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

Phase 4

Completed

• Conditions: Smoking Cessation
• Interventions: Drug: bupropion hydrochloride; Drug: varenicline tartrate; Drug: Nicotine Replacement Therapy Patch; Drug: placebo

• Registration Number: NCT01574703
• Lead Sponsor: Pfizer

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 Timeline

• Study First Submitted: 2012-04-06
• Study First Submitted QC: 2012-04-09
• Study First Posted: 2012-04-10
• Study Start: 2012-05
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Results First Submitted: 2016-07-07
• Status Verified: 2016-10
• Results First Submitted QC: 2016-10-31
• Last Update Submitted: 2016-10-31
• Results First Posted: 2016-12-29
• Last Update Posted: 2016-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4595

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
bupropion	bupropion hydrochloride	-
varenicline	varenicline tartrate	-
Nicotine Replacement Therapy Patch	Nicotine Replacement Therapy Patch	-
placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
Time to Occurrence of Major Adverse Cardiovascular Event (MACE) During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936.	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

Name	Time	Method
Time to MACE Until the End of Study NCT01574703.	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 up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936.	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.
Time to MACE up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936.	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.
Incidence of MACE Assessed During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936.	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.	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.	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.	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.	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.

Trial Locations

Locations (131)

Coastal Clinical Research, Inc.; 🇺🇸 Mobile, Alabama, United States

Pharmacology Research Institute; 🇺🇸 Los Alamitos, California, United States

Synergy Clinical Research Center of Escondido; 🇺🇸 Escondido, California, United States

Sun Valley Research Center; 🇺🇸 Imperial, California, United States

Omega Clinical Trials; 🇺🇸 La Habra, California, United States

Pacific Treatment and Research Center; 🇺🇸 La Jolla, California, United States

Pharmacology Research Institute (PRI); 🇺🇸 Newport Beach, California, United States

North County Clinical Research; 🇺🇸 Oceanside, California, United States

NRC Research Institute; 🇺🇸 Orange, California, United States

California Neuroscience Research Medical Group, Inc.; 🇺🇸 Sherman Oaks, California, United States

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