12 Week Evaluation of the Safety and Efficacy of a Flexible Dose 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

NCT00150228
A3051016

Details and patient eligibility

About

The purpose of the study was to measure the safety and efficacy of a 12-week flexible dosing strategy of CP-526,555 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 A3051019

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Subjects must have smoked an average of at least ten cigarettes per day during the past year
  • No period of abstinence greater than three months in the past year

Exclusion criteria

  • Subjects with history of clinically significant cardiovascular disease
  • Subjects with uncontrolled hypertension.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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