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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01574703
First received: April 6, 2012
Last updated: October 31, 2016
Last verified: October 2016
April 6, 2012
October 31, 2016
May 2012
July 2015   (Final data collection date for primary outcome measure)
Time to Occurrence of Major Adverse Cardiovascular Event (MACE) During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936. [ Time Frame: Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks). ]
This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug). The measure type mentioned in the outcome data table is Hazard Ratio relative to Placebo.
Time to major cardiovascular event (MACE; defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke) evaluated during the treatment phase (up to date of last dose of study drug in study A3051123) [ Time Frame: 12 weeks ]
Complete list of historical versions of study NCT01574703 on ClinicalTrials.gov Archive Site
  • Time to MACE up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936. [ Time Frame: Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days. ]
    This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug) plus 30 days follow-up. The measure type mentioned in the outcome data table is Hazard Ratio.
  • Time to MACE Until the End of Study NCT01574703. [ Time Frame: Baseline until end of study (end of study is defined as last visit in study NCT01574703 [up to Week 52], or in study NCT01456936 [up to 24 Weeks] for those participants not enrolled into study NCT01574703). ]
    This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated until end of study. The measure type mentioned in the outcome data table is Hazard Ratio.
  • Incidence of MACE Assessed During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936. [ Time Frame: Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks). ]
    This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug).
  • Incidence of MACE + Assessed During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936. [ Time Frame: Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks). ]
    This is an adjudicated endpoint. MACE + is defined as any MACE or a new onset or worsening peripheral vascular disease (PVD) requiring intervention, a need for coronary revascularization, or hospitalization for unstable angina.
  • Incidence of MACE Assessed up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936. [ Time Frame: Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days follow-up. ]
    This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug) plus 30 days follow-up.
  • Incidence of MACE+ Assessed up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936. [ Time Frame: Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days follow-up. ]
    This is an adjudicated endpoint. MACE + is defined as any MACE or a new onset or worsening PVD requiring intervention, a need for coronary revascularization, or hospitalization for unstable angina.
  • Incidence of MACE Assessed Until End of Study NCT01574703. [ Time Frame: Baseline until end of study (end of study is defined as last visit in study NCT01574703 [up to Week 52], or in study NCT01456936 [up to 24 Weeks] for those participants not enrolled into study NCT01574703). ]
    This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated until end of study.
  • Incidence of MACE+ Assessed Until End of Study NCT01574703. [ Time Frame: Baseline until end of study (end of study is defined as last visit in study NCT01574703 [up to Week 52], or in study NCT01456936 [up to 24 Weeks] for those participants not enrolled into study NCT01574703). ]
    This is an adjudicated endpoint. MACE+ is defined as any MACE or a new onset or worsening PVD requiring intervention, a need for coronary revascularization, or hospitalization for unstable angina.
  • Time to MACE up to date of last dose of study drug plus 30 days in study A3051123 [ Time Frame: 16 weeks ]
  • Time to MACE until the end of study (A3051148) [ Time Frame: 52 weeks ]
  • Incidence of each of the following events assessed up to date of last dose of study drug: [ Time Frame: 12 weeks ]
    • MACE;
    • MACE + (defined as any MACE or a new onset or worsening peripheral vascular disease (PVD) requiring intervention, a need for coronary revascularization,or hospitalization for unstable angina; • CV deaths; • Non fatal MI; • Non fatal stroke.
  • Incidence of each of the following events will be assessed up to date of last dose of study drug plus 30 days. [ Time Frame: 16 weeks ]
    • MACE;
    • MACE + (defined as any MACE or a new onset or worsening peripheral vascular disease (PVD) requiring intervention,a need for coronary revascularization, or hospitalization for unstable angina; • CV deaths; • Non fatal MI; • Non fatal stroke.
  • Incidence of each of the following events will be assessed until end of study: [ Time Frame: 52 weeks ]
    • MACE;
    • MACE + (defined as any MACE or a new onset or worsening peripheral vascular disease (PVD) requiring intervention, a need for coronaryrevascularization, or hospitalization for unstable angina; • CV deaths; • Non fatal MI; • Non fatal stroke.
Not Provided
Not Provided
 
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: 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