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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01392469
Recruitment Status : Completed
First Posted : July 12, 2011
Last Update Posted : June 13, 2018
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief 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.

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Drug: Imatinib Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 20, 2011
Actual Primary Completion Date : October 25, 2012
Actual Study Completion Date : October 25, 2012

Arm Intervention/treatment
Experimental: QTI571 Drug: Imatinib

Primary Outcome Measures :
  1. 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 [ Time Frame: 36 days ]

Secondary Outcome Measures :
  1. Measure: Number of patients with adverse events as a measure of the safety and tolerability of QTI571 when co-administered with sildenafil and bosentan. [ Time Frame: 36 days ]
  2. Measure: To evaluate the pharmacokinetics of QTI571 and its active metabolite in terms of AUCtau and Cmax in patients with Pulmonary Arterial Hypertension [ Time Frame: 28 days ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01392469

United States, Florida
Novartis Investigative Site
Tampa, Florida, United States, 33606
Novartis Investigative Site
Weston, Florida, United States, 33331
United States, New York
Novartis Investigative Site
Mineola, New York, United States, 11501
Australia, New South Wales
Novartis Investigative Site
Darlinghurst, New South Wales, Australia, 2010
Novartis Investigative Site
Bruxelles, Belgium, 1070
Novartis Investigative Site
Leuven, Belgium, 3000
Novartis Investigative Site
Berlin, Germany, 12683
Novartis Investigative Site
Hannover, Germany, 30625
Novartis Investigative Site
Roma, RM, Italy, 00161
Novartis Investigative Site
Vilnius, Lithuania, LT-08661
United Kingdom
Novartis Investigative Site
London, United Kingdom, NW3 2PR
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals Identifier: NCT01392469     History of Changes
Other Study ID Numbers: CQTI571A2102
2010-021344-17 ( EudraCT Number )
First Posted: July 12, 2011    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: Yes

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Pulmonary arterial hypertension
pulmonary vascular resistance

Additional relevant MeSH terms:
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Imatinib Mesylate
Sildenafil Citrate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Urological Agents
Antihypertensive Agents
Endothelin Receptor Antagonists