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Oral treprostinil

FREEDOM-C: Oral Treprostinil in Combination With an Endothelin Receptor Antagonist (ERA) and/or a Phosphodiesterase-5 (PDE-5) Inhibitor 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

354

previstos

Centros

72

Fin del objetivo primario

sep 2008

fecha real

Qué significa cada fase y cada estado.

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

Qué mide

Six Minute Walk Distance (6MWD) (del registro, en inglés) (inicio y 16 semanas)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis study was an international, multi-center, randomized, double-blind, placebo-controlled study in subjects with PAH who were currently receiving approved therapy for their PAH (i.e., endothelin receptor antagonist and/or phosphodiesterase-5 inhibitor). Study visits occurred at 4 week intervals for 16 weeks; the key measure of efficacy was the 6-minute walk test. Study procedures included routine blood tests, medical history, physical exams, disease evaluation, and exercise tests. One optional substudy was also a part of FREEDOM-C at select centers - a hemodynamic substudy with a right heart catheterization at Baseline and Week 16. Patients who completed all assessments for 16-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 (NCT00325442), actualizada en jul 2017.