Expired Study
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Atlanta, Georgia


Purpose:

The primary purpose of this study is to evaluate the safety and efficacy of varenicline given for a twelve week treatment period in comparison with placebo and Zyban for smoking cessation.


Criteria:

Inclusion Criteria: - Subjects must have smoked an average of at least 10 cigarettes per day during the past year and over the month prior to the screening visit, with no period of abstinence greater than 3 months in the past year. Exclusion Criteria: - Subjects who have used bupropion (Zyban, or Wellbutrin) previously.


Study is Available At:


Original ID:

A3051028


NCT ID:

NCT00141206


Secondary ID:


Study Acronym:


Brief Title:

A Twelve-Week Study of Varenicline for Safety and Efficacy in Comparison With Placebo and Zyban for Smoking Cessation


Official Title:

A Twelve-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study With Follow-up Evaluating the Safety and Efficacy of Varenicline Tartrate ( CP-526,555) in Comparison to Zyban for Smoking Cessation


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

75 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Pfizer


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

1005


Enrollment Type:


Overall Contact Information

Official Name:Pfizer CT.gov Call Center
Study Director
Pfizer

Study Dates

Start Date:May 2003
Completion Date:April 2005
Completion Type:Actual
Verification Date:June 2007
Last Changed Date:June 1, 2007
First Received Date:August 30, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure:4 week Continuous Quit Rate ( 4 week CQR ) for weeks 9 -12
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Continuous abstinence Weeks 9-52
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Long-term Quit Rate Week 52
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Continuous abstinence Weeks 9 -24
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:7-day Point Prevalence Abstinence Weeks 12, 24, and 52
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:4-week Point Prevalence Abstinence at Week 52
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Minnesota Nicotine Withdrawal Scale
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Brief Questionnaire of Smoking Urges
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Smoking Effects Inventory
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change from baseline in bodyweight
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:varenicline (CP-526,555)

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Pfizer

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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