Safely Change From Bosentan to Ambrisentan in Pulmonary Hypertension (SCOBA-PH)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by University of Alabama at Birmingham.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Dr. Robert C Bourge, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01330108
First received: April 4, 2011
Last updated: April 16, 2012
Last verified: April 2012

April 4, 2011
April 16, 2012
May 2011
July 2012   (final data collection date for primary outcome measure)
Safety and tolerance [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Advantage for changing from bosentan to ambrisentan would be the lack of an increase in liver function test results.
Same as current
Complete list of historical versions of study NCT01330108 on ClinicalTrials.gov Archive Site
Six minute walk testing [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Evaluate the change in exercise tolerance
Same as current
Not Provided
Not Provided
 
Safely Change From Bosentan to Ambrisentan in Pulmonary Hypertension
Safely Change From Bosentan to Ambrisentan in Pulmonary Hypertension

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pulmonary Arterial Hypertension
Drug: ambrisentan
ambrisentan 2.5mg, 5mg, & 10mg. Daily dosage.
Other Name: Letairis
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
110
July 2013
July 2012   (final data collection date for primary outcome measure)

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.
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01330108
SCOBA-PH
No
Dr. Robert C Bourge, University of Alabama at Birmingham
University of Alabama at Birmingham
Not Provided
Principal Investigator: Robert C Bourge, MD Univerisity of Alabama at Birmingham
University of Alabama at Birmingham
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP