EXPEDITE: A Study of Remodulin Induction Followed by Orenitram Optimization to Treat Pulmonary Arterial Hypertension
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 30
Summary
- Conditions
- Pulmonary Arterial Hypertension
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 17 years and 85 years
- Gender
- Both males and females
Description
Subjects will be initiated on subcutaneous (SC) or intravenous (IV) treprostinil and titrated to a dose that improves the symptoms of PAH while minimizing excessive pharmacologic effects. After achieving a minimum SC/IV treprostinil dose of 20 ng/kg/min, subjects may begin a transition to oral trepr...
Subjects will be initiated on subcutaneous (SC) or intravenous (IV) treprostinil and titrated to a dose that improves the symptoms of PAH while minimizing excessive pharmacologic effects. After achieving a minimum SC/IV treprostinil dose of 20 ng/kg/min, subjects may begin a transition to oral treprostinil at the Transition Visit, which can occur at the Week 2, 4, or 8 study visit. After the Transition Visit, oral treprostinil titration will continue through Week 16 to reach the maximum tolerated dose.
Tracking Information
- NCT #
- NCT03497689
- Collaborators
- Not Provided
- Investigators
- Not Provided
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