A Study to Evaluate the Safety and Efficacy of Three Doses of a Controlled Release Formulation of Varenicline for Smoking Cessation

April 21, 2015 updated by: Pfizer

A Phase 2, Seven Week, Double-Blind, Placebo Controlled, Randomized, Parallel Group Study To Evaluate The Safety And Efficacy Of Three Doses Of A Controlled Release Formulation Of Varenicline For Smoking Cessation

The purpose of this study is to evaluate the safety, efficacy, and tolerability of twice daily (BID) administration of three dose strengths (1.2 mg, 1.8 mg, and 2.4 mg) of varenicline controlled release (CR) tablets in adult smokers.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female cigarette smokers between the ages of 18 and 75 years, inclusive, who are motivated to stop smoking.
  • Females of non-childbearing potential (surgically sterilized or at least 2 years postmenopausal) who are not nursing may be included.
  • Subjects must have smoked an average of at least 10 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.
  • Subjects hospitalized within the past 12 months due to suicidal ideation or suicidal behavior or subjects considered to have serious suicidal ideation or suicidal behavior within the past 12 months.
  • Subjects having active suicidal ideation or behavior identified at Screen or Baseline.
  • Subjects currently or within the past 12 months requiring treatment for depression. Subjects with current or prior history of panic disorder, anxiety disorder, hostility or aggression disorder, perceptual/thinking disturbances, psychosis, or bipolar disorder.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Drug: Varenicline Controlled Release 1.2 mg
Varenicline CR tablet 1.2 mg BID for 7 weeks
Experimental: Arm 2
Drug: Varenicline Controlled Release 1.8 mg
Varenicline CR tablet 1.8 mg BID for 7 weeks
Experimental: Arm 3
Drug: Varenicline Controlled Release 2.4 mg
Varenicline CR tablet 2.4 mg BID for 7 weeks
Active Comparator: Arm 4
Drug: Varenicline Immediate Release 1 mg
Varenicline IR tablet 1 mg BID for 7 weeks
Placebo Comparator: Arm 5
Drug: Placebo
Placebo BID for 7 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Continuous abstinence from smoking for weeks 4-7, carbon monoxide confirmed
Time Frame: 7 weeks
7 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
7- day point prevalence of non-smoking at week 7
Time Frame: 7 days
7 days
Scores on the Minnesota Nicotine Withdrawal Scale subscales
Time Frame: 7 weeks
7 weeks
Scores on the Modified Cigarette Evaluation Questionaire subscales
Time Frame: 7 weeks
7 weeks
PK analysis
Time Frame: 7 weeks
7 weeks
Safety Assessments: adverse events, C-SSRs, vital signs, body weight
Time Frame: 7 weeks
7 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Anticipated)

August 1, 2011

Study Completion (Anticipated)

August 1, 2011

Study Registration Dates

First Submitted

August 22, 2008

First Submitted That Met QC Criteria

August 25, 2008

First Posted (Estimate)

August 26, 2008

Study Record Updates

Last Update Posted (Estimate)

April 22, 2015

Last Update Submitted That Met QC Criteria

April 21, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A3051090

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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