Randomized Study Comparing the Efficacy and Safety of Varenicline Tartrate to Placebo in Smoking Cessation When Subjects Are Allowed to Set Their Own Quit Date

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NCT00691483

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Study Location
Pfizer Investigational Site
Litchfield Park, Arizona, 85340, United States
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Smoking Cessation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Men and women

- 18 to 75 yrs old

- Motivated to stop smoking

- Smoke at least 10 cigarettes/day

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Active psychiatric disease


- Severe or unstable cardiovascular or pulmonary disease


- Current or recent treatment to stop smoking


- Previous use of varenicline

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Advanced Information
Descriptive Information
Brief Title  ICMJE Randomized Study Comparing the Efficacy and Safety of Varenicline Tartrate to Placebo in Smoking Cessation When Subjects Are Allowed to Set Their Own Quit Date
Official Title  ICMJE A Phase 4, Prospective, Multi-National, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate Smoking Cessation With Varenicline Tartrate Compared With Placebo In The Setting Of Patient Self-Selected (Flexible) Quit Date
Brief Summary The hypothesis is that varenicline will be effective (compared with placebo) for smoking cessation when subjects are allowed to set their own quit date within the first 5 weeks of treatment.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Smoking Cessation
Intervention  ICMJE
  • Drug: placebo
    placebo tablet taken orally twice daily for 12 weeks
  • Drug: varenicline
    varenicline tablets, 1 mg taken orally twice daily for 12 weeks
    Other Name: Chantix, Champix
Study Arms  ICMJE
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
  • Experimental: varenicline
    Intervention: Drug: varenicline
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 17, 2009)		659
Original Estimated Enrollment  ICMJE
 (submitted: June 3, 2008)		652
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men and women
  • 18 to 75 yrs old
  • Motivated to stop smoking
  • Smoke at least 10 cigarettes/day

Exclusion Criteria:

  • Active psychiatric disease
  • Severe or unstable cardiovascular or pulmonary disease
  • Current or recent treatment to stop smoking
  • Previous use of varenicline
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Brazil,   Canada,   China,   Czech Republic,   France,   Germany,   Hungary,   Italy,   Korea, Republic of,   Mexico,   Taiwan,   United Kingdom,   United States
Removed Location Countries Poland
 
Administrative Information
NCT Number  ICMJE NCT00691483
Other Study ID Numbers  ICMJE A3051095
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP