Study of Ambrisentan in Participants With Pulmonary Hypertension

Pulmonary Hypertension Clinical Trial

— ABS-LT  

Official title:

ABS-LT: A Phase 3, Long-Term, Open Label, Multicenter Safety Study of Ambrisentan in Subjects With Pulmonary Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00777920
• Other study ID #: GS-US-300-0124
• Status: Completed
• Phase: Phase 3
• Start date: November 17, 2008
• Est. completion date: September 11, 2019

Study information

• Verified date: September 2020
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to monitor the long-term safety of ambrisentan in adult participants with pulmonary hypertension. The available ambrisentan doses for this study are 2.5, 5, or 10 mg administered orally once daily. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: September 11, 2019
• Est. primary completion date: September 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Men and women with pulmonary hypertension who are discontinuing a clinical study of ambrisentan due to study closure by the sponsor. Eligible participants are those participating in countries where ambrisentan is not yet commercially available. Participants 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.

Key Exclusion Criteria:

• Participants who have discontinued an ambrisentan clinical study for any other reason than sponsor-initiated study closure are not eligible.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Drug:
• Ambrisentan
Tablet administered orally once daily

Locations

Country	Name	City	State
Argentina	Clinica Independencia Munro	Buenos Aires
Argentina	Hospital Británico de Buenos Aires	Buenos Aires
Argentina	Instituto de Investigaciones Clínicas Mar del Plata	Buenos Aires
Argentina	Sanatorio Otamendi y Miroli	Buenos Aires
Argentina	UAI Hospital Universitario	Buenos Aires
Argentina	Fundación Rusculleda	Cordoba
Argentina	Hospital Privado Centro Medico de Cordoba S.A.	Cordoba
Argentina	Instituto de Cardiologia Hospital Italiano de Cordoba	Cordoba
Argentina	Instituto de Cardiologia J.F. Cabral	Corrientes
Argentina	Hospital Italiano	Rosario
Australia	St. Vincent's Hospital	Darlinghurst	New South Wales
Australia	Royal Perth Hospital	Perth	Western Australia
Brazil	Instituto de Pneumologia e Pediatria Clínica e Pesquisas LTDA ME	Belo Horizonte
Brazil	Irmandade Santa Casa de Misericordia de Porto Alegre	Porto Alegre
Brazil	UBEA, Hospital Sao Lucas de Pontifícia	Porto Alegre
Brazil	Hospital Universitario Clementino Fraga Filho	Rio de Janeiro
Brazil	Hospital das Clinicas da FMUSP	Sao Paulo
Brazil	Universidade do Estado de Sao Paulo - UNIFESP	Sao Paulo
Canada	Peter Lougheed Centre	Calgary	Alberta
Chile	Centro de Estudios Cardiologicos Santiago Oriente	Santiago
Chile	Hospital Clinico de la Pontificia Universidad Catolica de Chile	Santiago
Chile	Instituto Nacional del Torax	Santiago
Mexico	Instituto Nacional de Cardiologia Ignacio Chavez	Mexico City
Mexico	Unidad de Investigacion Clinica en Medicina S.C.	Monterrey
Russian Federation	Russian Cardiology Research Complex	Moscow
Russian Federation	State Medico Stomatologic University	Moscow
Russian Federation	Almazov's Federal Heart, Blood & Endocrinology Center	St. Petersburg
Russian Federation	Pavlov's State Medical University of St. Petersburg	St. Petersburg
Ukraine	Department of Acute Myocardial Infarction	Kharkov
Ukraine	Department of Propedeutics of Internal Medicine No 1	Kiev
United States	Atlanta Institute for Medical Research, Inc.	Atlanta	Georgia
United States	University of Colorado Health Science Center	Aurora	Colorado
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	BACH Cardiology/Children's Hospital	Boston	Massachusetts
United States	Boston University Medical Center	Boston	Massachusetts
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	Tufts Medical Center	Boston	Massachusetts
United States	University of Connecticut Health Center	Farmington	Connecticut
United States	University of Iowa	Iowa City	Iowa
United States	Lexington Pulmonary and Critical Care Medicine	Lexington	South Carolina
United States	Newark Beth Israel Medical Center	Newark	New Jersey
United States	Arizona Pulmonary Specialists	Phoenix	Arizona
United States	University of Pittsburgh Medical Center Presbyterian	Pittsburgh	Pennsylvania
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Mary Parkes Asthma Center University of Rochester	Rochester	New York
United States	Washington University Medical Center	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Canada,  Chile,  Mexico,  Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Adverse Events (AEs) Associated With Long-Term Exposure to Ambrisentan		First dose date of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks)