A Study of Ubenimex in Patients With Pulmonary Arterial Hypertension (WHO Group 1) (NCT02664558) | Clinical Trial Compass
CompletedPhase 2
A Study of Ubenimex in Patients With Pulmonary Arterial Hypertension (WHO Group 1)
United States61 participantsStarted 2016-04
Plain-language summary
This proof-of-concept study is designed as a Phase 2, multicenter, randomized, double-blind, placebo controlled study comparing ubenimex with placebo in patients with pulmonary arterial hypertension (PAH) (World Health Organization \[WHO\] Group 1) and have a WHO/New York Heart Association (NYHA) Functional Classification (WHO/NYHA-FC) of II or III.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Male or female, 18-75 years old.
✓. Has a diagnosis of WHO Group 1 PAH.
✓. Right heart catheterization performed at Screening with results that are:
✓. Mean pulmonary arterial pressure ≥25 mmHg (at rest) and
✓. Pulmonary venous hypertension (measured as pulmonary capillary wedge pressure (PCWP) ≤15 mmHg. If PCWP is not available, then mean left atrial pressure or left ventricular end-diastolic pressure ≤15 mmHg in the absence of left atrial obstruction. and
✓. Be on stable dose of at least one of the following PAH-specific therapies: endothelin receptor antagonist, an agent acting on the nitric oxide pathway (phosphodiesterase type 5 inhibitor or soluble guanylate cyclase stimulator), and/or a prostacyclin or prostacyclin analog.
Exclusion criteria
✕. History of uncontrolled hypertension
✕. Persistent hypotension at Screening.
✕. Evidence or history of left-sided heart disease and/or clinically significant cardiac disease in which pulmonary hypertension is more likely WHO Group 2.
✕. Acute decompensated heart failure within 1 month of Screening.