Safely Change From Bosentan to Ambrisentan in Pulmonary Hypertension

NCT01330108 | Completed Phase 4 Results

• 1 other identifier: SCOBA-PH
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Arterial Hypertension

Keywords

Pulmonary Arterial Hypertension; PAH; WHO Group 1

Outcome Measures

Primary Outcomes (1)

• 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  If a subject was not able tolerate ambrisentan, subject was returned to use of bosentan and ambrisentan was withdrawn within first 12 weeks of start.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.

  baseline to 12 weeks

Secondary Outcomes (1)

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

  baseline to 12 weeks

Study Arms (1)

Ambrisentan

EXPERIMENTAL

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

Drug: ambrisentan

Interventions

ambrisentan DRUG

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

Also known as: Letairis

Ambrisentan

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

ambrisentan

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

There is bias in the study due to the fact that subjects have been proven to tolerate the initial drug in the study (bosentan) and adequate time was not allowed for subjects to be able to tolerate ambisentan

Results Point of Contact

• Title: Robert C Bourge
• Organization: University of Alabama at Birmingham

bbourge@uab.edu

205-934-3624

Study Officials

• Robert C Bourge, MD

  Univerisity of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2011
• First Posted: April 6, 2011
• Study Start: May 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: August 11, 2014
• Results First Posted: August 11, 2014

Record last verified: 2014-06

Locations

US (1)