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

NCT00738595 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2009-05-29

No results posted yet for this study

Summary

This study will investigate the efficacy of EVT 302, a potent and selective inhibitor of Monoamine Oxidase - B, in improving quit rates in chronic cigarette smokers who are motivated to quit smoking. EVT 302 will be compared to placebo both with and without open label nicotine replacement therapy.

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.

Sponsors & Collaborators

  • PRA Health Sciences

    collaborator INDUSTRY

  • Clinpharm International Management Holding GmbH

    collaborator UNKNOWN

  • Evotec Neurosciences GmbH

    lead INDUSTRY

Principal Investigators

  • H D Stahl, MD, PhD · ClinPharm International, Leipzig, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2009-03-31
Completion
2009-05-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00738595 on ClinicalTrials.gov