Overview

Evaluation of the Effect of AVE0657 in Cheynes-Stokes Breathing Syndrome Patients

Status:
Terminated
Trial end date:
2009-03-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sanofi
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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.