At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multinational, Multicentre, Randomized, Double-blind Study To Assess The Efficacy And Safety Of Oral Sildenafil 20mg Tid Or Placebo When Added To Bosentan In The Treatment Of Subjects, Aged 18 Years And Above, With Pulmonary Arterial Hypertension (Pah)
In Brief
A Phase 4 clinical trial evaluating Bosentan, Placebo, and 1 other intervention for Pulmonary Arterial Hypertension. Completed, enrolled 105 participants across 30 sites in 10 countries.
Detailed Summary
To assess the efficacy and safety of sildenafil when added to patients with PAH who are taking bosentan as all or part of their background therapy.
Study Details
Timeline
Interventions
Bosentan + Placebo for 12 weeks of the study (double blind), then 12 months open label phase (bosentan + sildenafil)
Bosentan + Placebo for 12 weeks of the study (double blind), then 12 months open label phase (bosentan + sildenafil)
Bosentan + Sildenafil for 12 weeks of the study (double blind), then 12 months open label phase
Bosentan + Sildenafil for 12 weeks of the study (double blind), then 12 months open label phase