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

Phase 2CompletedNCT00150241

Pfizer625 enrolled

Overview

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

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 cardiovascular disease * Myocardial infarction * Significant arrhythmias * Poorly controlled hypertension

Locations (7)

Pfizer Investigational Site

Los Angeles, California, United States

Pfizer Investigational Site

Farmington, Connecticut, United States

Pfizer Investigational Site

Minneapolis, Minnesota, United States

Pfizer Investigational Site

Omaha, Nebraska, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

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

7-day Point Prevalence of abstinence Week 52

Number of cigarettes smoked per day

Minnesota Nicotine Withdrawal Scale

Smoking Effects Inventory

Brief Questionnaire of Smoking Urge

Data from ClinicalTrials.gov

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