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NCT00150228 Clinical Trial

12 Week Evaluation of the Safety and Efficacy of a Flexible Dose of CP-526,555 and Placebo for Smoking Cessation

Smoking Cessation Clinical Trial

Official title:
A Twelve-Week Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating the Safety and Efficacy of a Flexible-Dosing Strategy for CP-526,555 ( 0.5 mg to 2.0 mg Total Daily Dose ) in Smoking Cessation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00150228
Other study ID # A3051016
Secondary ID
Status Completed
Phase Phase 2
First received September 6, 2005
Last updated May 31, 2007
Start date December 2001
Est. completion date September 2002

Study information
Verified date May 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 purpose of the study was to measure the safety and efficacy of a 12-week flexible dosing strategy of CP-526,555 compared with placebo for smoking cessation. Post-treatment follow-up of smoking status to one year from randomization was performed in a non-treatment extension Protocol A3051019

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date September 2002
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Subjects must have smoked an average of at least ten cigarettes per day during the past year

- No period of abstinence greater than three months in the past year

Exclusion Criteria:

- Subjects with history of clinically significant cardiovascular disease

- Subjects with uncontrolled hypertension.

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:
• CP-526,555 (varenicline)

Locations
Country Name City State
United States Pfizer Investigational Site Albert Lea Minnesota
United States Pfizer Investigational Site La Crosse Wisconsin
United States Pfizer Investigational Site Lexington Kentucky
United States Pfizer Investigational Site Madison Wisconsin
United States Pfizer Investigational Site Philadelphia Pennsylvania
United States Pfizer Investigational Site Providence Rhode Island
United States Pfizer Investigational Site Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 4-week continuous quit rate (CQR) at Weeks 4-7 and 9-12 .
Secondary Continuous abstinence rate from target quit date to end of treatment (Week 12)
Secondary 7-day point prevalence of abstinence at Week 12
Secondary Number of cigarettes smoked per day
Secondary Urge to smoke and withdrawal symptoms assessed by Minnesota Nicotine Withdrawal Scale
Secondary Rewarding effects of smoking assessed by Smoking Effects Inventory
Secondary weight change from baseline
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