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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00694720

Enrollment

Registered

2008-06-10

Start date

2008-06-30

Completion date

2009-03-31

Last updated

2009-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cheyne-Stokes Respiration, Heart Failure, Sleep Apnea Syndromes

Keywords

Cheyne-stokes breathing

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.

Interventions

DRUGAVE0657

capsules once a day at bedtime

DRUGplacebo

capsules once a day at bedtime

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Change in the Apnea Hypopnea Index (AHI)	2 days

Secondary

Measure	Time frame
Safety and tolerability	5 days

Countries

France, Germany, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026