This study is a non-drug follow up study to A3051123 for cardiac assessments after use of smoking cessation treatments.
- Conditions
- icotine Addiction with the desire to quit smokingMedDRA version: 17.1Level: PTClassification code 10053325Term: Smoking cessation therapySystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]
- Registration Number
- EUCTR2011-005513-37-SK
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 8000
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method