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Ambrisentan · ARTEMIS-IPF

(ARTEMIS-IPF) Randomized, Placebo-Controlled Study to Evaluate Safety and Effectiveness of Ambrisentan in IPF

Ensayo de GILEAD SCIENCES, INC. en fibrosis pulmonar idiopatica.

Más ensayos de: Fibrosis pulmonar idiopática.

Fase

Fase 3

Estado

Interrumpido

Participantes

494

previstos

Centros

185

Fin del objetivo primario

feb 2011

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, doble ciego. Comenzó en dic 2008.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Lack of efficacy».

Qué mide

tiempo hasta la muerte o progresion de la enfermedad (IPF). (hasta 48 meses)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe ARTEMIS-IPF study was conducted to determine if ambrisentan was effective in delaying disease progression and death in participants with idiopathic pulmonary fibrosis (IPF), to evaluate its safety, and to evaluate its effect on development of pulmonary hypertension, quality of life, and dyspnea (shortness of breath) symptoms in this participant population. Participants were randomized in a 2:1 ratio to receive ambrisentan or placebo, respectively. Participation in the study was to be up to 4 years, depending on how long it would take to enroll participants and observe study events. After randomization, visits to the clinic took place every 3 months, and laboratory procedures were performed every month.

Más ensayos de GILD

Todos los de GILD, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00768300), actualizada en feb 2014.