A Double-Blind, Randomized, Placebo-Controlled, Study Evaluating the Safety and Activity of Four Escalating Single Doses of AVE0657 in Congestive Heart Failure Patients Presenting as Cheyne-Stokes Breathing Syndrome

Sanofi1 site in 1 country8 target enrollmentJune 2008

ConditionsHeart Failure Sleep Apnea Syndromes Cheyne-Stokes Respiration

Interventionsplacebo AVE0657

DrugsAVE0657 placebo

Overview

Phase: Phase 2
Intervention: placebo
Conditions: Heart Failure
Sponsor: Sanofi
Enrollment: 8
Locations: 1
Primary Endpoint: Change in the Apnea Hypopnea Index (AHI)
Status: Terminated
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2008

End Date

March 2009

Last Updated

17 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sanofi

Eligibility 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.