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

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Coastal Clinical Research, Inc.
Mobile, Alabama, 36608 United States
Contact
1-800-718-1021
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.

NCT01574703
Pfizer
Completed
Study To Evaluate Cardiac Assessments Following Different Treatments Of Smoking Cessation Medications In Subjects With And Without Psychiatric Disorders.

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Study To Evaluate Cardiac Assessments Following Different Treatments Of Smoking Cessation Medications In Subjects With And Without Psychiatric Disorders.
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
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.
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Smoking Cessation
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4595
July 2015
July 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Brazil,   Bulgaria,   Canada,   Chile,   Denmark,   Finland,   Germany,   Mexico,   New Zealand,   Russian Federation,   Slovakia,   South Africa,   Spain,   United States
 
 
NCT01574703
A3051148
2011-005513-37 ( EudraCT Number )
CATS ( Other Identifier: Alias Study Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2016

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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