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: August 12, 2015
Last verified: August 2015
  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: Interventional
Study Design: Intervention Model: Single Group Assignment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Enrollment: 4605
Study Start Date: May 2012
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: placebo Drug: placebo
All dosing to have taken place per study A3051123
Experimental: varenicline Drug: varenicline tartrate
All dosing to have taken place per study A3051123
Other Name: Chantix; Champix
Experimental: bupropion Drug: bupropion hydrochloride
All dosing to have taken place per study A3051123
Other Name: Zyban
Experimental: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

  Show 136 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, 2011-005513-37, CATS
Study First Received: April 6, 2012
Last Updated: August 12, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
smoking cessation
psychiatric disease
cardiovascular events

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

ClinicalTrials.gov processed this record on August 31, 2015