Study of Ambrisentan in Subjects With Pulmonary Hypertension
Status: | Active, not recruiting |
---|---|
Conditions: | High Blood Pressure (Hypertension), High Blood Pressure (Hypertension) |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 11/22/2018 |
Start Date: | November 17, 2008 |
End Date: | October 2019 |
ABS-LT: A Phase 3, Long-Term, Open Label, Multicenter Safety Study of Ambrisentan in Subjects With Pulmonary Hypertension
This Phase 3, international, multicenter, open-label study will monitor the long-term safety
of ambrisentan in adults with pulmonary hypertension. The available ambrisentan doses for
this study are 5 or 10 mg administered orally once daily; the approved doses of ambrisentan
in the United States, Canada, and the European Union are 5 and 10 mg. Investigators will be
able to adjust ambrisentan dose as clinically indicated. A minimum of 4 weeks between dose
adjustments is required. Participants receiving other therapies for pulmonary hypertension
that are not contraindicated for concomitant use with ambrisentan are permitted to enroll in
this study and continue to receive such therapies. Participants enrolled in this study will
receive treatment with ambrisentan until such time as the investigator or participant chooses
to stop ambrisentan treatment, ambrisentan becomes commercially available, or the Sponsor
stops the study.
of ambrisentan in adults with pulmonary hypertension. The available ambrisentan doses for
this study are 5 or 10 mg administered orally once daily; the approved doses of ambrisentan
in the United States, Canada, and the European Union are 5 and 10 mg. Investigators will be
able to adjust ambrisentan dose as clinically indicated. A minimum of 4 weeks between dose
adjustments is required. Participants receiving other therapies for pulmonary hypertension
that are not contraindicated for concomitant use with ambrisentan are permitted to enroll in
this study and continue to receive such therapies. Participants enrolled in this study will
receive treatment with ambrisentan until such time as the investigator or participant chooses
to stop ambrisentan treatment, ambrisentan becomes commercially available, or the Sponsor
stops the study.
Inclusion Criteria:
- Men and women with pulmonary hypertension (PH) who are discontinuing a clinical study
of ambrisentan due to study closure by the Sponsor. Eligible subjects are those
participating in countries where ambrisentan is not yet commercially available.
Subjects participating in countries where ambrisentan is commercially available may be
eligible if they do not qualify for treatment per the current prescribing information
of that country.
Exclusion Criteria:
- Subjects who have discontinued an ambrisentan clinical study for any other reason than
Sponsor-initiated study closure are not eligible.
We found this trial at
17
sites
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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University of Iowa With just over 30,000 students, the University of Iowa is one of...
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Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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1 Boston Medical Center Place
Boston, Massachusetts 02118
Boston, Massachusetts 02118
617.638.8000
Boston University Medical Center Boston Medical Center is an extraordinary community of health care providers...
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263 Farmington Ave
Farmington, Connecticut 06030
Farmington, Connecticut 06030
(860) 679-2000
University of Connecticut Health Center UConn Health is a vibrant, integrated academic medical center that...
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Newark Beth Israel Medical Center Newark Beth Israel Medical Center, a regional care, teaching hospital...
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