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Ambrisentan · ABS-LT

Study of Ambrisentan in Participants With Pulmonary Hypertension

Ensayo de GILEAD SCIENCES, INC. en Hipertension pulmonar.

Más ensayos de: Hipertensión pulmonar.

Fase

Fase 3

Estado

Completado

Participantes

140

previstos

Centros

46

Fin del objetivo primario

sep 2019

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en nov 2008.

Qué mide

Porcentaje de participantes con acontecimientos adversos (AE) asociados con la exposicion a largo plazo a ambrisentan (First dose date of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe 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.

Más ensayos de GILD

Todos los de GILD, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00777920), actualizada en sep 2020.