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UT-15C 1 mg

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

Retirado antes de empezar

Centros

31

Fin del objetivo primario

ene 2009

fecha real

Qué significa cada fase y cada estado.

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

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Study stopped prior to subject enrollment.».

Qué mide

Change in six-minute walk distance from Baseline to Week 12 (del registro, en inglés) (12 semanas)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis study is an international, multi-center, randomized, double-blind, placebo-controlled study in subjects with PAH who are currently receiving approved therapy for their PAH (i.e., endothelin receptor antagonist and/or phosphodiesterase-5 inhibitor)or as a monotherapy treatment. Study visits will occur at 4 week intervals for 12 weeks with the key measure of efficacy being the 6-minute walk test. Study procedures include routine blood tests, medical history, physical exams, disease evaluation, and exercise tests. At the end of the first 12-weeks, the patient will be un-blinded. Patients will continue with another 12-Week open label portion with visits occuring at 4-week intervals. Patients who complete all assessments for 24-weeks will also be eligible to enter a 36 month open-label, extension phase study (FREEDOM - EXT).

Más ensayos de UTHR

Todos los de UTHR, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00760916), actualizada en ene 2013.