Extension to QTI571A2301 to Evaluate the Long-term Safety, Tolerability and Efficacy of Imatinib in Severe Pulmonary Arterial Hypertension (PAH)
Status: | Terminated |
---|---|
Conditions: | High Blood Pressure (Hypertension) |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | April 2010 |
End Date: | April 2014 |
An Extension to QTI571A2301 to Evaluate the Long-term Safety, Tolerability and Efficacy of Oral QTI571 (Imatinib) in the Treatment of Severe Pulmonary Arterial Hypertension: IMPRES Extension
This is a multinational, multi center extension study. This study will provide data on the
long-term safety, tolerability, and efficacy of imatinib in the treatment of severe
pulmonary arterial hypertension.
long-term safety, tolerability, and efficacy of imatinib in the treatment of severe
pulmonary arterial hypertension.
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:
- 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)
Other protocol-defined inclusion/exclusion criteria may apply
We found this trial at
24
sites
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Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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