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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:
Sanofi

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

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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
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

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




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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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.


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
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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
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Principal Investigator: Patrick LEVY, Professor Hôpital Michallon - Grenoble - France

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Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00694720    
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:
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Sleep Apnea Syndromes
Respiratory Aspiration
Cheyne-Stokes Respiration
Heart Failure
Syndrome
Disease
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms