Study to evaluate the efficacy, safety, tolerability and pharmacokinetics of JTT-251 administered for 24 weeks in participants with pulmonary arterial hypertension (PAH)
This is a study to evaluate the efficacy, safety, tolerability and pharmacokinetics of JTT-251 administered for 24 weeks in participants with pulmonary arterial hypertension (PAH). Participants completing this study (RELIEF-PAH) will be eligible to enroll in an open-label extension study (RELIEF-PAH OLE) to evaluate the long-term efficacy, safety, tolerability and pharmacokinetics of JTT-251 in participants with PAH.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Change in six-minute walk distance (6MWD) compared to baseline
Time frame: 24 Weeks
Change in World Health Organization (WHO) functional classification compared to baseline
Time frame: 24 Weeks
Change in pulmonary vascular resistance (PVR) compared to baseline
Assessed by right heart catheterization (RHC)
Time frame: 4, 12, 24 and 28 Weeks
Number of adverse events
Time frame: 28 Weeks
JTT-251 trough plasma concentrations
Time frame: 4, 12 and 24 Weeks
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