Study of Ambrisentan in Participants With Pulmonary Hypertension

NCT00777920 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: GS-US-300-0124
• Study Type: interventional
• Target: 140
• Locations: 9 countries
• Sites: 46

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.

Conditions

Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

Ambrisentan

EXPERIMENTAL

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

Interventions

Ambrisentan DRUG

Tablet administered orally once daily

Also known as: Letairis®, Volibris

Ambrisentan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (46)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Arizona Pulmonary Specialists

Phoenix, Arizona, 85013, United States

Location

University of Colorado Health Science Center

Aurora, Colorado, 80045, United States

Location

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

Atlanta Institute for Medical Research, Inc.

Atlanta, Georgia, 30030, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

BACH Cardiology/Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Boston University Medical Center

Boston, Massachusetts, 02118, United States

Location

Washington University Medical Center

St Louis, Missouri, 63110, United States

Location

Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

Location

Mary Parkes Asthma Center University of Rochester

Rochester, New York, 14623, United States

Location

University of Pittsburgh Medical Center Presbyterian

Pittsburgh, Pennsylvania, 15213, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Lexington Pulmonary and Critical Care Medicine

Lexington, South Carolina, 29072, United States

Location

Clinica Independencia Munro

Buenos Aires, 1605, Argentina

Location

Instituto de Investigaciones Clínicas Mar del Plata

Buenos Aires, B7600FZN, Argentina

Location

Sanatorio Otamendi y Miroli

Buenos Aires, C1115AAb, Argentina

Location

Hospital Británico de Buenos Aires

Buenos Aires, C1280AEB, Argentina

Location

UAI Hospital Universitario

Buenos Aires, C1437BZL, Argentina

Location

Instituto de Cardiologia J.F. Cabral

Corrientes, W3400AMZ, Argentina

Location

Fundación Rusculleda

Córdoba, X5003DCE, Argentina

Location

Instituto de Cardiologia Hospital Italiano de Cordoba

Córdoba, X5004FJE, Argentina

Location

Hospital Privado Centro Medico de Cordoba S.A.

Córdoba, X5016KEH, Argentina

Location

Hospital Italiano

Rosario, S2001ODA, Argentina

Location

St. Vincent's Hospital

Darlinghurst, New South Wales, 2010, Australia

Location

Royal Perth Hospital

Perth, Western Australia, 6000, Australia

Location

Instituto de Pneumologia e Pediatria Clínica e Pesquisas LTDA ME

Belo Horizonte, 30380-090, Brazil

Location

UBEA, Hospital Sao Lucas de Pontifícia

Porto Alegre, 90610 000, Brazil

Location

Irmandade Santa Casa de Misericordia de Porto Alegre

Porto Alegre, 92020-090, Brazil

Location

Hospital Universitario Clementino Fraga Filho

Rio de Janeiro, 21949-900, Brazil

Location

Universidade do Estado de Sao Paulo - UNIFESP

São Paulo, 4023-062, Brazil

Location

Hospital das Clinicas da FMUSP

São Paulo, CEP05403-000, Brazil

Location

Peter Lougheed Centre

Calgary, Alberta, T1Y 6J4, Canada

Location

Centro de Estudios Cardiologicos Santiago Oriente

Santiago, 7500503, Chile

Location

Instituto Nacional del Torax

Santiago, 7500691, Chile

Location

Hospital Clinico de la Pontificia Universidad Catolica de Chile

Santiago, 8330074, Chile

Location

Instituto Nacional de Cardiologia Ignacio Chavez

Mexico City, 14080, Mexico

Location

Unidad de Investigacion Clinica en Medicina S.C.

Monterrey, 64718, Mexico

Location

State Medico Stomatologic University

Moscow, 109263, Russia

Location

Russian Cardiology Research Complex

Moscow, 121552, Russia

Location

Almazov's Federal Heart, Blood & Endocrinology Center

Saint Petersburg, 194156, Russia

Location

Pavlov's State Medical University of St. Petersburg

Saint Petersburg, 197022, Russia

Location

Department of Acute Myocardial Infarction

Kharkiv, 61039, Ukraine

Location

Department of Propedeutics of Internal Medicine No 1

Kiev, 3049, Ukraine

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

ambrisentan

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Gilead Clinical Study Information Center
• Organization: Gilead Sciences

GileadClinicalTrials@gilead.com

1-833-445-3230 (GILEAD-0)

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2008
• First Posted: October 22, 2008
• Study Start: November 17, 2008
• Primary Completion: September 11, 2019
• Study Completion: September 11, 2019
• Last Updated: September 30, 2020
• Results First Posted: September 30, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (16); UA (2); AU (2); ME (2); BR (6); RU (4); CL (3); AR (10); CA (1)