A Twelve-Week Study of Varenicline for Safety and Efficacy in Comparison With Placebo for Smoking Cessation

Smoking Cessation Clinical Trial

Official title:

A Twelve-Week, Double-Blind, Placebo-Controlled, Multicenter Study With Follow-up Evaluating the Safety and Efficacy of Varenicline Tartrate 1 MG BID for Smoking Cessation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00141167
• Other study ID #: A3051045
• Status: Completed
• Phase: Phase 3
• First received: August 30, 2005
• Last updated: September 3, 2010
• Start date: February 2005
• Est. completion date: January 2006

Study information

• Verified date: September 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The primary purpose of this study is to evaluate the safety and efficacy of varenicline given for a twelve week treatment period in comparison with placebo for smoking cessation.

Other known NCT identifiers

• NCT00155298

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Subjects must have smoked an average of at least 10 cigarettes per day during the past year and over the month prior to the screening visit, with no period of abstinence greater than 3 months in the past year.

Exclusion Criteria:

• Subjects who have used bupropion, Zyban, or Wellbutrin previously.

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:
• varenicline

Locations

Country	Name	City	State
Korea, Republic of	Pfizer Investigational Site	Anyang-Si	Gyeonggi-do
Korea, Republic of	Pfizer Investigational Site	Daegu-si
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Taiwan	Pfizer Investigational Site	Hualien
Taiwan	Pfizer Investigational Site	Kaohsiung
Taiwan	Pfizer Investigational Site	Kweishan	Taoyuan County
Taiwan	Pfizer Investigational Site	Taichung
Taiwan	Pfizer Investigational Site	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Korea, Republic of,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	4 week continuous quit rate ( 4 week CQR ) for weeks 9 -12
Secondary	Continuous abstinence rate weeks 9-24
Secondary	Long-term Quit Rate at week 24
Secondary	7 day point prevalence week 12 and 24
Secondary	Results of Minnesota Nicotine Withdrawal Scale
Secondary	Brief Questionnaire of Smoking Urges
Secondary	Smoking Effects Inventory