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

NCT00741884 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2015-04-22

No results posted yet for this study

Summary

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.

Conditions

  • Smoking Cessation

Interventions

DRUG

Varenicline Controlled Release 1.2 mg

Varenicline CR tablet 1.2 mg BID for 7 weeks

DRUG

Varenicline Controlled Release 1.8 mg

Varenicline CR tablet 1.8 mg BID for 7 weeks

DRUG

Varenicline Controlled Release 2.4 mg

Varenicline CR tablet 2.4 mg BID for 7 weeks

DRUG

Varenicline Immediate Release 1 mg

Varenicline IR tablet 1 mg BID for 7 weeks

DRUG

Placebo

Placebo BID for 7 weeks

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2011-08-31
Completion
2011-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00741884 on ClinicalTrials.gov