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OpenTrials
Completed

NCT Number: NCT00150228

12 Week Evaluation of the Safety and Efficacy of a Flexible Dose of CP-526,555 and Placebo for Smoking Cessation

The purpose of the study was to measure the safety and efficacy of a 12-week flexible dosing strategy of CP-526,555 compared with placebo for smoking cessation. Post-treatment follow-up of smoking status to one year from randomization was performed in a non-treatment extension Protocol A3051019

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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, Lexington, Kentucky, 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 an average of at least ten cigarettes per day during the past year
  • No period of abstinence greater than three months in the past year

Exclusion criteria

  • Subjects with history of clinically significant cardiovascular disease
  • Subjects with uncontrolled hypertension.

Treatment and study plan

CP-526,555 (varenicline)

Drug

Primary outcomes

  1. 4-week continuous quit rate (CQR) at Weeks 4-7 and 9-12 .

Secondary outcomes

  1. Continuous abstinence rate from target quit date to end of treatment (Week 12)

  2. 7-day point prevalence of abstinence at Week 12

  3. Number of cigarettes smoked per day

  4. Urge to smoke and withdrawal symptoms assessed by Minnesota Nicotine Withdrawal Scale

  5. Rewarding effects of smoking assessed by Smoking Effects Inventory

  6. weight change from baseline

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Twelve-Week Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating the Safety and Efficacy of a Flexible-Dosing Strategy for CP-526,555 ( 0.5 mg to 2.0 mg Total Daily Dose ) in Smoking Cessation

Important dates

Study start
2001
Study completion
2002
First posted
Sep 8, 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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