A Study to Evaluate the Safety and Efficacy of Three Doses of a Controlled Release Formulation of Varenicline for Smoking Cessation
NCT ID: NCT00741884
Last Updated: 2015-04-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2010-08-31
2011-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm 1
Varenicline Controlled Release 1.2 mg
Varenicline CR tablet 1.2 mg BID for 7 weeks
Arm 2
Varenicline Controlled Release 1.8 mg
Varenicline CR tablet 1.8 mg BID for 7 weeks
Arm 3
Varenicline Controlled Release 2.4 mg
Varenicline CR tablet 2.4 mg BID for 7 weeks
Arm 4
Varenicline Immediate Release 1 mg
Varenicline IR tablet 1 mg BID for 7 weeks
Arm 5
Placebo
Placebo BID for 7 weeks
Interventions
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Varenicline Controlled Release 1.2 mg
Varenicline CR tablet 1.2 mg BID for 7 weeks
Varenicline Controlled Release 1.8 mg
Varenicline CR tablet 1.8 mg BID for 7 weeks
Varenicline Controlled Release 2.4 mg
Varenicline CR tablet 2.4 mg BID for 7 weeks
Varenicline Immediate Release 1 mg
Varenicline IR tablet 1 mg BID for 7 weeks
Placebo
Placebo BID for 7 weeks
Eligibility Criteria
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Inclusion Criteria
* Females of non-childbearing potential (surgically sterilized or at least 2 years postmenopausal) who are not nursing may be included.
* 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 hospitalized within the past 12 months due to suicidal ideation or suicidal behavior or subjects considered to have serious suicidal ideation or suicidal behavior within the past 12 months.
* Subjects having active suicidal ideation or behavior identified at Screen or Baseline.
* Subjects currently or within the past 12 months requiring treatment for depression. Subjects with current or prior history of panic disorder, anxiety disorder, hostility or aggression disorder, perceptual/thinking disturbances, psychosis, or bipolar disorder.
18 Years
75 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Pfizer, Inc.
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A3051090
Identifier Type: -
Identifier Source: org_study_id
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