Rapid Switch From Flolan to Remodulin in the Outpatient Clinic
VT
Overseen byVictor Tapson, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Waitlist Available
Sponsor: United Therapeutics
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?
The purpose of this 8-week study is to compare the effects of switching from therapy with epoprostenol or Flolan to IV Remodulin. This study will also assess the effect that changing to Remodulin will have on patient satisfaction with their treatment and impact on quality of life.
Research Team
VT
Victor Tapson, MD
Principal Investigator
Duke Health
Eligibility Criteria
Inclusion Criteria
Be male or if female, be physiologically incapable of childbearing or practicing an acceptable method of birth control (women of childbearing potential must have a negative pregnancy test).
Have a current World Health Organization (WHO) functional classification of II-III status
Diagnosis of one of the following WHO Classifications of pulmonary hypertension: Group 1 pulmonary arterial hypertension (IPAH, FPAH, APAH);Group 3 pulmonary hypertension associated with lung disease (Mild interstitial lung disease associated with predominant features of right heart failure as seen in Group 1 PAH patients); Group 4 pulmonary hypertension due to chronic thromboembolic pulmonary hypertension (CTEPH)
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Treatment Details
Interventions
- treprostinil sodium (Prostacyclin Analogue)
Participant Groups
1Treatment groups
Experimental Treatment
Group I: treprostinil sodiumExperimental Treatment1 Intervention
all subjects had switched from IV epoprostenol to IV treprostinil sodium
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Who Is Running the Clinical Trial?
United Therapeutics
Lead Sponsor
Trials
112
Recruited
14,500+
Dr. Martine Rothblatt
United Therapeutics
Chief Executive Officer since 1996
PhD in Medical Ethics from the Royal London College of Medicine and Dentistry, JD and MBA from UCLA
Dr. Michael Benkowitz
United Therapeutics
Chief Medical Officer since 2023
MD from Harvard Medical School