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Trial record 1 of 1 for:    NCT00741884
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A Study to Evaluate the Safety and Efficacy of Three Doses of a Controlled Release Formulation of Varenicline for Smoking Cessation

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ClinicalTrials.gov Identifier: NCT00741884
Recruitment Status : Withdrawn
First Posted : August 26, 2008
Last Update Posted : April 22, 2015
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE August 22, 2008
First Posted Date  ICMJE August 26, 2008
Last Update Posted Date April 22, 2015
Study Start Date  ICMJE August 2010
Estimated Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 25, 2008)
Continuous abstinence from smoking for weeks 4-7, carbon monoxide confirmed [ Time Frame: 7 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 17, 2008)
  • 7- day point prevalence of non-smoking at week 7 [ Time Frame: 7 days ]
  • Scores on the Minnesota Nicotine Withdrawal Scale subscales [ Time Frame: 7 weeks ]
  • Scores on the Modified Cigarette Evaluation Questionaire subscales [ Time Frame: 7 weeks ]
  • PK analysis [ Time Frame: 7 weeks ]
  • Safety Assessments: adverse events, C-SSRs, vital signs, body weight [ Time Frame: 7 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2008)
  • 7- day point prevalence of non-smoking at week 7 [ Time Frame: 7 days ]
  • Scores on the Minnesota Nicotine Withdrawal Scale subscales [ Time Frame: 7 weeks ]
  • Scores on the Modified Cigarette Evaluation Questionnaire subscales [ Time Frame: 7 weeks ]
  • PK analysis [ Time Frame: 7 weeks ]
  • Safety Assessments: adverse events, C-SSRs, vital signs, body weight [ Time Frame: 7 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety and Efficacy of Three Doses of a Controlled Release Formulation of Varenicline for Smoking Cessation
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Smoking Cessation
Intervention  ICMJE
  • Drug: Varenicline Controlled Release 1.2 mg
    Varenicline CR tablet 1.2 mg BID for 7 weeks
  • Drug: Varenicline Controlled Release 1.8 mg
    Varenicline CR tablet 1.8 mg BID for 7 weeks
  • Drug: Varenicline Controlled Release 2.4 mg
    Varenicline CR tablet 2.4 mg BID for 7 weeks
  • Drug: Varenicline Immediate Release 1 mg
    Varenicline IR tablet 1 mg BID for 7 weeks
  • Drug: Placebo
    Placebo BID for 7 weeks
Study Arms  ICMJE
  • Experimental: Arm 1
    Intervention: Drug: Varenicline Controlled Release 1.2 mg
  • Experimental: Arm 2
    Intervention: Drug: Varenicline Controlled Release 1.8 mg
  • Experimental: Arm 3
    Intervention: Drug: Varenicline Controlled Release 2.4 mg
  • Active Comparator: Arm 4
    Intervention: Drug: Varenicline Immediate Release 1 mg
  • Placebo Comparator: Arm 5
    Intervention: Drug: Placebo
Publications * Not Provided

*   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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: April 21, 2015)
0
Original Estimated Enrollment  ICMJE
 (submitted: August 25, 2008)
305
Estimated Study Completion Date  ICMJE August 2011
Estimated Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00741884
Other Study ID Numbers  ICMJE A3051090
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 Center Pfizer
PRS Account Pfizer
Verification Date April 2015

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