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.
Verified May 2013 by Pfizer
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01574703
First received: April 6, 2012
Last updated: May 1, 2013
Last verified: May 2013
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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:
Drug Information available for:
Nicotine tartrate
Bupropion hydrochloride
Bupropion
Nicotine polacrilex
Varenicline
Varenicline tartrate
U.S. FDA Resources
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01574703
Show 98 Study Locations
Contacts
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Show 98 Study LocationsSponsors 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: | May 1, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
smoking cessation psychiatric disease cardiovascular events |
Additional relevant MeSH terms:
|
Mental Disorders Smoking 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 May 23, 2013