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Evaluation of the Effect of AVE0657 on Obstructive Sleep Apnea

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00614250
First Posted: February 13, 2008
Last Update Posted: July 20, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sanofi
  Purpose
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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00614250


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

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00614250     History of Changes
Other Study ID Numbers: ACT6796
EudraCT 2007-002174-58
First Submitted: January 31, 2008
First Posted: February 13, 2008
Last Update Posted: July 20, 2009
Last Verified: July 2009

Keywords provided by Sanofi:
Obstructive sleep apnea

Additional relevant MeSH terms:
Sleep Apnea, Obstructive
Apnea
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases