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

Primary Purpose

Pulmonary Arterial Hypertension

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

ambrisentan

About this trial

This is an interventional treatment trial for Pulmonary Arterial Hypertension focused on measuring Pulmonary Arterial Hypertension, PAH, WHO Group 1

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
World Health Organization (WHO) PAH Type I
WHO class I-IV symptoms (no functional class exclusion).
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:

Known intolerance or allergy to ambrisentan.
Prior therapy with ambrisentan.
Current therapy with two phosphodiesterase-5 inhibitors.
Change in other approved therapy for PAH (including phosphodiesterase-5 inhibitors and prostanoids) within 4 weeks of baseline study visit.
Planned addition of prostanoid for clinical reasons within 3 months of baseline study visit.
Active participation in another clinical study involving the medical therapy of PAH.
Uncontrolled systemic hypertension or angina pectoris
Serum creatinine greater than 2.5 at or within 4 weeks of baseline.
Serum liver function studies greater than 3 x normal at or within 4 weeks of baseline study visit.
In the opinion of the investigator, a change in PAH therapy would present significant risk to the subject.
In the opinion of the investigator, the participant is unlikely to survive for 12 weeks after study entry.
In the opinion of the investigator, the participant is likely to undergo lung or heart-lung transplantation within 12 weeks of study entry.
A woman of childbearing potential who is not using an acceptable form of contraception.
Pregnancy.
In the opinion of the investigator, a participant who is not capable or willing to follow the study procedures.

Sites / Locations

University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ambrisentan

Arm Description

patients currently on bosentan to ambrisentan for the treatment of pulmonary arterial hypertension.

Outcomes

Primary Outcome Measures

Number of Subjects Not Able to Tolerate Ambrisentan

If a subject was not able tolerate ambrisentan, subject was returned to use of bosentan and ambrisentan was withdrawn within first 12 weeks of start. A subject was considered to not be able to tolerate ambrisentan if they experienced an adverse event or side effect that was not acceptable to the subject.

Secondary Outcome Measures

Mean Change in Distance for a Six Minute Walk at 12 Weeks Post Start of Ambrisentan

Evaluate the change in exercise tolerance. Measured the distance a subject was capable of walking in 6 minutes at basline compared to the distance at 12 weeks. The distance was measured in meters. A postive result reflects the distance increased at 12 weeks, a negative result reflects how much shorter the distance was.

Full Information

NCT ID

NCT01330108

First Posted

April 4, 2011

Last Updated

July 17, 2014

Sponsor

University of Alabama at Birmingham

1. Study Identification

Unique Protocol Identification Number

NCT01330108

Brief Title

Safely Change From Bosentan to Ambrisentan in Pulmonary Hypertension

Acronym

SCOBA-PH

Official Title

Safely Change From Bosentan to Ambrisentan in Pulmonary Hypertension

Study Type

Interventional

2. Study Status

Record Verification Date

June 2014

Overall Recruitment Status

Completed

Study Start Date

May 2011 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Alabama at Birmingham

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed Description

The therapy of pulmonary arterial hypertension (PAH) has been revolutionized with the development and subsequent instruction of oral endothelin receptor antagonists (ERA). The first approved ERA, bosentan (Tracleer, Actelion, Inc.) is an effective drug widely used throughout the world in the therapy of PAH. Newer ERA's, with purported advantages over the first approved drug have since been tested and subsequently been approved for the therapy of PAH in the USA and other countries including ambrisentan (Letairis, Gilead Sciences, Inc.). However, there is little data available on the efficacy, safety and tolerability of the elective change from oral bosentan to oral ambrisentan in PAH.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Arterial Hypertension

Keywords

Pulmonary Arterial Hypertension, PAH, WHO Group 1

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ambrisentan

Arm Type

Experimental

Arm Description

patients currently on bosentan to ambrisentan for the treatment of pulmonary arterial hypertension.

Intervention Type

Drug

Intervention Name(s)

ambrisentan

Other Intervention Name(s)

Letairis

Intervention Description

ambrisentan 2.5mg, 5mg, & 10mg. Daily dosage.

Primary Outcome Measure Information:

Title

Number of Subjects Not Able to Tolerate Ambrisentan

Description

Time Frame

baseline to 12 weeks

Secondary Outcome Measure Information:

Title

Mean Change in Distance for a Six Minute Walk at 12 Weeks Post Start of Ambrisentan

Description

Time Frame

baseline to 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. World Health Organization (WHO) PAH Type I WHO class I-IV symptoms (no functional class exclusion). 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: Known intolerance or allergy to ambrisentan. Prior therapy with ambrisentan. Current therapy with two phosphodiesterase-5 inhibitors. Change in other approved therapy for PAH (including phosphodiesterase-5 inhibitors and prostanoids) within 4 weeks of baseline study visit. Planned addition of prostanoid for clinical reasons within 3 months of baseline study visit. Active participation in another clinical study involving the medical therapy of PAH. Uncontrolled systemic hypertension or angina pectoris Serum creatinine greater than 2.5 at or within 4 weeks of baseline. Serum liver function studies greater than 3 x normal at or within 4 weeks of baseline study visit. In the opinion of the investigator, a change in PAH therapy would present significant risk to the subject. In the opinion of the investigator, the participant is unlikely to survive for 12 weeks after study entry. In the opinion of the investigator, the participant is likely to undergo lung or heart-lung transplantation within 12 weeks of study entry. A woman of childbearing potential who is not using an acceptable form of contraception. Pregnancy. In the opinion of the investigator, a participant who is not capable or willing to follow the study procedures.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert C Bourge, MD

Organizational Affiliation

Univerisity of Alabama at Birmingham

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Alabama at Birmingham

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35249

Country

United States

12. IPD Sharing Statement

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