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

This study has been terminated.
(Termination due to not achieving the recruitment target because of change in the development program for QTI571 in PAH.)
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01392469
First received: May 10, 2011
Last updated: February 20, 2017
Last verified: February 2017
  Purpose
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 Intervention Phase
Pulmonary Arterial Hypertension
Drug: Imatinib
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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:
  • 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 ]
  • 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 ]

Enrollment: 21
Study Start Date: April 20, 2011
Study Completion Date: December 24, 2012
Primary Completion Date: December 24, 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: QTI571 Drug: Imatinib

  Eligibility

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01392469

Locations
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
Belgium
Novartis Investigative Site
Leuven, Belgium, 3000
Germany
Novartis Investigative Site
Berlin, Germany, 12683
Novartis Investigative Site
Hannover, Germany, 30625
Italy
Novartis Investigative Site
Roma, RM, Italy, 00161
Lithuania
Novartis Investigative Site
Vilnius, Lithuania, LT-08661
United Kingdom
Novartis Investigative Site
London, United Kingdom, NW3 2PR
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01392469     History of Changes
Other Study ID Numbers: CQTI571A2102
2010-021344-17 ( EudraCT Number )
Study First Received: May 10, 2011
Last Updated: February 20, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis:
Pulmonary arterial hypertension
pulmonary vascular resistance
imatinib
bosentan
sildenafil

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

ClinicalTrials.gov processed this record on March 24, 2017