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A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, EFFICACY AND SAFETY STUDY OF MONOTHERAPY SITAXSENTAN SODIUM VERSUS COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WIT...

Mise à jour : Il y a 4 ans
Référence : EUCTR2008-005887-14

A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, EFFICACY AND SAFETY STUDY OF MONOTHERAPY SITAXSENTAN SODIUM VERSUS COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION WHO HAVE COMPLETED STUDY B1321001

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Extrait

The primary objective of this study is to evaluate the efficacy of sitaxsentan (100 mg once daily) plus sildenafil (20 mg TID) as compared to sitaxsentan monotherapy by determining time to clinical worsening in the treatment of subjects with PAH who have completed study B1321001.

Critère d'inclusion

  • pulmonary arterial hypertension

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