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

This study has been terminated.
(Termination following reassessment of the potential benefit-risk of AVE0657)
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00694720
First received: May 7, 2008
Last updated: April 30, 2009
Last verified: April 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Heart Failure
Sleep Apnea Syndromes
Cheyne-Stokes Respiration
 Drug: AVE0657
Drug: placebo
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Change in the Apnea Hypopnea Index (AHI) [ Time Frame: 2 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]

Enrollment: 8
Study Start Date: June 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose Level 1 Drug: AVE0657
capsules once a day at bedtime
Experimental: Dose Level 2 Drug: AVE0657
capsules once a day at bedtime
Experimental: Dose Level 3 Drug: AVE0657
capsules once a day at bedtime
Experimental: Dose Level 4 Drug: AVE0657
capsules once a day at bedtime
Placebo Comparator: Placebo
12 subjects: 3 subjects per dose level
 Drug: placebo
capsules once a day at bedtime

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00694720

Locations
France
Sanofi-Aventis Administrative Office
Paris, France
Germany
Sanofi-Aventis Administrative Office
Berlin, Germany
Spain
Sanofi-Aventis Administrative Office
Barcelona, Spain
Sponsors and Collaborators
Sanofi
Investigators
Principal Investigator: Patrick LEVY, Professor Hôpital Michallon - Grenoble - France
  More Information

No publications provided

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00694720     History of Changes
Other Study ID Numbers: ACT6795, EudraCT 2007-002172-34
Study First Received: May 7, 2008
Last Updated: April 30, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Spain: Ethics Committee

Keywords provided by Sanofi:
Cheyne-stokes breathing

Additional relevant MeSH terms:
Respiratory Aspiration
Cheyne-Stokes Respiration
Heart Failure
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
 Heart Diseases
Cardiovascular Diseases
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 21, 2013