Study of Ambrisentan in Participants With Pulmonary Hypertension (ABS-LT)

September 8, 2020 updated by: Gilead Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1280AEB
        • Hospital Britanico de Buenos Aires
      • Buenos Aires, Argentina, 1605
        • Clinica Independencia Munro
      • Buenos Aires, Argentina, B7600FZN
        • Instituto de Investigaciones Clinicas Mar del Plata
      • Buenos Aires, Argentina, C1115AAb
        • Sanatorio Otamendi y Miroli
      • Buenos Aires, Argentina, C1437BZL
        • UAI Hospital Universitario
      • Cordoba, Argentina, X5003DCE
        • Fundación Rusculleda
      • Cordoba, Argentina, X5004FJE
        • Instituto de Cardiologia Hospital Italiano de Cordoba
      • Cordoba, Argentina, X5016KEH
        • Hospital Privado Centro Medico de Cordoba S.A.
      • Corrientes, Argentina, W3400AMZ
        • Instituto de Cardiologia J.F. Cabral
      • Rosario, Argentina, S2001ODA
        • Hospital Italiano
  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • St. Vincent's Hospital
    • Western Australia
      • Perth, Western Australia, Australia, 6000
        • Royal Perth Hospital
  • Brazil
      • Belo Horizonte, Brazil, 30380-090
        • Instituto de Pneumologia e Pediatria Clínica e Pesquisas LTDA ME
      • Porto Alegre, Brazil, 90610 000
        • UBEA, Hospital Sao Lucas de Pontifícia
      • Porto Alegre, Brazil, 92020-090
        • Irmandade Santa Casa de Misericordia de Porto Alegre
      • Rio de Janeiro, Brazil, 21949-900
        • Hospital Universitario Clementino Fraga Filho
      • Sao Paulo, Brazil, 4023-062
        • Universidade do Estado de Sao Paulo - UNIFESP
      • Sao Paulo, Brazil, CEP05403-000
        • Hospital das Clínicas da FMUSP
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T1Y 6J4
        • Peter Lougheed Centre
  • Chile
      • Santiago, Chile, 7500503
        • Centro de Estudios Cardiologicos Santiago Oriente
      • Santiago, Chile, 7500691
        • Instituto Nacional del Tórax
      • Santiago, Chile, 8330074
        • Hospital Clinico de la Pontificia Universidad Catolica de Chile
  • Mexico
      • Mexico City, Mexico, 14080
        • Instituto Nacional de Cardiologia Ignacio Chavez
      • Monterrey, Mexico, 64718
        • Unidad de Investigacion Clinica en Medicina S.C.
  • Russian Federation
      • Moscow, Russian Federation, 109263
        • State Medico Stomatologic University
      • Moscow, Russian Federation, 121552
        • Russian Cardiology Research Complex
      • St. Petersburg, Russian Federation, 194156
        • Almazov's Federal Heart, Blood & Endocrinology Center
      • St. Petersburg, Russian Federation, 197022
        • Pavlov's State Medical University of St. Petersburg
  • Ukraine
      • Kharkov, Ukraine, 61039
        • Department of Acute Myocardial Infarction
      • Kiev, Ukraine, 3049
        • Department of Propedeutics of Internal Medicine No 1
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Arizona Pulmonary Specialists
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Health Science Center
    • Connecticut
      • Farmington, Connecticut, United States, 06030
        • University of Connecticut Health Center
    • Georgia
      • Atlanta, Georgia, United States, 30030
        • Atlanta Institute for Medical Research, Inc.
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
      • Boston, Massachusetts, United States, 02115
        • Brigham & Women's Hospital
      • Boston, Massachusetts, United States, 02118
        • Boston University Medical Center
      • Boston, Massachusetts, United States, 02115
        • BACH Cardiology/Children's Hospital
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University Medical Center
    • New Jersey
      • Newark, New Jersey, United States, 07112
        • Newark Beth Israel Medical Center
    • New York
      • Rochester, New York, United States, 14623
        • Mary Parkes Asthma Center University of Rochester
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center Presbyterian
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
    • South Carolina
      • Lexington, South Carolina, United States, 29072
        • Lexington Pulmonary and Critical Care Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ambrisentan
Participants will receive ambrisentan 2.5 mg, 5 mg or 10 mg tablet orally once daily until such time as the investigator or participant chooses to stop ambrisentan treatment, ambrisentan becomes commercially available, or the sponsor stops the study.
Drug: Ambrisentan
Tablet administered orally once daily
Other Names:
  • Letairis®
  • Volibris

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 17, 2008

Primary Completion (Actual)

September 11, 2019

Study Completion (Actual)

September 11, 2019

Study Registration Dates

First Submitted

July 1, 2008

First Submitted That Met QC Criteria

October 21, 2008

First Posted (Estimate)

October 22, 2008

Study Record Updates

Last Update Posted (Actual)

September 30, 2020

Last Update Submitted That Met QC Criteria

September 8, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-300-0124

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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