Overview

This trial is active, not recruiting.

Condition pulmonary arterial hypertension
Treatment ambrisentan
Phase phase 4
Sponsor University of Alabama at Birmingham
Start date May 2011
End date July 2012
Trial size 110 participants
Trial identifier NCT01330108, SCOBA-PH

Summary

The primary objective of this study is to assess the safety and tolerance of changing patients currently on bosentan to ambrisentan for the treatment of pulmonary arterial hypertension.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Safety and tolerance
time frame: 12 weeks

Secondary Outcomes

Measure
Six minute walk testing
time frame: 12 weeks

Eligibility Criteria

Male or female participants at least 19 years old.

Inclusion Criteria: 1. Patients followed routinely in the pulmonary vascular disease clinic at the University of Alabama in Birmingham, greater than or equal to 19 years of age. 2. World Health Organization (WHO) PAH Type I 3. WHO class I-IV symptoms (no functional class exclusion). 4. On bosentan, twice a day, with a maximum daily dose of 250mg, on a stable dose for 3 months with no clinical indication to discontinue the drug (i.e., increased liver function studies or other intolerance). Patients may be on other drug therapies for PAH, and also may be on oxygen therapy (intermittent or continuous). Exclusion Criteria: 1. Known intolerance or allergy to ambrisentan. 2. Prior therapy with ambrisentan. 3. Current therapy with two PDE-5 inhibitors. 4. Change in other approved therapy for PAH (including PDE-5 inhibitors and prostanoids) within 4 weeks of baseline study visit. 5. Planned addition of prostanoid for clinical reasons within 3 months of baseline study visit. 6. Active participation in another clinical study involving the medical therapy of PAH. 7. Uncontrolled systemic hypertension or angina pectoris 8. Serum creatinine greater than 2.5 at or within 4 weeks of baseline. 9. Serum liver function studies greater than 3 x normal at or within 4 weeks of baseline study visit. 10. In the opinion of the investigator, a change in PAH therapy would present significant risk to the subject. 11. In the opinion of the investigator, the participant is unlikely to survive for 12 weeks after study entry. 12. In the opinion of the investigator, the participant is likely to undergo lung or heart-lung transplantation within 12 weeks of study entry. 13. A woman of childbearing potential who is not using an acceptable form of contraception. 14. Pregnancy. 15. In the opinion of the investigator, a participant who is not capable or willing to follow the study procedures.

Additional Information

Official title Safely Change From Bosentan to Ambrisentan in Pulmonary Hypertension
Principal investigator Robert C Bourge, MD
Trial information was received from ClinicalTrials.gov and was last updated in April 2012.
Information provided to ClinicalTrials.gov by University of Alabama at Birmingham.