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OpenTrials
Completed

NCT Number: NCT00143325

An Open Label Study That Compares Varenicline to Transdermal Nicotine Patch for Smoking Cessation

Open-label comparison of standard 12-week regimen of varenicline with standard 10-week regimen of transdermal nicotine patch for smoking cessation.

Completed

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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, Brussels, Belgium

Loading trial locations.

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 15 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 for the last 4 weeks of varenicline and NRT (Nicotine Replacement Therapy) treatment period

Secondary outcomes

  1. Continuous abstinence last 4 weeks of treatment through Weeks 24 and 52

  2. 7-day point prevalence of abstinence: end of treatment, Weeks 24 and 52

  3. 4-week Point Prevalence of abstinence at Week 52

  4. Long-Term Quit Rate at Weeks 24 and 52

  5. Minnesota Nicotine Withdrawal Scale

  6. Smoking Effects Inventory

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

An Open-Label, Multicenter Study With Follow-Up Evaluating the Safety and Efficacy of Varenicline Tartrate in Comparison to Transdermal Nicotine Patch for Smoking Cessation

Important dates

Study start
2005
Study completion
2006
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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