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Study of Ambrisentan in Subjects With Pulmonary Hypertension (ABS-LT)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00777920
First Posted: October 22, 2008
Last Update Posted: October 26, 2017
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.
Information provided by (Responsible Party):
Gilead Sciences
  Purpose
This Phase 3, international, multicenter, open-label study will monitor the long-term safety of ambrisentan in adults with pulmonary hypertension. The available ambrisentan doses for this study are 5 or 10 mg administered orally once daily; the approved doses of ambrisentan in the United States, Canada, and the European Union are 5 and 10 mg. 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.

Condition Intervention Phase
Pulmonary Hypertension Drug: Ambrisentan Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Incidence and severity of adverse events (AEs) associated with long-term exposure to ambrisentan in participants with pulmonary hypertension [ Time Frame: Up to 9 years ]
    Incidence and severity of AEs will be summarized.


Estimated Enrollment: 300
Study Start Date: November 2008
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ambrisentan
Participants will receive ambrisentan 5 mg or 10 mg once daily.
Drug: Ambrisentan
Ambrisentan tablet administered orally once daily
Other Name: Letairis

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women with pulmonary hypertension (PH) who are discontinuing a clinical study of ambrisentan due to study closure by the Sponsor. Eligible subjects are those participating in countries where ambrisentan is not yet commercially available. Subjects 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.

Exclusion Criteria:

  • Subjects who have discontinued an ambrisentan clinical study for any other reason than Sponsor-initiated study closure are not eligible.
  Contacts and Locations
Information from the National Library of Medicine

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


  Show 46 Study Locations
Sponsors and Collaborators
Gilead Sciences
  More Information

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00777920     History of Changes
Other Study ID Numbers: GS-US-300-0124
First Submitted: July 1, 2008
First Posted: October 22, 2008
Last Update Posted: October 26, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Ambrisentan
Antihypertensive Agents