Calendario›UTHR›Oral treprostinil

Oral treprostinil

FREEDOM - M: Oral Treprostinil as Monotherapy for the Treatment of Pulmonary Arterial Hypertension (PAH)

Ensayo de UNITED THERAPEUTICS Corp en Hipertension pulmonar.

Más ensayos de: Hipertensión pulmonar.

Fase

Fase 3

Estado

Completado

Participantes

349

previstos

Centros

77

Fin del objetivo primario

abr 2011

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, doble ciego. Comenzó en oct 2006.

Qué mide

Six Minute Walk Distance (6MWD) (del registro, en inglés) (inicio y semana 12)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis study was an international, multicenter, randomized (2:1 active:placebo), double-blind, placebo-controlled study in subjects with PAH who were NOT currently receiving approved therapy for their PAH. Study visits occurred at 4 week intervals for 12 weeks (with an additional visit at Week 11) with the key measure of efficacy being the 6-minute walk test. Study procedures included routine blood tests, medical history, physical exams, disease evaluation, and exercise tests. Two optional substudies were also a part of FREEDOM-M at select centers - a hemodynamic substudy with a right heart catheterization at Baseline and Week 12 and a genetics and biomarkers substudy with blood samples collected at Baseline and Week 12. Patients who completed all assessments for 12 weeks were also eligible to enter an open-label, extension phase study (FREEDOM - EXT).

Más ensayos de UTHR

Todos los de UTHR, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00325403), actualizada en dic 2023.