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NCT00150254 Clinical Trial

12 Week Evaluation of the Safety and Efficacy of 4 Dosing Strategies 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 Four Dosing Strategies for CP-526,555 ( 0.5 mg BID Titrated, 0.5 mg BID, 1 mg BID, and Titrated 1 mg BID ) in Smoking Cessation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00150254
Other study ID # A3051007
Secondary ID
Status Completed
Phase Phase 2
First received September 6, 2005
Last updated June 1, 2007
Start date September 2001
Est. completion date October 2002

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 purpose of the study is to measure the safety and efficacy of four dosing strategies of CP-526,555 for 12 weeks 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 A3051018

Recruitment information / eligibility
Status Completed
Enrollment 625
Est. completion date October 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 on average of at least ten cigarettes per day during the past year

- Subjects must have no period of abstinence greater than three months in the past year

Exclusion Criteria:

- Subjects with any history of clinically significant cardiovascular disease

- 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 Cincinnati Ohio
United States Pfizer Investigational Site Farmington Connecticut
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site Jackson Mississippi
United States Pfizer Investigational Site Jackson Florida
United States Pfizer Investigational Site Lexington Kentucky
United States Pfizer Investigational Site Los Angeles California
United States Pfizer Investigational Site New Orleans Louisiana
United States Pfizer Investigational Site Omaha Nebraska
United States Pfizer Investigational Site Portland Oregon
United States Pfizer Investigational Site San Bernardino California
United States Pfizer Investigational Site Upland California
United States Pfizer Investigational Site West Covina California

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 9-12 and Weeks 4-7
Secondary Continuous abstinence rate from target quit date to end of treatment (Week 12)
Secondary Carbon monoxide(CO)-confirmed 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 baselin
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Completed NCT02997657 - Positive Psychotherapy for Smoking Cessation Enhanced With Text Messaging: A Randomized Controlled Trial N/A
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