7 results
Primary: to assess the longterm safety and tolerability of ambrisentan 5mg in subjects with inoperable CTEPH. Secondary: to collect supportive efficacy data.
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.
The primary objective of this study is to compare the two treatment strategies; first-line combination therapy (ambrisentan and tadalafil) versus first-line monotherapy (ambrisentan or tadalafil) in subjects with PAH. This will be assessed by time…
This is a feasibility study to assess this new device after 6 months use. There are 3 objectives that have to be fulfilled in order use this device in the future:1. Safety of the NewBreez® at 6 months: has there been further damage done to the…
Primary: to assess the efficacy of ambrisentan 5mg after treatment period of 16 weeks, in subjects with inoperable CTEPH. Secondary: safety and tolerability.
Safety:* Evaluate the safety of AVXS-101 through incidence of adverse events (AEs) and/or serious adverse events (SAEs)* Evaluate the safety of AVXS-101 based on the change from baseline in clinical laboratory parametersEfficacy objectives will be…