Status:
COMPLETED
Evaluation of the Effect of AVE0657 on Obstructive Sleep Apnea
Lead Sponsor:
Sanofi
Conditions:
Sleep Apnea, Obstructive
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- Subjects diagnosed with Obstructive Sleep Apnea Hypopnea Syndrome based on International Classification of Sleep Disorders
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00614250
Start Date
January 1 2008
End Date
January 1 2009
Last Update
July 20 2009
Active Locations (3)
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1
Sanofi- Aventis Administrative Office
Paris, France
2
Sanofi-Aventis Administrative Office
Berlin, Germany
3
Sanofi-Aventis Administrative Office
Barcelona, Spain