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OpenTrials
Completed

NCT Number: NCT00614250

Evaluation of the Effect of AVE0657 on Obstructive Sleep Apnea

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.

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Key information

Conditions

Sleep Apnea, Obstructive Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sanofi- Aventis Administrative Office, Paris, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AVE0657

Drug

capsules once a day at bedtime

Placebo

Drug

capsules once a day at bedtime

Primary outcomes

  1. Change in Apnea Hypopnea Index (AHI)

    Time frame: 2 days

Secondary outcomes

  1. Safety and tolerability

    Time frame: 5 days

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 13, 2008
Registry last updated
Jul 20, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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