Clinical trials: sponsored by Novartis Pharmaceuticals
Relapse Remitting Multiple Sclerosis
Study to Assess the Effect of Ofatumumab in Treatment Naïve, Very Early RRMS Patients Benchmarked Against Healthy Controls.
This study evaluates the impact of ofatumumab in Relapsing Remitting Multiple Sclerosis (RRMS) participants that are very early in the course of their disease using clinical and magnetic resonance imaging (MRI) outcomes.
- Trial name
- AGNOS (NCT05084638)
- Testing
- Ofatumumab
- Where
- 36 sites in United States, Puerto Rico
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Neuroendocrine Neoplasms
A Prospective, Open-label Study of [68Ga]Ga-DOTA-TATE in Patients With Neuroendocrine Neoplasms (NENs) and Healthy Volunteers in Japan
The purpose of this study was to evaluate the diagnostic performance of [68Ga]Ga-DOTA-TATE Positron Emission Tomography (PET)/Computerized Tomography (CT) imaging compared with conventional imaging (CIM) as standard of truth in…
- Trial name
- NCT06240741
- Testing
- [68Ga]Ga-DOTA-TATE, 68Ge/68Ga Generator
- Where
- 8 sites in Japan
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Tendinopathy
Study of Efficacy and Safety of AIN457/Secukinumab in Patients With Rotator Cuff Tendinopathy
The purpose of this study was to investigate the efficacy and safety of secukinumab subcutaneously (s.c.) compared to placebo in adult patients with moderate to severe rotator cuff tendinopathy and failure to conventional therapy.
- Trial name
- UnchAIN (NCT05569174)
- Testing
- Secukinumab
- Where
- 19 sites in Germany
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Cryptosporidium Infection, Cryptosporidiosis
Study of Efficacy and Safety of ABO809 in Healthy Participants
The purpose of this Phase I controlled human infection model (CHIM) study was to determine if oral administration of a good manufacturing practice (GMP) supply of Cryptosporidium parvum oocysts (ABO809) to healthy volunteers…
- Trial name
- NCT05036668
- Testing
- Cryptosporidium parvum oocysts (ABO809)
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Homozygous Familial Hypercholesterolemia
A Study of Inclisiran in Participants With Homozygous Familial Hypercholesterolemia (HoFH)
This study was a Phase III,A two-part (double-blind placebo-controlled/open-label) multicenter study to evaluate safety, tolerability, and efficacy of inclisiran in subjects with homozygous familial hypercholesterolemia (HoFH).
- Trial name
- ORION-5 (NCT03851705)
- Testing
- Inclisiran Sodium for injection
- Where
- 13 sites in Hong Kong, Israel and 6 more
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Malaria
Study to Assess Safety, Tolerability and Phamacokinetics of KAE609 Administered Intravenously in Healthy Subjects
This was a randomized, subject and investigator-blinded, placebo-controlled, single and multiple ascending intravenous (iv) dose study in healthy subjects to assess the safety and tolerability of KAE609 given in the vein.
- Trial name
- NCT04321252
- Testing
- KAE609
- Where
- Belgium
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Alzheimers Disease
A Study of CNP520 Versus Placebo in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease
The purpose of this study is to determine the effects of CNP520 on cognition, global clinical status, and underlying AD pathology, as well as the safety of CNP520, in people at risk for the onset of clinical symptoms of AD based…
- Trial name
- GS2 (NCT03131453)
- Testing
- CNP520 50mg, CNP520 15mg
- Where
- 194 sites in United States, Argentina and 23 more
- Volunteers
- 1,145 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Obesity
Effects of Carbohydrate in Diet and Supplements on the Gastrointestinal Tolerability of LIK066
The purpose of this study was to determine if LIK066 taken with a meal containing low carbohydrate is associated with less diarrhea compared to a high carbohydrate meal and to assess the potential effects of supplements such as…
- Trial name
- NCT03198767
- Testing
- LIK066, Carbohydrate 50%, Carbohydrate 25%
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Cystic Fibrosis
Safety, Tolerability, Pharmacokinetics, and Preliminary Pharmacodynamics of QBW251 in Healthy Subjects and Cystic Fibrosis Patients
This study is designed to assess the safety, tolerability, pharmacokinetics and preliminary pharmacodynamics (proof of concept) of QBW251 in healthy subjects and cystic fibrosis patients following single and multiple doses.
- Trial name
- NCT02190604
- Testing
- QBW251
- Where
- 23 sites in United States, Belgium and 5 more
- Volunteers
- 153 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Hepatic Impairment
Pharmacokinetics of BAF312 in Patients With Hepatic Impairment
This study will investigate the pharmacokinetics of BAF312 in patients with mild, moderate and severe hepatic impairment compared to healthy control subjects.
- Trial name
- NCT01565902
- Testing
- BAF312
- Where
- 3 sites in Hungary, Russia
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Chronic Heart Failure With Reduced Ejection Fraction
randOmized stUdy Using acceleromeTry to Compare Sacubitril/valsarTan and Enalapril in Patients With Heart Failure
The purpose of this randomized, actively controlled, double-blind study with prospective data collection was to assess differences between sacubitril/valsartan versus enalapril in increasing exercise capacity and non-sedentary…
- Trial name
- OUTSTEP-HF (NCT02900378)
- Testing
- LCZ696 (Sacubitril/Valsartan), Enalapril
- Where
- 119 sites in Belgium, Bulgaria and 17 more
- Volunteers
- 621 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Cognition, Brain Volume Loss
Effect of Fingolimod on Neurodegeneration
This was a 24-month, open-label, multicenter study with a single treatment arm design. Primary objective of this study was: -To investigate the effects of Fingolimod on cognitive performance in highly active relapsing remitting…
- Trial name
- NCT02575365
- Testing
- 0,5 mg Fingolimod
- Where
- 3 sites in Turkey (Türkiye)
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Alzheimer's Disease
Dose-ranging Safety and Tolerability Study in Subjects ≥60 Years of Age
The study determined the safety of CNP520 in healthy elderly over 3 months. Data relevant for Pharmacokinetic/Pharmacodynamic modeling were obtained in order to define the target dose in subsequent efficacy studies.
- Trial name
- NCT02576639
- Testing
- CNP520
- Where
- 11 sites in United States, Belgium and 3 more
- Volunteers
- 124 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Chronic Obstructive Pulmonary Disease (COPD) With Cachexia
BYM338 in Chronic Obstructive Pulmonary Disease (COPD) Patients With Cachexia
This study will assess the pharmacodynamics, pharmacokinetics, safety and tolerability of BYM338 in patients with COPD and cachexia. The primary outcome will be a change in thigh muscle volume compared to placebo.
- Trial name
- NCT01669174
- Testing
- BYM338
- Where
- 9 sites in United States, Netherlands and 1 more
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Mild and Moderate Renal Impairment
Pharmacokinetics of LCZ696 in Subjects With Mild and Moderate Renal Impairment Compared to Healthy Subjects With Normal Renal Function
The purpose of this study is to determine the multiple dose pharmacokinetics of LCZ696 and its metabolites in subjects with mild to moderate renal impairment and to evaluate the safety of LCZ696 in this population.
- Trial name
- NCT01569815
- Testing
- LCZ696
- Where
- 3 sites in Germany, Russia and 1 more
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Pharmacokinetics, Renal Impaired
Multiple Dose Pharmacokinetics of LCZ696 and Its Metabolites in Subjects With Severe Renal Impairment vs. Matched Healthy Subjects With Normal Renal Function
An open label, parallel-group study to determine multiple dose pharmacokinetics of LCZ696 and its metabolites in subjects with severe renal impairment compared to matched healthy subjects with normal renal function
- Conditions
- Pharmacokinetics, Renal Impaired, Healthy Volunteer
- Trial name
- NCT01569828
- Testing
- LCZ696A
- Where
- 3 sites in Germany, Russia and 1 more
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Hepatic Impairment
A Study of LCZ696 in Subjects With Mild and Moderate Hepatic Impairment Compared With Normal Healthy Volunteers
This is a study to characterize the pharmacokinetics as well as safety and tolerability of a single oral dose of LCZ696 200 mg in subjects with mild and moderate hepatic impairment compared to matched healthy subjects
- Trial name
- NCT01621633
- Testing
- LCZ696
- Where
- Germany
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals