Clinical trials: sponsored by Novartis Pharmaceuticals
Acute Myeloid Leukemia
Study to Assess the Safety and Efficacy of Midostaurin (PKC412) in Combination With Standard Chemotherapy During Induction and Consolidation Followed by 12 Months of Maintenance Monotherapy in Patients With Newly-diagnosed FMS-like Tyrosine 3 (FLT3) Kinase Receptor-mutated Acute Myeloid Leukemia.
The purpose of this study was to gather and evaluate additional safety and efficacy data on the combination of midostaurin and standard of care for adult patients with newly diagnosed Fms-like tyrosine kinase receptor (FLT3)…
- Trial name
- NCT03379727
- Testing
- Midostaurin, Cytarabine, anthracycline ((daunorubicin or idarubicin): Induction Phase only
- Where
- 86 sites in Bulgaria, Croatia and 13 more
- Volunteers
- 301 people
- Sponsor
- Novartis Pharmaceuticals
Heart Failure, Heart Failure, Systolic
COmparing arNi and Ace For Improving Erectile Dysfunction in mEN With reduCed Ejection Fraction Heart Failure
The purpose of this study was to determine the effect of sacubitril/valsartan (LCZ696) vs. Enalapril on improvement in erectile function and ability in male patients with chronic heart failure with reduced ejection fraction and…
- Conditions
- Heart Failure, Heart Failure, Systolic, Erectile Dysfunction
- Trial name
- CONFIDENCE-HF (NCT03917459)
- Testing
- LCZ696, Enalapril
- Where
- 13 sites in Germany
- Volunteers
- 27 people
- Sponsor
- Novartis Pharmaceuticals
Poor Graft Function
Study of Efficacy and Safety of Eltrombopag in Patients With Poor Graft Function
The purpose of this study was to evaluate the efficacy of eltrombopag for poor graft function (PGF) on overall hematologic response (partial and complete), as determined by platelet, hemoglobin and neutrophil counts by 16 weeks…
- Trial name
- ELTION (NCT03718533)
- Testing
- Eltrombopag
- Where
- 7 sites in Spain
- Volunteers
- 10 people
- Sponsor
- Novartis Pharmaceuticals
Renal Impairment
Pharmacokinetics Study of TNO155 in Participants With Mild, Moderate, or Severe Renal Impairment Compared to Matched Healthy Participants
The purpose of this Phase 1 study is to evaluate the effect of various degrees of renal impairment on plasma pharmacokinetics (PK), safety and tolerability of TNO155.
- Trial name
- NCT05541159
- Testing
- TNO155
- Volunteers
- healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Hepatic Impairment
Pharmacokinetics of TNO155 in Participants With Mild, Moderate, or Severe Hepatic Impairment Compared to Matched Healthy Participants
The purpose of this study is to evaluate the effect of various degrees of hepatic impairment on plasma pharmacokinetics (PK), safety and tolerability of TNO155.
- Trial name
- NCT05490030
- Testing
- TNO155
- Volunteers
- healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Diffuse Large B-cell Lymphoma
Real-World HRU and Costs in DLBCL Pts With Tisa-cel and Axi-cel, a Medicare Study.
This was a retrospective non-interventional cohort study design using the Centers for Medicare and Medicaid Services (CMS) 100% Medicare data (2015Q1-2020Q4).
- Trial name
- NCT06271369
- Where
- United States
- Volunteers
- 613 people
- Sponsor
- Novartis Pharmaceuticals
B-cell Acute Lymphoblastic Leukemia
Study of Efficacy and Safety of CTL019 in Pediatric ALL Patients
This is a single arm, open-label, multi-center, phase II study to determine the efficacy and safety of CTL019 in pediatric patients with r/r B-cell ALL.
- Trial name
- ELIANA (NCT02435849)
- Testing
- CTL019
- Where
- 23 sites in United States, Australia and 9 more
- Volunteers
- 80 people
- Sponsor
- Novartis Pharmaceuticals
Secondary Progressive Multiple Sclerosis (SPMS)
Long Term Special Drug Use-results Surveillance for Mayzent in SPMS Patients
This study is a single cohort, central registration system, all-case, open-label, multicenter observational study in patients using Mayzent for the indication of secondary progressive multiple sclerosis.
- Trial name
- NCT04593927
- Testing
- Mayzent
- Where
- 174 sites in Japan
- Volunteers
- 451 people
- Sponsor
- Novartis Pharmaceuticals
BRAF-positive Metastatic Melanoma
Real-World Patient Characteristics, Treatment Patterns, and Clinical Outcomes Among Patients With BRAF-Positive Metastatic Melanoma
This was a retrospective, longitudinal, observational study conducted using the Flatiron Health electronic health record (EHR)-derived database.
- Trial name
- NCT06251934
- Where
- United States
- Volunteers
- 785 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Myelogenous Leukemia (CML), Metastatic Gastrointestinal Stromal Tumors (GIST)
Study to Allow Access to Nilotinib for Patients Who Are on Nilotinib Treatment in a Novartis-sponsored Study
The purpose of this study was to allow continued use of nilotinib in patients who were on nilotinib treatment in a Novartis-sponsored, Oncology Clinical Development \& Medical Affairs (CD\&MA) study and were benefiting from the…
- Conditions
- Chronic Myelogenous Leukemia (CML), Metastatic Gastrointestinal Stromal Tumors (GIST), Acute Lymphoblastic Leukemia (ALL), Receptor Tyrosine Kinase (KIT) Mutated Melanoma
- Trial name
- NCT01735955
- Testing
- Nilotinib
- Where
- 33 sites in United States, Austria and 14 more
- Volunteers
- 57 people
- Sponsor
- Novartis Pharmaceuticals
Glomerulonephritis
Study on Efficacy and Safety of LNP023 in C3 Glomerulopathy Patients Transplanted and Not Transplanted
The study is an open-label, two cohort non-randomized study evaluating the efficacy, safety, and pharmacokinetics of LNP023 in patients with C3G (Cohort A) and patients who have undergone kidney transplant and have C3G recurrence…
- Trial name
- NCT03832114
- Testing
- LNP023
- Where
- 9 sites in United States, France and 4 more
- Volunteers
- 27 people
- Sponsor
- Novartis Pharmaceuticals
Advanced Breast Cancer
A Study of Everolimus Plus Exemestane in Chinese Postmenopausal Women With Estrogen Receptor Positive, Locally Advanced, Recurrent, or Metastatic Breast Cancer After Recurrence or Progression on Non-steroidal Aromatase Inhibitor
This study aimed at evaluating the safety and efficacy of everolimus plus exemestane in Chinese postmenopausal women with ER+ HER2- locally advanced, recurrent, or metastatic breast cancer after recurrence or progression on…
- Trial name
- BOLERO-5 (NCT03312738)
- Testing
- Everolimus, Exemestane
- Where
- 15 sites in China
- Volunteers
- 159 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Myeloid Leukemia With T315I Mutation
Real-world Effectiveness of Asciminib and Treatment Patterns in Patients With Chronic Myeloid Leukemia With T315I Mutation - a Chart Review Study of Patients Treated in the Asciminib Managed Access Program (MAP)
This non-interventional study (NIS) was a retrospective chart review analyzing existing data from patients participating in the asciminib MAP.
- Trial name
- NCT06211153
- Where
- Switzerland
- Volunteers
- 31 people
- Sponsor
- Novartis Pharmaceuticals
Advanced Solid Tumors
A Study of BLZ945 Single Agent or BLZ945 in Combination With PDR001 in Advanced Solid Tumors
The purpose of this first-in-human (FIH) study of BLZ945 given as a single agent or in combination with PDR001 was to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and anti-tumor activity of…
- Trial name
- NCT02829723
- Testing
- BLZ945, PDR001
- Where
- 14 sites in United States, Israel and 6 more
- Volunteers
- 192 people
- Sponsor
- Novartis Pharmaceuticals
Heart Failure
The Effects of Sacubitril/Valsartan on Cardiac Oxygen Consumption and Efficiency of Cardiac Work in Heart Failure Patients
This is a phase IV, prospective, randomized, double-blind, double-dummy, parallel-group study. The study assessed the effects of 6 weeks of stable sacubitril/valsartan therapy, as compared with valsartan therapy, on the…
- Trial name
- TurkuPET (NCT03300427)
- Testing
- sacubitril/valsatran, valsartan
- Where
- Finland
- Volunteers
- 55 people
- Sponsor
- Novartis Pharmaceuticals
Neovascular (Wet) Age-related Macular Degeneration
Real-world Evaluation of BEOVU (Brolucizumab) Effectiveness and Durability for Treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD)
This was a retrospective, observational cohort study. Data were analyzed from the Intelligent Research in Sight (IRIS) registry from October 8, 2019, through November 26, 2021, with a follow-up period of 12 months following the…
- Trial name
- NCT06184360
- Where
- United States
- Volunteers
- 2,079 people
- Sponsor
- Novartis Pharmaceuticals
Spinal Muscular Atrophy
Real-World Use of Novel Treatments in Patients With Spinal Muscular Atrophy (SMA): A Multi-Site Retrospective Chart Review of Pediatric SMA Patients Outside of the United States
This global, retrospective, non-interventional, medical chart review (MCR), descriptive study collected patient-level data in regions outside the US.
- Trial name
- NCT06178393
- Where
- United States
- Volunteers
- 162 people
- Sponsor
- Novartis Pharmaceuticals
Neovascular Age-related Macular Degeneration
Injection Intervals in Real-world Neovascular Age-related Macular Degeneration (nAMD) Patients Switching to Brolucizumab With at Least 12 Months of Follow-up
This retrospective study included nAMD patients whose eyes were grouped into the following cohorts, with the overall cohort receiving ≥ 1 brolucizumab injection; the 12-month and 18-month brolucizumab (BRO) cohorts, which…
- Trial name
- NCT06178770
- Where
- United States
- Volunteers
- 414 people
- Sponsor
- Novartis Pharmaceuticals
Psoriatic Arthritis, Psoriasis
Incidence of Psoriatic Arthritis Among Psoriasis Patients Newly Initiated With Secukinumab in a US Claims Database and a UK Registry
This was a retrospective cohort study to assess the incidence rate of psoriatic arthritis (PsA) among psoriasis (PsO) patients newly initiated on secukinumab or any biologics/apremilast (small molecule).
- Trial name
- NCT06172426
- Where
- Switzerland
- Volunteers
- 1,171 people
- Sponsor
- Novartis Pharmaceuticals
Diffuse Astrocytoma, Anaplastic Astrocytoma
Study of Efficacy and Safety of Dabrafenib in Combination With Trametinib in Pediatric Patients With BRAF V600 Mutation Positive LGG or Relapsed or Refractory HGG Tumors
The purpose of this study was to investigate the activity of dabrafenib in combination with trametinib in children and adolescent patients with BRAF V600 mutation positive low grade glioma (LGG) or relapsed or refractory high…
- Conditions
- Diffuse Astrocytoma, Anaplastic Astrocytoma, Astrocytoma, Oligodendroglioma, Childhood
- Trial name
- NCT02684058
- Testing
- Dabrafenib, trametinib, Carboplatin
- Where
- 57 sites in United States, Argentina and 18 more
- Volunteers
- 151 people
- Sponsor
- Novartis Pharmaceuticals
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