Clinical trials: sponsored by Novartis Pharmaceuticals
Chagas Disease, Heart Failure
Efficacy and Safety of Sacubitril/Valsartan Compared With Enalapril on Morbidity, Mortality, and NT-proBNP Change in Patients With CCC
The purpose of this study was to evaluate the effect of sacubitril/valsartan 200 mg BID compared with enalapril 10 mg BID, in addition to conventional heart failure (HF) treatment, in improving a hierarchical composite of…
- Trial name
- PARACHUTE-HF (NCT04023227)
- Testing
- Sacubitril/valsartan, Enalapril
- Where
- 79 sites in Argentina, Brazil and 2 more
- Volunteers
- 922 people
- Sponsor
- Novartis Pharmaceuticals
Multiple Sclerosis
A Real-world Study Comparing the Effectiveness of Ofatumumab and Ocrelizumab Treatment in Multiple Sclerosis Patients
The aim of this study was to compare the effectiveness and economic burden of ofatumumab (OMB) and ocrelizumab (OCR) treatment in multiple sclerosis (MS) patients in the United States using data from an administrative claims…
- Trial name
- NCT07566988
- Where
- United States
- Volunteers
- 2,604 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Spontaneous Urticaria
A Real-world Study of Remibrutinib in Chronic Spontaneous Urticaria Patients
This is a United States (US) based, prospective, non-interventional, provider-referral study to evaluate the real-world effectiveness and patient-centered outcomes of remibrutinib in chronic spontaneous urticaria (CSU) patients…
- Trial name
- RELIEF (NCT07408219)
- Where
- United States
- Volunteers
- 350 people
- Sponsor
- Novartis Pharmaceuticals
Prostate Cancer
Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer in Japan
The purpose of this study is to assess the efficacy, tolerability, safety, pharmacokinetic (PK) and dosimetry of 177Lu-PSMA-617, in participants with progressive prostate-specific membrane antigen (PSMA)-positive metastatic…
- Trial name
- NCT05114746
- Testing
- 177Lu-PSMA-617, 68Ga-PSMA-11, Best supportive/best standard of care
- Where
- 8 sites in Japan
- Volunteers
- 94 people
- Sponsor
- Novartis Pharmaceuticals
Acute Myeloid Leukemia
A Study of Siremadlin in Combination With Venetoclax Plus Azacitidine in Adult Participants With Acute Myeloid Leukemia (AML) Who Are Ineligible for Chemotherapy.
A study of siremadlin in combination with venetoclax plus azacitidine in adult participants with AML who are ineligible for chemotherapy.
- Trial name
- NCT05155709
- Testing
- siremadlin, venetoclax, azacitidine
- Where
- 10 sites in United States, Hong Kong and 5 more
- Volunteers
- 14 people
- Sponsor
- Novartis Pharmaceuticals
Uncomplicated Plasmodium Falciparum Malaria
Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Participants With Uncomplicated Plasmodium Falciparum Malaria (Cohort B2)
This was Cohort B2 of the Platform study (NCT05750628) to evaluate the efficacy and safety of Cipargamin + KLU156 in participants with uncomplicated Plasmodium falciparum malaria.
- Trial name
- PLATINUM (NCT07235033)
- Testing
- KAE609, SoC (Coartem), KLU156
- Where
- 3 sites in Côte d’Ivoire, Gabon and 1 more
- Volunteers
- 60 people
- Sponsor
- Novartis Pharmaceuticals
Uncomplicated Plasmodium Falciparum Malaria
Efficacy, Safety and Tolerability of KAF156 in Combination With Lumefantrine Solid Dispersion Formulation (LUM-SDF) in Pediatric Population With Uncomplicated Plasmodium Falciparum Malaria
This study aimed to determine the efficacy, safety and tolerability of the investigational drug KAF156 in combination with a solid dispersion formulation of lumefantrine (LUM-SDF) in pediatric patients (6 months to < 18 years of…
- Trial name
- KALUMI (NCT04546633)
- Testing
- KAF156, LUM-SDF, Coartem
- Where
- 9 sites in Burkina Faso, Côte d’Ivoire and 3 more
- Volunteers
- 295 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Implementation Study to Describe and Compare Retention Rate and Adherence to Adjuvant Therapy With Ribociclib With and Without Usage of Mobile Application in Patients With HR+ HER2-negative Stage II and III Breast Cancer in Real-world Practice
This study is designed to evaluate the effect of using the application on the adherence of patients with luminal HER2- breast cancer (BC) stage II-III to adjuvant therapy with ribociclib in combination with an aromatase inhibitor…
- Trial name
- IMPULSE (NCT06905301)
- Testing
- Ribociclib, Letrozole, Anastrozole
- Where
- 7 sites in Russia
- Volunteers
- 240 people
- Sponsor
- Novartis Pharmaceuticals
Atherosclerotic Cardiovascular Disease
Study to Evaluate the Impact of a Targeted Lipid Optimization Program on LDL-C Control in At-risk Adult Patients With Dyslipidemia
This study is an open label, randomized, prospective, type I hybrid effectiveness- implementation, pragmatic clinical trial to evaluate the impact of a targeted lipid optimization program on LDL-C control in participants with…
- Trial name
- OPTIMA (NCT07034690)
- Testing
- Educational Material, Standard of care
- Where
- United Arab Emirates
- Volunteers
- 326 people
- Sponsor
- Novartis Pharmaceuticals
Gastroenteropancreatic Neuroendocrine Tumor
Italian Prospective Observational Study Assessing the Effectiveness and Outcomes Associated With Lutathera Treatment in GEP-NETs
This is a multicentre long-term non-interventional study of adult subjects diagnosed with unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive GEP-NETs who have been prescribed…
- Trial name
- REAL-LU (NCT04727723)
- Testing
- Lutathera®
- Where
- 18 sites in Italy
- Volunteers
- 164 people
- Sponsor
- Novartis Pharmaceuticals
Multiple Sclerosis (MS)
Assessment of the Quality of Life of Multiple Sclerosis Patients Treated With Ofatumumab in Real-life in France
SEPROS is a non-interventional study, based on primary data collection of MS adult patients who initiated ofatumumab as per neurologist practice and regardless of the study protocol.
- Trial name
- SEPROS (NCT06157086)
- Testing
- ofatumumab
- Where
- 49 sites in France
- Volunteers
- 302 people
- Sponsor
- Novartis Pharmaceuticals
Atypical Hemolytic Uremic Syndrome
Efficacy and Safety of Switching From Anti-C5 Antibody Treatment to Iptacopan Treatment in Study Participants With Atypical Hemolytic Uremic Syndrome (aHUS)
The purpose of this Phase 3 study is to evaluate the efficacy and safety of iptacopan upon switching from anti-C5 antibody to iptacopan treatment in study participants with aHUS.
- Trial name
- NCT05935215
- Testing
- Iptacopan
- Where
- 31 sites in China, France and 6 more
- Volunteers
- 50 people
- Sponsor
- Novartis Pharmaceuticals
Lymphoma, Leukemia
Managed Access Programs for CTL019, Tisagenlecleucel
The purpose of this registration is to list Managed Access Programs (MAPs) related to CTL019, Tisagenlecleucel
- Conditions
- Lymphoma, Leukemia, Off-label Indications
- Trial name
- NCT03601442
- Testing
- CTL019
- Sponsor
- Novartis Pharmaceuticals
Psoriasis, Metabolic Syndrome
Comparison of Secukinumab 300 mg Combined With a Lifestyle Intervention to Secukinumab Alone for the Treatment of Moderate to Severe Psoriasis Patients With Concomitant Metabolic Syndrome
This study was a randomized, open-label, parallel-group, active comparator controlled study with two treatment arms designed to answer the question whether the combination of Secukinumab with lifestyle intervention could…
- Trial name
- METABOLYX (NCT03440736)
- Testing
- Secukinumab, Life-style intervention
- Where
- 75 sites in Germany
- Volunteers
- 781 people
- Sponsor
- Novartis Pharmaceuticals
Melanoma
Dabrafenib With Trametinib in the Adjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma (COMBI-AD).
This was a two-arm, randomized, double-blind Phase III study of dabrafenib in combination with trametinib versus 2 placebos in the adjuvant treatment of melanoma after surgical resection.
- Trial name
- COMBI-AD (NCT01682083)
- Testing
- Dabrafenib, Trametinib
- Where
- 168 sites in United States, Argentina and 23 more
- Volunteers
- 870 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Myeloid Leukemia (CML)
Open-label Study of Asciminib for CML-CP or CML-AP Patients With T315I Mutation Who Are Resistant, Intolerant or Ineligible to Ponatinib.
The objective of this Phase II study is to assess the potential of asciminib in managing CML-CP or CML-AP in patient carrying the T315I mutation.
- Trial name
- ASC4TARGET (NCT06514534)
- Testing
- ABL001/Asciminib
- Where
- 6 sites in France
- Volunteers
- 20 people
- Sponsor
- Novartis Pharmaceuticals
CML, Chronic Myelogenous Leukemia
Study of Efficacy and Safety of Asciminib in Combination With Imatinib in Patients With Chronic Myeloid Leukemia in Chronic Phase (CML-CP) Who Have Been Previously Treated With Imatinib and Have Not Achieved Deep Molecular Response.
To evaluate efficacy, safety and pharmacokinetic profile of asciminib 40mg+imatinib or asciminib 60mg+imatinib versus continued imatinib and versus nilotinib in pre-treated patients with Chronic Myeloid Leukemia in chronic phase…
- Conditions
- CML, Chronic Myelogenous Leukemia, Leukemia, Myeloid Chronic, Hematologic Diseases
- Trial name
- NCT03578367
- Testing
- Asciminib add-on, Imatinib, Nilotinib
- Where
- 30 sites in United States, Austria and 13 more
- Volunteers
- 104 people
- Sponsor
- Novartis Pharmaceuticals
Osteoarthritis
Study of Safety, Tolerability, Preliminary Efficacy of Intra-articular LNA043 Injections in Patients With Articular Cartilage Lesions and Knee Osteoarthritis.
The purpose of this two-part study is to assess the efficacy, safety and tolerability of multiple intra-articular (i.a.) injections of LNA043, in regenerating the articular surface in patients with cartilage lesions of the knee…
- Trial name
- NCT03275064
- Testing
- LNA043
- Where
- 19 sites in United States, Czechia and 1 more
- Volunteers
- 142 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Myeloid Leukemia
Asciminib RMP Study
This study is a prospective, open-label, multi-center, non-comparative, observational study to assess safety and effectiveness of Asciminib in the real-world clinical setting in Korean Chronic myeloid leukemia (CML) patients.
- Trial name
- NCT05943522
- Testing
- Asciminib
- Where
- 17 sites in South Korea
- Volunteers
- 600 people
- Sponsor
- Novartis Pharmaceuticals
Follicular Lymphoma (FL)
A Phase III Trial Comparing Tisagenlecleucel to Standard of Care (SoC) in Adult Participants With r/r Follicular Lymphoma
This trial will compare tisagenlecleucel to standard of care in adult participants with relapsed or refractory (r/r) follicular lymphoma.
- Trial name
- LEDA (NCT05888493)
- Testing
- Tisagenlecleucel, Lenalidomide and rituximab (R2) in 28-day cycles for up to 12 cycles., Rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone or prednisolone (R-CHOP) in 21-day cycles for 6 to 8 cycles
- Where
- 30 sites in Australia, Austria and 9 more
- Volunteers
- 109 people
- Sponsor
- Novartis Pharmaceuticals
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