotine patch (NRT). In addition, subjects will receive blinded placebo treatments for the study drugs they are not randomized to receive.

Active comparator: varenicline -

Active comparator: bupropion -

Active comparator: Nicotine Replacement Therapy Patch -


Treatment: Drugs: Placebo
Triple dummy placebo for each treatment arm

Treatment: Drugs: varenicline tartrate
Subjects will be titrated to the full dose during the first week in the following manner: 0.5 mg (tablet form) once a day for 3 days, 0.5 mg twice a day for 4 days, then 1 mg twice a day for 11 weeks

Treatment: Drugs: bupropion hydrochloride
Subjects will receive 150 mg (tablet form) once a day for 3 days and then will take 150 mg twice a day for the remainder of the treatment period (11 weeks and 4 days).

Treatment: Drugs: Nicotine Replacement Therapy Patch
Subjects will start active dosing the morning of the Week 1 visit and will receive a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Occurrence of Neuropsychiatric (NPS) Adverse Events (AE) - the Primary Study Endpoint
Assessment method [1] 0 0
The primary safety endpoint is the occurrence of at least one treatment emergent "severe" adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent "moderate" or "severe" adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide.
Timepoint [1] 0 0
Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
Primary outcome [2] 0 0
Estimated NPS AE Rate (%), by Cohort
Assessment method [2] 0 0
The primary safety endpoint is the occurrence of at least one treatment emergent "severe" adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent "moderate" or "severe" adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Estimated NPS AE rate (%) was calculated based on least-squares means analysis.
Timepoint [2] 0 0
Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
Secondary outcome [1] 0 0
Occurrence of the Components of the NPS AE Primary Endpoint, Non-psychiatric History Cohort
Assessment method [1] 0 0
The safety endpoint is the occurrence of at least one treatment emergent "severe" adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent "moderate" or "severe" adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Each of these 16 components is reported below.
Timepoint [1] 0 0
Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
Secondary outcome [2] 0 0
Occurrence of the Components of the NPS AE Primary Endpoint, Psychiatric History Cohort
Assessment method [2] 0 0
The safety endpoint is the occurrence of at least one treatment emergent "severe" adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent "moderate" or "severe" adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Each of these 16 components is reported below.
Timepoint [2] 0 0
Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
Secondary outcome [3] 0 0
Occurrence of the Components of NPS AE Primary Endpoint (Overall)
Assessment method [3] 0 0
The NPS AE composite results (as previously described) are for the two cohorts combined and are presented below.
Timepoint [3] 0 0
Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
Secondary outcome [4] 0 0
Occurrence of Severe-only NPS AEs in the Primary Endpoint, by Cohort
Assessment method [4] 0 0
The primary safety endpoint is the occurrence of at least one treatment emergent "severe" adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent "moderate" or "severe" adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Only those events rated as severe are reported; this excludes any moderate events in the primary NPS AE endpoint.
Timepoint [4] 0 0
Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
Secondary outcome [5] 0 0
Occurrence of the Components of the Observed Severe-only NPS AE Primary Endpoint, Non-psychiatric History Cohort
Assessment method [5] 0 0
The safety endpoint is the occurrence of at least one treatment emergent "severe" adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent "moderate" or "severe" adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Only those events rated as severe are reported; this excludes any moderate events in the primary NPS AE endpoint.
Timepoint [5] 0 0
Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
Secondary outcome [6] 0 0
Occurrence of the Components of the Observed Severe-only NPS AE Primary Endpoint, Psychiatric History Cohort
Assessment method [6] 0 0
The safety endpoint is the occurrence of at least one treatment emergent "severe" adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent "moderate" or "severe" adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Only those events rated as severe are reported; this excludes any moderate events in the primary NPS AE endpoint.
Timepoint [6] 0 0
Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
Secondary outcome [7] 0 0
Occurrence of the Components of Severe-only NPS AE Endpoint (Overall)
Assessment method [7] 0 0
The NPS AE endpoint was the occurrence of at least 1 treatment-emergent "severe" AE of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least 1 treatment-emergent "severe" AE of agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Only those events rated as severe are reported; this excludes any moderate events in the primary NPS AE endpoint.
Timepoint [7] 0 0
Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
Secondary outcome [8] 0 0
Hospital Anxiety and Depression Scale (HADS) Total Score, Non-psychiatric History Cohort
Assessment method [8] 0 0
The HADS is a subject self-reporting scale completed in person at clinic visits at Baseline and Weeks 1 through 6, 8, 10, 12, 13, 16, 20, and 24. It contains 14 individual item responses ranging in increasing severity from 0 (normal) to 3 (most severe) for a total range of 0 to 42. Of the 14 items, 7 assess anxiety and 7 assess depression, providing 2 subscales with ranges of 0 to 21. For each subscale, 0 to 7 is considered normal, while 15 to 21 represents severe symptoms.
Timepoint [8] 0 0
Baseline to Week 24
Secondary outcome [9] 0 0
HADS Total Score, Psychiatric History Cohort
Assessment method [9] 0 0
The HADS is a subject self-reporting scale completed in person at clinic visits at Baseline and Weeks 1 through 6, 8, 10, 12, 13, 16, 20, and 24. It contains 14 individual item responses ranging in increasing severity from 0 (normal) to 3 (most severe) for a total range of 0 to 42. Of the 14 items, 7 assess anxiety and 7 assess depression, providing 2 subscales with ranges of 0 to 21. For each subscale, 0 to 7 is considered normal, while 15 to 21 represents severe symptoms.
Timepoint [9] 0 0
Baseline to Week 24
Secondary outcome [10] 0 0
HADS Total Score (Overall)
Assessment method [10] 0 0
The HADS is a subject self-reporting scale completed in person at clinic visits at Baseline and Weeks 1 through 6, 8, 10, 12, 13, 16, 20, and 24. It contains 14 individual item responses ranging in increasing severity from 0 (normal) to 3 (most severe) for a total range of 0 to 42. Of the 14 items, 7 assess anxiety and 7 assess depression, providing 2 subscales with ranges of 0 to 21. For each subscale, 0 to 7 is considered normal, while 15 to 21 represents severe symptoms.
Timepoint [10] 0 0
Baseline to Week 24
Secondary outcome [11] 0 0
Positive Responses for Suicidal Behavior and/or Ideation by Columbia Suicide Severity Rating Scale (C-SSRS) - Non-psychiatric History Cohort
Assessment method [11] 0 0
The C-SSRS is a semi-structured interview designed to evaluate an individual's degree of suicidal ideation, preparatory acts or behavior to actual attempt, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent". Answers at screening are for lifetime history. Answers for all other visits are since last visit.The scale is also used to record any completed suicides.
Timepoint [11] 0 0
Lifetime, Baseline and Treatment-Emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
Secondary outcome [12] 0 0
Positive Responses for Suicidal Behavior and/or Ideation by Columbia Suicide Severity Rating Scale (C-SSRS) - Psychiatric History Cohort
Assessment method [12] 0 0
The C-SSRS is a semi-structured interview designed to evaluate an individual's degree of suicidal ideation, preparatory acts or behavior to actual attempt, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent". Answers at screening are for lifetime history. Answers for all other visits are since last visit. The scale is also used to record any completed suicides.
Timepoint [12] 0 0
Lifetime, Baseline and Treatment-Emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
Secondary outcome [13] 0 0
Positive Responses for Suicidal Behavior and/or Ideation by Columbia Suicide Severity Rating Scale (C-SSRS) - Overall
Assessment method [13] 0 0
The C-SSRS is a semi-structured interview designed to evaluate an individual's degree of suicidal ideation, preparatory acts or behavior to actual attempt, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent". Answers at screening are for lifetime history. Answers for all other visits are since last visit. The scale is also used to record any completed suicides.
Timepoint [13] 0 0
Lifetime, Baseline and Treatment-Emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.
Secondary outcome [14] 0 0
Clinical Global Impression of Improvement (CGI-I), "No Change" Rating by Visit
Assessment method [14] 0 0
The CGI-I is a clinician rated instrument that measures change in participant's psychiatric condition (or lack thereof in the stratum without psychiatric disorders) on a 7 point scale ranging from 1 (very much improved) to 7 (very much worse), with 4 = no change. The ratings were applicable even to those without psychiatric diagnoses (eg, those with no psychiatric symptoms would be rated as "normal, not at all ill" on the CGI-S at baseline and assuming no psychiatric symptoms emerge during the trial, would be rated as "no change" on the CGI-I at follow-up visits). For those participants with a psychiatric diagnosis, the clinician should rate the severity of the mental illness with respect to the clinician's experience with the psychiatric population to which the participant belongs.
Timepoint [14] 0 0
Baseline to Week 24
Secondary outcome [15] 0 0
CO-Confirmed Continuous Abstinence for Weeks 9 Through 12, Non-psychiatric History Cohort
Assessment method [15] 0 0
A responder to this endpoint requires the answer "no" to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 12 (inclusive).
Timepoint [15] 0 0
Week 9 through Week 12
Secondary outcome [16] 0 0
CO-Confirmed Continuous Abstinence for Weeks 9 Through 12, Psychiatric History Cohort
Assessment method [16] 0 0
A responder to this endpoint requires the answer "no" to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 12 (inclusive).
Timepoint [16] 0 0
Week 9 through Week 12
Secondary outcome [17] 0 0
CO-Confirmed Continuous Abstinence for Weeks 9 Through 12 (Overall)
Assessment method [17] 0 0
A responder to this endpoint requires the answer "no" to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 12 (inclusive).
Timepoint [17] 0 0
Week 9 through Week 12
Secondary outcome [18] 0 0
CO-confirmed Continuous Abstinence From Week 9 Through Week 24, Non-psychiatric History Cohort
Assessment method [18] 0 0
A responder to this endpoint requires the answer "no" to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 24 (inclusive).
Timepoint [18] 0 0
Week 9 through Week 24
Secondary outcome [19] 0 0
CO-confirmed Continuous Abstinence From Week 9 Through Week 24, Psychiatric History Cohort
Assessment method [19] 0 0
A responder to this endpoint requires the answer "no" to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 24 (inclusive).
Timepoint [19] 0 0
Week 9 through Week 24
Secondary outcome [20] 0 0
CO-confirmed Continuous Abstinence From Week 9 Through Week 24 (Overall)
Assessment method [20] 0 0
A responder to this endpoint requires the answer "no" to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 24 (inclusive).
Timepoint [20] 0 0
Week 9 through Week 24
Secondary outcome [21] 0 0
7-Day Point Prevalence of Abstinence, Non-psychiatric History Cohort
Assessment method [21] 0 0
A responder to this endpoint requires the answer "no" to both questions 3 and 6 on the nicotine use inventory at that specific visit. NUI Question 3 (Baseline through Week 24): Has the subject smoked any cigarettes (even a puff) in the last 7 days? NUI Question 6 (Baseline through Week 12): Has the subject used any other nicotine containing products in the last 7 days? NUI Question 6 (Week 13 through Week 24): Has the subject used any other tobacco products in the last 7 days?
Timepoint [21] 0 0
24 Weeks
Secondary outcome [22] 0 0
7-Day Point Prevalence of Abstinence, Psychiatric History Cohort
Assessment method [22] 0 0
A responder to this endpoint requires the answer "no" to both questions 3 and 6 on the nicotine use inventory at that specific visit. NUI Question 3 (Baseline through Week 24): Has the subject smoked any cigarettes (even a puff) in the last 7 days? NUI Question 6 (Baseline through Week 12): Has the subject used any other nicotine containing products in the last 7 days? NUI Question 6 (Week 13 through Week 24): Has the subject used any other tobacco products in the last 7 days?
Timepoint [22] 0 0
24 Weeks
Secondary outcome [23] 0 0
7-Day Point Prevalence of Abstinence (Overall)
Assessment method [23] 0 0
A responder to this endpoint requires the answer "no" to both questions 3 and 6 on the nicotine use inventory at that specific visit. NUI Question 3 (Baseline through Week 24): Has the subject smoked any cigarettes (even a puff) in the last 7 days? NUI Question 6 (Baseline through Week 12): Has the subject used any other nicotine containing products in the last 7 days? NUI Question 6 (Week 13 through Week 24): Has the subject used any other tobacco products in the last 7 days?
Timepoint [23] 0 0
24 Weeks

Eligibility
Key inclusion criteria
* Male or female cigarette smokers, 18- 75 years, motivated to stop smoking and considered suitable for a smoking cessation attempt.
* Smoked an average of at least 10 cigarettes per day during past year and during the month prior to the screening visit, and exhaled carbon monoxide (CO) >10 ppm at screening.
* For Neuropsychiatric cohort- subjects must have proper diagnosis as outlined in protocol.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Subjects with a past or current diagnosis of one of the following disorders:

a. Psychotic Disorders:
* Schizophreniform
* Delusional Disorder
* Psychotic Disorder NOS b. All Delirium, Dementia, and Amnestic and Other Cognitive Disorders c. All Substance Induced Disorders (Other than nicotine)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2015
Sample size
Target
Accrual to date
Final
8144
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Royal Brisbane & Women's Hospital - Herston
Recruitment hospital [2] 0 0
Monash Alfred Psychiatry Research Centre - Melbourne
Recruitment postcode(s) [1] 0 0
4029 - Herston
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Idaho
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Kansas
Country [12] 0 0
United States of America
State/province [12] 0 0
Kentucky
Country [13] 0 0
United States of America
State/province [13] 0 0
Louisiana
Country [14] 0 0
United States of America
State/province [14] 0 0
Maine
Country [15] 0 0
United States of America
State/province [15] 0 0
Massachusetts
Country [16] 0 0
United States of America
State/province [16] 0 0
Minnesota
Country [17] 0 0
United States of America
State/province [17] 0 0
Mississippi
Country [18] 0 0
United States of America
State/province [18] 0 0
Missouri
Country [19] 0 0
United States of America
State/province [19] 0 0
New Jersey
Country [20] 0 0
United States of America
State/province [20] 0 0
New York
Country [21] 0 0
United States of America
State/province [21] 0 0
North Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
Ohio
Country [23] 0 0
United States of America
State/province [23] 0 0
Oregon
Country [24] 0 0
United States of America
State/province [24] 0 0
Pennsylvania
Country [25] 0 0
United States of America
State/province [25] 0 0
Rhode Island
Country [26] 0 0
United States of America
State/province [26] 0 0
South Carolina
Country [27] 0 0
United States of America
State/province [27] 0 0
Tennessee
Country [28] 0 0
United States of America
State/province [28] 0 0
Texas
Country [29] 0 0
United States of America
State/province [29] 0 0
Virginia
Country [30] 0 0
United States of America
State/province [30] 0 0
Wisconsin
Country [31] 0 0
Argentina
State/province [31] 0 0
Buenos Aires
Country [32] 0 0
Brazil
State/province [32] 0 0
CE
Country [33] 0 0
Brazil
State/province [33] 0 0
RS
Country [34] 0 0
Brazil
State/province [34] 0 0
SP
Country [35] 0 0
Bulgaria
State/province [35] 0 0
Bourgas
Country [36] 0 0
Bulgaria
State/province [36] 0 0
Kazanlak
Country [37] 0 0
Bulgaria
State/province [37] 0 0
Novi Iskar
Country [38] 0 0
Bulgaria
State/province [38] 0 0
Pleven
Country [39] 0 0
Bulgaria
State/province [39] 0 0
Plovdiv
Country [40] 0 0
Bulgaria
State/province [40] 0 0
Ruse
Country [41] 0 0
Bulgaria
State/province [41] 0 0
Sofia
Country [42] 0 0
Bulgaria
State/province [42] 0 0
Troyan
Country [43] 0 0
Canada
State/province [43] 0 0
Ontario
Country [44] 0 0
Canada
State/province [44] 0 0
Quebec
Country [45] 0 0
Chile
State/province [45] 0 0
Maule
Country [46] 0 0
Chile
State/province [46] 0 0
Valparaiso, V Region
Country [47] 0 0
Denmark
State/province [47] 0 0
Ballerup
Country [48] 0 0
Denmark
State/province [48] 0 0
Vejle
Country [49] 0 0
Finland
State/province [49] 0 0
Espoo
Country [50] 0 0
Finland
State/province [50] 0 0
Kuopio
Country [51] 0 0
Finland
State/province [51] 0 0
Nummela
Country [52] 0 0
Finland
State/province [52] 0 0
Oulu
Country [53] 0 0
Finland
State/province [53] 0 0
Pori
Country [54] 0 0
Finland
State/province [54] 0 0
Turku
Country [55] 0 0
Germany
State/province [55] 0 0
Sachsen
Country [56] 0 0
Germany
State/province [56] 0 0
Berlin
Country [57] 0 0
Germany
State/province [57] 0 0
Freiburg
Country [58] 0 0
Germany
State/province [58] 0 0
Hamburg
Country [59] 0 0
Germany
State/province [59] 0 0
Muenchen
Country [60] 0 0
Germany
State/province [60] 0 0
Tuebingen
Country [61] 0 0
Mexico
State/province [61] 0 0
D.f.
Country [62] 0 0
Mexico
State/province [62] 0 0
Mexico DF
Country [63] 0 0
Mexico
State/province [63] 0 0
Michoacan
Country [64] 0 0
Mexico
State/province [64] 0 0
Nuevo Leon
Country [65] 0 0
New Zealand
State/province [65] 0 0
Rotorua
Country [66] 0 0
Russian Federation
State/province [66] 0 0
Moscow
Country [67] 0 0
Russian Federation
State/province [67] 0 0
Nizhni Novgorod
Country [68] 0 0
Russian Federation
State/province [68] 0 0
Saint-Petersburg
Country [69] 0 0
Russian Federation
State/province [69] 0 0
Smolensk
Country [70] 0 0
Russian Federation
State/province [70] 0 0
St. Petersburg
Country [71] 0 0
Slovakia
State/province [71] 0 0
Bratislava
Country [72] 0 0
Slovakia
State/province [72] 0 0
Levice
Country [73] 0 0
Slovakia
State/province [73] 0 0
Rimavska Sobota
Country [74] 0 0
Slovakia
State/province [74] 0 0
Roznava
Country [75] 0 0
South Africa
State/province [75] 0 0
Cape Town
Country [76] 0 0
South Africa
State/province [76] 0 0
Gauteng
Country [77] 0 0
South Africa
State/province [77] 0 0
Kwa-Zulu Natal
Country [78] 0 0
South Africa
State/province [78] 0 0
Kwazulu Natal
Country [79] 0 0
South Africa
State/province [79] 0 0
Western Cape
Country [80] 0 0
Spain
State/province [80] 0 0
Barcelona
Country [81] 0 0
Spain
State/province [81] 0 0
Caceres
Country [82] 0 0
Spain
State/province [82] 0 0
Madrid
Country [83] 0 0
Spain
State/province [83] 0 0
Zaragoza

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
GlaxoSmithKline
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01456936