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

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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.


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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Birmingham, Alabama 35209
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Chicago, Illinois 60612
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Chicago, IL
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Cincinnati, Ohio 45229
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Cleveland, Ohio 44109
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Cleveland, Ohio 44109
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Durham, North Carolina 27710
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Durham, NC
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Houston, Texas 77030
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Houston, TX
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Houston, Texas 77030
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Houston, TX
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Los Angeles, California 90095
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Los Angeles, CA
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Milwaulkee, Wisconsin 53215
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Milwaulkee, WI
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Mineola, New York 11501
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Mineola, NY
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230 Park Avenue, 21st Floor
New York, New York 10169
1-888-669-6682)
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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230 Park Avenue, 21st Floor
New York, New York 10169
1-888-669-6682)
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
?
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from
New York, NY
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Oklahoma City, Oklahoma 73104
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Oklahoma City, OK
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Omaha, Nebraska 68144
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Omaha, NE
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Phoenix, Arizona 85012
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Phoenix, AZ
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Pittsburgh, Pennsylvania 15224
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Pittsburgh, Pennsylvania 15224
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Rochester, Minnesota 55905
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Rochester, MN
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San Francisco, California 94121
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San Francisco, CA
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St. Louis, Missouri 63110
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Tualatin, Oregon 97062
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Weston, Florida 33331
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