Expired Study
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Dallas, Texas


Purpose:

The primary purpose of this study is a comparison of abstinence maintenance in subjects randomized to double-blind varenicline or placebo from Weeks 13 -24 in subjects who responded to an intial 12-week open label course of varenicline, with post-treatment follow-up of smoking status to Week 52.


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 with clinically significant cardiovascular disease in the past 6 months.


Study is Available At:


Original ID:

A3051035


NCT ID:

NCT00143286


Secondary ID:


Study Acronym:


Brief Title:

A 52-Week Multicenter Study Evaluating the Safety and Efficacy of Varenicline for the Maintenance of Smoking Cessation


Official Title:

A 52-Week Multicenter Study Evaluating the Safety and Efficacy of Varenicline ( CP-526,555) for the Maintenance of 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:

2000


Enrollment Type:


Overall Contact Information

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

Study Dates

Start Date:April 2003
Completion Date:March 2005
Completion Type:Actual
Verification Date:June 2007
Last Changed Date:June 1, 2007
First Received Date:August 31, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Time to first cigarette post randomization
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:4-week Point Prevalence of abstinence at Week 52
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:7-day Point Prevalence of abstinence at Weeks 24, 52
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Long term quit rate at Week 52
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Continuous abstinence Weeks 13-52
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Continuous abstinence Weeks 13 -24.
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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