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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 [1056 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 [1221 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...

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...

Effects of Varenicline, Depressive Symptoms, and Region of Enrollment on Smoking Cessation in Depressed Smokers.

Despite effective treatments, relapse to smoking remains a vexing global health problem. One predictor of relapse is depressive symptoms. Medications such as varenicline reduce withdrawal-related symp...

Systematic Review and Meta-Analysis to Assess the Safety of Buproprion and Varenicline in Pregnancy.

Smoking in pregnancy is a substantial public health issue, but, apart from nicotine replacement therapy (NRT), pharmacological therapies are not generally used to promote cessation. Bupropion and vare...

Understanding the link between contingency management and smoking cessation: The roles of sex and self-efficacy.

Little is known about the mechanisms linking contingency management (CM) treatment with smoking cessation, and recent research suggests that the CM approach is associated with better smoking cessation...

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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