Evaluation of the Effect of AVE0657 on Obstructive Sleep Apnea

Phase 2

Completed

• Conditions: Sleep Apnea, Obstructive
• Interventions: Drug: AVE0657; Drug: placebo

• Registration Number: NCT00614250
• Lead Sponsor: Sanofi

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-31
• Study First Submitted QC: 2008-01-31
• Study First Posted: 2008-02-13
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-17
• Last Update Posted: 2009-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose Level 4	AVE0657	-
Placebo	placebo	12 subjects: 3 subjects per dose level
Dose Level 1	AVE0657	-
Dose Level 2	AVE0657	-
Dose Level 3	AVE0657	-

Primary Outcome Measures

Name	Time	Method
Change in Apnea Hypopnea Index (AHI)	2 days

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability	5 days

Trial Locations

Locations (2)

Sanofi-Aventis Administrative Office; 🇪🇸 Barcelona, Spain

Sanofi- Aventis Administrative Office; 🇫🇷 Paris, France