Clinical Trial Results:
Estudio clínico de Fase 2A, multicéntrico aleatorizado, doble ciego, controlado con placebo y con un fármaco activo, de diseño cruzado con dos cohortes y dos dosis, para la evaluación de la eficacia de la administración una vez al día de un inhibidor de la fosfodiesterasa 5 (PF 00489791) para el tratamiento del vasospasmo en el fenómeno de Raynaud primario y secundario.
A PHASE 2A RANDOMIZED DOUBLE-BLINDED, PLACEBO AND ACTIVE CONTROLLED TWO COHORT TWO DOSES CROSS-OVER MULTI-CENTER CLINICAL STUDY TO ASSESS EFFICACY OF A ONCE DAILY ADMINISTRATION OF A PHOSPHODIESTERASE 5 INHIBITOR (PF-00489791) FOR THE TREATMENT OF VASOSPASM IN PRIMARY AND SECONDARY RAYNAUD?S PHENOMENON
Summary
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EudraCT number |
2010-019009-40 |
Trial protocol |
ES SE CZ DE HU |
Global completion date |
31 May 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 |
25 Sep 2016
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First version publication date |
25 Sep 2016
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Other versions |
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Summary report(s) |
A7331010 Public Disclosure Synopsis |
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.