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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
  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
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Further study details as provided by Sanofi:

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

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

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   (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
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, see Learn About Clinical Studies.

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

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

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

ClinicalTrials.gov processed this record on June 23, 2017