Pulmonary Arterial Hypertension
Conditions
Interventions
investigational material(s)
Generic name etc : QTI571
INN of investigational material :
Therapeutic category code : 219 Other cardiovascular agents
Dosage and Administration for Investigational mater
Sponsors
Novartis Pharma K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 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) Other protocol-defined inclusion/exclusion criteria may apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients with Adverse Events as a measure of the safety and tolerability of QTI571 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Six-Minute Walk Distance (6MWD) from baseline Time to clinical worsening (TTCW) endpoints | — |
Outcome results
None listed