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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 [1007 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 [1268 Associated PubMed Articles listed on BioPortfolio]

An RCT with the Combination of Varenicline and Bupropion for Smoking Cessation: Clinical Implications for Front Line Use.

Despite the availability of several efficacious smoking cessation treatments, less than 25% of smokers who quit remain abstinent 1 year post treatment. This study aimed to determine if varenicline and...

Effect of Varenicline Combined With Medical Management on Alcohol Use Disorder With Comorbid Cigarette Smoking: A Randomized Clinical Trial.

Individuals with alcohol use disorder have high rates of cigarette smoking. Varenicline tartrate, an approved treatment for smoking cessation, may reduce both drinking and smoking.

Pilot Randomized Trial of an Automated Smoking Cessation Intervention via Mobile Phone Text Messages as an Adjunct to Varenicline in Primary Care.

Varenicline is a safe and effective aid to smoking cessation but most trials have involved frequent visits or intensive behavioral support unlike that typically provided in primary care. The current s...

Comparative effectiveness of varenicline and nicotine replacement therapy for smoking cessation in older and younger smokers: a prospective cohort in Taiwan.

The effectiveness of varenicline compared to nicotine replacement therapy (NRT) in achieving smoking cessation in older smokers has not been investigated. This study prospectively compared the effecti...

Brain Responses to Cigarette-Related and Emotional Images in Smokers During Smoking Cessation: No Effect of Varenicline or Bupropion on the Late Positive Potential.

Varenicline and bupropion are two effective smoking cessation pharmacotherapies. Researchers have hypothesized that they might be effective, in part, because they reduce cue reactivity and cue-induced...

Medical and Biotech [MESH] Definitions

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

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.

An alkaloid that has actions similar to NICOTINE on nicotinic cholinergic receptors but is less potent. It has been proposed for a variety of therapeutic uses including in respiratory disorders, peripheral vascular disorders, insomnia, and smoking cessation.

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