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Varenicline Tartarate

Phase 3

Smoking Cessation | Small molecule | Psychiatry |Pfizer, Inc.|Last Updated: Apr 20, 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment504

FDA Designations

No designations recorded

Clinical trial landscape

Varenicline Tartarate · 1 trial · 1 indication

Phase 3 1
NCT00285012Smoking Cessation in Subjects With Mild-to-moderate Chronic Obstructive Pulmonary Disease (COPD).Smoking Cessation
COMPLETED504 Analytics
PHASE3COMPLETED
Smoking Cessation in Subjects With Mild-to-moderate Chronic Obstructive Pulmonary Disease (COPD).
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Study Endpoints

Primary Endpoints

Number of Subjects With Four Week Continuous Quit Rate (CQR)
Week 9 through Week 12

Number of subjects who reported no smoking and no use of other nicotine-containing products since the last study visit (on the Nicotine Use Inventory \[NUI\]) and with end-expiratory exhaled carbon monoxide (CO) measurement less than or equal to 10 parts per million (ppm) for weeks 9 through 12 (inclusive).

Secondary Endpoints

Number of Subjects With Continuous Abstinence (CA)
Week 9 through Week 24 and Week 52
Number of Subjects With Long Term Quit Rate (LTQR)
Week 24, Week 52
Number of Subjects With 7-Day Point Prevalence of Abstinence
Week 12, Week 24, Week 52
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
placeboPLACEBO_COMPARATOR -
vareniclineEXPERIMENTAL -

Interventions

NameTypeDescription
placeboDRUG1mg (placebo) by mouth twice daily for 12 weeks (first week is up titration schedule---0.5mg once daily for 3 days, 0.5mg twice daily for 4 days)
Varenicline TartarateDRUG1 mg by mouth twice daily for 12 weeks (first week is up titration schedule---0.5mg once daily for 3 days, 0.5mg twice daily for 4 days)
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Eligibility Criteria

Age Range35 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites32

Inclusion Criteria: * Subjects will be current cigarette smokers who have smoked an average of at least 10 cigarettes per day during the past year and during the month prior to the screening visit. * mild to moderate COPD confirmed by spirometry * Subjects must have a clinical diagnosis of COPD. E...

Countries:United StatesFranceItalySpain
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Frequently asked questions about Varenicline Tartarate

What is Varenicline Tartarate used for?

Varenicline Tartarate is used for smoking cessation. It is being developed as a treatment to help people stop smoking, specifically studied in subjects with mild-to-moderate chronic obstructive pulmonary disease (COPD). The drug is a small molecule in the psychiatry therapeutic area.

Who makes Varenicline Tartarate?

Varenicline Tartarate is being developed by Pfizer, Inc., a company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 3 clinical development for smoking cessation.

What phase is Varenicline Tartarate in?

Varenicline Tartarate is in Phase 3 clinical development. It is an investigational drug for smoking cessation and has not been approved by regulatory authorities. The Phase 3 trial has been completed.

What clinical trials is Varenicline Tartarate in?

Varenicline Tartarate has one completed Phase 3 clinical trial with the identifier NCT00285012. The trial, titled "Smoking Cessation in Subjects With Mild-to-moderate Chronic Obstructive Pulmonary Disease (COPD)," enrolled 504 participants across the United States, France, Italy, and Spain.

Is Varenicline Tartarate the same as varenicline?

Varenicline Tartarate is a salt form of varenicline, a medication used for smoking cessation. The drug is being developed by Pfizer, Inc. and has been studied in a Phase 3 trial for smoking cessation in patients with mild-to-moderate COPD.