This study is a non-drug follow up study to A3051123 for cardiac assessments after use of smoking cessation treatments.

• Register: EUCTR
• Last refreshed on: 14 September 2015
• Main ID: EUCTR2011-005513-37-DE
• Date of registration: 10/01/2012
• Prospective Registration: Yes
• Primary sponsor: Pfizer Inc., 235 East 42nd Street, New York, NY 10017 US
• Public title: This study is a non-drug follow up study to A3051123 for cardiac assessments after use of smoking cessation treatments.
• Scientific 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 - CATS - Cardiac Assessments after Treatment Study
• Date of first enrolment: 25/07/2012
• Target sample size: 8000
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-005513-37
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

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

• Name: Clinical Trials.gov Call Center
• Affiliation: Pfizer Inc

• Name: Clinical Trials.gov Call Center
• Affiliation: Pfizer Inc

Key inclusion & exclusion 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:
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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]

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

Intervention(s)

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
Current Sponsor code: CP-526,555
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

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
Current Sponsor code: CP-526,555
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Trade Name: Zyban Bupropion hydrochloride
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: BUPROPION HYDROCHLORIDE - No IMP is being administered to trial subjects
CAS Number: 31677-93-7
Current Sponsor code: Bupropion Hydrochloride
Other descriptive name: Zyban
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Trade Name: NiQuitin
Product Code: Transdermal nicotine Patch (NRT)
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: Nicotine - No IMP is being administered to trial subjects
CAS Number: 54-11-5
Current Sponsor code: NRT
Other descriptive name: NICOTINE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 7-
Pharmaceutical form of the placebo: Transdermal patch
Route of administration of the placebo: Transdermal use

Trade Name: NiQuitin
Product Code: Transdermal nicotine Patch (NRT)
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: Nicotine - No IMP is being administered to trial subjects
CAS Number: 54-11-5
Current S

Primary Outcome(s)

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).

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.

Timepoint(s) of evaluation of this end point: Time to major cardiovascular event (MACE) during treatment phase of A3051123 (parent study).

Secondary Outcome(s)

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)

Secondary ID(s)

A3051148

Source(s) of Monetary Support

Pfizer Inc., 235 East 42nd Street, New York, NY 10017