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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01574703
First received: April 6, 2012
Last updated: June 30, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Smoking Cessation
Drug: placebo
Drug: varenicline tartrate
Drug: bupropion hydrochloride
Drug: Nicotine Replacement Therapy Patch
Phase 4

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: A Phase 4, Non-Treatment Follow-Up For Cardiac Assessments Following Use Of Different Treatments For Smoking Cessation In Subjects With And Without A History Of Psychiatric Disorders

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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: - MACE; - MACE + (defined as any MACE or a new onset or worsening peripheral vascular disease (PVD) requiring intervention, a need for coronary revascularization, [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • or hospitalization for unstable angina; • CV deaths; • Non fatal MI; • Non fatal stroke. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • 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 ]

Estimated Enrollment: 8000
Study Start Date: May 2012
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
placebo Drug: placebo
All dosing to have taken place per study A3051123
varenicline Drug: varenicline tartrate
All dosing to have taken place per study A3051123
Other Name: Chantix; Champix
bupropion Drug: bupropion hydrochloride
All dosing to have taken place per study A3051123
Other Name: Zyban
Nicotine Replacement Therapy Patch Drug: Nicotine Replacement Therapy Patch
All dosing to have taken place per study A3051123
Other Name: NRT

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01574703

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Show 131 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01574703     History of Changes
Other Study ID Numbers: A3051148
Study First Received: April 6, 2012
Last Updated: June 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
smoking cessation
psychiatric disease
cardiovascular events

Additional relevant MeSH terms:
Smoking
Mental Disorders
Habits
Nicotine
Nicotine polacrilex
Varenicline
Bupropion
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on July 20, 2014