Clinical Trial Results:
A prospective, randomized, open-label, active-controlled study in adult subjects with acute bacterial sinusitis comparing the clinical efficacy of telithromycin (KETEK®) 800 mg once a day for 5 days versus amoxicillin-clavulanic acid (AUGMENTIN®) 875/125 mg twice a day for 10 days.
Summary
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EudraCT number |
2004-001460-42 |
Trial protocol |
DE |
Global completion date |
19 Dec 2005
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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 |
01 May 2016
|
First version publication date |
01 May 2016
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Other versions |
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Summary report(s) |
HMR3647A_4023 |
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.