Study To Evaluate Cardiac Assessments Following Different Treatments Of Smoking Cessation Medications In Subjects With And Without Psychiatric Disorders. (CATS)
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| ClinicalTrials.gov Identifier: NCT01574703 |
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Recruitment Status :
Completed
First Posted : April 10, 2012
Results First Posted : December 29, 2016
Last Update Posted : December 29, 2016
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Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Smoking Cessation | Drug: placebo Drug: varenicline tartrate Drug: bupropion hydrochloride Drug: Nicotine Replacement Therapy Patch | Phase 4 |
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 : | Interventional (Clinical Trial) |
| Actual Enrollment : | 4595 participants |
| Allocation: | Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| 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 |
| Study Start Date : | May 2012 |
| Actual Primary Completion Date : | July 2015 |
| Actual Study Completion Date : | July 2015 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Bupropion
| Arm | Intervention/treatment |
|---|---|
| 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 |
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01574703
Locations
Show 134 study locations
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01574703 |
| Other Study ID Numbers: |
A3051148 2011-005513-37 ( EudraCT Number ) CATS ( Other Identifier: Alias Study Number ) |
| First Posted: | April 10, 2012 Key Record Dates |
| Results First Posted: | December 29, 2016 |
| Last Update Posted: | December 29, 2016 |
| Last Verified: | October 2016 |
Keywords provided by Pfizer:
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smoking cessation psychiatric disease cardiovascular events |
Additional relevant MeSH terms:
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Mental Disorders Problem Behavior Behavioral Symptoms Bupropion Nicotine Varenicline Ganglionic Stimulants Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Nicotinic Agonists Cholinergic Agonists Cholinergic Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Dopamine Agents Cytochrome P-450 CYP2D6 Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors |