NCT00625469

Pulmonary Arterial Hypertension Secondary to Idiopathic Pulmonary Fibrosis and Treatment With Bosentan

Treatment of Pulmonary Arterial Hypertension Secondary to Idiopathic Pulmonary Hypertension With Bosentan: A Single Center Pilot Study

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Rajan Saggar · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Pulmonary Arterial Hypertension (PAH) in the setting of Idiopathic Pulmonary Fibrosis(IPF)is a risk factor for morbidity and mortality in the peri-lung transplant(LT) setting. Currently there is no significant data to support the use of pulmonary vasodilators for PAH in the setting of interstitial lung disease such as IPF. The majority of IPF patients have PAH either at rest or during exercise. The study hypothesis is that bosentan may improve morbidity and mortality in the peri-LT setting in both IPF cohorts with either resting or exercise PAH.

Detailed description

The purpose of this study was to evaluate bosentan in the setting of exercise or resting pulmonary hypertension in patients with underlying pulmonary fibrosis.

Conditions

• Pulmonary Arterial Hypertension
• Idiopathic Pulmonary Fibrosis

Interventions

Type	Name	Description
DRUG	bosentan	62.5mg orally bid for first month, followed by 125mg bid thereafter

Timeline

• Start date: 2007-10-01
• Primary completion: 2009-06-01
• Completion: 2009-12-01
• First posted: 2008-02-28
• Last updated: 2018-03-06

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study