Efficacy, Safety, Tolerability and Pharmacokinetics (PK) of Nilotinib (AMN107) in Pulmonary Arterial Hypertension (PAH)
NCT ID: NCT01179737
Last Updated: 2014-05-01
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
23 participants
INTERVENTIONAL
2010-07-31
2013-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Nilotinib
Participants in cohort 1 were assigned to receive nilotinib 50 mg during 14 days, followed by 150 mg during 14 days, followed by 300 mg during 140 days. Participants in cohort 2 were assigned to receive nilotinib 300 mg during 168 days
Nilotinib
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
Participants were assigned to receive placebo to nilotinib to match 50 mg and 150 mg capsules during 168 days.
Placebo to nilotinib
Placebo to nilotinib capsules for oral administration to match 50 mg, 150 mg and 300 mg capsules twice a day
Interventions
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Nilotinib
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
Placebo to nilotinib capsules for oral administration to match 50 mg, 150 mg and 300 mg capsules twice a day
Eligibility Criteria
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Inclusion Criteria
* 6MWD ≥ 150 m and ≤ 450 m at screening
* Current diagnosis of PAH according to Dana Point 2008 Meeting
* Inadequate clinical response on one or more class(es) of PAH drug
* Stabilization of pulmonary hypertension medications for ≥ 2 months on approved therapeutic dose of at least one PAH drug and still symptomatic with WHO functional Class II or III performance.
Exclusion Criteria
* In treatment with chronic nitric oxide therapy
* Pre-existing lung disease
* Use of drugs prolonging the QT interval or strong CYP3A4 inhibitors
* Long QT syndrome or QTc \> 450 ms males; \> 470 ms females.
* WHO Class IV
* Pulmonary capillary wedge pressure \> 15 mm Hg
* Other diagnosis of PAH in WHO Diagnostic Group 1
* PAH associated with: venous hypertension (WHO Diagnostic Group II), hypoxia (WHO Diagnostic Group III), chronic pulmonary thromboembolic disease (WHO Diagnostic Group IV) or other miscellaneous causes (WHO Diagnostic Class V, which includes sarcoidosis, histiocytosis X, lymphangiomatosis, compression of pulmonary vessels)
* Thrombocytopenia \< 50 x109/L (50 x 103/µL)
* Uncontrolled systemic arterial hypertension, systolic \> 160 mm Hg or diastolic \>90 mm Hg
* Any advanced, severe, or unstable disease of any type that may interfere with the primary and secondary endpoint evaluations.
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Boston, Massachusetts, United States
Novartis Investigative Site
Ann Arbor, Michigan, United States
Novartis Investigative Site
Chapel Hill, North Carolina, United States
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
Novartis Investigative Site
Singapore, Singapore, Singapore
Novartis Investigative Site
Seoul, Korea, South Korea
Novartis Investigative Site
Zurich, Switzerland, Switzerland
Countries
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Other Identifiers
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2010-019883-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CAMN107X2201
Identifier Type: -
Identifier Source: org_study_id
NCT01531270
Identifier Type: -
Identifier Source: nct_alias
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