Clinical trials: Cholesterol, LDL
Coronary Heart Disease
The VA HDL Intervention Trial (HIT): Secondary Prevention of Coronary Heart Disease in Men With Low HDL-Cholesterol and Desirable LDL-Cholesterol
This was a double-blind randomized trial comparing 1200 mg per day of gemfibrozil with placebo in 2531 men with coronary heart disease, an HDL-C of 40mg/dl or less, an LDL-C of 140 mg/dl or less, and triglycerides of 300mg/dl or…
- Trial name
- HIT (NCT00283335)
- Testing
- gemfibrozil
- Where
- United States
- Volunteers
- 2,531 people
- Sponsor
- VA Office of Research and Development
Familial Hypercholesterolemia - Heterozygous
Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Heterozygous Familial Hypercholesterolemia
This was a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in adolescents with heterozygous familial hypercholesterolemia (HeFH) and elevated low density lipoprotein cholesterol…
- Trial name
- ORION-16 (NCT04652726)
- Testing
- Inclisiran
- Where
- 59 sites in United States, Argentina and 24 more
- Volunteers
- 141 people
- Sponsor
- Novartis Pharmaceuticals
Familial Hypercholesterolemia
A Registration Study for Familial Hypercholesterolemia in Taiwan
Familial hypercholesterolemia (FH) is an inherited disorder of lipoprotein metabolism, transmitted in an autosomal dominant manner and clinically characterized by elevated levels of total cholesterol (TC) and low-density…
- Trial name
- NCT03152656
- Where
- Taiwan
- Volunteers
- 1,000 people
- Sponsor
- National Taiwan University Hospital
Heterozygous Familial Hypercholesterolemia
Trial Assessing Efficacy, Safety and Tolerability of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition in Paediatric Subjects With Genetic Low-Density Lipoprotein (LDL) Disorders
A study to assess safety and efficacy of evolocumab (AMG-145) in paediatric subjects aged 10-17 years diagnosed with heterozygous familial hypercholesterolemia.
- Trial name
- HAUSER-RCT (NCT02392559)
- Testing
- Evolocumab
- Where
- 66 sites in United States, Australia and 24 more
- Volunteers
- 158 people
- Sponsor
- Amgen
Familial Hypobetalipoproteinemia
Prevalence of fAmilial hypobetalipopRoTeinemIa in psychiaTrIc pOpulatioN (PARTITION)
The links between low LDL-C levels and psychologic symptoms (psychotic disorders, mood disorders, aggressivity, suicidal risk, etc.) and cognitive deficits (mainly executing functioning) are debated.
- Trial name
- NCT03549637
- Testing
- Psychiatric population
- Where
- France
- Volunteers
- 896 people
- Sponsor
- Nantes University Hospital
Familial Hypercholesterolemia, Lipid Disorder
Familial Hypercholesterolemia Canada / Hypercholesterolemie Familiale Canada
Familial hypercholesterolemia (FH) is the most frequent genetic lipoprotein disorder associated with premature CAD. In Canada, the burden of disease is estimated to be approximately 83,500 patients.
- Trial name
- FHCanada (NCT02009345)
- Where
- Canada
- Volunteers
- 6,000 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Diabetes Mellitus, Macular Edema
Laser and Medical Treatment of Diabetic Macular Edema
This study will compare the side effects of two laser treatments for diabetic macular edema, a common condition in patients with diabetes.
- Trial name
- NCT00027287
- Testing
- Vitamin E
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- National Eye Institute (NEI)
Familial Hypercholesterolemia, Familial Hypercholesterolemia - Heterozygous
Early Detection of Familial Hypercholesterolemia in Children
Heterozigous FH is an underdiagnosed disease in the paediatric population. Its early detection, would allow us to initiate lifestyle therapeutical changes and early pharmacological therapy if necessary.
- Conditions
- Familial Hypercholesterolemia, Familial Hypercholesterolemia - Heterozygous, Familial Hypercholesterolemia - Homozygous
- Trial name
- DECOPIN (NCT04370899)
- Testing
- lifestyle assessment
- Where
- 2 sites in Spain
- Volunteers
- 400 people
- Sponsor
- Institut Investigacio Sanitaria Pere Virgili
Familial Hypercholesterolemia - Homozygous
Study to Evaluate Safety, Tolerability and Efficacy of Inclisiran in Children With Homozygous Familial Hypercholesterolemia
This is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in children (aged 2 to <12 years) with homozygous familial hypercholesterolemia (HoFH) and elevated low density lipoprotein…
- Trial name
- ORION-19 (NCT06597006)
- Testing
- Inclisiran
- Where
- 19 sites in United States, Austria and 9 more
- Volunteers
- 9 people
- Sponsor
- Novartis Pharmaceuticals
Hypercholesterolemia, Cardiovascular Risk Factor
The Effect of Psyllium Fibre on LDL-C, Non-HDL-C, and Apolioprotein-B: A Systematic Review and Meta-analysis
Serum cholesterol is a major modifiable risk factor for cardiovascular disease, which despite considerable reduction in prevalence, remains the leading cause of premature mortality worldwide.
- Trial name
- NCT03346733
- Testing
- Psyllium Fibre
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Unity Health Toronto
ACS (Acute Coronary Syndrome), Hyperlipidemia
Electronic Health Record Augmented LDL-Cholesterol Optimization and Control Via Active Lipid Engagement (EHR-LOCALE): A Quality Improvement Implementation Study
The purpose of this study is to determine whether a proactive, EHR-guided approach helps more individuals reach safe cholesterol levels, improves medication use, and reduces future heart attacks and strokes, compared to usual…
- Conditions
- ACS (Acute Coronary Syndrome), Hyperlipidemia, Dyslipidemia, Low-Density-Lipoprotein-cholesterol Level
- Trial name
- EHR-LOCALE (NCT07685639)
- Testing
- Pharmacist-led lipid optimization pathway
- Where
- 2 sites in Canada
- Volunteers
- 2,000 people
- Sponsor
- University of Alberta
Overweight, Obesity
Meta-analyses of the Effect of Liquid Meal Replacements on Cardiometabolic Risk
Obesity is a major risk factor for cardiovascular disease and diabetes. Weight loss is an important therapeutic goal for overweight and obese patients to reduce their risk of developing cardiovascular disease and diabetes.
- Conditions
- Overweight, Obesity, Type 2 Diabetes
- Trial name
- NCT02779790
- Testing
- Liquid Meal Replacements
- Where
- Canada
- Volunteers
- 1 people, healthy volunteers welcome
- Sponsor
- John Sievenpiper
Familial Hypercholesterolemia - Homozygous
Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Homozygous Familial Hypercholesterolemia
This was a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in adolescents with homozygous familial hypercholesterolemia (HoFH) and elevated low density lipoprotein cholesterol (LDL-C).
- Trial name
- ORION-13 (NCT04659863)
- Testing
- Inclisiran
- Where
- 11 sites in United States, Canada and 6 more
- Volunteers
- 13 people
- Sponsor
- Novartis Pharmaceuticals
Macular Edema, Diabetes Mellitus
Laser and Antioxidant Treatment of Diabetic Macular Edema
This study will compare the side effects of two laser treatments for diabetic macular edema, a common condition in patients with diabetes.
- Trial name
- NCT00055042
- Testing
- Vitamin E
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- National Eye Institute (NEI)
Down Syndrome, Autism Spectrum Disorder
Neuro-Nutrition to Support Physiological Function and Cognitive Skills in People With Down Syndrome, Autism Spectrum Disorder, and ADHD
This study aimed to evaluate the impact of a specialized nutritional intervention on physiological performance, sleep quality, and cognitive abilities in individuals with neurodevelopmental disorders, specifically Down syndrome…
- Conditions
- Down Syndrome, Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder (ADHD)
- Trial name
- NEURODIET-DSAA (NCT07165509)
- Testing
- T-2 Nutritional Supplement, Structured Dietary Program
- Where
- Mexico
- Volunteers
- 76 people
- Sponsor
- Elizabeth Guadalupe Ibarra Coronado
HIV Infections
Atazanavir Versus Lopinavir/Ritonavir (LPV/RTV) in Patients Who Have Not Had Success With Protease Inhibitor-Containing HAART Regimen(s)
This study will compare 2 treatments in the way they affect cholesterol levels and the amount of HIV in the blood.
- Trial name
- NCT00028301
- Testing
- Atazanavir, Lopinavir/Ritonavir
- Where
- 97 sites in United States, Argentina and 13 more
- Sponsor
- Bristol-Myers Squibb
Familial Hypercholesterolemia - Heterozygous
Study to Evaluate Efficacy and Safety of Inclisiran in Children With Heterozygous Familial Hypercholesterolemia
This is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in children (aged 6 to <12 years) with heterozygous familial hypercholesterolemia (HeFH) and elevated low density lipoprotein…
- Trial name
- ORION-20 (NCT06597019)
- Testing
- Inclisiran
- Where
- 66 sites in United States, Argentina and 21 more
- Volunteers
- 60 people
- Sponsor
- Novartis Pharmaceuticals
Homozygous Familial Hypercholesterolemia
NGGT006 Gene Therapy for Homozygous Familial Hypercholesterolemia
This is an early phase 1, open-label, single-center, dose-escalation, pilot trial to evaluate the safety and efficacy of an intravenous infusion of NGGT006 in homozygous familial hypercholesterolemia (HoFH) patients with LDLR…
- Trial name
- NCT06125847
- Testing
- NGGT006
- Where
- China
- Volunteers
- 21 people
- Sponsor
- First Affiliated Hospital Xi'an Jiaotong University
Hypercholesterolemia
Effect of Ezetimibe Treatment on Low-density Lipoprotein Cholesterol (LDL-C) Levels in Participants With Coronary Heart Disease (CHD) Already Treated With a Statin (MK-0653A-205 AM1)
This non-interventional longitudinal study is a follow-up of the Austrian Cholesterol Screening and Treatment project (ACT I), which assessed the cholesterol status, including achievement of the target levels applicable at that…
- Trial name
- ACT II (NCT01381679)
- Testing
- Ezetimibe
- Volunteers
- 1,682 people
- Sponsor
- Organon and Co
Cardiovascular Diseases
Meta-analysis of 46 FDA Identified Studies on Lipid Markers
The FDA have revised the data on soy and concluded that a heart health claim is no longer justified based on more recent studies. They are allowing and established panel for public input.
- Trial name
- NCT03468127
- Testing
- Soy foods
- Where
- 2 sites in Canada
- Volunteers
- 1 people, healthy volunteers welcome
- Sponsor
- University of Toronto