Clareo Health | Extension to QTI571A2301 to Evaluate the Long-term Safety, Tolerability and Efficacy of Imatinib in Severe Pulmonary Arterial Hypertension (PAH)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients who participated in CQTI571A2301 clinical trial and completed the week 24 visit of the study protocol, including all Study Completion assessments
Patients who withdrew from the CQTI571A2301 study prematurely for reasons not related to study drug or not related to a safety issue but performed all Study Completion assessments
You may not be if
Patients with a pulmonary capillary wedge pressure \> 15 mmHg at time of Study Completion assessments in core protocol CQTI571A2301. If pulmonary capillary wedge pressure is not attainable, then a left atrial pressure measurement may be used in its place.
LVEF \< 45%
Patients with thrombocytopenia, platelet count \< 50E9/L (50E3/µL)
Patients with uncontrolled systemic arterial hypertension, systolic \> 160 mmHg or diastolic \> 90 mmHg
Patients with a QTcF \> 450 ms for males and \> 470 ms for females in the absence of right branch bundle block (based on Visit 1 ECG if required to be performed)
