Trial Outcomes & Findings for Varenicline (Champix®) Special Investigation (Regulatory Post Marketing Commitment Plan) (NCT NCT01061710)
NCT ID: NCT01061710
Last Updated: 2015-02-11
Results Overview
An AE was any untoward medical occurrence attributed to veranicline in a participant who received veranicline. Treatment related adverse events were evaluated in company with the causal relationship to veranicline.
COMPLETED
20 participants
24 weeks
2015-02-11
Participant Flow
This survey enrolled those who participated in preceding varenicline Drug Use Investigation protocol A3051109 (NCT00772941) and retreated with varenicline within 52 weeks of initial treatment.
Participant milestones
| Measure |
Varenicline (Champix®)
The usual adult dosage for oral use is as follows: Day 1 through Day 3, 0.5 mg once daily after eating; Day 4 through Day 7, 0.5 mg twice daily after eating in the morning and evening; and Day 8 and thereafter, 1 mg twice daily after eating in the morning and evening. Treatment period was 12 weeks. Participants were retreated within 52 weeks of initial treatment.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
Varenicline (Champix®)
The usual adult dosage for oral use is as follows: Day 1 through Day 3, 0.5 mg once daily after eating; Day 4 through Day 7, 0.5 mg twice daily after eating in the morning and evening; and Day 8 and thereafter, 1 mg twice daily after eating in the morning and evening. Treatment period was 12 weeks. Participants were retreated within 52 weeks of initial treatment.
|
|---|---|
|
Overall Study
Protocol Violation
|
14
|
Baseline Characteristics
Varenicline (Champix®) Special Investigation (Regulatory Post Marketing Commitment Plan)
Baseline characteristics by cohort
| Measure |
Varenicline (Champix®)
n=6 Participants
The usual adult dosage for oral use is as follows: Day 1 through Day 3, 0.5 mg once daily after eating; Day 4 through Day 7, 0.5 mg twice daily after eating in the morning and evening; and Day 8 and thereafter, 1 mg twice daily after eating in the morning and evening. Treatment period was 12 weeks. Participants were retreated within 52 weeks of initial treatment.
|
|---|---|
|
Age, Customized
<65 years
|
3 participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
3 participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
0 participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: The safety analysis population comprised participants who had been enrolled in varenicline protocol A3051109 and retreated with varenicline within 52 weeks of initial treatment.
An AE was any untoward medical occurrence attributed to veranicline in a participant who received veranicline. Treatment related adverse events were evaluated in company with the causal relationship to veranicline.
Outcome measures
| Measure |
Varenicline (Champix®)
n=6 Participants
The usual adult dosage for oral use is as follows: Day 1 through Day 3, 0.5 mg once daily after eating; Day 4 through Day 7, 0.5 mg twice daily after eating in the morning and evening; and Day 8 and thereafter, 1 mg twice daily after eating in the morning and evening. Treatment period was 12 weeks. Participants were retreated within 52 weeks of initial treatment.
|
|---|---|
|
Number of Participants With Treatment-Related Adverse Events (AEs)
|
0 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: The efficacy analysis population comprised the participants who had at least one post-baseline efficacy measurement among the safety analysis population.
Number of participants who succeeded in smoking cessation from 12 weeks through 24 weeks of the observation period.
Outcome measures
| Measure |
Varenicline (Champix®)
n=6 Participants
The usual adult dosage for oral use is as follows: Day 1 through Day 3, 0.5 mg once daily after eating; Day 4 through Day 7, 0.5 mg twice daily after eating in the morning and evening; and Day 8 and thereafter, 1 mg twice daily after eating in the morning and evening. Treatment period was 12 weeks. Participants were retreated within 52 weeks of initial treatment.
|
|---|---|
|
Number of Responders to Varenicline Treatment
|
2 Participants
Interval 4.3 to 77.7
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: The safety analysis population comprised participants who had been enrolled in varenicline protocol A3051109 and retreated with varenicline within 52 weeks of initial treatment.
An AE was any untoward medical occurrence attributed to varenicline in a participant who received varenicline. Treatment related adverse events were evaluated in company with the causal relationship to veranicline.
Outcome measures
| Measure |
Varenicline (Champix®)
n=6 Participants
The usual adult dosage for oral use is as follows: Day 1 through Day 3, 0.5 mg once daily after eating; Day 4 through Day 7, 0.5 mg twice daily after eating in the morning and evening; and Day 8 and thereafter, 1 mg twice daily after eating in the morning and evening. Treatment period was 12 weeks. Participants were retreated within 52 weeks of initial treatment.
|
|---|---|
|
Number of Treatment-Related Adverse Events (AEs) Unlisted in Japanese Package Insert
|
0 Participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: The safety analysis population comprised participants who had been enrolled in varenicline protocol A3051109 and retreated with varenicline within 52 weeks of initial treatment. Because of the small population size, no risk analyses were performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 weeksPopulation: The efficacy analysis population comprised the participants who had at least one post-baseline efficacy measurement among the safety analysis population. Because of the small population size, no risk analyses were performed.
Outcome measures
Outcome data not reported
Adverse Events
Varenicline (Champix®)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER