Clinical Trials Logo
  1. Home
  2. Smoking Cessation
  3. NCT00143286
  4. Details
NCT00143286 Clinical Trial

A 52-Week Multicenter Study Evaluating the Safety and Efficacy of Varenicline for the Maintenance of Smoking Cessation

Smoking Cessation Clinical Trial

Official title:
A 52-Week Multicenter Study Evaluating the Safety and Efficacy of Varenicline ( CP-526,555) for the Maintenance of Smoking Cessation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00143286
Other study ID # A3051035
Secondary ID
Status Completed
Phase Phase 3
First received August 31, 2005
Last updated June 1, 2007
Start date April 2003
Est. completion date March 2005

Study information
Verified date June 2007
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The primary purpose of this study is a comparison of abstinence maintenance in subjects randomized to double-blind varenicline or placebo from Weeks 13 -24 in subjects who responded to an intial 12-week open label course of varenicline, with post-treatment follow-up of smoking status to Week 52.

Recruitment information / eligibility
Status Completed
Enrollment 2000
Est. completion date March 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• varenicline (CP-526,555)

Locations
Country Name City State
Canada Pfizer Investigational Site Calgary Alberta
Canada Pfizer Investigational Site Cornwall Prince Edward Island
Canada Pfizer Investigational Site Halifax Nova Scotia
Canada Pfizer Investigational Site Ottawa Ontario
Canada Pfizer Investigational Site Sherbrooke Quebec
Canada Pfizer Investigational Site Toronto Ontario
Czech Republic Pfizer Investigational Site Prague 2
Denmark Pfizer Investigational Site Aarhus C
Denmark Pfizer Investigational Site Frederikssund
Denmark Pfizer Investigational Site Hellerup Copenhagen
Norway Pfizer Investigational Site Bergen
Norway Pfizer Investigational Site Honefoss
Norway Pfizer Investigational Site Oslo
Sweden Pfizer Investigational Site Göteborg
Sweden Pfizer Investigational Site Helsingborg
Sweden Pfizer Investigational Site Stockholm
United Kingdom Pfizer Investigational Site London Surrey
United Kingdom Pfizer Investigational Site London
United States Pfizer Investigational Site Dallas Texas
United States Pfizer Investigational Site Lexington Kentucky
United States Pfizer Investigational Site Mogadore Ohio
United States Pfizer Investigational Site Santa Ana California
United States Pfizer Investigational Site Seattle Washington
United States Pfizer Investigational Site West Palm Beach Florida

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada,  Czech Republic,  Denmark,  Norway,  Sweden,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Continuous abstinence Weeks 13 -24.
Secondary Continuous abstinence Weeks 13-52
Secondary Long term quit rate at Week 52
Secondary 7-day Point Prevalence of abstinence at Weeks 24, 52
Secondary 4-week Point Prevalence of abstinence at Week 52
Secondary Time to first cigarette post randomization
See also
  Status Clinical Trial Phase
Completed NCT04043728 - Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study N/A
Completed NCT03999411 - Smartphone Intervention for Smoking Cessation and Improving Adherence to Treatment Among HIV Patients Phase 4
Completed NCT04617444 - The ESTxENDS Trial- Substudy on Effects of Using Electronic Nicotine Delivery Systems (ENDS) on Olfactory Function N/A
Completed NCT02796391 - Facilitating Smoking Cessation With Reduced Nicotine Cigarettes Phase 2
Completed NCT03397511 - Incorporating Financial Incentives to Increase Smoking Cessation Among Asian Americans Residing in New York City N/A
Not yet recruiting NCT05188287 - A Culturally Tailored Smartphone Application for African American Smokers N/A
Recruiting NCT05264428 - The Effect of Honey on Lessening the Withdrawal Symptoms N/A
Recruiting NCT05846841 - Personalized Tobacco Treatment in Primary Care (MOTIVATE) N/A
Completed NCT04133064 - Assessment of the Pivot Breath Sensor: Single-Arm Cohort Study N/A
Completed NCT03187730 - Integrating Financial Management Counseling and Smoking Cessation Counseling to Reduce Health and Economic Disparities in Low-Income Immigrants Phase 4
Completed NCT03474783 - To Explore the Factors Affecting the Effectiveness of Smoking Cessation N/A
Completed NCT04635358 - Feasibility Study of Smoking Cessation for the Staff of a Hospital Center N/A
Terminated NCT03670264 - BE Smokefree: Behavioral Economics Incentives to Engage Adolescents in Smoking Cessation N/A
Not yet recruiting NCT06307496 - VIDeOS for Smoking Cessation N/A
Completed NCT02997657 - Positive Psychotherapy for Smoking Cessation Enhanced With Text Messaging: A Randomized Controlled Trial N/A
Completed NCT02905656 - Strategies to Promote Cessation in Smokers Who Are Not Ready To Quit N/A
Completed NCT03206619 - A Health Recommeder System to Tailor Message Preferences in a Smoking Cessation Programme
Completed NCT02562521 - A Smoking Cessation Intervention for Yale Dining Employees Phase 4
Completed NCT02239770 - Pharmacokinetics of Nicotine Film in Smokers N/A
Recruiting NCT02422914 - Benefits of Tobacco Free Cigarette N/A

External Links