Clinical trial NCT00777920: Study of Ambrisentan in Participants With Pulmonary Hypertension
Official title: ABS-LT: A Phase 3, Long-Term, Open Label, Multicenter Safety Study of Ambrisentan in Subjects With Pulmonary Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Hypertension
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2008-10-22
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of Participants With Adverse Events (AEs) Associated With Long-Term Exposure to Ambrisentan
timeFrame: First dose date of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Arizona Pulmonary Specialists
state: Arizona
city: Aurora
country: United States
facility: University of Colorado Health Science Center
state: Colorado
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
city: Atlanta
country: United States
facility: Atlanta Institute for Medical Research, Inc.
state: Georgia
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: BACH Cardiology/Children's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston University Medical Center
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University Medical Center
state: Missouri
city: Newark
country: United States
facility: Newark Beth Israel Medical Center
state: New Jersey
city: Rochester
country: United States
facility: Mary Parkes Asthma Center University of Rochester
state: New York
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center Presbyterian
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Lexington
country: United States
facility: Lexington Pulmonary and Critical Care Medicine
state: South Carolina
city: Buenos Aires
country: Argentina
facility: Clinica Independencia Munro
city: Buenos Aires
country: Argentina
facility: Instituto de Investigaciones Clínicas Mar del Plata
city: Buenos Aires
country: Argentina
facility: Sanatorio Otamendi y Miroli
city: Buenos Aires
country: Argentina
facility: Hospital Británico de Buenos Aires
city: Buenos Aires
country: Argentina
facility: UAI Hospital Universitario
city: Cordoba
country: Argentina
facility: Fundación Rusculleda
city: Cordoba
country: Argentina
facility: Instituto de Cardiologia Hospital Italiano de Cordoba
city: Cordoba
country: Argentina
facility: Hospital Privado Centro Medico de Cordoba S.A.
city: Corrientes
country: Argentina
facility: Instituto de Cardiologia J.F. Cabral
city: Rosario
country: Argentina
facility: Hospital Italiano
city: Darlinghurst
country: Australia
facility: St. Vincent's Hospital
state: New South Wales
city: Perth
country: Australia
facility: Royal Perth Hospital
state: Western Australia
city: Belo Horizonte
country: Brazil
facility: Instituto de Pneumologia e Pediatria Clínica e Pesquisas LTDA ME
city: Porto Alegre
country: Brazil
facility: UBEA, Hospital Sao Lucas de Pontifícia
city: Porto Alegre
country: Brazil
facility: Irmandade Santa Casa de Misericordia de Porto Alegre
city: Rio de Janeiro
country: Brazil
facility: Hospital Universitario Clementino Fraga Filho
city: Sao Paulo
country: Brazil
facility: Universidade do Estado de Sao Paulo - UNIFESP
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas da FMUSP
city: Calgary
country: Canada
facility: Peter Lougheed Centre
state: Alberta
city: Santiago
country: Chile
facility: Centro de Estudios Cardiologicos Santiago Oriente
city: Santiago
country: Chile
facility: Instituto Nacional del Torax
city: Santiago
country: Chile
facility: Hospital Clinico de la Pontificia Universidad Catolica de Chile
city: Mexico City
country: Mexico
facility: Instituto Nacional de Cardiologia Ignacio Chavez
city: Monterrey
country: Mexico
facility: Unidad de Investigacion Clinica en Medicina S.C.
city: Moscow
country: Russian Federation
facility: State Medico Stomatologic University
city: Moscow
country: Russian Federation
facility: Russian Cardiology Research Complex
city: St. Petersburg
country: Russian Federation
facility: Almazov's Federal Heart, Blood & Endocrinology Center
city: St. Petersburg
country: Russian Federation
facility: Pavlov's State Medical University of St. Petersburg
city: Kharkov
country: Ukraine
facility: Department of Acute Myocardial Infarction
city: Kiev
country: Ukraine
facility: Department of Propedeutics of Internal Medicine No 1
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: