Pulmonary Hypertension Clinical Trial
Official title:
A Multicenter, Randomized, Parallel Placebo-Controlled Study of the Safety and Efficacy of Subcutaneous Remodulin® Therapy After Transition From Flolan® in Patients With Pulmonary Arterial Hypertension
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.
This trial is a multicenter, randomized, parallel placebo-controlled study of Remodulin in
patients with pulmonary arterial hypertension with WHO Functional Class II or III clinical
status 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 randomized to study drug (1:1 Remodulin: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 be
done according to a recommended schedule, which may be modified if necessary according to
the patient's clinical status. The dose changes will continue until Flolan therapy has been
discontinued and the patient is stable on study drug, or until the patient has met the
primary endpoint criteria.
Patients who are transitioned off Flolan, who are stable on study drug, and who have
demonstrated the ability to properly self-administer 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. At weeks other than Weeks 1, 4, and
8, the site staff will contact the patient to assess progress and adjust the study drug dose
if necessary. 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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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