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
  Purpose

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.


Condition Intervention Phase
Pulmonary Arterial Hypertension
Drug: ambrisentan
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safely Change From Bosentan to Ambrisentan in Pulmonary Hypertension

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Six minute walk testing [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Evaluate the change in exercise tolerance


Estimated Enrollment: 110
Study Start Date: May 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: ambrisentan
    ambrisentan 2.5mg, 5mg, & 10mg. Daily dosage.
    Other Name: Letairis
  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01330108

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Robert C Bourge, MD Univerisity of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: Dr. Robert C Bourge, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01330108     History of Changes
Other Study ID Numbers: SCOBA-PH
Study First Received: April 4, 2011
Last Updated: April 16, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
Pulmonary Arterial Hypertension
PAH
WHO Group 1

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
Bosentan
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014