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OpenTrials
Completed

NCT Number: NCT00143286

A 52-Week Multicenter Study Evaluating the Safety and Efficacy of Varenicline for the Maintenance of Smoking Cessation

The primary purpose of this study is a comparison of abstinence maintenance in subjects randomized to double-blind varenicline or placebo from Weeks 13 -24 in subjects who responded to an intial 12-week open label course of varenicline, with post-treatment follow-up of smoking status to Week 52.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 with clinically significant cardiovascular disease in the past 6 months.

Treatment and study plan

varenicline (CP-526,555)

Drug

Primary outcomes

  1. Continuous abstinence Weeks 13 -24.

Secondary outcomes

  1. Continuous abstinence Weeks 13-52

  2. Long term quit rate at Week 52

  3. 7-day Point Prevalence of abstinence at Weeks 24, 52

  4. 4-week Point Prevalence of abstinence at Week 52

  5. Time to first cigarette post randomization

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Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A 52-Week Multicenter Study Evaluating the Safety and Efficacy of Varenicline ( CP-526,555) for the Maintenance of Smoking Cessation

Important dates

Study start
2003
Study completion
2005
First posted
Sep 2, 2005
Registry last updated
Jun 4, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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