A Study to Evaluate the Safety and Efficacy of Three Doses of a Controlled Release Formulation of Varenicline for Smoking Cessation
A Phase 2, Seven Week, Double-Blind, Placebo Controlled, Randomized, Parallel Group Study To Evaluate The Safety And Efficacy Of Three Doses Of A Controlled Release Formulation Of Varenicline For Smoking Cessation
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate the safety, efficacy, and tolerability of twice daily (BID) administration of three dose strengths (1.2 mg, 1.8 mg, and 2.4 mg) of varenicline controlled release (CR) tablets in adult smokers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Aug 2010
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 22, 2008
CompletedFirst Posted
Study publicly available on registry
August 26, 2008
CompletedStudy Start
First participant enrolled
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedApril 22, 2015
April 1, 2015
1 year
August 22, 2008
April 21, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Continuous abstinence from smoking for weeks 4-7, carbon monoxide confirmed
7 weeks
Secondary Outcomes (5)
7- day point prevalence of non-smoking at week 7
7 days
Scores on the Minnesota Nicotine Withdrawal Scale subscales
7 weeks
Scores on the Modified Cigarette Evaluation Questionaire subscales
7 weeks
PK analysis
7 weeks
Safety Assessments: adverse events, C-SSRs, vital signs, body weight
7 weeks
Study Arms (5)
Arm 1
EXPERIMENTALArm 2
EXPERIMENTALArm 3
EXPERIMENTALArm 4
ACTIVE COMPARATORArm 5
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Male or female cigarette smokers between the ages of 18 and 75 years, inclusive, who are motivated to stop smoking.
- 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.
You may not qualify if:
- Subjects with clinically significant cardiovascular disease in the past 6 months.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 22, 2008
First Posted
August 26, 2008
Study Start
August 1, 2010
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
April 22, 2015
Record last verified: 2015-04