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Assessment of Safety and Efficacy of Varenicline in Patients That Wish to Stop Smoking
This study is currently recruiting participants.
Verified by Pfizer, December 2008
Sponsored by: Pfizer
Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00594204
  Purpose

The primary objective of this protocol is to evaluate 12 weeks of treatment of varenicline compared to placebo for smoking cessation. Abstinence from cigarette smoking and other tobacco products (e.g., pipe, cigars, chew, snuff.) use during non-treatment follow-up period will also be evaluated.


Condition Intervention Phase
Smoking Cessation
Drug: varenicline tartrate (CP-526, 555-18)
Drug: Placebo
Phase IV

MedlinePlus related topics: Quitting Smoking Smoking
Drug Information available for: Varenicline Varenicline tartrate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title: A 12-Week, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study With Follow-Up Evaluating The Safety And Efficacy Of Varenicline Tartrate 1 Mg Bid For Smoking Cessation

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The primary endpoint is the 4-week continuous abstinence rate (CAR) for Weeks 9-12. [ Time Frame: 9-12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Continuous abstinence rate (CAR) from Week 9 through Week 24. [ Time Frame: week 9-24 ] [ Designated as safety issue: No ]
  • Seven-day point prevalence of nonsmoking at Weeks 12 and 24. [ Time Frame: week 12-24 ] [ Designated as safety issue: No ]
  • Incidence rate of adverse events, premature discontinuations during the study, and changes in vital signs. [ Time Frame: through 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: April 2008
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
I: Active Comparator Drug: varenicline tartrate (CP-526, 555-18)
1 mg twice a day for 12 weeks, starting with a 1-week titration period.
II: Placebo Comparator Drug: Placebo
matching placebo 1 tablet twice a day for 12 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Current male or female cigarette smokers who are motivated to stop smoking.
  • Smoked an average of 10 cigarettes per day during past year and the month prior to first visit.

Exclusion Criteria:

  • Patients who have used a nicotine replacement product, bupropion, clonidine or notriptyline within the past 6 months.
  • Patients currently with depression or diagnosed with depression in past 12 months.
  • Past or present history of psychosis, panic disorder, or bipolar disorder.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00594204

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Show 41 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

Responsible Party: Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers: A3051080
Study First Received: January 3, 2008
Last Updated: December 29, 2008
ClinicalTrials.gov Identifier: NCT00594204  
Health Authority: Brazil: National Committee of Ethics in Research; Brazil: National Health Surveillance Agency

Study placed in the following topic categories:
Smoking

Additional relevant MeSH terms:
Habits

ClinicalTrials.gov processed this record on January 16, 2009