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NCT00371813 Clinical Trial

An Investigation of Effectiveness and Safety of Varenicline Tartrate in Helping People Quit Smoking

Smoking Cessation Clinical Trial

Official title:
A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Multinational Study Of Efficacy And Safety Of Varenicline Tartrate For Smoking Cessation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00371813
Other study ID # A3051055
Secondary ID
Status Completed
Phase Phase 3
First received August 31, 2006
Last updated April 21, 2015
Start date September 2006
Est. completion date June 2007

Study information
Verified date April 2015
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

To investigate safety and efficacy of varenicline tartrate in helping people quit smoking

Recruitment information / eligibility
Status Completed
Enrollment 334
Est. completion date June 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Current cigarette smokers between the ages of 18 and 75 years, who are motivated to stop smoking

Exclusion Criteria:

- Patients currently suffering from depression, or have been diagnosed with depression in the last 12 months, or subjects with past or present history of psychosis, panic disorder, or bipolar disorder

- Any subject with known severe chronic obstructive pulmonary disease (COPD)

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:
• Varenicline tartrate

• Placebo

Locations
Country Name City State
China Pfizer Investigational Site Beijing
China Pfizer Investigational Site Beijing
China Pfizer Investigational Site Beijing
China Pfizer Investigational Site Beijing
China Pfizer Investigational Site Guangzhou
China Pfizer Investigational Site Shanghai
China Pfizer Investigational Site Shen Yang
China Pfizer Investigational Site Shenyang Liaoning
China Pfizer Investigational Site Tanjin
Singapore Pfizer Investigational Site Singapore
Singapore Pfizer Investigational Site Singapore
Singapore Pfizer Investigational Site Singapore
Thailand Pfizer Investigational Site Bangkok
Thailand Pfizer Investigational Site Chiang Mai

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

China,  Singapore,  Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary To compare 12 weeks of treatment with varenicline 1 mg BID to placebo for smoking cessation, and to evaluate continuous abstinence from smoking for 12 weeks after the treatment period.
Secondary To gather safety data for 12 weeks of treatment with varenicline 1 mg BID or placebo followed by 12 weeks of non-treatment follow-up.
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