Evaluation of the Effect of AVE0657 in Cheynes-Stokes Breathing Syndrome Patients
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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
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Sponsor:
Sanofi
Information provided by:
Sanofi
Tracking Information | ||||
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First Submitted Date ICMJE | May 7, 2008 | |||
First Posted Date ICMJE | June 10, 2008 | |||
Last Update Posted Date | May 1, 2009 | |||
Study Start Date ICMJE | June 2008 | |||
Actual Primary Completion Date | March 2009 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Change in the Apnea Hypopnea Index (AHI) [ Time Frame: 2 days ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
Safety and tolerability [ Time Frame: 5 days ] | |||
Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Evaluation of the Effect of AVE0657 in Cheynes-Stokes Breathing Syndrome Patients | |||
Official Title ICMJE | 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 | |||
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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE |
8 | |||
Original Estimated Enrollment ICMJE |
36 | |||
Actual Study Completion Date ICMJE | March 2009 | |||
Actual Primary Completion Date | March 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | France, Germany, Spain | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00694720 | |||
Other Study ID Numbers ICMJE | ACT6795 EudraCT 2007-002172-34 |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | ICD Study Director, sanofi-aventis | |||
Study Sponsor ICMJE | Sanofi | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Sanofi | |||
Verification Date | April 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |