Recent Updates
Recently added Catalysts

EVT 302,

Phase 2

Smoking Cessation | Small molecule | Other |Evotec SE|Last Updated: May 29, 2009

Success Probability
Subscribe to view
Market & Valuation
Subscribe to view
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment490
FDA Designations
No designations recorded
Clinical trial landscape

EVT 302, · 2 trials · 1 indication

Phase 2 2
NCT00738595Phase II Study to Evaluate the Effectiveness of EVT 302 in Smoking Cessation.Smoking Cessation
COMPLETED400 Analytics
NCT00622752Effects of EVT 302 With or Without NRT on Craving and Withdrawal in Healthy Male Smokers Deprived of CigarettesSmoking Cessation
COMPLETED90 Analytics
PHASE2COMPLETED
Phase II Study to Evaluate the Effectiveness of EVT 302 in Smoking Cessation.
Smoking Cessation
NCT00738595400
Unlock trial analytics
PHASE2COMPLETED
Effects of EVT 302 With or Without NRT on Craving and Withdrawal in Healthy Male Smokers Deprived of Cigarettes
Smoking Cessation
NCT0062275290
Unlock trial analytics
Study Endpoints
Primary Endpoints
The four-week continuous quit rate over the last four weeks of treatment
Last 4 weeks of therapy
Reduction in Craving and withdrawal
Within 12 hours of the last cigarette
Secondary Endpoints
7 -week abstinence
7 weeks post quit day
7-day point prevalence quit rate
weekly for 7 weeks
Daily cigarettes smoked
Daily
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALEVT 302, 5 mg once Daily
2PLACEBO_COMPARATORPlacebo once daily
3EXPERIMENTALEVT 302 plus open label Nicotine replacement
4ACTIVE_COMPARATORPlacebo plus nicotine replacement therapy
Interventions
NameTypeDescription
EVT 302DRUGEVT 302 5 mg once daily
PlaceboDRUGPlacebo to match EVT 302, 5 mg
EVT 302 plus open label Nicotine replacementDRUGDouble-blind EVT 302 plus open label nicotine replacement
Placebo plus open label Nicotine ReplacementDRUGDouble-blind placebo plus open label Nicotine replacement patch 21 mg once daily.
EVT 302, 10 mgDRUG2 X EVT 302, 5 mg tablets
Nicotine replacement therapy (NRT)DRUGNRT patch containing 21 mg of nicotine
NRT placeboDEVICEMedically inert plaster cut to match the NRT plaster
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * Smoker of at least 10 cigarettes daily * Motivated to quit smoking * Reports at least one unsuccessful attempt to quit in the last 2 years * In generally good health * Provides written informed consent to participate in the sudy Exclusion Criteria: * Pregnant or nursing fema...

Countries:Germany
Unlock Eligibility Criteria