Clinical trials: sponsored by Novartis Pharmaceuticals
Multiple Sclerosis
Effectiveness of Ofatumumab in Real-world Practice
This study used a retrospective single cohort pre-post design on Optum® Clinformatics® Data Mart (CDM) data from 20 August 2019 to 31 December 2023 (study period).
- Trial name
- NCT06760624
- Where
- United States
- Volunteers
- 779 people
- Sponsor
- Novartis Pharmaceuticals
Hyperlipidemia
Study of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inclisiran in Chinese Participants With Elevated Serum LDL-C
Study to evaluate the pharmacokinetics and pharmacodynamics of inclisiran treatment given as single subcutaneous injection in Chinese participants with elevated low-density lipoprotein cholesterol (LDL-C) despite treatment with…
- Trial name
- ORION-14 (NCT04774003)
- Testing
- 100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran), 300 mg inclisiran sodium (equivalent to 284 mg inclisiran)
- Where
- 3 sites in China
- Volunteers
- 40 people
- Sponsor
- Novartis Pharmaceuticals
Neovascular Age-related Macular Degeneration (nAMD)
Observational Study to Evaluate Fluid Resolution and Effectiveness of Brolucizumab for nAMD in Portugal
This study is a prospective, observational, non-interventional, multicenter, open-label, single arm study in patients being treated for nAMD with brolucizumab in Portugal.
- Trial name
- BLUESKY-PT (NCT04764656)
- Testing
- Brolucizumab
- Where
- 11 sites in Portugal
- Volunteers
- 81 people
- Sponsor
- Novartis Pharmaceuticals
Multiple Sclerosis, Relapsing-Remitting
A Canadian Study of Persistence on Ofatumumab Using Patient Support Program Data
This was an observational, non-interventional, real world study involving secondary use of de-identified aggregate data from patients prescribed ofatumumab, collected by the Kesimpta Go Program in Canada.
- Trial name
- CAPES (NCT06854341)
- Where
- United States
- Volunteers
- 5,448 people
- Sponsor
- Novartis Pharmaceuticals
Retinopathy of Prematurity
A 24-week Study Evaluating the Effectiveness and Safety of Lucentis® 0.2mg in Retinopathy of Prematurity Participants in China
This is a 24-week, multicenter, open-label, single-arm, observational, post approval commitment study, which is designed to collect effectiveness, safety and other clinical information of intravitreal ranibizumab 0.2 mg for the…
- Trial name
- NCT05576792
- Testing
- Ranibizumab
- Where
- China
- Volunteers
- 62 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Chemotherapy and Lapatinib or Trastuzumab in Treating Women With HER2/Neu-Positive Metastatic Breast Cancer
This was a multi-center, multinational, randomized, open-label, Phase III study comparing combination taxane-based chemotherapy plus lapatinib to combination taxane-based chemotherapy plus trastuzumab in women with documented…
- Trial name
- NCT00667251
- Testing
- trastuzumab, docetaxel, lapatinib ditosylate
- Where
- 257 sites in United States, Argentina and 19 more
- Volunteers
- 652 people
- Sponsor
- Novartis Pharmaceuticals
Neoplasms, Breast
ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation) Study; BIG 2-06/N063D
This was a four-arm (parallel group) randomized, open-label, multicenter Phase 3 study to investigate the use of a combination of Lapatinib and Trastuzumab, a sequence of Trastuzumab followed by Lapatinib, and Lapatinib alone…
- Trial name
- ALTTO (NCT00490139)
- Testing
- Lapatinib, Trastuzumab
- Where
- 924 sites in United States, Argentina and 42 more
- Volunteers
- 8,381 people
- Sponsor
- Novartis Pharmaceuticals
Acute Myeloid Leukemia
A Study of Midostaurin Efficacy and Safety in Newly Diagnosed Patients With FLT3-mutated AML
This study evaluated the efficacy and safety of midostaurin in combination with daunorubicin/cytarabine induction, high dose cytarabine consolidation and midostaurin single agent continuation therapy in newly diagnosed patients…
- Trial name
- NCT03280030
- Testing
- Midostaurin
- Where
- 34 sites in Hong Kong, Japan and 4 more
- Volunteers
- 67 people
- Sponsor
- Novartis Pharmaceuticals
Neovascular Age-related Macular Degeneration (nAMD)
Study to Evaluate the Safety and Effectiveness of Intravitreal Injections (IVI) of Brolucizumab in Patients With Neovascular Age-related Macular Degeneration (nAMD)
The purpose of this study was to generate additional safety and effectiveness data in Indian neovascular age-related macular degeneration (nAMD) patients that more closely resemble the real-world population intended to be treated…
- Trial name
- NCT05269966
- Testing
- Injection Brolucizumab
- Where
- 10 sites in India
- Volunteers
- 105 people
- Sponsor
- Novartis Pharmaceuticals
Neoplasms, Breast
A Study to Compare the Safety and Efficacy of an Aromatase Inhibitor in Combination With Lapatinib, Trastuzumab or Both for the Treatment of Hormone Receptor Positive, HER2+ Metastatic Breast Cancer
A study to compare the safety and efficacy of an aromatase inhibitor in combination with lapatinib, trastuzumab or both for the treatment of hormone receptor positive, HER2+ metastatic breast cancer (MBC).
- Trial name
- NCT01160211
- Testing
- Lapatinib, Trastuzumab, Aromatase Inhibitor
- Where
- 110 sites in United States, Argentina and 27 more
- Volunteers
- 369 people
- Sponsor
- Novartis Pharmaceuticals
Advanced, Metastatic Breast Cancer
Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer
The primary purpose of this study was to assess the efficacy of ribociclib, as measured by progression free survival (PFS), in postmenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2…
- Trial name
- MONALEESA-2 (NCT01958021)
- Testing
- Ribociclib, Letrozole
- Where
- 221 sites in United States, Argentina and 27 more
- Volunteers
- 668 people
- Sponsor
- Novartis Pharmaceuticals
Heart Failure With Preserved Ejection Fraction (HFpEF)
Changes in NT-proBNP, Safety, and Tolerability in HFpEF Patients With a WHF Event (HFpEF Decompensation) Who Have Been Stabilized and Initiated at the Time of or Within 30 Days Post-decompensation (PARAGLIDE-HF)
The effect of sacubitril/valsartan vs. valsartan on changes in NT-proBNP, safety, and tolerability in HFpEF patients with a WHF event (HFpEF decompensation) who had been stabilized and initiated at the time of or within 30 days…
- Trial name
- PARAGLIDE-HF (NCT03988634)
- Testing
- sacubitril/valsartan, valsartan
- Where
- 97 sites in United States, Canada
- Volunteers
- 467 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Spontaneous Urticaria
A Safety and Efficacy Study of Ligelizumab in the Treatment of CSU in Japanese Patients Inadequately Controlled With H1- Antihistamines
The purpose of this study was to evaluate the safety and efficacy of ligelizumab in adult Japanese subjects with CSU, who remain symptomatic despite treatment with H1-antihistamines (AHs) at locally approved doses.
- Trial name
- NCT03907878
- Testing
- Ligelizumab
- Where
- 11 sites in Japan
- Volunteers
- 66 people
- Sponsor
- Novartis Pharmaceuticals
Kidney Diseases
Clinical Outcomes of C3 Glomerulopathy and IC-MPGN in Russia: Hybrid Retrospective - Prospective Study
The study is planned to study specificity of the clinical course and treatment outcomes of C3 glomerulopathy (C3G) and Immune-complex membranoproliferative glomerulonephritis (IC-MPGN) in patients aged under 18 years and 18 years…
- Trial name
- CRYSTAL (NCT06851845)
- Testing
- No intervention
- Volunteers
- 100 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment.
To determine whether treatment with alpelisib plus fulvestrant prolonged progression-free survival (PFS) compared to fulvestrant and placebo in men and postmenopausal women with hormone receptor positive (HR+), human epidermal…
- Trial name
- SOLAR-1 (NCT02437318)
- Testing
- Fulvestrant, Alpelisib
- Where
- 197 sites in United States, Argentina and 29 more
- Volunteers
- 572 people
- Sponsor
- Novartis Pharmaceuticals
Pancreatic Neuroendocrine Tumors
Phase IV Study of the Safety and Efficacy of Everolimus in Adult Patients With Progressive pNET in China
To evaluate safety and efficacy of everolimus (Afinitor®) in Chinese adult patients with local advanced or metastatic, well differentiated progressive pancreatic neuroendocrine tumors.
- Trial name
- NCT02842749
- Testing
- everolimus
- Where
- 5 sites in China
- Volunteers
- 61 people
- Sponsor
- Novartis Pharmaceuticals
Non-Small Cell Lung Cancer
LDK378 Versus Chemotherapy in ALK Rearranged (ALK Positive) Patients Previously Treated With Chemotherapy (Platinum Doublet) and Crizotinib
The primary purpose of the study was to compare the antitumor activity of LDK378 vs. chemotherapy in patients previously treated with chemotherapy (platinum doublet) and crizotinib.
- Trial name
- NCT01828112
- Testing
- Ceritinib, Pemetrexed, Docetaxel
- Where
- 97 sites in United States, Belgium and 18 more
- Volunteers
- 231 people
- Sponsor
- Novartis Pharmaceuticals
Spinal Muscular Atrophy (SMA)
Registry of Patients With a Diagnosis of Spinal Muscular Atrophy (SMA)
Spinal muscular atrophy (SMA) is a neurogenetic disorder caused by a loss or mutation in the survival motor neuron 1 gene (SMN1) on chromosome 5q13, which leads to reduced SMN protein levels and a selective dysfunction of motor…
- Trial name
- NCT04174157
- Testing
- Prospective observational registry, Zolgensma
- Where
- 99 sites in United States, Greece and 9 more
- Volunteers
- 700 people
- Sponsor
- Novartis Pharmaceuticals
Non Alcoholic Steatohepatitis (NASH)
Efficacy, Safety and Tolerability of the Combination of Tropifexor & Licogliflozin and Each Monotherapy, Compared With Placebo in Adult Patients With NASH and Liver Fibrosis.
Randomized, double-blind, parallel-group, multicenter study to assess efficacy, safety, and tolerability of oral tropifexor \& licogliflozin combination therapy and each monotherapy, compared with placebo for treatment of adult…
- Trial name
- ELIVATE (NCT04065841)
- Testing
- Tropifexor, Licogliflozin
- Where
- 80 sites in United States, Argentina and 22 more
- Volunteers
- 234 people
- Sponsor
- Novartis Pharmaceuticals
Dry Eye
A Study to Assess the Safety and Efficacy of ECF843 vs Vehicle in Subjects With Dry Eye Disease
The study was planned to be conducted in 2 parts: Part 1 to determine the efficacy and safety of ECF843 vs vehicle, followed by Part 2 with additional exploratory assessments of ECF843 vs Vehicle.
- Trial name
- NCT04391894
- Testing
- ECF843, ECF843 vehicle
- Where
- 52 sites in United States
- Volunteers
- 718 people
- Sponsor
- Novartis Pharmaceuticals
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