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Varenicline (Champix®) Special Investigation (Regulatory Post Marketing Commitment Plan)

2014-07-23 21:10:51 | BioPortfolio

Summary

To collect the efficacy and safety information in the subjects who have been retreated with varenicline (Champix®) within 52 weeks of initial treatment for their appropriate use in daily practice and are participants for varenicline Drug Use Investigation protocol A3051109 ((NCT# NCT00772941).

Description

The subjects have been retreated with varenicline within 52 weeks, and subjects have been enrolled to varenicline Drug Use Investigation protocol A3051109.

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Conditions

Smoking Cessation

Intervention

varenicline

Status

Not yet recruiting

Source

Pfizer

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:10:51-0400

Clinical Trials [1099 Associated Clinical Trials listed on BioPortfolio]

Long-term Varenicline Treatment for Smoking Cessation

This is a clinical study of the efficacy and safety of up to 52 weeks of varenicline therapy in conjunction with individual counseling for smoking cessation. Adult volunteers in generally...

Comparison of Varenicline and Placebo for Smoking Cessation in Schizophrenia

The purpose of this proposed pilot study is to examine the use of varenicline in people with schizophrenia to specifically assess tolerability and efficacy for smoking cessation. Specifica...

A Seven-Week Dose-Ranging Study of CP-526,555 Compared With Placebo and Zyban for Smoking Cessation

The purpose of the study is to measure the safety and efficacy of three doses of varenicline for smoking cessation.

Assessment of Safety and Efficacy of Varenicline in Patients That Wish to Stop Smoking

The primary objective of this protocol is to evaluate 12 weeks of treatment of varenicline compared to placebo for smoking cessation. Abstinence from cigarette smoking and other tobacco p...

Post Marketing Surveillance Study of Champix in Smoking Cessation for Filipino Patients

The primary objective of this Post-Marketing Study is to monitor the safety of a novel smoking cessation drug Varenicline (Champix™) 0.5 mg and 1 mg tablets as used in clinical practice ...

PubMed Articles [1227 Associated PubMed Articles listed on BioPortfolio]

Varenicline for long term smoking cessation in patients with COPD.

Quitting smoking is key for patients with Chronic Obstructive Pulmonary Disease (COPD). Standard recommendations for quitting smoking are implemented for COPD as well. Varenicline Tartrate (VT) is the...

Predictors of reduced smoking quantity among recovering alcohol dependent men in a smoking cessation trial.

Adults with alcohol dependence (AD) have exceptionally high smoking rates and poor smoking cessation outcomes. Discovery of factors that predict reduced smoking among AD smokers may help improve treat...

New insights on the effects of varenicline on nicotine reward, withdrawal and hyperalgesia in mice.

Varenicline, a partial agonist for α4β2* nicotinic acetylcholine receptors (nAChRs) and a full agonist for α3β4 and α7 nAChRs, is approved for smoking cessation treatment. Although, partial agoni...

Integrated Treatment for Smoking Cessation, Anxiety, and Depressed Mood in People Living With HIV: A Randomized Controlled Trial.

Among people living with HIV, cigarette smoking rates are higher than among the general population, and anxiety, depression, and their disorders are common and associated with smoking and poorer outco...

Associations of the Stoptober smoking cessation program with information seeking for smoking cessation: A Google trends study.

The national smoking cessation program Stoptober was introduced in October 2012 in England and in October 2014 in the Netherlands. There is little evidence on the extent to which the Stoptober program...

Medical and Biotech [MESH] Definitions

A benzazepine derivative that functions as an ALPHA4/BETA2 NICOTINIC RECEPTOR partial agonist. It is used for SMOKING CESSATION.

A decrease in the incidence and frequency of SMOKING. Smoking reduction differs from SMOKING CESSATION in that the smoker continues to smoke albeit at a lesser frequency without quitting.

Discontinuation of the habit of smoking, the inhaling and exhaling of tobacco smoke.

Cessation of the habit of using tobacco products for smoking or chewing, including the use of snuff.

A unicyclic, aminoketone antidepressant. The mechanism of its therapeutic actions is not well understood, but it does appear to block dopamine uptake. The hydrochloride is available as an aid to smoking cessation treatment.

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