Evaluation of the Effect of AVE0657 on Obstructive Sleep Apnea

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00614250

Enrollment

Registered

2008-02-13

Start date

2008-01-31

Completion date

2009-01-31

Last updated

2009-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnea, Obstructive

Keywords

Obstructive sleep apnea

Brief summary

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.

Interventions

DRUGAVE0657

capsules once a day at bedtime

DRUGplacebo

capsules once a day at bedtime

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame
Change in Apnea Hypopnea Index (AHI)	2 days

Secondary

Measure	Time frame
Safety and tolerability	5 days

Countries

France, Germany, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026