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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

Page last updated: August 23, 2015

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