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CP-526, 555

Phase 2

Smoking Cessation | Small molecule | Psychiatry |Pfizer, Inc.|Last Updated: Oct 19, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials4
Total Enrollment2,150

FDA Designations

No designations recorded

Clinical trial landscape

CP-526, 555 · 4 trials · 1 indication

Phase 2 4
NCT0013975012 Week Evaluation of the Safety and Efficacy of 3 Doses of CP-526,555 and Placebo for Smoking CessationSmoking Cessation
COMPLETED600 Analytics
NCT0015022812 Week Evaluation of the Safety and Efficacy of a Flexible Dose of CP-526,555 and Placebo for Smoking CessationSmoking Cessation
COMPLETED300 Analytics
NCT0015025412 Week Evaluation of the Safety and Efficacy of 4 Dosing Strategies of CP-526,555 and Placebo for Smoking Cessation.Smoking Cessation
COMPLETED625 Analytics
NCT00150241A Seven-Week Dose-Ranging Study of CP-526,555 Compared With Placebo and Zyban for Smoking CessationSmoking Cessation
COMPLETED625 Analytics
PHASE2COMPLETED
12 Week Evaluation of the Safety and Efficacy of 3 Doses of CP-526,555 and Placebo for Smoking Cessation
Smoking CessationUnlock trial analytics
PHASE2COMPLETED
12 Week Evaluation of the Safety and Efficacy of a Flexible Dose of CP-526,555 and Placebo for Smoking Cessation
Smoking CessationUnlock trial analytics
PHASE2COMPLETED
12 Week Evaluation of the Safety and Efficacy of 4 Dosing Strategies of CP-526,555 and Placebo for Smoking Cessation.
Smoking CessationUnlock trial analytics
PHASE2COMPLETED
A Seven-Week Dose-Ranging Study of CP-526,555 Compared With Placebo and Zyban for Smoking Cessation
Smoking CessationUnlock trial analytics

Study Endpoints

Primary Endpoints

4-week continuous quit rate (CQR) for Weeks 9-12
4-week continuous quit rate (CQR) at Weeks 4-7 and 9-12 .
4 week continuous quit rate (CQR) at Weeks 9-12 and Weeks 4-7
The primary efficacy outcome is smoking abstinence for any continuous 4-week period (4-week CQR) during the study treatment phase.

Secondary Endpoints

Continuous abstinence for Weeks 9-52 and Weeks 9-24
Long-term quit rate at Week 52
4-week CQR for Weeks 4-7
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
CP-526,555 (varenicline)DRUG -
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Eligibility Criteria

Age Range20 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites15

Inclusion Criteria: * Cigarette smokers who are motivated to stop smoking and have smoked an average of at least 10 cigarettes per day Exclusion Criteria: * Subjects who have used a nicotine replacement product within 30 days of the study screening visit or intend to use it during the study.

Countries:JapanUnited States
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Frequently asked questions about CP-526, 555

What is CP-526,555 used for?

CP-526,555 is an investigational small molecule being developed for smoking cessation. It is in Phase 2 clinical development and has been studied in four completed trials enrolling a total of 2,150 participants. The drug is not approved and remains under clinical investigation.

Who makes CP-526,555?

CP-526,555 is being developed by Pfizer, Inc., which trades under the ticker PFE. The company has sponsored four Phase 2 clinical trials of the drug for smoking cessation, all of which have been completed.

What phase is CP-526,555 in?

CP-526,555 is in Phase 2 clinical development. All four of its clinical trials are Phase 2 studies and have been completed. The drug is investigational and has not been approved by regulatory authorities for any use.

What clinical trials is CP-526,555 in?

CP-526,555 has been studied in four completed Phase 2 trials: NCT00139750 (600 participants in Japan), NCT00150228 (300 participants in the US), NCT00150241 (625 participants in the US), and NCT00150254 (625 participants in the US). All trials evaluated the drug for smoking cessation.

Is CP-526,555 the same as varenicline?

CP-526,555 is the investigational code name for the drug that was later developed as varenicline, marketed as Chantix. The clinical trials listed under CP-526,555 are the Phase 2 studies that evaluated this compound for smoking cessation.