A Seven-Week Dose-Ranging Study of CP-526,555 Compared With Placebo and Zyban for Smoking Cessation
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
1 other identifier
interventional
625
1 country
7
Brief Summary
The purpose of the study is to measure the safety and efficacy of three doses of varenicline for smoking cessation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2000
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2000
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2002
CompletedFirst Submitted
Initial submission to the registry
September 6, 2005
CompletedFirst Posted
Study publicly available on registry
September 8, 2005
CompletedOctober 19, 2015
October 1, 2015
September 6, 2005
October 16, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
The primary efficacy outcome is smoking abstinence for any continuous 4-week period (4-week CQR) during the study treatment phase.
Secondary Outcomes (7)
Fixed window 4-week CQR, Weeks 3-6, 4-7
Continuous abstinence from Target Quit Date to Weeks 12, 24, and 52
7-day Point Prevalence of abstinence Week 52
Number of cigarettes smoked per day
Minnesota Nicotine Withdrawal Scale
- +2 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Subjects with any history of cardiovascular disease
- Myocardial infarction
- Significant arrhythmias
- Poorly controlled hypertension
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (7)
Pfizer Investigational Site
Los Angeles, California, United States
Pfizer Investigational Site
Farmington, Connecticut, United States
Pfizer Investigational Site
Minneapolis, Minnesota, United States
Pfizer Investigational Site
Omaha, Nebraska, United States
Pfizer Investigational Site
New York, New York, United States
Pfizer Investigational Site
Portland, Oregon, United States
Pfizer Investigational Site
Morgantown, West Virginia, United States
Related Publications (2)
Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6.
PMID: 37230961DERIVEDLivingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.
PMID: 37142273DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 6, 2005
First Posted
September 8, 2005
Study Start
February 1, 2000
Study Completion
January 1, 2002
Last Updated
October 19, 2015
Record last verified: 2015-10