Pulmonary HypertensionPhase 3ABS-LTNCT00777920
Study of Ambrisentan in Participants With Pulmonary Hypertension
A Phase 3 study testing Ambrisentan in people with Pulmonary Hypertension, run by Gilead Sciences at 46 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- Ambrisentan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 46 sitesin 9 countries
- Study dates
- 17 Nov 2008to 11 Sep 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
46 sites in 9 countries.
46 sites in 9 countries
United States16 sites
Atlanta Institute for Medical Research, Inc.
Atlanta, Georgia, 30030
University of Colorado Health Science Center
Aurora, Colorado, 80045
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Tufts Medical Center
Boston, Massachusetts, 02111
BACH Cardiology/Children's Hospital
Boston, Massachusetts, 02115
Brigham & Women's Hospital
Boston, Massachusetts, 02115
Boston University Medical Center
Boston, Massachusetts, 02118
University of Connecticut Health Center
Farmington, Connecticut, 06030
University of Iowa
Iowa City, Iowa, 52242
Lexington Pulmonary and Critical Care Medicine
Lexington, South Carolina, 29072
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
Arizona Pulmonary Specialists
Phoenix, Arizona, 85013
University of Pittsburgh Medical Center Presbyterian
Pittsburgh, Pennsylvania, 15213
Rhode Island Hospital
Providence, Rhode Island, 02903
Mary Parkes Asthma Center University of Rochester
Rochester, New York, 14623
Washington University Medical Center
St Louis, Missouri, 63110
Argentina10 sites
Clinica Independencia Munro
Buenos Aires, 1605
Instituto de Investigaciones Clínicas Mar del Plata
Buenos Aires, B7600FZN
Sanatorio Otamendi y Miroli
Buenos Aires, C1115AAb
Hospital Británico de Buenos Aires
Buenos Aires, C1280AEB
UAI Hospital Universitario
Buenos Aires, C1437BZL
Fundación Rusculleda
Córdoba, X5003DCE
Instituto de Cardiologia Hospital Italiano de Cordoba
Córdoba, X5004FJE
Hospital Privado Centro Medico de Cordoba S.A.
Córdoba, X5016KEH
Instituto de Cardiologia J.F. Cabral
Corrientes, W3400AMZ
Hospital Italiano
Rosario, S2001ODA
Brazil6 sites
Instituto de Pneumologia e Pediatria Clínica e Pesquisas LTDA ME
Belo Horizonte, 30380-090
UBEA, Hospital Sao Lucas de Pontifícia
Porto Alegre, 90610 000
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre, 92020-090
Hospital Universitario Clementino Fraga Filho
Rio de Janeiro, 21949-900
Universidade do Estado de Sao Paulo - UNIFESP
São Paulo, 4023-062
Hospital das Clinicas da FMUSP
São Paulo, CEP05403-000
Russia4 sites
State Medico Stomatologic University
Moscow, 109263
Russian Cardiology Research Complex
Moscow, 121552
Almazov's Federal Heart, Blood & Endocrinology Center
Saint Petersburg, 194156
Pavlov's State Medical University of St. Petersburg
Saint Petersburg, 197022
Chile3 sites
Centro de Estudios Cardiologicos Santiago Oriente
Santiago, 7500503
Instituto Nacional del Torax
Santiago, 7500691
Hospital Clinico de la Pontificia Universidad Catolica de Chile
Santiago, 8330074
Australia2 sites
St. Vincent's Hospital
Darlinghurst, New South Wales, 2010
Royal Perth Hospital
Perth, Western Australia, 6000
Mexico2 sites
Instituto Nacional de Cardiologia Ignacio Chavez
Mexico City, 14080
Unidad de Investigacion Clinica en Medicina S.C.
Monterrey, 64718
Ukraine2 sites
Department of Acute Myocardial Infarction
Kharkiv, 61039
Department of Propedeutics of Internal Medicine No 1
Kiev, 3049
About this study
Official title: ABS-LT: A Phase 3, Long-Term, Open Label, Multicenter Safety Study of Ambrisentan in Subjects With Pulmonary Hypertension
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
- Being tested
- Ambrisentan
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmbrisentanDrug
Also called Letairis®, Volibris
Tablet administered orally once daily
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Ambrisentan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Adverse Events (AEs) Associated With Long-Term Exposure to Ambrisentan
Measured: First dose date of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2008 (estimated)
- Study start17 Nov 2008
- Primary completion11 Sep 2019
- Study completion11 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00777920
- Sponsor's protocol ID
- GS-US-300-0124
- Acronym
- ABS-LT
- Status last verified
- Sep 2020
- First submitted
- 1 Jul 2008
- Last updated
- 30 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ABS-LT: A Phase 3, Long-Term, Open Label, Multicenter Safety Study of Ambrisentan in Subjects With Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT00777920
- Acronym / sponsor ID
- ABS-LT / GS-US-300-0124
- Conditions
- Pulmonary Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 17 Nov 2008 (actual)
- Primary completion
- 11 Sep 2019 (actual)
- Study completion
- 11 Sep 2019 (actual)
- First posted
- 22 Oct 2008 (estimated)
- Results
- Posted 30 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ambrisentan | Experimental | Drug: AmbrisentanParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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 (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmbrisentanAlso: Letairis®, VolibrisTablet administered orally once daily | Drug | Ambrisentan |
Primary outcome
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Pulmonary Hypertension
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
Pulmonary Arterial Hypertension
RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
Pulmonary Disease, Pulmonary Hypertension
Active, not recruitingPhase 1
Study of Intravenous ZMA001 in Healthy Subjects
Pulmonary Arterial Hypertension PAH
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilead Study Director study director
Gilead Sciences
46 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ambrisentan in people with Pulmonary Hypertension, run by Gilead Sciences at 46 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in United States, Argentina, Brazil, Russia, Chile and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2020.