Evaluation of the Effect of AVE0657 on Obstructive Sleep Apnea

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi

Criteria

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.