Study to Evaluate the Efficacy, Safety, Tolerability and Immunogenicity of 100µg NIC002 Vaccine in Cigarette Smokers Who Are Motivated to Quit Smoking.
NCT ID: NCT00736047
Last Updated: 2017-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
200 participants
INTERVENTIONAL
2008-08-31
2009-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
NIC002
2
Placebo
Interventions
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NIC002
Placebo
Eligibility Criteria
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Inclusion Criteria
* Subjects must be smoking 10 or more cigarettes per day during the past 12 months
* The exhaled breath carbon monoxide (CO) concentration must be 10 ppm or more at screening. Urine cotinine at screening must be positive.
* The Fagerström Test for Nicotine Dependence (FTND) score of 5 or above at screening.
Exclusion Criteria
* Prior use of smoking cessation aid.
18 Years
65 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis
Role: PRINCIPAL_INVESTIGATOR
Novartis Investigator Site
Locations
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Novartis Investigative Site
Mainz, , Germany
Novartis Investigator Site
Neuss, , Germany
Countries
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Other Identifiers
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CNIC002A2201
Identifier Type: -
Identifier Source: org_study_id
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