N/A
Completed N=20
Varenicline (Champix®) Special Investigation (Regulatory Post Marketing Commitment Plan)
Source: ClinicalTrials.gov NCT01061710 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Feb 2015
Primary outcomePrimary: Number of Participants With Treatment-Related Adverse Events (AEs) — 0 Participants
Summary
The purpose of this study is to collect the efficacy and safety information in subjects who have been retreated with varenicline (Champix®) within 52 weeks of initial treatment for their appropriate use in daily practice and are participants for varenicline Drug Use Investigation protocol A3051109 ((NCT# NCT00772941).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Related Adverse Events (AEs) |
— | — |
| PRIMARY Number of Responders to Varenicline Treatment |
2 | — |
| SECONDARY Number of Treatment-Related Adverse Events (AEs) Unlisted in Japanese Package Insert |
— | — |
| SECONDARY Number of Participants With Risk Factors Likely to Affect the Frequency of Treatment-Related Adverse Events (AEs) |
— | — |
| SECONDARY Number of Participants With Risk Factors Likely to Affect the Proportion of Responders |
— | — |
Eligibility Criteria
Inclusion Criteria
- Male or Female subjects intend to quit tobacco use who are prescribed varenicline (Champix®) by their Physicians
- Subjects who are prescribed varenicline (Champix®) for the second time within 52 weeks of initial treatment.
Exclusion Criteria
Non-participants of varenicline (Champix®) Drug use Investigation protocol A3051109.
Data sourced from ClinicalTrials.gov (NCT01061710). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.