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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00777920
Registration number
NCT00777920
Ethics application status
Date submitted
1/07/2008
Date registered
22/10/2008
Date last updated
30/09/2020
Titles & IDs
Public title
Study of Ambrisentan in Participants With Pulmonary Hypertension
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Scientific title
ABS-LT: A Phase 3, Long-Term, Open Label, Multicenter Safety Study of Ambrisentan in Subjects With Pulmonary Hypertension
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Secondary ID [1]
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GS-US-300-0124
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Universal Trial Number (UTN)
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Trial acronym
ABS-LT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pulmonary Hypertension
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Cardiovascular
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Hypertension
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Ambrisentan
Experimental: 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.
Treatment: Drugs: Ambrisentan
Tablet administered orally once daily
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Adverse Events (AEs) Associated With Long-Term Exposure to Ambrisentan
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Assessment method [1]
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Timepoint [1]
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First dose date of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks)
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Eligibility
Key inclusion criteria
Key
- 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
17/11/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
11/09/2019
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Sample size
Target
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Accrual to date
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Final
140
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Recruitment in Australia
Recruitment state(s)
NSW,WA
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Recruitment hospital [1]
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St. Vincent's Hospital - Darlinghurst
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Recruitment hospital [2]
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Royal Perth Hospital - Perth
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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6000 - Perth
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Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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Colorado
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Connecticut
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Georgia
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Iowa
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Massachusetts
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Missouri
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New Jersey
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New York
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Pennsylvania
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Rhode Island
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South Carolina
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Argentina
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Buenos Aires
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Argentina
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Cordoba
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Argentina
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Corrientes
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Argentina
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Rosario
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Brazil
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Belo Horizonte
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Brazil
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Porto Alegre
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Brazil
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Rio de Janeiro
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Brazil
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Sao Paulo
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Canada
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Alberta
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Chile
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Santiago
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Mexico
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Mexico City
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Mexico
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Monterrey
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Russian Federation
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Moscow
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Russian Federation
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St. Petersburg
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Ukraine
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Kharkov
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Ukraine
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Kiev
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Gilead Sciences
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Address
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00777920
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Gilead Study Director
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Address
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Gilead Sciences
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00777920
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