Study of Ambrisentan in Participants With Pulmonary Hypertension (ABS-LT)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00777920 |
Recruitment Status :
Completed
First Posted : October 22, 2008
Results First Posted : September 30, 2020
Last Update Posted : September 30, 2020
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Condition or disease | Intervention/treatment | Phase |
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Pulmonary Hypertension | Drug: Ambrisentan | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 140 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | ABS-LT: A Phase 3, Long-Term, Open Label, Multicenter Safety Study of Ambrisentan in Subjects With Pulmonary Hypertension |
Actual Study Start Date : | November 17, 2008 |
Actual Primary Completion Date : | September 11, 2019 |
Actual Study Completion Date : | September 11, 2019 |

Arm | Intervention/treatment |
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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.
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Drug: Ambrisentan
Tablet administered orally once daily
Other Names:
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- 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) ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00777920

Study Director: | Gilead Study Director | Gilead Sciences |
Documents provided by Gilead Sciences:
Responsible Party: | Gilead Sciences |
ClinicalTrials.gov Identifier: | NCT00777920 |
Other Study ID Numbers: |
GS-US-300-0124 |
First Posted: | October 22, 2008 Key Record Dates |
Results First Posted: | September 30, 2020 |
Last Update Posted: | September 30, 2020 |
Last Verified: | September 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |
Hypertension, Pulmonary Hypertension Vascular Diseases Cardiovascular Diseases |
Lung Diseases Respiratory Tract Diseases Ambrisentan Antihypertensive Agents |