NCT00323297

Assess the Efficacy and Safety of Sildenafil When Added to Bosentan in the Treatment of Pulmonary Arterial Hypertension

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)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	Bosentan	Bosentan + Placebo for 12 weeks of the study (double blind), then 12 months open label phase (bosentan + sildenafil)
OTHER	Placebo	Bosentan + Placebo for 12 weeks of the study (double blind), then 12 months open label phase (bosentan + sildenafil)
DRUG	Bosentan	Bosentan + Sildenafil for 12 weeks of the study (double blind), then 12 months open label phase
DRUG	Sildenafil Citrate	Bosentan + Sildenafil for 12 weeks of the study (double blind), then 12 months open label phase

Timeline

• Start date: 2006-09-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2006-05-09
• Last updated: 2021-02-01
• Results posted: 2013-11-19

Locations

30 sites across 10 countries: United States, Australia, Czechia, France, Germany, Greece, Israel, Italy, Taiwan, United Kingdom