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

Phase 2

Terminated

• Conditions: Heart Failure; Sleep Apnea Syndromes; Cheyne-Stokes Respiration
• Interventions: Drug: AVE0657; Drug: placebo

• Registration Number: NCT00694720
• Lead Sponsor: Sanofi

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-05-07
• Study Start: 2008-06
• Study First Submitted QC: 2008-06-06
• Study First Posted: 2008-06-10
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-30
• Last Update Posted: 2009-05-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose Level 1	AVE0657	-
Dose Level 2	AVE0657	-
Dose Level 3	AVE0657	-
Placebo	placebo	12 subjects: 3 subjects per dose level
Dose Level 4	AVE0657	-

Primary Outcome Measures

Name	Time	Method
Change in the Apnea Hypopnea Index (AHI)	2 days

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability	5 days

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇪🇸 Barcelona, Spain