Clinical trials: Nutritional Risk
Hypercholesterolemia
Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe on Top of Statin in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY COMBO II)
Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9).
- Trial name
- NCT01644188
- Testing
- Alirocumab, Ezetimibe, Lipid Modifying Therapy (LMT)
- Where
- 126 sites in United States, Canada and 8 more
- Volunteers
- 720 people
- Sponsor
- Sanofi
Hyperlipidemia
Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Subjects Currently Not Receiving Drug Therapy for Easing Lipid Levels-2
The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneous (SC) monotherapy every 2 weeks (Q2W) and monthly (QM), compared with placebo and ezetimibe, on percent change from baseline in low-density…
- Trial name
- MENDEL-2 (NCT01763827)
- Testing
- Evolocumab, Ezetimibe
- Where
- 83 sites in United States, Australia and 8 more
- Volunteers
- 615 people
- Sponsor
- Amgen
Hypertriglyceridemia, Cardiovascular Disease
[E]PANOVA Combined With a [S]TATIN in [P]ATIENTS With HYPERT[R]IGLYCER[I]DEMIA to Reduce Non-HDL CHOLES[T]EROL
The primary objective is to evaluate the efficacy of adding Epanova (2 g or 4 g daily) to an optimal statin monotherapy for lowering non-high-density lipoprotein (non-HDL) cholesterol in subjects with persistent…
- Trial name
- ESPRIT (NCT01408303)
- Testing
- Olive oil, 4g, omega-3-carboxylic acids, 2g, omega-3-carboxylic acids, 4g
- Where
- 89 sites in United States
- Volunteers
- 646 people
- Sponsor
- AstraZeneca
Diabetes Mellitus, Type 2
Post-authorisation Safety Study in Patients With Type 2 Diabetes to Assess the Risk of Liver Injury, Kidney Injury, Urinary Tract and Genital Infections, and Diabetic Ketoacidosis in Patients Treated With Empagliflozin, Compared to DPP-4 Inhibitors
Empagliflozin (Jardiance), a highly potent and selective inhibitor of the sodium-glucose cotransporter 2 (SGLT2), was approved in Europe in May 2014 for the treatment of type 2 diabetes mellitus (T2DM) to improve glycaemic…
- Trial name
- NCT02864914
- Testing
- Empagliflozin, DPP-4 inhibitors
- Where
- United Kingdom
- Volunteers
- 333,580 people
- Sponsor
- Boehringer Ingelheim
Myelodysplastic Syndrome, Iron Overload
Study of Deferasirox for Treatment of Transfusional Iron Overload in Myelodysplastic Patients
The purpose of this trial is to examine the safety and efficacy of deferasirox in patients with Myelodysplastic Syndrome (MDS) and chronic iron overload from blood transfusions.
- Trial name
- NCT00110266
- Testing
- Deferasirox
- Where
- 48 sites in United States, Canada
- Volunteers
- 176 people
- Sponsor
- Novartis Pharmaceuticals
Dyslipidemia, Cardiovascular Diseases
Treatment of High and Very High riSk Dyslipidemic pAtients for the PreveNTion of CardiOvasculaR Events
High and Very High Risk cardiovascular patient journeys seems to vary from country to country, and current understanding of the process is incomplete.
- Conditions
- Dyslipidemia, Cardiovascular Diseases, Hypercholesterolemia, Atherosclerotic Cardiovascular Disease
- Trial name
- SANTORINI (NCT04271280)
- Testing
- Non-interventional
- Where
- 540 sites in Austria, Belgium and 12 more
- Volunteers
- 9,559 people
- Sponsor
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Hypercholesterolaemia
Usability Study of the Commercial Auto-injector Device and the New Auto-injector Device (SYDNEY) in Patients With High or Very High CV Risk With Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy
Primary Objective: To collect real-use (usability) data assessing the robustness and user interaction of the new alirocumab auto-injector device (which is referred to as SYDNEY), in unsupervised settings.
- Trial name
- NCT03415178
- Testing
- Alirocumab SAR236553, Current auto-injector device (AI), New auto-injector device (SYDNEY)
- Where
- 13 sites in United States
- Volunteers
- 69 people
- Sponsor
- Sanofi
Nutritional and Metabolic Diseases, Inflammation
A Study of Strawberries and Disease Risk
The purpose of this study is to test whether compounds found in strawberries (polyphenolics which are typically found in berry products, tea, coffee, red wine, and chocolate) will help reduce insulin resistance and inflammation…
- Conditions
- Nutritional and Metabolic Diseases, Inflammation, Physiological Responses
- Trial name
- STRB (NCT01199848)
- Testing
- 10G, 20G, 40G
- Where
- United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Clinical Nutrition Research Center, Illinois Institute of Technology
Diabetes Mellitus, Type 2
BI 10773 (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME).
The aim of the present study is to investigate the safety of BI 10773 treatment in patients with Type 2 Diabetes Mellitus and high cardiovascular risk.
- Trial name
- NCT01131676
- Testing
- BI 10773 low dose, BI 10773 high dose
- Where
- 615 sites in United States, Argentina and 40 more
- Volunteers
- 7,064 people
- Sponsor
- Boehringer Ingelheim
Cardiovascular Diseases, Coronary Artery Disease
Study On Liprimar (Atorvastatin) In Patients With Coronary Heart Disease (CHD) And High Risk Of Cardiovascular Complications
In which CHD patients with high risk of CV complications are different doses of LIPRIMAR used? For this purpose, data on hyperlipidemia will be elicited over and above the basic nosographic and demographic data, concomitant…
- Trial name
- LIGHT (NCT00993915)
- Testing
- Atorvastatin
- Volunteers
- 687 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Hypercholesterolemia, Dyslipidemia
Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin
The purpose of this study is to compare the efficacy and safety of pitavastatin with that of simvastatin in patients with risk factors for heart disease.
- Trial name
- NCT00309738
- Testing
- pitavastatin, simvastatin
- Where
- 35 sites in Denmark, Netherlands and 2 more
- Volunteers
- 355 people
- Sponsor
- Kowa Research Europe
Type 2 Diabetes Mellitus
Bexagliflozin Efficacy and Safety Trial
The purpose of this study is to investigate the effect of bexagliflozin in lowering hemoglobin A1c (HbA1c) levels in patients with type 2 diabetes mellitus (T2DM) and increased risk of cardiovascular adverse events.
- Trial name
- BEST (NCT02558296)
- Testing
- Bexagliflozin
- Where
- 157 sites in United States, Canada and 8 more
- Volunteers
- 1,700 people
- Sponsor
- Theracos
Diabetes
Clinical Characteristics and Disease Burden of Diabetic Patients Based on Tianjin Regional Database
The study aims to investigate the clinical characteristics, treatment, and economic burden of disease of Chinese diabetic/non-diabetic patients with/without established cardiovascular disease (CVD), chronic kidney disease (CKD)…
- Trial name
- NCT04903496
- Where
- China
- Volunteers
- 1,233,162 people
- Sponsor
- Boehringer Ingelheim
Diabetes Mellitus, Type 2, Coronary Artery Disease
Effect of RVX000222 on Time to Major Adverse Cardiovascular Events in High-Risk T2DM Subjects With CAD
The purpose of this study is to determine whether bromodomain extraterminal domain (BET) inhibition treatment with RVX000222 in high-risk type 2 diabetes mellitus patients with coronary artery disease increases the time to major…
- Trial name
- BETonMACE (NCT02586155)
- Testing
- Apabetalone, Atorvastatin, Rosuvastatin
- Where
- 214 sites in Argentina, Australia and 13 more
- Volunteers
- 2,425 people
- Sponsor
- Resverlogix Corp
Myelodysplastic Syndromes, Iron Overload
Study for the Treatment of Transfusional Iron Overload in Myelodysplastic Patients
Thirty patients were to be enrolled and 24 patients were actually enrolled into this open-label, single-arm trial designed to assess the safety and tolerability of oral deferasirox in adult transfusion dependent myelodysplastic…
- Trial name
- NCT00117507
- Testing
- Deferasirox
- Where
- 3 sites in United States
- Volunteers
- 24 people
- Sponsor
- Novartis Pharmaceuticals
Hyperlipidemia
Randomized Clinical Trial Of Bococizumab (PF-04950615; RN316) In Subjects With Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events
This study is a multicenter, randomized study in subjects with high cholesterol receiving highly effective statins to assess the efficacy, safety and tolerability of Bococizumab (PF-04950615;RN316) to lower LDL-C.
- Trial name
- SPIRE-HR (NCT01968954)
- Testing
- Bococizumab (PF-04950615;RN316)
- Where
- 103 sites in United States, Australia and 7 more
- Volunteers
- 711 people
- Sponsor
- Pfizer
Frontotemporal Dementia
A Phase 3 Study to Evaluate Efficacy and Safety of AL001 in Frontotemporal Dementia (INFRONT-3)
A phase 3 double blind, placebo controlled study evaluating the efficacy and safety of AL001 in participants at risk for or with frontotemporal dementia due to heterozygous mutations in the progranulin gene.
- Trial name
- NCT04374136
- Testing
- Part 1 Blinded - AL001, Part 2 (OLE Treatment) - AL001
- Where
- 44 sites in United States, Argentina and 14 more
- Volunteers
- 119 people
- Sponsor
- Alector Inc.
Hypercholesterolemia, Heterozygous Familial Hypercholesterolemia
Study of Efficacy and Safety of Inclisiran in Japanese Participants With High Cardiovascular Risk and Elevated LDL-C
This was a placebo-controlled, double-blind, randomized trial in Japanese participants with history of coronary artery disease (CAD) or participants categorized in 'high risk' by JAS 2017 guideline, or Japanese participants with…
- Trial name
- ORION-15 (NCT04666298)
- Testing
- Inclisiran sodium
- Where
- 42 sites in Japan
- Volunteers
- 312 people
- Sponsor
- Novartis Pharmaceuticals
Diabetes Mellitus, Type 2
Thiazolidinedione Intervention With Vitamin D Evaluation
This study will answer two separate questions. The first question is to test the cardiovascular effects of long-term treatment with rosiglitazone or pioglitazone when used as part of standard of care compared to similar standard…
- Trial name
- TIDE (NCT00879970)
- Testing
- pioglitazone, rosiglitazone, Vitamin D
- Where
- 331 sites in United States, Argentina and 23 more
- Volunteers
- 1,332 people
- Sponsor
- GlaxoSmithKline
Coronary Artery Disease, Coronary Heart Disease
Safety and Efficacy Study Using ABT-335 (Investigational Drug) in Combination With Atorvastatin, to Study the Effects on Thickening of the Blood Vessel Wall in Patients With Abnormal Lipid (Fat) Levels in the Blood
The primary purpose of this study is to test the effect and safety of once daily ABT-335 on the thickness of the lining of the carotid artery (a blood vessel to the brain) in patients with abnormal blood lipids who have optimal…
- Conditions
- Coronary Artery Disease, Coronary Heart Disease, Dyslipidemia
- Trial name
- FIRST (NCT00616772)
- Testing
- ABT-335, Atorvastatin
- Where
- 124 sites in United States
- Volunteers
- 682 people
- Sponsor
- AbbVie (prior sponsor, Abbott)