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 |
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.
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
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