Phase II Study to Evaluate the Effectiveness of EVT 302 in Smoking Cessation.

PHASE2CompletedINTERVENTIONAL
Enrollment

400

Participants

Timeline

Start Date

August 31, 2008

Primary Completion Date

March 31, 2009

Study Completion Date

May 31, 2009

Conditions
Smoking Cessation
Interventions
DRUG

EVT 302

EVT 302 5 mg once daily

DRUG

Placebo

Placebo to match EVT 302, 5 mg

DRUG

EVT 302 plus open label Nicotine replacement

Double-blind EVT 302 plus open label nicotine replacement

DRUG

Placebo plus open label Nicotine Replacement

Double-blind placebo plus open label Nicotine replacement patch 21 mg once daily.

Trial Locations (9)

Unknown

Evotec Study Site 2, Berlin

Evotec Study Site 3, Bochum

Evotec Study Site 8, Chemnitz

Evotec Study Site 4, Dresden

Evotec Study Site 5, Frankfurt

Evotec Study Site 7, Görlitz

Evotec Study Site 1, Leipzig

Evotec Study Site 6, Magdeburg

Evotec Study Site 9, Potsdam

Sponsors
All Listed Sponsors
collaborator

PRA Health Sciences

INDUSTRY

collaborator

Clinpharm International Management Holding GmbH

UNKNOWN

lead

Evotec Neurosciences GmbH

INDUSTRY