Status:
COMPLETED
Efficacy and Safety of Dianicline Treatment as an Aid to Smoking Cessation in Cigarette Smokers (AMERIDIAN)
Lead Sponsor:
Sanofi
Conditions:
Smoking Cessation
Tobacco Use Cessation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary study objective is to demonstrate the efficacy of dianicline as an aid to smoking cessation in cigarette smokers. The main secondary objectives are to assess the: craving for cigarettes, n...
Eligibility Criteria
Inclusion
- Outpatients, over legal age, smoking at least 10 cigarettes/day as a mean within the 2 months preceding the screening visit.
Exclusion
- Patients who have taken an investigational drug within the past six months prior to the screening visit.
- Patients who had a previous quit attempt (= or \>1 day with the aid of pharmacological adjunct) in the previous three months (before screening).
- Patients who have smoked or consumed non-tobacco cigarettes or any form of tobacco product (other than cigarettes such as cigars, pipes, smokeless tobacco, etc) more than 3 times within the 3 months preceding the screening visit.
- Patients who currently present with (based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition \[DSM-IV\]):
- Psychotic disorder
- Major depressive episode
- Pregnant or breast-feeding women.
- Women of childbearing potential not protected by effective contraceptive method of birth control and/or who are unwilling or unable to be tested for pregnancy. Medically acceptable methods of birth control for this study include approved hormonal contraceptive medications or devices, approved intra-uterine contraceptive devices, use of two combined barrier methods.
- Patients who have suffered from a myocardial infarction, unstable angina or other major cardiovascular event within the past week prior to screening.
- Patients who have a history of multiple allergic reactions to medications in two drug classes.
- Patients who have QTcF \> 500 ms on the electrocardiogram (ECG).
- Patients with mild, moderate or severe renal impairment.
- Patients who have an abnormal laboratory test of potential clinical significance at screening.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
630 Patients enrolled
Trial Details
Trial ID
NCT00387946
Start Date
September 1 2006
End Date
September 1 2007
Last Update
February 17 2012
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Administrative Office
Bridgewater, New Jersey, United States, 08807
2
Administrative Office
Laval, Quebec, Canada