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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01392469
First received: May 10, 2011
Last updated: April 30, 2013
Last verified: April 2013

May 10, 2011
April 30, 2013
April 2011
July 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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.
 
Completed
21
July 2012
July 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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   United Kingdom,   Australia,   Belgium,   Germany,   Italy,   Lithuania
 
NCT01392469
CQTI571A2102, 2010-021344-17
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
April 2013

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