Pharmacokinetic Effects of QTI571 on Sildenafil and Bosentan in Pulmonary Arterial Hypertension Participants
Completed · Phase 3
Conditions studied: Pulmonary Arterial Hypertension
In brief
The purpose of this study was to investigate the effects of QTI571 (imatinib) on pharmacokinetics of bosentan and sildenafil at steady state when co-administered to participants with pulmonary arterial hypertension.
Key facts
- Study ID
- NCT01392469
- Run by
- Novartis Pharmaceuticals
- People needed
- 21
- Starts
- 2011-04-20
- Expected to finish
- 2012-10-25
- Last updated by the study team
- 2021-06-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Participants with Pulmonary arterial hypertension (PAH) in World Health Organization (WHO) Diagnostic Group 1, with pulmonary vascular resistance > 800 dyne*sec*cm\^-5,
- On stable doses of bosentan and sildenafil
You may not qualify if…
- Other diagnosis of PAH in World Health Organization (WHO) Diagnostic Group 1 such as congenital large or small unrepaired systemic to pulmonary shunts, portal hypertension, Human Immunodeficiency Virus (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
Where it is running
- Novartis Investigative Site — Tampa, Florida, United States
- Novartis Investigative Site — Weston, Florida, United States
- Novartis Investigative Site — Mineola, New York, United States
- Novartis Investigative Site — Darlinghurst, New South Wales, Australia
- Novartis Investigative Site — Brussels, Belgium
- Novartis Investigative Site — Leuven, Belgium
- Novartis Investigative Site — Berlin, Germany
- Novartis Investigative Site — Hanover, Germany
- Novartis Investigative Site — Roma, RM, Italy
- Novartis Investigative Site — Vilnius, Lithuania
- Novartis Investigative Site — London, United Kingdom
Full record on ClinicalTrials.gov
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