A Transition Study From Flolan® to Remodulin® in Patients With Pulmonary Arterial Hypertension
Condition: Pulmonary Arterial Hypertension; Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      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.
    

Intervention name(s): treprostinil sodium
Intervention type(s): Drug
Intervention MeSH terms: Treprostinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment