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Evaluation of the Effect of AVE0657 on Obstructive Sleep Apnea

This study has been completed.
Information provided by:
Sanofi Identifier:
First received: January 31, 2008
Last updated: July 17, 2009
Last verified: July 2009
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.

Condition Intervention Phase
Sleep Apnea, Obstructive Drug: AVE0657 Drug: placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Change in Apnea Hypopnea Index (AHI) [ Time Frame: 2 days ]

Secondary Outcome Measures:
  • Safety and tolerability [ Time Frame: 5 days ]

Enrollment: 38
Study Start Date: January 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose Level 1 Drug: AVE0657
capsules once a day at bedtime
Experimental: Dose Level 2 Drug: AVE0657
capsules once a day at bedtime
Experimental: Dose Level 3 Drug: AVE0657
capsules once a day at bedtime
Experimental: Dose Level 4 Drug: AVE0657
capsules once a day at bedtime
Placebo Comparator: Placebo
12 subjects: 3 subjects per dose level
Drug: placebo
capsules once a day at bedtime


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00614250

Sanofi- Aventis Administrative Office
Paris, France
Sanofi-Aventis Administrative Office
Berlin, Germany
Sanofi-Aventis Administrative Office
Barcelona, Spain
Sponsors and Collaborators
Principal Investigator: Patrick LEVY, Professor Hôpital Michallon - Grenoble - France
  More Information

Responsible Party: ICD Study Director, sanofi-aventis Identifier: NCT00614250     History of Changes
Other Study ID Numbers: ACT6796
EudraCT 2007-002174-58
Study First Received: January 31, 2008
Last Updated: July 17, 2009

Keywords provided by Sanofi:
Obstructive sleep apnea

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases processed this record on September 21, 2017