A Seven-Week Dose-Ranging Study of CP-526,555 Compared With Placebo and Zyban for Smoking Cessation

Smoking Cessation Clinical Trial

Official title:

A Seven-Week Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating the Safety and Efficacy of Three Doses of CP-526,555 ( 0.3 mg QD, 1 mg QD, and 1 mg BID ) in Comparison With Zyban in Smoking Cessation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00150241
• Other study ID #: A3051002
• Status: Completed
• Phase: Phase 2
• First received: September 6, 2005
• Last updated: October 16, 2015
• Start date: February 2000
• Est. completion date: January 2002

Study information

• Verified date: October 2015
• 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 three doses of varenicline for smoking cessation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 625
• Est. completion date: January 2002
• 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 cardiovascular disease

• Myocardial infarction

• Significant arrhythmias

• Poorly controlled hypertension

Study Design

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

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Drug:
• CP-526,555 (varenicline)

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Farmington	Connecticut
United States	Pfizer Investigational Site	Los Angeles	California
United States	Pfizer Investigational Site	Minneapolis	Minnesota
United States	Pfizer Investigational Site	Morgantown	West Virginia
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	Omaha	Nebraska
United States	Pfizer Investigational Site	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary efficacy outcome is smoking abstinence for any continuous 4-week period (4-week CQR) during the study treatment phase.
Secondary	Fixed window 4-week CQR, Weeks 3-6, 4-7
Secondary	Continuous abstinence from Target Quit Date to Weeks 12, 24, and 52
Secondary	7-day Point Prevalence of abstinence Week 52
Secondary	Number of cigarettes smoked per day
Secondary	Minnesota Nicotine Withdrawal Scale
Secondary	Smoking Effects Inventory
Secondary	Brief Questionnaire of Smoking Urge

External Links

•   To obtain contact information for a study center near you, click here.