Status:
TERMINATED
Evaluation of the Effect of AVE0657 in Cheynes-Stokes Breathing Syndrome Patients
Lead Sponsor:
Sanofi
Conditions:
Heart Failure
Sleep Apnea Syndromes
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The primary objective of this study is to assess the activity on breathing parameters of 4 escalating doses of AVE0657 in comparison to placebo in patients with Cheynes-Stokes Breathing Syndrome.
Eligibility Criteria
Inclusion
- Presence of Congestive heart failure (CHF) defined as ejection fraction ≤40% by history of echocardiography data and New York heart Association (NYHA) class II-III and of typical cyclic crescendo and decrescendo change in breathing amplitude AHI ≥10 and \<60 and majority of the apneas to be ≥60% central in origin.
Exclusion
- Subject on supplemental oxygen
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00694720
Start Date
June 1 2008
End Date
March 1 2009
Last Update
May 1 2009
Active Locations (3)
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1
Sanofi-Aventis Administrative Office
Paris, France
2
Sanofi-Aventis Administrative Office
Berlin, Germany
3
Sanofi-Aventis Administrative Office
Barcelona, Spain