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

This study is ongoing, but not recruiting participants.

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

History of Changes

Tracking Information

First Received Date ^ICMJE

April 4, 2011

Last Updated Date

April 16, 2012

Start Date ^ICMJE

May 2011

Estimated Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01330108 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Six minute walk testing [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Evaluate the change in exercise tolerance

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Safely Change From Bosentan to Ambrisentan in Pulmonary Hypertension

Official Title ^ICMJE

Safely Change From Bosentan to Ambrisentan in Pulmonary Hypertension

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Pulmonary Arterial Hypertension

Intervention ^ICMJE

Drug: ambrisentan

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

Other Name: Letairis

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

110

Estimated Completion Date

July 2013

Estimated Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 PDE-5 inhibitors.
Change in other approved therapy for PAH (including PDE-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.

Gender

Both

Ages

19 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01330108

Other Study ID Numbers ^ICMJE

SCOBA-PH

Has Data Monitoring Committee

Responsible Party

Dr. Robert C Bourge, University of Alabama at Birmingham

Study Sponsor ^ICMJE

University of Alabama at Birmingham

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Robert C Bourge, MD

Univerisity of Alabama at Birmingham

Information Provided By

University of Alabama at Birmingham

Verification Date

April 2012

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

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