Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
The purpose of this trial was to establish the safety, tolerability and PK of nilotinib in this population and to test the hypothesis that 6 months
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
World Health Organization (WHO) Functional Class II or III
6MWD ≥ 150 m and ≤ 450 m at screening
Current diagnosis of PAH according to Dana Point 2008 Meeting
Inadequate clinical response on one or more class(es) of PAH drug
Stabilization of pulmonary hypertension medications for ≥ 2 months on approved therapeutic dose of at least one PAH drug and still symptomatic with WHO functional Class II or III performance.
You may not be if
Women of child-bearing potential not practicing birth control
In treatment with chronic nitric oxide therapy
Pre-existing lung disease
Use of drugs prolonging the QT interval or strong CYP3A4 inhibitors
Long QT syndrome or QTc \> 450 ms males; \> 470 ms females.
WHO Class IV
Pulmonary capillary wedge pressure \> 15 mm Hg
Other diagnosis of PAH in WHO Diagnostic Group 1
PAH associated with: venous hypertension (WHO Diagnostic Group II), hypoxia (WHO Diagnostic Group III), chronic pulmonary thromboembolic disease (WHO Diagnostic Group IV) or other miscellaneous causes (WHO Diagnostic Class V, which includes sarcoidosis, histiocytosis X, lymphangiomatosis, compression of pulmonary vessels)
Thrombocytopenia \< 50 x109/L (50 x 103/µL)
Uncontrolled systemic arterial hypertension, systolic \> 160 mm Hg or diastolic \>90 mm Hg
Any advanced, severe, or unstable disease of any type that may interfere with the primary and secondary endpoint evaluations.
