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

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Pfizer

Status and phase

Completed
Phase 2

Conditions

Smoking Cessation

Treatments

Drug: CP-526,555 (varenicline)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00150254
A3051007

Details and patient eligibility

About

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

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

13

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Data sourced from clinicaltrials.gov

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