Study of the Initial Combination of Bosentan With Iloprost in the Treatment of Pulmonary Hypertension Patients
Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
Previous studies suggest that combinations of existing therapies may be effective for
pulmonary arterial hypertension (PAH). However, all of these studies are sequential
combination therapy, for example, by adding sildenafil to previously prescribed bosentan.
This kind of therapy model is not enough for PAH patients, especially those with New York
Heart Association (NYHA) class Ⅲ and Ⅳ. In this randomized, multicenter study, the
investigators evaluate the safety and efficacy of combining inhaled iloprost, a prostacyclin
analog, with the endothelin receptor antagonist bosentan in treatment naive patients with PAH
by comparing with bosentan monotherapy. Efficacy endpoints include change from baseline in
6-min-walk distance (6-MWD), modified (NYHA) functional class, hemodynamic parameters, and
time to clinical worsening.
Phase:
Phase 3
Details
Lead Sponsor:
Air Force Military Medical University, China Fourth Military Medical University