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Trial record 18 of 649 for:    Russian Federation | Chile

Study Evaluating The Safety And Efficacy Of Varenicline and Bupropion For Smoking Cessation In Subjects With And Without A History Of Psychiatric Disorders (EAGLES)

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ClinicalTrials.gov Identifier: NCT01456936
Recruitment Status : Completed
First Posted : October 21, 2011
Results First Posted : May 2, 2016
Last Update Posted : June 10, 2016
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE October 14, 2011
First Posted Date  ICMJE October 21, 2011
Results First Submitted Date  ICMJE January 12, 2016
Results First Posted Date  ICMJE May 2, 2016
Last Update Posted Date June 10, 2016
Study Start Date  ICMJE November 2011
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2016)
  • Occurrence of Neuropsychiatric (NPS) Adverse Events (AE) - the Primary Study Endpoint [ Time Frame: Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days. ]
    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 (%), by Cohort [ Time Frame: Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days. ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 19, 2011)
  • At least 1 severe AE of anxiety depression, feeling abnormal, or hostility and/or moderate or severe AE of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation/behavior/completed [ Time Frame: Week 12 ]
  • 4 week Carbon Monoxide (CO) confirmed continuous abstinence for Weeks 9 through 12. [ Time Frame: Week 12 ]
Change History Complete list of historical versions of study NCT01456936 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2016)
  • Occurrence of the Components of the NPS AE Primary Endpoint, Non-psychiatric History Cohort [ Time Frame: Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days. ]
    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.
  • Occurrence of the Components of the NPS AE Primary Endpoint, Psychiatric History Cohort [ Time Frame: Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days. ]
    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.
  • Occurrence of the Components of NPS AE Primary Endpoint (Overall) [ Time Frame: Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days. ]
    The NPS AE composite results (as previously described) are for the two cohorts combined and are presented below.
  • Occurrence of Severe-only NPS AEs in the Primary Endpoint, by Cohort [ Time Frame: Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days. ]
    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.
  • Occurrence of the Components of the Observed Severe-only NPS AE Primary Endpoint, Non-psychiatric History Cohort [ Time Frame: Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days. ]
    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.
  • Occurrence of the Components of the Observed Severe-only NPS AE Primary Endpoint, Psychiatric History Cohort [ Time Frame: Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days. ]
    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.
  • Occurrence of the Components of Severe-only NPS AE Endpoint (Overall) [ Time Frame: Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days. ]
    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.
  • Hospital Anxiety and Depression Scale (HADS) Total Score, Non-psychiatric History Cohort [ Time Frame: Baseline to Week 24 ]
    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.
  • HADS Total Score, Psychiatric History Cohort [ Time Frame: Baseline to Week 24 ]
    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.
  • HADS Total Score (Overall) [ Time Frame: Baseline to Week 24 ]
    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.
  • Positive Responses for Suicidal Behavior and/or Ideation by Columbia Suicide Severity Rating Scale (C‑SSRS) - Non-psychiatric History Cohort [ Time Frame: Lifetime, Baseline and Treatment-Emergent is first dose date to last dose date (up to 12 weeks) plus 30 days. ]
    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.
  • Positive Responses for Suicidal Behavior and/or Ideation by Columbia Suicide Severity Rating Scale (C‑SSRS) - Psychiatric History Cohort [ Time Frame: Lifetime, Baseline and Treatment-Emergent is first dose date to last dose date (up to 12 weeks) plus 30 days. ]
    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.
  • Positive Responses for Suicidal Behavior and/or Ideation by Columbia Suicide Severity Rating Scale (C‑SSRS) - Overall [ Time Frame: Lifetime, Baseline and Treatment-Emergent is first dose date to last dose date (up to 12 weeks) plus 30 days. ]
    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.
  • Clinical Global Impression of Improvement (CGI‑I), "No Change" Rating by Visit [ Time Frame: Baseline to Week 24 ]
    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.
  • CO‑Confirmed Continuous Abstinence for Weeks 9 Through 12, Non-psychiatric History Cohort [ Time Frame: Week 9 through Week 12 ]
    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).
  • CO‑Confirmed Continuous Abstinence for Weeks 9 Through 12, Psychiatric History Cohort [ Time Frame: Week 9 through Week 12 ]
    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).
  • CO‑Confirmed Continuous Abstinence for Weeks 9 Through 12 (Overall) [ Time Frame: Week 9 through Week 12 ]
    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).
  • CO-confirmed Continuous Abstinence From Week 9 Through Week 24, Non-psychiatric History Cohort [ Time Frame: Week 9 through Week 24 ]
    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).
  • CO-confirmed Continuous Abstinence From Week 9 Through Week 24, Psychiatric History Cohort [ Time Frame: Week 9 through Week 24 ]
    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).
  • CO-confirmed Continuous Abstinence From Week 9 Through Week 24 (Overall) [ Time Frame: Week 9 through Week 24 ]
    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).
  • 7‑Day Point Prevalence of Abstinence, Non-psychiatric History Cohort [ Time Frame: 24 Weeks ]
    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?
  • 7‑Day Point Prevalence of Abstinence, Psychiatric History Cohort [ Time Frame: 24 Weeks ]
    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?
  • 7‑Day Point Prevalence of Abstinence (Overall) [ Time Frame: 24 Weeks ]
    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?
Original Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2011)
  • Carbon Monoxide (CO) confirmed continuous abstinence from Week 9 through Week 24 [ Time Frame: Week 24 ]
  • The presence or absence of each component comprising the primary neuropsychiatric adverse event endpoint. [ Time Frame: Week 12 ]
  • Individual item responses and overall scores for Hospital Anxiety and Depression Scale [ Time Frame: 12 weeks ]
  • Individual item responses and overall scores for Columbia Suicide Severity Rating Scale [ Time Frame: 12 weeks ]
  • Individual item responses and overall scores for Global Clinical Impression of Improvement [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating The Safety And Efficacy Of Varenicline and Bupropion For Smoking Cessation In Subjects With And Without A History Of Psychiatric Disorders
Official Title  ICMJE 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
Brief Summary This study is being conducted to assess varenicline and bupropion as aids to smoking cessation treatment in subjects with and without an established diagnosis of major psychiatric disorder and to characterize the neuropsychiatric safety profile (pre-specified adverse events (AEs) in both of these populations).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Smoking Cessation
Intervention  ICMJE
  • Drug: Placebo
    Triple dummy placebo for each treatment arm
  • Drug: 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
    Other Name: Chantix; Champix
  • Drug: 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).
  • Drug: 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.
    Other Name: NRT
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Placebo
  • Active Comparator: varenicline
    Intervention: Drug: varenicline tartrate
  • Active Comparator: bupropion
    Intervention: Drug: bupropion hydrochloride
  • Active Comparator: Nicotine Replacement Therapy Patch
    Intervention: Drug: Nicotine Replacement Therapy Patch
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 9, 2016)
8144
Original Estimated Enrollment  ICMJE
 (submitted: October 19, 2011)
8000
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Chile,   Russian Federation,   Argentina,   Australia,   Brazil,   Bulgaria,   Canada,   Denmark,   Finland,   Germany,   Mexico,   New Zealand,   Slovakia,   South Africa,   Spain,   United States
Removed Location Countries France,   Puerto Rico
 
Administrative Information
NCT Number  ICMJE NCT01456936
Other Study ID Numbers  ICMJE A3051123
2010-022914-15 ( EudraCT Number )
EAGLES ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE GlaxoSmithKline
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP