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Evaluation of the Effect of AVE0657 on Obstructive Sleep Apnea

Primary Purpose

Sleep Apnea, Obstructive

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AVE0657
placebo
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea, Obstructive focused on measuring Obstructive sleep apnea

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sanofi- Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Dose Level 1

Dose Level 2

Dose Level 3

Dose Level 4

Placebo

Arm Description

12 subjects: 3 subjects per dose level

Outcomes

Primary Outcome Measures

Change in Apnea Hypopnea Index (AHI)

Secondary Outcome Measures

Safety and tolerability

Full Information

First Posted
January 31, 2008
Last Updated
July 17, 2009
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00614250
Brief Title
Evaluation of the Effect of AVE0657 on Obstructive Sleep Apnea
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive
Keywords
Obstructive sleep apnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dose Level 1
Arm Type
Experimental
Arm Title
Dose Level 2
Arm Type
Experimental
Arm Title
Dose Level 3
Arm Type
Experimental
Arm Title
Dose Level 4
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
12 subjects: 3 subjects per dose level
Intervention Type
Drug
Intervention Name(s)
AVE0657
Intervention Description
capsules once a day at bedtime
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
capsules once a day at bedtime
Primary Outcome Measure Information:
Title
Change in Apnea Hypopnea Index (AHI)
Time Frame
2 days
Secondary Outcome Measure Information:
Title
Safety and tolerability
Time Frame
5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick LEVY, Professor
Organizational Affiliation
Hôpital Michallon - Grenoble - France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sanofi- Aventis Administrative Office
City
Paris
Country
France
Facility Name
Sanofi-Aventis Administrative Office
City
Berlin
Country
Germany
Facility Name
Sanofi-Aventis Administrative Office
City
Barcelona
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

Evaluation of the Effect of AVE0657 on Obstructive Sleep Apnea

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