Evaluation of the Effect of AVE0657 on Obstructive Sleep Apnea

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00614250
First received: January 31, 2008
Last updated: July 17, 2009
Last verified: July 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov 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
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Spain: Ethics Committee

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 Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on August 18, 2014