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

Sanofi2 sites in 2 countries38 target enrollmentJanuary 2008

ConditionsSleep Apnea, Obstructive

InterventionsAVE0657 placebo

DrugsAVE0657 placebo

Overview

Phase: Phase 2
Intervention: AVE0657
Conditions: Sleep Apnea, Obstructive
Sponsor: Sanofi
Enrollment: 38
Locations: 2
Primary Endpoint: Change in Apnea Hypopnea Index (AHI)
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2008

End Date

January 2009

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sanofi

Eligibility 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.