Varenicline (Champix®) Special Investigation (Regulatory Post Marketing Commitment Plan)

NCT01061710 | Completed Results

• 1 other identifier: A3051117
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Smoking Cessation

Keywords

Smoking; smoking cessation; Japanese; varenicline; retreatment; Regulatory Post Marketing Commitment Plan

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Treatment-Related Adverse Events (AEs)

  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.

  24 weeks

• Number of Responders to Varenicline Treatment

  Number of participants who succeeded in smoking cessation from 12 weeks through 24 weeks of the observation period.

  24 weeks

Secondary Outcomes (3)

• Number of Treatment-Related Adverse Events (AEs) Unlisted in Japanese Package Insert

  24 weeks

• Number of Participants With Risk Factors Likely to Affect the Frequency of Treatment-Related Adverse Events (AEs)

  24 weeks

• Number of Participants With Risk Factors Likely to Affect the Proportion of Responders

  24 weeks

Study Arms (1)

varenicline (Champix®)

Subjects who have been retreated with varenicline within 52 weeks and have been enrolled to varenicline protocol A3051109.

Drug: varenicline

Interventions

varenicline DRUG

Dosage form: tablet 0.5mg, tablet 1mg. The usual adult dosage for oral use is 0.5 mg once daily after eating on Days 1 to 3; 0.5 mg twice daily after eating in the morning and evening on Days 4 to 7, and 1 mg twice daily after eating in the morning and evening on Day 8 and thereafter. The drug should be administered to subjects for 12 weeks.

Also known as: Chantix, Champix

varenicline (Champix®)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The subjects who have been retreated with varenicline in A3051109 (NCT# NCT00772941) within 52 weeks of initial treatment.

You may qualify if:

• 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.

You may not qualify if:

• Non-participants of varenicline (Champix®) Drug use Investigation protocol A3051109.

Sponsors & Collaborators

• Pfizer: lead

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Smoking Cessation; Smoking

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2010
• First Posted: February 3, 2010
• Study Start: July 1, 2010
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: February 11, 2015
• Results First Posted: February 11, 2015

Record last verified: 2015-01