New Trial Medication for Pulmonary Arterial Hypertension
Trial Objectives
The new investigational drug Ralinepag is designed to help the body receive prostacyclin known to widened blood vessels and relax artery walls, and potentially improve blood flow in adults with Pulmonary Arterial Hypertension (PAH). The ADVANCE OUTCOMES study is evaluating the effects of adding Ralinepag, to patients’ current PAH therapies. Once screened, participants will have 16 weeks to find their optimal dose before continuing to treatment.
Participants will have the option to continue in an extension study of Ralinepag (ADVANCE-extension) if they are eligible. The extension study will look at the effect of Ralinepag over a longer period of time.
Who Can Participate
Adults between 18 and 75 who have been diagnosed with Pulmonary Arterial Hypertension.
Age: 18-75 Gender: Any
Estimated Time Commitment
Up to 42 months
Time Commitment Details
The first four weeks will be spent screening participants. This will be followed by 16 weeks to find the optimal dosage for participants, after which treatment will start and patients will check in every 12 weeks until the end of the study, which is individual to each participant. After treatment there will be a final follow up after 30 days. There will be both clinic visits and telephone calls throughout the trial.
Payment & Reimbursement
Payment: Provided
Travel Reimbursement: Available
Trial Contact
For more information, contact:
Jennifer Underwood
303.398.1518
Trial Location
National Jewish Main Campus, Denver, CO
Trial Sponsors
United Therapeutics
Principal Investigators
Marjorie Patricia George, MD
Co-Investigators
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Andrew M. Freeman, MD, FACC, FACP
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Darlene Kim, MD, FACC