Clinical Trial Results:
Minimum effective dose-finding study of BF2.649, in patients with moderate to severe Obstructive Sleep Apnea, experiencing Excessive Daytime Sleepiness (EDS) despite regular use of nCPAP, and patients having refused this therapy. Randomized, double blind study with BF2.649 (5-, 10-, 20-, 40- mg/d), or placebo
Summary
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EudraCT number |
2010-019413-25 |
Trial protocol |
FR |
Global completion date |
02 Dec 2011
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Paediatric regulatory details
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Is the trial part of an agreed EMA paediatric investigation plan? |
No
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Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
No
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Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
No
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Results information
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Results version number |
v1(current) |
This version publication date |
11 Jan 2022
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First version publication date |
11 Jan 2022
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Other versions |
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Summary report(s) |
P09-16 SCR Summary |
Note: The legislation allows summary attachments to be posted instead of the full dataset for this trial. Refer to Commission Guideline 2012/C 302/03
for further information.