A Transition Study From Flolan® to Remodulin® in Patients With Pulmonary Arterial Hypertension
Status:
Completed
Trial end date:
2005-08-01
Target enrollment:
Participant gender:
Summary
This 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.