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Assessment of Safety and Efficacy of Varenicline in Patients That Wish to Stop Smoking

NCT00594204 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 593

Last updated 2010-07-20

Study results available
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Summary

The primary objective of this protocol is to evaluate 12 weeks of treatment of varenicline compared to placebo for smoking cessation. Abstinence from cigarette smoking and other tobacco products (e.g., pipe, cigars, chew, snuff.) use during non-treatment follow-up period will also be evaluated.

Conditions

  • Smoking Cessation

Interventions

DRUG

varenicline tartrate (CP-526, 555-18)

1 mg twice a day for 12 weeks, starting with a 1-week titration period.

DRUG

Placebo

matching placebo 1 tablet twice a day for 12 weeks

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2009-06-30
Completion
2009-08-31

Countries

  • Brazil
  • Colombia
  • Costa Rica
  • Egypt
  • Jordan
  • Lebanon
  • Mexico
  • Saudi Arabia
  • South Africa
  • United Arab Emirates
  • Venezuela

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00594204 on ClinicalTrials.gov