Patients suffering from Obstructiv-Sleep Apnea Hypopnea Syndrome (OSAHS) MedDRA version: 9.1 Level: LLT Classification code 10055577 Term: Obstructive sleep apnea syndrome
Conditions
Sponsors
sanofi-aventis recherche & développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Main inclusion criteria: -OSAHS with an AHI (number/hour) =15 and up to 35 including =60% obstructive or mixed AH. -Daytime sleepiness or at least 2 of the following: choking/gasping during sleep, recurrent awakenings from sleep, daytime fatigue, unrefreshing sleep, impaired concentration along with irritability or mood swings Other inclusion criterias: •Related to Subjects: Out-patients =18 years of age or the legal age of consent in the area where the study is being done male and female patients but less then 75 years. •Related to sleep disorders: Each subject must have the history of OSAHS for at least one month preceding the study visit. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Medical condition that may interfere with the study conduct and/or assessment: -Patients treated by CPAP, oral appliance during 4-week period prior to randomization. -Chronic respiratory disease (chronic obstructive pulmonary disease (COPD), pulmonary fibrosis or asthma) or FEV/FVC <60% -Body mass index (BMI) of =20 kg/M2 or =35 kg/M2 -Surgical procedure to correct apnea within the last 3 months. •Related to subjects: -Women of childbearing potential without effective contraceptive measures, lactating or who are pregnant. -Inability to meet some specific protocol requirements (eg, need for spending 2 nights in Sleep Laboratory). -Subject is the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol. -Night shift workers and individuals who napped 3 or more times per week over the preceding month. -Consumption of xanthine-containing beverages (eg, tea, coffee, or cola) comprising usually more than 5 cups or glasses per day. -Participation in another trial having received study medication within two months before the screening visit. -Subjects unwilling or unable to provide written, signed and dated informed consent. -Subjects who are unable to participate for the entire duration of the study, or in the opinion of the investigator, are likely to be non-compliant with the obligations inherent in the trial participation. •Related to concomitant illnesses: -Subjects presenting with acute or chronic pain resulting in sleep disturbance. -Subjects with current active psychiatric disturbances according to DSM IV criteria including but not limited to psychosis, schizophrenia, bipolar disorder, obsessive compulsive disorder, major depression, anxiety disorders, panic disorders, eating disorder, alcohol or substance abuse or dependence -except nicotine-, or a history of lifetime psychosis. -Subjects with mental retardation or dementia of Alzheimer’s or vascular type. -Subjects with a history of epilepsy or seizures (not including benign neonatal and childhood convulsions). -Evidence of any Laboratory abnormality, clinically significant severe or unstable, acute or chronically progressive medical or surgical disorder, or any condition that may interfere with the absorption, metabolism, distribution or excretion of the study drug, or may affect patient safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess: -The activity of 4 doses of AVE0657, 40, 100, 160 and 320 mg/day, in comparison to placebo in patients with CSBS -The safety and the tolerability by monitoring of adverse events, clinical laboratories and ECG. ;Secondary Objective: To evaluate the pharmacokinetic parameters of AVE0657 in patients with Obstructive Sleep Apnea Hypopnea Syndrome.;Primary end point(s): Apnea Hypopnea Index (AHI), AHI will be compared as change on Day 2 to baseline AHI measurement. | — |
Countries
France, Germany, Spain
Outcome results
None listed