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dianicline

Phase 3

Smoking | Small molecule | Other |Sanofi|Last Updated: Dec 19, 2008

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment602
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00356967Efficacy and Safety of Dianicline Versus Placebo as an Aid to Smoking CessationPHASE3 COMPLETED 602 — — Jun 1, 2006Jun 1, 2007Dec 19, 20086 Belgium, Denmark +4
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Study Endpoints
Primary Endpoints
to assess the continuous abstinence from tobacco smoking at every visit during the last four weeks of treatment through direct inquiry of patients
exhaled carbon monoxide testing
and plasma cotinine measurements
Secondary Endpoints
questionnaire of smoking urge
Hughes and Hatsukami Minnesota Withdrawal Scale to measure nicotine withdrawal
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
dianiclineDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Outpatients over the legal age smoking at least 10 cigarettes per day for at least 2 months Exclusion Criteria: * Insufficient level of motivation * Another participant in the household * Patients with current psychotic disorder or major depressive disorder The investigator...

Countries:BelgiumDenmarkFranceNorwaySpainSweden
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