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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00741884
First received: August 22, 2008
Last updated: January 4, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention Phase
Smoking Cessation
Drug: Varenicline Controlled Release 1.2 mg
Drug: Varenicline Controlled Release 1.8 mg
Drug: Varenicline Controlled Release 2.4 mg
Drug: Varenicline Immediate Release 1 mg
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Continuous abstinence from smoking for weeks 4-7, carbon monoxide confirmed [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 7- day point prevalence of non-smoking at week 7 [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Scores on the Minnesota Nicotine Withdrawal Scale subscales [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
  • Scores on the Modified Cigarette Evaluation Questionaire subscales [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
  • PK analysis [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
  • Safety Assessments: adverse events, C-SSRs, vital signs, body weight [ Time Frame: 7 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 305
Study Start Date: August 2010
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00741884

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00741884     History of Changes
Other Study ID Numbers: A3051090
Study First Received: August 22, 2008
Last Updated: January 4, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Smoking
Habits
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 16, 2014