NCT00143299

Brief Summary

The primary purpose of this study is to obtain safety information on cigarette smokers treated with 52 weeks of varenicline regardless of smoking status.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
375

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2003

Geographic Reach
2 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 2, 2005

Completed
Last Updated

June 4, 2007

Status Verified

June 1, 2007

First QC Date

August 31, 2005

Last Update Submit

June 1, 2007

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

  • Summarization of safety data in smokers treated with either varenicline or placebo.

Secondary Outcomes (1)

  • Information will be collected for the 7 day point prevalence of smoking cessation.

Interventions

varenicline (CP-526,555)DRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Subjects with clinically significant, recent cardiovascular disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Pfizer Investigational Site

Denver, Colorado, 80212, United States

Location

Pfizer Investigational Site

Milford, Massachusetts, 01757, United States

Location

Pfizer Investigational Site

Albuquerque, New Mexico, 87108, United States

Location

Pfizer Investigational Site

Syracuse, New York, 13210, United States

Location

Pfizer Investigational Site

Charlotte, North Carolina, 28207, United States

Location

Pfizer Investigational Site

Oklahoma City, Oklahoma, 73103, United States

Location

Pfizer Investigational Site

Harleysville, Pennsylvania, 19438, United States

Location

Pfizer Investigational Site

Richmond, Virginia, 23249, United States

Location

Pfizer Investigational Site

Woodville South, South Australia, 5011, Australia

Location

Related Publications (1)

  • Williams KE, Reeves KR, Billing CB Jr, Pennington AM, Gong J. A double-blind study evaluating the long-term safety of varenicline for smoking cessation. Curr Med Res Opin. 2007 Apr;23(4):793-801. doi: 10.1185/030079907x182185.

    PMID: 17407636DERIVED

MeSH Terms

Conditions

Smoking Cessation

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinoxalines

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 31, 2005

First Posted

September 2, 2005

Study Start

October 1, 2003

Study Completion

March 1, 2005

Last Updated

June 4, 2007

Record last verified: 2007-06

Locations

AU(1)US(8)