Study Stopped
Termination following reassessment of the potential benefit-risk of AVE0657
Evaluation of the Effect of AVE0657 in Cheynes-Stokes Breathing Syndrome Patients
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
2 other identifiers
interventional
8
3 countries
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 heart-failure
Started Jun 2008
Shorter than P25 for phase_2 heart-failure
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 7, 2008
CompletedStudy Start
First participant enrolled
June 1, 2008
CompletedFirst Posted
Study publicly available on registry
June 10, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedMay 1, 2009
April 1, 2009
9 months
May 7, 2008
April 30, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in the Apnea Hypopnea Index (AHI)
2 days
Secondary Outcomes (1)
Safety and tolerability
5 days
Study Arms (5)
Dose Level 1
EXPERIMENTALDose Level 2
EXPERIMENTALDose Level 3
EXPERIMENTALDose Level 4
EXPERIMENTALPlacebo
PLACEBO COMPARATOR12 subjects: 3 subjects per dose level
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (3)
Sanofi-Aventis Administrative Office
Paris, France
Sanofi-Aventis Administrative Office
Berlin, Germany
Sanofi-Aventis Administrative Office
Barcelona, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patrick LEVY, Professor
Hôpital Michallon - Grenoble - France
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 7, 2008
First Posted
June 10, 2008
Study Start
June 1, 2008
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
May 1, 2009
Record last verified: 2009-04