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

History of Changes

Tracking Information

First Received Date ^ICMJE

April 6, 2012

Last Updated Date

October 31, 2016

Start Date ^ICMJE

May 2012

Primary Completion Date

July 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

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 ]

Change History

Complete list of historical versions of study NCT01574703 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

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.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

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

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

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 *

Not Provided

* 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

Enrollment ^ICMJE

4595

Completion Date

July 2015

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

Sexes Eligible for Study:

All

Ages

18 Years to 75 Years (Adult, Senior)

Accepts Healthy Volunteers

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

Not Provided

Responsible Party

Pfizer

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

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

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