12 Week Evaluation of the Safety and Efficacy of 4 Dosing Strategies of CP-526,555 and Placebo for Smoking Cessation.

Pfizer625 enrolled

Overview

The purpose of the study is to measure the safety and efficacy of four dosing strategies of CP-526,555 for 12 weeks 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 A3051018

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

625

Conditions

Smoking Cessation

Interventions

CP-526,555 (varenicline)DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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 clinically significant cardiovascular disease * Uncontrolled hypertension

Locations (13)

Pfizer Investigational Site

Los Angeles, California, United States

Pfizer Investigational Site

San Bernardino, California, United States

Pfizer Investigational Site

Upland, California, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Carbon monoxide(CO)-confirmed 7-day point prevalence of abstinence at Week 12

Number of cigarettes smoked per day

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

Rewarding effects of smoking assessed by Smoking Effects Inventory

Weight change from baselin

Data from ClinicalTrials.gov

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