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Oral treprostinil
Oral Treprostinil in Subjects With Pulmonary Hypertension Associated With Heart Failure With Preserved Ejection Fraction
Ensayo de UNITED THERAPEUTICS Corp en Hipertension pulmonar · Insuficiencia cardiaca con fraccion de eyeccion preservada.
Más ensayos de: Hipertensión pulmonar.
- Fase
- Fase 3
- Estado
- Interrumpido
- Participantes
- 84
- Centros
- 82
- Fin del objetivo primario
- dic 2019
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en ago 2017.
Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Terminated by sponsor».
Qué mide
Cambio en la 6MWD desde el inicio hasta la semana 24 (del inicio a la semana 24)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis was a multicenter, randomized (1:1; oral treprostinil to placebo), double-blind, placebo-controlled study in subjects with World Health Organization (WHO) Group 2 pulmonary hypertension (PH) associated with heart failure with preserved ejection fraction (HFpEF). Once randomized, subjects took the initial dose of study drug at the study site on the day of randomization. Subjects returned to the study site for visits scheduled at Weeks 6, 12, 18, and 24. The duration of study participation was approximately 28 weeks from Screening until study completion (includes a 30-day Screening Phase and 24-week Treatment Phase). The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment. As only a small portion of the anticipated total subjects had been enrolled, with many terminating early due to the study termination, there was a limited ability to explore the effect of oral treprostinil in this indication in this study.
Más ensayos de UTHR
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| Parenteral Treprostinil · ARTISAN | Fase 4 | En marcha, sin reclutar | abr 2026 (prevista, ya pasada: sin actualizar en el registro) |
| Ralinepag | Fase 3 | Reclutando por invitación | dic 2026 (prevista) |
| Oral treprostinil · ADAPT | no aplica | En marcha, sin reclutar | mar 2027 (prevista) |
| Inhaled Treprostinil | Fase 3 | Reclutando pacientes | nov 2027 (prevista) |
| 10 GE Xenokidney · EXPAND | Fase 1/2 | Reclutando pacientes | oct 2028 (prevista) |
| GGTA1 KO Thymokidney · EXTEND | Fase 1/2 | Reclutando pacientes | nov 2029 (prevista) |
Todos los de UTHR, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT03037580), actualizada en oct 2020.