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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00625469
• Date of registration: 19/02/2008
• Prospective Registration: No
• Primary sponsor: Rajan Saggar
• Public title: Pulmonary Arterial Hypertension Secondary to Idiopathic Pulmonary Fibrosis and Treatment With Bosentan
• Scientific title: Treatment of Pulmonary Arterial Hypertension Secondary to Idiopathic Pulmonary Hypertension With Bosentan: A Single Center Pilot Study
• Date of first enrolment: October 2007
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT00625469
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Rajan Saggar, MD
• Affiliation: University of California, Los Angeles

Key inclusion & exclusion criteria

Inclusion Criteria:

- Idiopathic Pulmonary Fibrosis referred for lung transplantation

- Minimum 50 meter 6 minute walk distance

- No significant underlying liver disease

Exclusion Criteria:

- Significant liver disease or cirrhosis

- non ambulatory

- previous adverse reaction/allergy to Bosentan



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Idiopathic Pulmonary Fibrosis

Pulmonary Arterial Hypertension

Intervention(s)

Drug: bosentan

Primary Outcome(s)

6 minute walk distance [Time Frame: monthly assessement until date of lung transplantation]

Secondary Outcome(s)

right heart catheterization hemodynamics [Time Frame: variable based on time between listing and actual lung transplantation]

chemokine peripheral blood analysis [Time Frame: monthly]

Secondary ID(s)

IPF/PAH

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Actelion