Evaluation of the Effect of AVE0657 on Obstructive Sleep Apnea - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00614250

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 II

MedlinePlus related topics: Sleep Apnea

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Sanofi-Aventis:

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 ]

Estimated Enrollment:	36
Study Start Date:	January 2008
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Dose Level 1: Experimental	Drug: AVE0657 capsules once a day at bedtime
Dose Level 2: Experimental	Drug: AVE0657 capsules once a day at bedtime
Dose Level 3: Experimental	Drug: AVE0657 capsules once a day at bedtime
Dose Level 4: Experimental	Drug: AVE0657 capsules once a day at bedtime
Placebo: Placebo Comparator 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

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-Aventis

Investigators

Principal Investigator:

Patrick LEVY, Professor

Hôpital Michallon - Grenoble - France

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	sanofi-aventis ( ICD Study Director )
Study ID Numbers:	ACT6796, EudraCT 2007-002174-58
Study First Received:	January 31, 2008
Last Updated:	December 11, 2008
ClinicalTrials.gov Identifier:	NCT00614250
Health Authority:	France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Spain: Ethics Committee

Keywords provided by Sanofi-Aventis:

Obstructive sleep apnea

Study placed in the following topic categories:

Signs and Symptoms
Sleep Apnea Syndromes
Respiratory Tract Diseases
Apnea
Respiration Disorders

Sleep Apnea, Obstructive
Dyssomnias
Sleep Disorders
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 14, 2009