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

Phase 2TerminatedNCT00694720

Sanofi8 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Heart Failure Sleep Apnea Syndromes Cheyne-Stokes Respiration

Interventions

AVE0657DRUG

capsules once a day at bedtime

placeboDRUG

capsules once a day at bedtime

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (3)

Sanofi-Aventis Administrative Office

Paris, France

Sanofi-Aventis Administrative Office

Berlin, Germany

Sanofi-Aventis Administrative Office

Barcelona, Spain

Outcomes

Primary Outcomes

Change in the Apnea Hypopnea Index (AHI)

Time frame: 2 days

Secondary Outcomes

Safety and tolerability

Time frame: 5 days

Data from ClinicalTrials.gov

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