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Efficacy and Safety of Dianicline Treatment as an Aid to Smoking Cessation in Cigarette Smokers (AMERIDIAN)

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: October 13, 2006
Last Update Posted: February 17, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
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, nicotine withdrawal symptoms, and safety of dianicline.

Condition Intervention Phase
Smoking Cessation Tobacco Use Cessation Drug: SSR591813L (dianicline) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: An International, Seven-week, Double-blind, Placebo-controlled, Two Parallel Group Study to Assess the Efficacy of Dianicline 40 mg Bid as an Aid to Smoking Cessation in Cigarette Smokers

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • To assess the continuous abstinence from tobacco smoking at every visit during the last 4 weeks of treatment period, i.e. from week 4 to week 7, through direct inquiry of patients, exhaled carbon monoxide (CO) testing, and plasma cotinine measurements

Secondary Outcome Measures:
  • Questionnaire of Smoking Urges to assess craving for cigarettes; Hughes and Hatsukami Minnesota Withdrawal Scale to measure nicotine withdrawal, number of smoke-free days, and average number of cigarettes smoked from smoking status interview

Enrollment: 630
Study Start Date: September 2006
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Outpatients, over legal age, smoking at least 10 cigarettes/day as a mean within the 2 months preceding the screening visit.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00387946

United States, New Jersey
Administrative Office
Bridgewater, New Jersey, United States, 08807
Canada, Quebec
Administrative Office
Laval, Quebec, Canada
Sponsors and Collaborators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00387946     History of Changes
Other Study ID Numbers: EFC5514
First Submitted: October 12, 2006
First Posted: October 13, 2006
Last Update Posted: February 17, 2012
Last Verified: February 2012

Keywords provided by Sanofi: