Nicotine Addiction with the desire to quit smoking MedDRA version: 18.0 Level: PT Classification code 10053325 Term: Smoking cessation therapy System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Champix
Product Code: CP-526,555
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Varenicline tartrate - No IMP is being administered to trial subjects
CAS Number: 375815-87-5
Sponsors
Pfizer Inc., 235 East 42nd Street, New York, NY 10017 US
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subject eligibility should be reviewed and documented by an appropriately qualified member of the investigator’s study team before subjects are included in the study. • Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study. • Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. • Randomized to and completed study A3051123. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 7544 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 456
Exclusion criteria
Exclusion criteria: Subjects presenting with any of the following will not be included in the study: 1. Participation in study A3051123 ceased (ie, withdrew, lost to follow-up, etc.) prior to Week 24 final visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the CV safety assessment will be to characterize the cardiovascular safety profiles of varenicline and bupropion compared to placebo.;Secondary Objective: The secondary objective will be to characterize the cardiovascular safety profiles for the following comparisons: 1. NRT vs. Placebo. 2. Varenicline vs. Bupropion. 3. Varenicline vs. NRT. 4. Bupropion vs. NRT. ;Primary end point(s): The primary endpoint for the CV surveillance will be the 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).;Timepoint(s) of evaluation of this end point: Time to major cardiovascular event (MACE) during treatment phase of A3051123 (parent study). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Time to MACE will also be evaluated (1) up to date of last dose of study drug plus 30 days and (2) until the end of study. Incidence of each of the following events will be assessed (1) up to date of last dose of study drug, (2) up to date of last dose of study drug plus 30 days, and (3) 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 revascularization, or hospitalization for unstable angina; • CV deaths; • Non fatal MI; • Non fatal stroke. Note: All time to event endpoints start at date of first study drug during study A3051123. ;Timepoint(s) of evaluation of this end point: 1. up to last dose of study drug in A3051123 2. Time to Mace until last dose of study drug + 30 days and 3. until end of study (Week 52) | — |
Countries
Argentina, Australia, Brazil, Bulgaria, Canada, Chile, Czech Republic, Denmark, Egypt, Finland, France, Germany, Mexico, New Zealand, Russian Federation, Slovakia, South Africa, Spain, United States
Contacts
Public ContactClinical Trials.gov Call Center
Pfizer Inc
Outcome results
None listed