A Study of the Efficacy and Safety of Varenicline in Japa... | NCT00635401

Studies
A Study of the Efficacy and Safety of Varenicline in Japanese Smokers Motivated to Quit Smoking

NCT00635401

Sponsor

Pfizer

Status

Completed

Last Update Posted

Apr 10, 2008Estimated

Enrollment

30Actual

Phase

Phase 2

Conditions

Smoking

Interventions

Varenicline

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2004

Primary Completion Date

Not provided

Completion Date

Aug 2004Actual

First Submitted Date

Mar 5, 2008

First Submission Date that Met QC Criteria

Mar 5, 2008

First Posted Date

Mar 13, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 7, 2008

Last Update Posted Date

Apr 10, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of varenicline in Japanese smokers. Efficacy is evaluated by continuous quit rate and withdrawal symptoms of smokers. Safety is evaluated by adverse events, laboratory tests, and other safety tests.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
0.5 mg BID	Experimental		Drug: Varenicline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Varenicline	Drug	0.5 mg BID for 7 weeks	0.5 mg BID	Chantix, Champix, CP-526,555

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Carbon monoxide (CO)-confirmed 4-week continuous quit rate (4-week CQR) from Weeks 4 to 7.		Weeks 4-7

Secondary Outcomes

Measure	Description	Time Frame
CO-confirmed 7-day Point Prevalence from Week 2 through Week 7.		Weeks 2-7
Continuous abstinence rate from target quit date (TQD) from Week 2 through Week 7.		Weeks 2-7

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Japanese smokers motivated to quit smoking
No period without smoking of more than 3 months
Smoked an average of at least 10 cigarettes/day in the past year

Exclusion Criteria:

Subjects who have used nicotine replacement therapy within 1 month of the study screening visit
Subjects intending to use nicotine replacement therapy or other smoking cessation treatments during the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Chuo-ku Fukuoka	Fukuoka		Japan
Pfizer Investigational Site

Label	URL
To obtain contact information for a study center near you, click here.	View source

ID	Term
D012907	Smoking

ID	Term
D001519	Behavior

Intervention Browse Module

MeSH Terms

ID	Term
D000068580	Varenicline

Ancestor Terms

ID	Term
D001552	Benzazepines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided