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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00694720
• Other study ID #: ACT6795
• Secondary ID: EudraCT 2007-002
• Status: Terminated
• Phase: Phase 2
• First received: May 7, 2008
• Last updated: April 30, 2009
• Start date: June 2008
• Est. completion date: March 2009

Study information

• Verified date: April 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesSpain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cheyne-Stokes Respiration
• Heart Failure
• Sleep Apnea Syndromes
• Syndrome

Intervention

Drug:
• AVE0657
capsules once a day at bedtime
• placebo
capsules once a day at bedtime

Locations

Country	Name	City	State
France	Sanofi-Aventis Administrative Office	Paris
Germany	Sanofi-Aventis Administrative Office	Berlin
Spain	Sanofi-Aventis Administrative Office	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

France,  Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Apnea Hypopnea Index (AHI)		2 days	No
Secondary	Safety and tolerability		5 days	Yes