Pharmacokinetic Effects of QTI571 on Sildenafil and Bosentan in Pulmonary Arterial Hypertension Patients
Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pulmonary Arterial Hypertension
Intervention: Imatinib (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Novartis Pharmaceuticals Official(s) and/or principal investigator(s): Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals
Summary
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.
Clinical Details
Official title: 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
Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Measure: To evaluate the effect of QTI571 on pharmacokinetics of of sildenafil and bosentan in terms of the changes in AUCtau and Cmax in patients with Pulmonary Arterial Hypertension
Secondary outcome: Measure: Number of patients with adverse events as a measure of the safety and tolerability of QTI571 when co-administered with sildenafil and bosentan.Measure: To evaluate the pharmacokinetics of QTI571 and its active metabolite in terms of AUCtau and Cmax in patients with Pulmonary Arterial Hypertension
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Novartis Investigative Site, Leuven 3000, Belgium
Novartis Investigative Site, Berlin 12683, Germany
Novartis Investigative Site, Hannover 30625, Germany
Novartis Investigative Site, Vilnius LT-08661, Lithuania
Novartis Investigative Site, London NW3 2PR, United Kingdom
Novartis Investigative Site, Tampa, Florida 33606, United States
Novartis Investigative Site, Weston, Florida 33331, United States
Novartis Investigative Site, Darlinghurst, New South Wales 2010, Australia
Novartis Investigative Site, Mineola, New York 11501, United States
Novartis Investigative Site, Roma, RM 00161, Italy
Additional Information
Starting date: April 2011
Last updated: April 30, 2013
|