N/A N=3,939

Drug Use Investigation Of Varenicline (Regulatory Post Marketing Commitment Plan)

Smoking Cessation

Bottom Line

View on ClinicalTrials.gov: NCT00772941 ↗

Enrolled (actual)

3,939

Serious AEs

0.3%

Results posted

Jan 2014

Primary outcome: Primary: Risk Factors for the Frequency of Treatment Related Adverse Events - Gender. — 377; 336 participants — p=<0.001

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Varenicline (Drug)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Pfizer
Primary completion: Dec 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Risk Factors for the Frequency of Treatment Related Adverse Events - Gender.	377; 336	<0.001 sig
PRIMARY Risk Factors for the Frequency of Treatment Related Adverse Events - Age.	571; 142	<0.001 sig
PRIMARY Risk Factors for the Frequency of Treatment Related Adverse Events - Chronic Obstructive Pulmonary Disease as a Complication.	23; 690	<0.001 sig
PRIMARY Risk Factors for the Frequency of Treatment Related Adverse Events - Concomitant Drugs.	289; 424	<0.001 sig
PRIMARY Risk Factors for the Frequency of Treatment Related Adverse Events - Concomitant Therapies.	45; 668	<0.001 sig
PRIMARY Risk Factors for the Frequency of Treatment Related Adverse Events - Weight at Baseline.	6; 98; 135; 110; 61; 31	<0.001 sig
PRIMARY Risk Factors for the Proportion of Responders - Tobacco Consumption Per Day.	1299; 817; 66	<0.001 sig
PRIMARY Risk Factors for the Proportion of Responders - Prolonged Administration After 12 Weeks.	39; 1993	<0.001 sig
PRIMARY Risk Factors for the Proportion of Responders - Antipsychotics as a Concomitant Drug.	85; 2111	<0.001 sig
PRIMARY Number of Participants With Treatment Related Adverse Events.	713	—
PRIMARY Number of Unlisted Treatment Related Adverse Events According to Japanese Package Insert.	30	—
SECONDARY Number of Participants With Continuous Abstinence Situation by 52 Weeks.	38	—

Summary

The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

Eligibility Criteria

Inclusion Criteria

Patients need to be administered Varenicline(Champix) in order to be enrolled in the surveillance.

Exclusion Criteria

Patients not administered Varenicline(Champix).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00772941). 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.