Study of Ambrisentan in Participants With Pulmonary Hypertension

Phase 3

Completed

Conditions: Pulmonary Hypertension

Interventions: Drug: Ambrisentan

Registration Number: NCT00777920

Lead Sponsor: Gilead Sciences

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 140

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ambrisentan	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.

Primary Outcome Measures

Name	Time	Method
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)

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (46): Atlanta Institute for Medical Research, Inc.
🇺🇸
Atlanta, Georgia, United States
Newark Beth Israel Medical Center
🇺🇸
Newark, New Jersey, United States
University of Pittsburgh Medical Center Presbyterian
🇺🇸
Pittsburgh, Pennsylvania, United States
BACH Cardiology/Children's Hospital
🇺🇸
Boston, Massachusetts, United States
Boston University Medical Center
🇺🇸
Boston, Massachusetts, United States
Hospital Clinico de la Pontificia Universidad Catolica de Chile
🇨🇱
Santiago, Chile
Unidad de Investigacion Clinica en Medicina S.C.
🇲🇽
Monterrey, Mexico
Hospital Privado Centro Medico de Cordoba S.A.
🇦🇷
Cordoba, Argentina
St. Vincent's Hospital
🇦🇺
Darlinghurst, New South Wales, Australia
Instituto de Cardiologia Hospital Italiano de Cordoba
🇦🇷
Cordoba, Argentina
Brigham & Women's Hospital
🇺🇸
Boston, Massachusetts, United States
Instituto Nacional de Cardiologia Ignacio Chavez
🇲🇽
Mexico City, Mexico
Pavlov's State Medical University of St. Petersburg
🇷🇺
St. Petersburg, Russian Federation
Department of Propedeutics of Internal Medicine No 1
🇺🇦
Kiev, Ukraine
Instituto de Cardiologia J.F. Cabral
🇦🇷
Corrientes, Argentina
Instituto de Pneumologia e Pediatria Clínica e Pesquisas LTDA ME
🇧🇷
Belo Horizonte, Brazil
Tufts Medical Center
🇺🇸
Boston, Massachusetts, United States
Hospital Italiano
🇦🇷
Rosario, Argentina
UBEA, Hospital Sao Lucas de Pontifícia
🇧🇷
Porto Alegre, Brazil
Royal Perth Hospital
🇦🇺
Perth, Western Australia, Australia
Hospital Universitario Clementino Fraga Filho
🇧🇷
Rio de Janeiro, Brazil
Hospital das Clinicas da FMUSP
🇧🇷
Sao Paulo, Brazil
University of Alabama at Birmingham
🇺🇸
Birmingham, Alabama, United States
Arizona Pulmonary Specialists
🇺🇸
Phoenix, Arizona, United States
University of Colorado Health Science Center
🇺🇸
Aurora, Colorado, United States
University of Iowa
🇺🇸
Iowa City, Iowa, United States
Washington University Medical Center
🇺🇸
Saint Louis, Missouri, United States
Mary Parkes Asthma Center University of Rochester
🇺🇸
Rochester, New York, United States
Lexington Pulmonary and Critical Care Medicine
🇺🇸
Lexington, South Carolina, United States
Clinica Independencia Munro
🇦🇷
Buenos Aires, Argentina
Sanatorio Otamendi y Miroli
🇦🇷
Buenos Aires, Argentina
Hospital Británico de Buenos Aires
🇦🇷
Buenos Aires, Argentina
Instituto de Investigaciones Clínicas Mar del Plata
🇦🇷
Buenos Aires, Argentina
Fundación Rusculleda
🇦🇷
Cordoba, Argentina
UAI Hospital Universitario
🇦🇷
Buenos Aires, Argentina
Universidade do Estado de Sao Paulo - UNIFESP
🇧🇷
Sao Paulo, Brazil
Peter Lougheed Centre
🇨🇦
Calgary, Alberta, Canada
Instituto Nacional del Torax
🇨🇱
Santiago, Chile
Centro de Estudios Cardiologicos Santiago Oriente
🇨🇱
Santiago, Chile
Almazov's Federal Heart, Blood & Endocrinology Center
🇷🇺
St. Petersburg, Russian Federation
Russian Cardiology Research Complex
🇷🇺
Moscow, Russian Federation
State Medico Stomatologic University
🇷🇺
Moscow, Russian Federation
Department of Acute Myocardial Infarction
🇺🇦
Kharkov, Ukraine
Irmandade Santa Casa de Misericordia de Porto Alegre
🇧🇷
Porto Alegre, Brazil
University of Connecticut Health Center
🇺🇸
Farmington, Connecticut, United States
Rhode Island Hospital
🇺🇸
Providence, Rhode Island, United States