Study To Evaluate Cardiac Assessments Following Different Treatments Of Smoking Cessation Medications In Subjects With And Without Psychiatric Disorders.

NCT01574703

Last updated date
Study Location
Coastal Clinical Research, Inc.
Mobile, Alabama, 36608, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Smoking Cessation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subjects will be eligible if they were randomized to study A3051123.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Participation in study A3051123 ceased (ie, withdrew consent, lost to follow-up, etc)
prior to final visit of study A3051123.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study To Evaluate Cardiac Assessments Following Different Treatments Of Smoking Cessation Medications In Subjects With And Without Psychiatric Disorders.
Official Title  ICMJE A Phase 4, Non-treatment Follow-up For Cardiac Assessments Following Use Of Smoking Cessation Treatments In Subjects With And Without A History Of Psychiatric Disorders
Brief Summary Non-treatment extension to study A3051123, aimed at collecting data on cardiovascular safety for all participants in the A3051123 trial for an additional 28 weeks, allowing for a total of 52 weeks of cardiovascular safety data collection.
Detailed Description This study is an extension protocol for study A3051123. No treatment is provided during this study. This study is to monitor for cardiovascular events 28 weeks after completion of A3051123. This study is an extension protocol for study A3051123. No treatment is provided during this study. This study is to monitor for cardiovascular events 28 weeks after completion of A3051123.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Smoking Cessation
Intervention  ICMJE
  • Drug: placebo
    All dosing to have taken place per study A3051123
  • Drug: varenicline tartrate
    All dosing to have taken place per study A3051123
    Other Name: Chantix; Champix
  • Drug: bupropion hydrochloride
    All dosing to have taken place per study A3051123
    Other Name: Zyban
  • Drug: Nicotine Replacement Therapy Patch
    All dosing to have taken place per study A3051123
    Other Name: NRT
Study Arms  ICMJE
  • Experimental: placebo
    Intervention: Drug: placebo
  • Experimental: varenicline
    Intervention: Drug: varenicline tartrate
  • Experimental: bupropion
    Intervention: Drug: bupropion hydrochloride
  • Experimental: Nicotine Replacement Therapy Patch
    Intervention: Drug: Nicotine Replacement Therapy Patch
Publications * Benowitz NL, Pipe A, West R, Hays JT, Tonstad S, McRae T, Lawrence D, St Aubin L, Anthenelli RM. Cardiovascular Safety of Varenicline, Bupropion, and Nicotine Patch in Smokers: A Randomized Clinical Trial. JAMA Intern Med. 2018 May 1;178(5):622-631. doi: 10.1001/jamainternmed.2018.0397.

*   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: October 31, 2016)
4595
Original Estimated Enrollment  ICMJE
 (submitted: April 9, 2012)
8000
Actual Study Completion Date  ICMJE July 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects will be eligible if they were randomized to study A3051123.

Exclusion Criteria:

  • Participation in study A3051123 ceased (ie, withdrew consent, lost to follow-up, etc) prior to final visit of study A3051123.
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 Argentina,   Australia,   Brazil,   Bulgaria,   Canada,   Chile,   Denmark,   Finland,   Germany,   Mexico,   New Zealand,   Russian Federation,   Slovakia,   South Africa,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01574703
Other Study ID Numbers  ICMJE A3051148
2011-005513-37 ( EudraCT Number )
CATS ( 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 Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2016

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