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

INTERVENTION: Product Code: AVE0657 Pharmaceutical Form: Capsule, hard CAS Number: 632355‐36‐3 Current Sponsor code: AVE0657 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20‐ Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Product Code: AVE0657 Pharmaceutical Form: Capsule, hard CAS Number: 632355‐36‐3 Current Sponsor code: AVE0657 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100‐ Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use CONDITION: Patients suffering from Obstructiv‐Sleep Apnea Hypopnea Syndrome (OSAHS) ; MedDRA version: 9.1 Level: LLT Classification code 10055577 Term: Obstructive sleep apnea syndrome PRIMARY OUTCOME: 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.; ; Primary end point(s): Apnea Hypopnea Index (AHI), AHI will be compared as change on Day 2 to baseline AHI measurement.; Secondary Objective: To evaluate the pharmacokinetic parameters of AVE0657 in patients with Obstructive Sleep Apnea Hypopnea Syndrome. 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