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Completed Phase 4 Interventional Results available

A Multi-National Study To Assess How Effective And Safe The Smoking Cessation Medicine Varenicline Is In Smokers Who Have Already Tried Varenicline In The Past As A Prescription Medicine From Their Usual Healthcare Provider

ClinicalTrials.gov ID: NCT01244061

Public ClinicalTrials.gov record NCT01244061. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 7:28 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 4 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating The Efficacy And Safety Of Re-Treatment With Varenicline In Subjects Who Are Currently Smoking, And Who Have Previously Taken Varenicline

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The main purpose of this study is to compare the effectiveness and safety of the re-treatment of smokers with varenicline with placebo for smoking cessation during the last 4 weeks of a 12 week course of treatment. The study will also assess whether smokers remain abstinent at Week 24 (12 weeks after the end of treatment) and Week 52 (40 weeks after the end of treatment).

Study identification

NCT ID
NCT01244061
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Lead sponsor
Pfizer
Industry
Enrollment
498 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 30, 2010
Primary completion
Oct 31, 2012
Completion
Oct 31, 2012
Last update posted
Jun 8, 2014

2010 – 2012

United States locations

U.S. sites
8
U.S. states
7
U.S. cities
7
Facility City State ZIP Site status
Ronald Reagan University of California Los Angeles Medical Center Los Angeles California 90095-6984
University of California Los Angeles David Geffen School of Medicine Los Angeles California 90095
Avail Clinical Research, LLC DeLand Florida 32720
Central Kentucky Research Associates, Inc. Lexington Kentucky 40509
The University of Maryland College Park Maryland 20742
The Center for Pharmaceutical Research, PC Kansas City Missouri 64114
Oregon Health and Science University Portland Oregon 97239-3098
Clinical Research Associates, Inc. Nashville Tennessee 37203

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 29 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01244061, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 8, 2014 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01244061 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →