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treprostinil
Safety, Efficacy, and Treatment Satisfaction Switching From Flolan to Remodulin Using the Crono Five Ambulatory Pump in Patients With PAH
Ensayo de UNITED THERAPEUTICS Corp en Hipertension arterial pulmonar.
Más ensayos de: Hipertensión arterial pulmonar.
- Fase
- Fase 4
- Estado
- Interrumpido
- Participantes
- 8
- Centros
- 3
- Fin del objetivo primario
- sep 2009
Qué significa cada fase y cada estado.
Estudio de intervención, de un solo grupo, abierto. Comenzó en feb 2007.
Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Study closed due to limited availability of eligible subjects and competition by for enrollment by other studies».
Qué mide
Change From Baseline at Week 8 in 6-Minute Walk Distance (6MWD) (del registro, en inglés) (semana 8)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe purpose of this 8-week study is to compare the effects of switching from intravenous Flolan to intravenous Remodulin therapy. Remodulin (treprostinil sodium) is an approved therapy for pulmonary arterial hypertension (PAH). Unlike Flolan, Remodulin does not need to be mixed daily and is stable at room temperature, so there is no need for ice packs. In addition, Remodulin is changed every 48hrs, instead of every 12-24 (with ice packs) or every 8 hours (without ice packs) with Flolan. Flolan is given using a type of portable medication pump called the CADD Legacy infusion pump. In this study, Remodulin will be given using a smaller and lighter medication pump called the Crono Five infusion pump. This study will also assess the effect that changing to Remodulin will have on treatment satisfaction and patient quality of life.
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 (NCT00439946), actualizada en dic 2023.