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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
May 10, 2011
February 20, 2017
April 20, 2011
December 24, 2012   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01392469 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Pharmacokinetic Effects of QTI571 on Sildenafil and Bosentan in Pulmonary Arterial Hypertension Patients
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.
Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Pulmonary Arterial Hypertension
Drug: Imatinib
Experimental: QTI571
Intervention: Drug: Imatinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
21
December 24, 2012
December 24, 2012   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   Germany,   Italy,   Lithuania,   United Kingdom,   United States
Romania,   Turkey
 
NCT01392469
CQTI571A2102
2010-021344-17 ( EudraCT Number )
Not Provided
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP