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NCT00143325 Clinical Trial

An Open Label Study That Compares Varenicline to Transdermal Nicotine Patch for Smoking Cessation

Smoking Cessation Clinical Trial

Official title:
An Open-Label, Multicenter Study With Follow-Up Evaluating the Safety and Efficacy of Varenicline Tartrate in Comparison to Transdermal Nicotine Patch for Smoking Cessation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00143325
Other study ID # A3051044
Secondary ID
Status Completed
Phase Phase 3
First received August 31, 2005
Last updated June 1, 2007
Start date January 2005
Est. completion date June 2006

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

Open-label comparison of standard 12-week regimen of varenicline with standard 10-week regimen of transdermal nicotine patch for smoking cessation.

Recruitment information / eligibility
Status Completed
Enrollment 730
Est. completion date June 2006
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 15 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
Belgium Pfizer Investigational Site Bruxelles
Belgium Pfizer Investigational Site Edegem
Belgium Pfizer Investigational Site Gent
France Pfizer Investigational Site Caen
France Pfizer Investigational Site Clermont-Ferrand
France Pfizer Investigational Site Limeil Brevannes
France Pfizer Investigational Site Limeil-Brevannes
France Pfizer Investigational Site Metz CEDEX 01
France Pfizer Investigational Site Metz Cedex 1
France Pfizer Investigational Site Paris
France Pfizer Investigational Site Vandoeuvre les Nancy
Netherlands Pfizer Investigational Site Amsterdam
Netherlands Pfizer Investigational Site Enschede
Netherlands Pfizer Investigational Site Maastricht
Netherlands Pfizer Investigational Site Zutphen
United Kingdom Pfizer Investigational Site London Surrey
United Kingdom Pfizer Investigational Site London
United Kingdom Pfizer Investigational Site Nottingham
United States Pfizer Investigational Site Farmington Connecticut
United States Pfizer Investigational Site Lexington Kentucky
United States Pfizer Investigational Site Palo Alto California
United States Pfizer Investigational Site Portland Oregon
United States Pfizer Investigational Site Santa Ana California
United States Pfizer Investigational Site Worcester Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Belgium,  France,  Netherlands,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Continuous abstinence for the last 4 weeks of varenicline and NRT (Nicotine Replacement Therapy) treatment period
Secondary Continuous abstinence last 4 weeks of treatment through Weeks 24 and 52
Secondary 7-day point prevalence of abstinence: end of treatment, Weeks 24 and 52
Secondary 4-week Point Prevalence of abstinence at Week 52
Secondary Long-Term Quit Rate at Weeks 24 and 52
Secondary Minnesota Nicotine Withdrawal Scale
Secondary Smoking Effects Inventory
See also
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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
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Completed NCT02562521 - A Smoking Cessation Intervention for Yale Dining Employees Phase 4
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