5 results
1. Overall survival (primary efficacy endpoint)2a. Efficacy: progression-free survival (PFS), overall response rate (ORR = CR + PR), and a clincal benefit rate (CBR) will be evaluated as CR + PR + SD for at least 3 months.2b. Safety: adverse events…
Primary: to assess the longterm safety and tolerability of ambrisentan 5mg in subjects with inoperable CTEPH. Secondary: to collect supportive efficacy data.
The Lipid-rich Plaque Study will be performed in patients undergoing IVUS-NIRS imaging (the index procedure) in whom a TVC catheter will be purchased and used for routine clinical indications. The study will test the ability of multi-vessel NIRS…
Primary: Longterm safety and tolerability of 2 dosages of ambrisentan. Secundary: Supportive efficacy data.
Primary: Safety and tolerability of 2 dosages of ambrisentan. Secundary: Efficacy and PK.