Clinical Trial Results:
Estudio multicéntrico, aleatorizado, doble ciego, doble enmascarado, controlado con placebo, con grupos paralelos y diseño adaptativo, de 26 semanas de tratamiento, para evaluar la eficacia, seguridad y tolerabilidad de dos dosis de indacaterol (seleccionadas entre 75, 150, 300 y 600 µg o.d.) en pacientes con enfermedad pulmonar obstructiva crónica, que utilizan formoterol (12 µg b.i.d.) y tiotropio abierto (18 μg o.d.) como controles activos.
Summary
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EudraCT number |
2006-001955-37 |
Trial protocol |
ES DE SE IT |
Global completion date |
23 Aug 2008
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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 |
21 Apr 2016
|
First version publication date |
21 Apr 2016
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Other versions |
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Summary report(s) |
CQAB149B2335S_CT_gov_results |
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.