Evaluation of the Effect of AVE0657 on Obstructive Sleep Apnea

A Double-blind, Randomized, Placebo-controlled, Study of the Safety and Activity of Four Escalating Single Doses of AVE0657 in Patients Suffering From Obstructive Sleep Apnea Hypopnea Syndrome

The primary objective of this study is to assess the activity of 4 escalating doses of AVE0657 in comparison to placebo in patients with Obstructive Sleep Apnea Hypopnea Syndrome.

Inclusion Criteria:

• Subjects diagnosed with Obstructive Sleep Apnea Hypopnea Syndrome based on International Classification of Sleep Disorders

Exclusion Criteria:

• Subjects having been treated by Continuous Positive Airway Pressure, oral appliance during 4-weeks prior to randomization
• Chronic respiratory disease or inadequate respiratory parameters
• Body Mass Index (BMI) of ≤20 kg/m² or ≥35 kg/m²
• Surgical procedure to correct apnea within the last three months.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.