Pharmacokinetic Effects of QTI571 on Sildenafil and Bosentan in Pulmonary Arterial Hypertension Patients



Status:Completed
Conditions:High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:6/15/2018
Start Date:April 20, 2011
End Date:October 25, 2012

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A Non-randomized, Multiple Dose, Three Treatment Period, Open-label, Single Sequence, Single Group Study to Evaluate the Pharmacokinetic Effect of Two Doses of QTI571 (Imatinib) on the Co-administered Drugs Sildenafil and Bosentan in Pulmonary Arterial Hypertension (PAH) Patients

This study will investigate the effects of QTI571 (imatinib) on pharmacokinetics of bosentan
and sildenafil at steady state when co-administered to pulmonary arterial hypertension
patients.


Inclusion Criteria:

- Pulmonary arterial hypertension (PAH) patients in WHO Diagnostic Group 1, with
pulmonary vascular resistance > 800 dyne•sec•cm-5,

- On stable doses of bosentan and sildenafil

Exclusion Criteria:

- Other diagnosis of PAH in WHO Diagnostic Group 1 such as congenital large or small
unrepaired systemic to pulmonary shunts, portal hypertension,HIV infection, glycogen
storage disease, Gaucher's disease, hereditary hemorrhagic teleangiectasia,
hemoglobinopathies, myeloproliferative disorders, veno-occlusive pulmonary disease

- Significant lung diseases not related to PAH

- Significant cardiovascular system disorders, hematological system disorders, liver
insufficiency

- Significant diseases in other organ system.

Other protocol-defined inclusion/exclusion criteria may apply
We found this trial at
4
sites
Mineola, New York 11501
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Mineola, NY
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Darlinghurst, New South Wales 2010
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Darlinghurst,
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Tampa, Florida 33613
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Tampa, FL
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Weston, Florida 33331
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Weston, FL
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