Safely Change From Bosentan to Ambrisentan in Pulmonary Hypertension

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01330108
• Date of registration: 04/04/2011
• Prospective Registration: Yes
• Primary sponsor: University of Alabama at Birmingham
• Public title: Safely Change From Bosentan to Ambrisentan in Pulmonary Hypertension SCOBA-PH
• Scientific title: Safely Change From Bosentan to Ambrisentan in Pulmonary Hypertension
• Date of first enrolment: May 2011
• Target sample size: 32
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01330108
• Study type: Interventional
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Robert C Bourge, MD
• Affiliation: Univerisity of Alabama at Birmingham

Key inclusion & exclusion 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.



Age minimum: 19 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Arterial Hypertension

Intervention(s)

Drug: ambrisentan

Primary Outcome(s)

Number of Subjects Not Able to Tolerate Ambrisentan [Time Frame: baseline to 12 weeks]

Secondary Outcome(s)

Mean Change in Distance for a Six Minute Walk at 12 Weeks Post Start of Ambrisentan [Time Frame: baseline to 12 weeks]

Secondary ID(s)

SCOBA-PH

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 11/08/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01330108