The purpose of this trial was to establish the safety, tolerability and PK of nilotinib in this population and to test the hypothesis that 6 months treatment with nilotinib will significantly reduce pulmonary artery resistance.
The purpose of this trial was to establish the safety, tolerability and PK of nilotinib in this population and to test the hypothesis that 6 months
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
23
Nilotinib capsules for oral administration at 50 mg, 150 mg twice a day and 300 mg (2 capsules of 150 mg) twice a day.
Placebo to nilotinib capsules for oral administration to match 50 mg, 150 mg and 300 mg capsules twice a day
Novartis Investigative Site
Boston, Massachusetts, United States
Novartis Investigative Site
Ann Arbor, Michigan, United States
Novartis Investigative Site
Chapel Hill, North Carolina, United States
Change in Pulmonary Vascular Resistance (PVR)
Change in pulmonary vascular resistance is measured via right heart catheter assessment according to local hospital procedures. It assesses several prognostic hemodynamic variables in pulmonary hypertension, including Pulmonary Vascular Resistance (PVR). Study was prematurely terminated and not powered for efficacy.
Time frame: 168 days
Change in Six-Minute Walk Distance (6MWD) From Baseline
During standardized walk course participants are connected to a portable pulse oximeter via a finger probe and instructed to walk at a comfortable speed for as far as they could manage in 6 minutes. Study was prematurely terminated and efficacy data were not analyzed or summarized
Time frame: Baseline, 168 days
Total Number of Adverse Events and Serious Adverse Events
Adverse events were summarized by the number of patients having any adverse event overall and presented in the safety section. Study was prematurely terminated.
Time frame: 168 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Novartis Investigative Site
Cleveland, Ohio, United States
Novartis Investigative Site
Nashville, Tennessee, United States
Novartis Investigative Site
Calgary, Alberta, Canada
Novartis Investigative Site
Hamburg, Germany
Novartis Investigative Site
Heidelberg, Germany
Novartis Investigative Site
Marburg, Germany
Novartis Investigative Site
Singapore, Singapore, Singapore
...and 3 more locations