A Study to Evaluate the Safety and Efficacy of Three Doses of a Controlled Release Formulation of Varenicline for Smoking Cessation

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00741884
• Other study ID #: A3051090
• Status: Withdrawn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• Status: Withdrawn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

• Smoking Cessation

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

External Links

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