Evaluation of the Effect of AVE0657 on Obstructive Sleep Apnea

Sleep Apnea, Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00614250
• Other study ID #: ACT6796
• Secondary ID: EudraCT 2007-002
• Status: Completed
• Phase: Phase 2
• First received: January 31, 2008
• Last updated: July 17, 2009
• Start date: January 2008
• Est. completion date: January 2009

Study information

• Verified date: July 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesSpain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Drug:
• AVE0657
capsules once a day at bedtime
• placebo
capsules once a day at bedtime

Locations

Country	Name	City	State
France	Sanofi- Aventis Administrative Office	Paris
Germany	Sanofi-Aventis Administrative Office	Berlin
Spain	Sanofi-Aventis Administrative Office	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

France,  Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Apnea Hypopnea Index (AHI)		2 days	No
Secondary	Safety and tolerability		5 days	Yes