Overview

This trial is active, not recruiting.

Condition pulmonary hypertension
Treatment ambrisentan
Phase phase 3
Sponsor Gilead Sciences
Start date June 2008
End date October 2017
Trial size 300 participants
Trial identifier NCT00777920, GS-US-300-0124

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Participants will receive ambrisentan 5 mg or 10 mg once daily.
ambrisentan Letairis
Ambrisentan tablet administered orally once daily

Primary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title ABS-LT: A Phase 3, Long-Term, Open Label, Multicenter Safety Study of Ambrisentan in Subjects With Pulmonary Hypertension
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Gilead Sciences.