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Oral treprostinil

Open-label Extension of Oral Treprostinil in Subjects With PH Associated With HFpEF

Ensayo de UNITED THERAPEUTICS Corp en Pulmonary Hypertension Associated With HFpEF (del registro, en inglés).

Fase

Fase 3

Estado

Interrumpido

Participantes

48

previstos

Centros

82

Fin del objetivo primario

mar 2020

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en ene 2018.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Terminated by Sponsor».

Qué mide

Long-term Safety of Oral Treprostinil in Subjects With PH Associated With HFpEF for Subjects Who Completed Study TDE-HF-301 (Baseline through study completion, up to approximately 25 months) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis was an open-label study to evaluate the safety of continued therapy with oral treprostinil in subjects who completed Study TDE-HF-301. This study provided long-term, open-label data regarding the effect of continued long-term oral treprostinil therapy for the treatment of pulmonary hypertension (PH) associated with heart failure with preserved ejection fraction (HFpEF). Subject visits occurred at Baseline, Weeks 6, 12, 18, 24, and every 12 weeks thereafter until either oral treprostinil was commercially available to treat PH associated with HFpEF or the study was discontinued by the Sponsor. The Sponsor terminated Studies TDE-HF-301 and TDE-HF-302 on 14 October 2019 due to slow enrollment. Safety data from the final subject in Study TDE-HF-302 were recorded on 02 March 2020. Due to the lower than expected number of subjects enrolled, the planned secondary efficacy-related endpoints were not analyzed.

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Todos los de UTHR, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT03043651), actualizada en sep 2020.