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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00694720
Recruitment Status : Terminated (Termination following reassessment of the potential benefit-risk of AVE0657)
First Posted : June 10, 2008
Last Update Posted : May 1, 2009
Sponsor:
Information provided by:

Study Description
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.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : June 2008
Primary Completion Date : March 2009
Study Completion Date : March 2009
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Change in the Apnea Hypopnea Index (AHI) [ Time Frame: 2 days ]

Secondary Outcome Measures :
  1. Safety and tolerability [ Time Frame: 5 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00694720     History of Changes
Other Study ID Numbers: ACT6795
EudraCT 2007-002172-34
First Posted: June 10, 2008    Key Record Dates
Last Update Posted: May 1, 2009
Last Verified: April 2009

Keywords provided by Sanofi:
Cheyne-stokes breathing

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