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 16, 2015

Last verified: October 2015

History of Changes

Tracking Information

First Received Date ^ICMJE

April 6, 2012

Last Updated Date

October 16, 2015

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 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 ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

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 in study A3051123 [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
Time to MACE until the end of study (A3051148) [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
Incidence of each of the following events assessed up to date of last dose of study drug: [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
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 • MACE; • MACE + (defined as any MACE or a new onset or worsening peripheral vascular disease (PVD) requiring intervention, [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
a need for coronary revascularization, or hospitalization for unstable angina; • CV deaths; • Non fatal MI; • Non fatal stroke. [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
Incidence of each of the following events will be assessed until end of study: • MACE; • MACE + (defined as any MACE or a new onset or worsening peripheral vascular disease (PVD) requiring intervention, a need for coronary [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
revascularization, or hospitalization for unstable angina; • CV deaths; • Non fatal MI; • Non fatal stroke. [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]
Time to MACE until the end of study (A3051148) [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
Incidence of each of the following events assessed up to date of last dose of study drug: [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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

Intervention Model: Single Group Assignment

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 Arm (s)

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

4599

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.

Gender

Both

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

United States, Argentina, Australia, Brazil, Bulgaria, Canada, Chile, Denmark, Finland, Germany, Mexico, New Zealand, Russian Federation, Slovakia, South Africa, Spain

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01574703

Other Study ID Numbers ^ICMJE

A3051148, 2011-005513-37, CATS

Has Data Monitoring Committee

Yes

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Pfizer

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

October 2015

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

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