12 Week Evaluation of the Safety and Efficacy of 4 Dosing Strategies of CP-526,555 and Placebo for Smoking Cessation.

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00150254
First received: September 6, 2005
Last updated: June 1, 2007
Last verified: June 2007
  Purpose

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


Condition Intervention Phase
Smoking Cessation
Drug: CP-526,555 (varenicline)
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 4 week continuous quit rate (CQR) at Weeks 9-12 and Weeks 4-7

Secondary Outcome Measures:
  • Continuous abstinence rate from target quit date to end of treatment (Week 12)
  • Carbon monoxide(CO)-confirmed 7-day point prevalence of abstinence at Week 12
  • Number of cigarettes smoked per day
  • Urge to smoke and withdrawal symptoms assessed by Minnesota Nicotine Withdrawal Scale
  • Rewarding effects of smoking assessed by Smoking Effects Inventory
  • Weight change from baselin

Estimated Enrollment: 625
Study Start Date: September 2001
Study Completion Date: October 2002
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00150254

Locations
United States, California
Pfizer Investigational Site
Los Angeles, California, United States
Pfizer Investigational Site
San Bernardino, California, United States
Pfizer Investigational Site
Upland, California, United States
Pfizer Investigational Site
West Covina, California, United States
United States, Connecticut
Pfizer Investigational Site
Farmington, Connecticut, United States
United States, Florida
Pfizer Investigational Site
Jackson, Florida, United States
United States, Kentucky
Pfizer Investigational Site
Lexington, Kentucky, United States
United States, Louisiana
Pfizer Investigational Site
New Orleans, Louisiana, United States
United States, Mississippi
Pfizer Investigational Site
Jackson, Mississippi, United States
United States, Nebraska
Pfizer Investigational Site
Omaha, Nebraska, United States
United States, Ohio
Pfizer Investigational Site
Cincinnati, Ohio, United States
United States, Oregon
Pfizer Investigational Site
Portland, Oregon, United States
United States, Texas
Pfizer Investigational Site
Houston, Texas, United States
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00150254     History of Changes
Other Study ID Numbers: A3051007
Study First Received: September 6, 2005
Last Updated: June 1, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Smoking
Food Habits
Habits
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 31, 2014