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treprostinil sodium

A Transition Study From Flolan® to Remodulin® in Patients With Pulmonary Arterial Hypertension

Ensayo de UNITED THERAPEUTICS Corp en Hipertension arterial pulmonar · Hipertension pulmonar.

Más ensayos de: Hipertensión arterial pulmonar · Hipertensión pulmonar.

Fase

Fase 4

Estado

Completado

Participantes

39

previstos

Centros

8

Fin del objetivo primario

ago 2005

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, doble ciego. Comenzó en oct 2002.

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis trial is a study of Remodulin in patients with pulmonary arterial hypertension who have been transitioned from Flolan therapy. The study consists of Screening, Baseline and Treatment Phases. Patients meeting all inclusion/exclusion criteria during the Screening Phase will enter the Baseline Phase, during which baseline exercise capacity, vital signs, and clinical signs and symptoms of the disease will be assessed. After confirmation of all inclusion/exclusion criteria, patients will be assigned to study drug (Remodulin or placebo) and will enter the Treatment Phase. The Treatment Phase begins with a Dose Transition Period, during which patients will begin receiving subcutaneous study drug at a low dose determined by the patient's current dose of Flolan. The study drug dose will be increased gradually while the Flolan dose is decreased gradually over a period of up to 14 days. The dose changes will continue until Flolan therapy has been discontinued and the patient is stable on study drug. Patients who are transitioned off Flolan, who are stable on study drug will be discharged from the clinic, and will continue to receive study drug on an outpatient basis. The patient will return to the clinic at Weeks 4 and 8 for assessments. Patients will remain on study drug for 8 weeks from the first dose of study drug. At Week 8, final assessments will be conducted and the patient will be dismissed from the study. Patients who successfully complete Week 8 assessments may be offered Remodulin therapy or other therapy, at the investigator's discretion.

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Ficha completa en ClinicalTrials.gov (NCT00058929), actualizada en mar 2013.