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

Sanofi

Status and phase: Terminated; Phase 2

Conditions: Sleep Apnea Syndromes; Cheyne-Stokes Respiration; Heart Failure

Treatments: Drug: AVE0657; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00694720

ACT6795

EudraCT 2007-002172-34

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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8 participants in 5 patient groups, including a placebo group

Dose Level 1

Experimental group

Treatment:

Drug: AVE0657

Dose Level 2

Experimental group

Treatment:

Drug: AVE0657

Dose Level 3

Experimental group

Treatment:

Drug: AVE0657

Dose Level 4

Experimental group

Treatment:

Drug: AVE0657

Placebo

Placebo Comparator group

Description:

12 subjects: 3 subjects per dose level

Treatment:

Drug: placebo