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OpenTrials
Completed

NCT Number: NCT00150241

A Seven-Week Dose-Ranging Study of CP-526,555 Compared With Placebo and Zyban for Smoking Cessation

The purpose of the study is to measure the safety and efficacy of three doses of varenicline for smoking cessation.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site, Los Angeles, California, United States

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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 on average of at least ten cigarettes per day during the past year
  • Subjects must have no period of abstinence greater than three months in the past year

Exclusion criteria

  • Subjects with any history of cardiovascular disease
  • Myocardial infarction
  • Significant arrhythmias
  • Poorly controlled hypertension

Treatment and study plan

CP-526,555 (varenicline)

Drug

Primary outcomes

  1. The primary efficacy outcome is smoking abstinence for any continuous 4-week period (4-week CQR) during the study treatment phase.

Secondary outcomes

  1. Fixed window 4-week CQR, Weeks 3-6, 4-7

  2. Continuous abstinence from Target Quit Date to Weeks 12, 24, and 52

  3. 7-day Point Prevalence of abstinence Week 52

  4. Number of cigarettes smoked per day

  5. Minnesota Nicotine Withdrawal Scale

  6. Smoking Effects Inventory

  7. Brief Questionnaire of Smoking Urge

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Seven-Week Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating the Safety and Efficacy of Three Doses of CP-526,555 ( 0.3 mg QD, 1 mg QD, and 1 mg BID ) in Comparison With Zyban in Smoking Cessation

Important dates

Study start
2000
Study completion
2002
First posted
Sep 8, 2005
Registry last updated
Oct 19, 2015

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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