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

Primary Purpose

Pulmonary Hypertension

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ambrisentan
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama at Birmingham
  • Arizona Pulmonary Specialists
  • University of Colorado Health Science Center
  • University of Connecticut Health Center
  • Atlanta Institute for Medical Research, Inc.
  • University of Iowa
  • Tufts Medical Center
  • BACH Cardiology/Children's Hospital
  • Brigham & Women's Hospital
  • Boston University Medical Center
  • Washington University Medical Center
  • Newark Beth Israel Medical Center
  • Mary Parkes Asthma Center University of Rochester
  • University of Pittsburgh Medical Center Presbyterian
  • Rhode Island Hospital
  • Lexington Pulmonary and Critical Care Medicine
  • Clinica Independencia Munro
  • Instituto de Investigaciones Clínicas Mar del Plata
  • Sanatorio Otamendi y Miroli
  • Hospital Británico de Buenos Aires
  • UAI Hospital Universitario
  • Fundación Rusculleda
  • Instituto de Cardiologia Hospital Italiano de Cordoba
  • Hospital Privado Centro Medico de Cordoba S.A.
  • Instituto de Cardiologia J.F. Cabral
  • Hospital Italiano
  • St. Vincent's Hospital
  • Royal Perth Hospital
  • Instituto de Pneumologia e Pediatria Clínica e Pesquisas LTDA ME
  • UBEA, Hospital Sao Lucas de Pontifícia
  • Irmandade Santa Casa de Misericordia de Porto Alegre
  • Hospital Universitario Clementino Fraga Filho
  • Universidade do Estado de Sao Paulo - UNIFESP
  • Hospital das Clinicas da FMUSP
  • Peter Lougheed Centre
  • Centro de Estudios Cardiologicos Santiago Oriente
  • Instituto Nacional del Torax
  • Hospital Clinico de la Pontificia Universidad Catolica de Chile
  • Instituto Nacional de Cardiologia Ignacio Chavez
  • Unidad de Investigacion Clinica en Medicina S.C.
  • State Medico Stomatologic University
  • Russian Cardiology Research Complex
  • Almazov's Federal Heart, Blood & Endocrinology Center
  • Pavlov's State Medical University of St. Petersburg
  • Department of Acute Myocardial Infarction
  • Department of Propedeutics of Internal Medicine No 1

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ambrisentan

Arm Description

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.

Outcomes

Primary Outcome Measures

Percentage of Participants With Adverse Events (AEs) Associated With Long-Term Exposure to Ambrisentan

Secondary Outcome Measures

Full Information

First Posted
July 1, 2008
Last Updated
September 8, 2020
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00777920
Brief Title
Study of Ambrisentan in Participants With Pulmonary Hypertension
Acronym
ABS-LT
Official Title
ABS-LT: A Phase 3, Long-Term, Open Label, Multicenter Safety Study of Ambrisentan in Subjects With Pulmonary Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
November 17, 2008 (Actual)
Primary Completion Date
September 11, 2019 (Actual)
Study Completion Date
September 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ambrisentan
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ambrisentan
Other Intervention Name(s)
Letairis®, Volibris
Intervention Description
Tablet administered orally once daily
Primary Outcome Measure Information:
Title
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)

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study of Ambrisentan in Participants With Pulmonary Hypertension

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