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Study of Ambrisentan in Participants With Pulmonary Hypertension

NCT ID: NCT00777920

Last Updated: 2020-09-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-17

Study Completion Date

2019-09-11

Brief Summary

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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.

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Detailed Description

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Conditions

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Pulmonary Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Ambrisentan

Intervention Type DRUG

Tablet administered orally once daily

Interventions

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Ambrisentan

Tablet administered orally once daily

Intervention Type DRUG

Other Intervention Names

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Letairis® Volibris

Eligibility Criteria

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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.

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gilead Study Director

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Arizona Pulmonary Specialists

Phoenix, Arizona, United States

Site Status

University of Colorado Health Science Center

Aurora, Colorado, United States

Site Status

University of Connecticut Health Center

Farmington, Connecticut, United States

Site Status

Atlanta Institute for Medical Research, Inc.

Atlanta, Georgia, United States

Site Status

University of Iowa

Iowa City, Iowa, United States

Site Status

Tufts Medical Center

Boston, Massachusetts, United States

Site Status

BACH Cardiology/Children's Hospital

Boston, Massachusetts, United States

Site Status

Brigham & Women's Hospital

Boston, Massachusetts, United States

Site Status

Boston University Medical Center

Boston, Massachusetts, United States

Site Status

Washington University Medical Center

St Louis, Missouri, United States

Site Status

Newark Beth Israel Medical Center

Newark, New Jersey, United States

Site Status

Mary Parkes Asthma Center University of Rochester

Rochester, New York, United States

Site Status

University of Pittsburgh Medical Center Presbyterian

Pittsburgh, Pennsylvania, United States

Site Status

Rhode Island Hospital

Providence, Rhode Island, United States

Site Status

Lexington Pulmonary and Critical Care Medicine

Lexington, South Carolina, United States

Site Status

Clinica Independencia Munro

Buenos Aires, , Argentina

Site Status

Instituto de Investigaciones Clínicas Mar del Plata

Buenos Aires, , Argentina

Site Status

Sanatorio Otamendi y Miroli

Buenos Aires, , Argentina

Site Status

Hospital Británico de Buenos Aires

Buenos Aires, , Argentina

Site Status

UAI Hospital Universitario

Buenos Aires, , Argentina

Site Status

Instituto de Cardiologia J.F. Cabral

Corrientes, , Argentina

Site Status

Fundación Rusculleda

Córdoba, , Argentina

Site Status

Instituto de Cardiologia Hospital Italiano de Cordoba

Córdoba, , Argentina

Site Status

Hospital Privado Centro Medico de Cordoba S.A.

Córdoba, , Argentina

Site Status

Hospital Italiano

Rosario, , Argentina

Site Status

St. Vincent's Hospital

Darlinghurst, New South Wales, Australia

Site Status

Royal Perth Hospital

Perth, Western Australia, Australia

Site Status

Instituto de Pneumologia e Pediatria Clínica e Pesquisas LTDA ME

Belo Horizonte, , Brazil

Site Status

UBEA, Hospital Sao Lucas de Pontifícia

Porto Alegre, , Brazil

Site Status

Irmandade Santa Casa de Misericordia de Porto Alegre

Porto Alegre, , Brazil

Site Status

Hospital Universitario Clementino Fraga Filho

Rio de Janeiro, , Brazil

Site Status

Universidade do Estado de Sao Paulo - UNIFESP

São Paulo, , Brazil

Site Status

Hospital das Clinicas da FMUSP

São Paulo, , Brazil

Site Status

Peter Lougheed Centre

Calgary, Alberta, Canada

Site Status

Centro de Estudios Cardiologicos Santiago Oriente

Santiago, , Chile

Site Status

Instituto Nacional del Torax

Santiago, , Chile

Site Status

Hospital Clinico de la Pontificia Universidad Catolica de Chile

Santiago, , Chile

Site Status

Instituto Nacional de Cardiologia Ignacio Chavez

Mexico City, , Mexico

Site Status

Unidad de Investigacion Clinica en Medicina S.C.

Monterrey, , Mexico

Site Status

State Medico Stomatologic University

Moscow, , Russia

Site Status

Russian Cardiology Research Complex

Moscow, , Russia

Site Status

Almazov's Federal Heart, Blood & Endocrinology Center

Saint Petersburg, , Russia

Site Status

Pavlov's State Medical University of St. Petersburg

Saint Petersburg, , Russia

Site Status

Department of Acute Myocardial Infarction

Kharkiv, , Ukraine

Site Status

Department of Propedeutics of Internal Medicine No 1

Kiev, , Ukraine

Site Status

Countries

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United States Argentina Australia Brazil Canada Chile Mexico Russia Ukraine

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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GS-US-300-0124

Identifier Type: -

Identifier Source: org_study_id

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