Overview

Safely Change From Bosentan to Ambrisentan in Pulmonary Hypertension

Status:
Completed
Trial end date:
2012-06-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Alabama at Birmingham
Treatments:
Ambrisentan
Bosentan
Criteria
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 phosphodiesterase-5 inhibitors.

4. Change in other approved therapy for PAH (including phosphodiesterase-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.