Evaluation of the Effect of AVE0657 on Obstructive Sleep Apnea

Sanofi

Status and phase: Completed; Phase 2

Conditions: Sleep Apnea, Obstructive

Treatments: Drug: placebo; Drug: AVE0657

Study type: Interventional

Funder types: Industry

Identifiers

NCT00614250

EudraCT 2007-002174-58

ACT6796

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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38 participants in 5 patient groups, including a placebo group

Dose Level 1

Experimental group

Treatment:

Drug: AVE0657

Dose Level 2

Experimental group

Treatment:

Drug: AVE0657

Dose Level 3

Experimental group

Treatment:

Drug: AVE0657

Dose Level 4

Experimental group

Treatment:

Drug: AVE0657

Placebo

Placebo Comparator group

Description:

12 subjects: 3 subjects per dose level

Treatment:

Drug: placebo