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

NCT00772941 | Completed Results

• 1 other identifier: A3051109
• Study Type: observational
• Target: 3,939
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (11)

• Risk Factors for the Frequency of Treatment Related Adverse Events - Gender.

  Number of participants with Treatment Related Adverse Events of Varenicline to determine whether gender is a significant risk factor.

  24 weeks

• Risk Factors for the Frequency of Treatment Related Adverse Events - Age.

  Number of participants with Treatment Related Adverse Events of Varenicline to determine whether age is a significant risk factor.

  24 weeks

• Risk Factors for the Frequency of Treatment Related Adverse Events - Chronic Obstructive Pulmonary Disease as a Complication.

  Number of participants with Treatment Related Adverse Events of Varenicline to determine whether Chronic obstructive pulmonary disease as a complication is a significant risk factor.

  24 weeks

• Risk Factors for the Frequency of Treatment Related Adverse Events - Concomitant Drugs.

  Number of participants with Treatment Related Adverse Events of Varenicline to determine whether taking concomitant drugs is a significant risk factor.

  24 weeks

• Risk Factors for the Frequency of Treatment Related Adverse Events - Concomitant Therapies.

  Number of participants with Treatment Related Adverse Events of Varenicline to determine whether receiving concomitant therapies is a significant risk factor.

  24 weeks

• Risk Factors for the Frequency of Treatment Related Adverse Events - Weight at Baseline.

  Number of participants with Treatment Related Adverse Events to determine whether weight at baseline is a significant risk factor.

  24 weeks

• Risk Factors for the Proportion of Responders - Tobacco Consumption Per Day.

  The primary analysis item was "the number of participants succeeding with continuous smoking cessation for the previous 4 weeks/the number of participants for efficacy evaluation excluding drop-out participants.

  24 weeks

• Risk Factors for the Proportion of Responders - Prolonged Administration After 12 Weeks.

  The primary analysis item was "the number of participants succeeding with continuous smoking cessation for the previous 4 weeks/the number of participants for efficacy evaluation excluding drop-out participants.

  24 weeks

• Risk Factors for the Proportion of Responders - Antipsychotics as a Concomitant Drug.

  The primary analysis item was "the number of participants succeeding with continuous smoking cessation for the previous 4 weeks/the number of participants for efficacy evaluation excluding drop-out participants.

  24 weeks

• Number of Participants With Treatment Related Adverse Events.

  Adverse events mean all unfavorable events that occur in participants after administration of Varenicline, irrespective of causal relationship to Varenicline (including clinically problematic abnormal changes in laboratory test values). Treatment related Adverse Events were evaluated in company with the causal relationship to Varenicline. The safety was evaluated on the first visit after 24 weeks; however, it was evaluated on the last visit for those who had stopped visiting before 24 weeks.

  24 weeks

• Number of Unlisted Treatment Related Adverse Events According to Japanese Package Insert.

  Adverse events mean all unfavorable events that occur in participants after administration of Varenicline, irrespective of causal relationship to Varenicline (including clinically problematic abnormal changes in laboratory test values). Numbers of Treatment Related Adverse Events were evaluated in company with the causal relationship to Varenicline. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert. The safety was evaluated on the first visit after 24 weeks; however, it was evaluated on the last visit for those who had stopped visiting before 24 weeks.

  24 weeks

Secondary Outcomes (1)

• Number of Participants With Continuous Abstinence Situation by 52 Weeks.

  52 weeks

Study Arms (1)

Varenicline

Patients taking Varenicline.

Drug: Varenicline

Interventions

Varenicline DRUG

Champix Tablets 0.5mg or Champix Tablets 1mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. "The usual adult dosage for oral use is 0.5 mg of varenicline once daily after eating for days 1 to 3, 0.5 mg twice daily after eating in the morning and evening for days 4 to 7, and 1 mg twice daily after eating in the morning and evening on and after day 8. The drug should be administered to patients for 12 weeks."

Also known as: Champix, Chantix

Varenicline

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 patients whom an investigator involving A3051109 prescribes the Varenicline(Champix).

You may qualify if:

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

You may not qualify if:

• Patients not administered Varenicline(Champix).

Sponsors & Collaborators

• Pfizer: lead

Related Links

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

MeSH Terms

Conditions

Smoking Cessation

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: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2008
• First Posted: October 15, 2008
• Study Start: February 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 28, 2014
• Results First Posted: January 24, 2014

Record last verified: 2014-01