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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00741884
Other study ID # A3051090
Secondary ID
Status Withdrawn
Phase Phase 2
First received August 22, 2008
Last updated April 21, 2015
Start date August 2010
Est. completion date August 2011

Study information

Verified date April 2015
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date August 2011
Est. primary completion date August 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Outcome

Type Measure Description Time frame Safety issue
Primary Continuous abstinence from smoking for weeks 4-7, carbon monoxide confirmed 7 weeks No
Secondary 7- day point prevalence of non-smoking at week 7 7 days No
Secondary Scores on the Minnesota Nicotine Withdrawal Scale subscales 7 weeks No
Secondary Scores on the Modified Cigarette Evaluation Questionaire subscales 7 weeks No
Secondary PK analysis 7 weeks No
Secondary Safety Assessments: adverse events, C-SSRs, vital signs, body weight 7 weeks Yes
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