Clinical trials: Elevated LDL Cholesterol
Hypercholesterolemia, Coronary Heart Disease
Comparison of Low and High Phytosterol Diets With Respect to Cholesterol Metabolism
The objective of this study is to compare cholesterol absorption and metabolism after feeding diets naturally low or high in phytosterols. All meals will be prepared in a metabolic kitchen and analyzed for phytosterols.
- Trial name
- Phyteaux-II (NCT00860509)
- Testing
- Low Phytosterol and High Phytosterol Diets
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Washington University School of Medicine
Cardiovascular Disease, Hyperlipidemia
The Effect of Avocado on Cardiovascular Disease (CVD) Risk Factors
The investigators propose to evaluate the effects of avocado consumption (by incorporating 1 unit of fruit per day into a healthy diet) on multiple cardiovascular disease (CVD) risk factors.
- Trial name
- NCT01235832
- Testing
- Avocado Diet, Lower-Fat Diet, Moderate Fat Diet
- Where
- United States
- Volunteers
- 54 people
- Sponsor
- Penn State University
Cardiovascular Diseases
A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High-Risk Patients With Hypertriglyceridemia and on Statin
AMR101 (icosapent ethyl [ethyl-EPA]) is a highly purified ethyl ester of eicosapentaenoic acid (EPA) developed by Amarin Pharma Inc.
- Trial name
- REDUCE-IT (NCT01492361)
- Testing
- AMR101, Statin therapy
- Where
- 410 sites in United States, Australia and 9 more
- Volunteers
- 8,179 people
- Sponsor
- Amarin Pharma Inc.
Atherosclerosis, Cardiovascular Diseases
Investigating the Lowest Threshold of Vascular Benefits From LDL Cholesterol Lowering in Patients With Stable CV Disease
The INTENSITY-HIGH study aims to answer if there are any limits to LDL reduction in relation to benefiting vascular health, exploring the mechanisms by which secondary prevention in patients with established heart disease may…
- Trial name
- INTENSITY-HIGH (NCT03355027)
- Testing
- Alirocumab 150 MG/ML, Ezetimibe 10Mg Tablet, Atorvastatin 40Mg Tablet
- Where
- United Kingdom
- Volunteers
- 60 people
- Sponsor
- Cambridge University Hospitals NHS Foundation Trust
Hypercholesterolemia, Dyslipidemia
Pharmacokinetic And Pharmacodynamic Study Of A Single-Dose Of PF-04950615 (RN316) In Combination With Atorvastatin
The primary objective of this study is to evaluate the pharmacokinetics and pharmacodynamics of a single dose of PF-04950615 (RN316) in volunteers on stable doses of atorvastatin.
- Trial name
- NCT01163851
- Testing
- 4 mg/kg, 0.5 mg/kg
- Where
- 5 sites in United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Pfizer
Hypercholesterolemia, Dyslipidemia
Safety And Tolerability Of Multiple Doses Of PF-04950615 (RN316) In Subjects With Hypercholesterolemia
The primary objective of this study is to evaluate the safety and tolerability of repeated doses of PF-04950615 (RN316) in study volunteers with hypercholesterolemia.
- Trial name
- NCT01243151
- Testing
- PF-04950615 (RN316)
- Where
- 9 sites in United States
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Pfizer
Elevated High-sensitivity C-Reactive Protein (hsCRP)
JUPITER - Crestor 20mg Versus Placebo in Prevention of Cardiovascular (CV) Events
The purpose of this study is to determine the safety and effectiveness of long-term therapy with rosuvastatin compared with a placebo, and to evaluate whether treatment with rosuvastatin might be effective in reducing the risk of…
- Trial name
- NCT00239681
- Testing
- Rosuvastatin
- Where
- 856 sites in United States, Argentina and 25 more
- Volunteers
- 17,802 people
- Sponsor
- AstraZeneca
Dyslipidemias, Hypercholesterolemia
Study of Obicetrapib & Ezetimibe Fixed Dose Combination on Top of Maximum Tolerated Lipid-Modifying Therapies
The study is a placebo-controlled, double-blind, randomized, phase 3 study in participants with heterozygous familial hypercholesterolemia (HeFH) and/or atherosclerotic cardiovascular disease (ASCVD) or multiple ASCVD risk…
- Conditions
- Dyslipidemias, Hypercholesterolemia, Familial Hypercholesterolemia, ASCVD
- Trial name
- TANDEM (NCT06005597)
- Testing
- Combination Therapy, Monotherapy obicetrapib, Monotherapy ezetimibe
- Where
- 45 sites in United States
- Volunteers
- 407 people
- Sponsor
- NewAmsterdam Pharma
Cardiovascular Disease
Clinical Study to Assess High-DHA Fish Oil on Biomarkers of Cardiovascular Disease Risk in Adults on Statin Therapy
The objective of this study is to determine the acute and chronic [4-week] effects of a high-DHA fish oil supplement on fasting and post-prandial (post-meal) biomarkers of cardiovascular disease risk, in adults on Statin therapy.
- Trial name
- NCT01690312
- Testing
- Fish Oil
- Where
- Canada
- Volunteers
- 36 people
- Sponsor
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
Primary Hypercholesterolemia, Mixed Dyslipidemia
Study to Assess in Home Use of Evolocumab (AMG 145) Administration Using Either an Automated Mini-doser or a Prefilled Autoinjector/Pen
The primary objective of this study was to assess users' ability to administer a full dose of evolocumab in a home-use setting using either an automated mini-doser (AMD) or autoinjector/pen (AI/pen).
- Trial name
- NCT01879319
- Testing
- Evolocumab AMD, Evolocumab AI/pen
- Where
- 27 sites in United States, Canada
- Volunteers
- 164 people
- Sponsor
- Amgen
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
Cardiovascular Disease, Diabetes
The Effects of Natural Versus Man-Made Trans Fatty Acids on Lipoprotein Profiles: A Pilot Study
The purpose of this study is to test the effects of natural vs. man-made trans fatty acids (trans fats) on blood cholesterol.
- Conditions
- Cardiovascular Disease, Diabetes, Dyslipidemia
- Trial name
- NCT00535886
- Testing
- Man-made Trans FA, Natural Trans FA, Oleic Acid
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- UCSF Benioff Children's Hospital Oakland
Inclisiran Formulation
Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a New Formulation of Inclisiran Containing Polysorbate 80 Compared to the Currently Marketed Formulation
The purpose of this study is to compare safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of the currently marketed formulation of inclisiran with a new formulation containing polysorbate 80 (PS80), after a…
- Trial name
- NCT07626281
- Testing
- Inclisiran formulation containing PS80, Currently marketed inclisiran formulation
- Where
- 6 sites in United States
- Volunteers
- 152 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Primary Hypercholesterolemia, Mixed Dyslipidemia
Study to Assess In-home Use of Evolocumab (AMG 145) Using a Prefilled Syringe or a Prefilled Autoinjector/Pen
The primary objective of this study was to assess users' ability to administer a full dose of evolocumab in home-use using either a pre-filled syringe or autoinjector/pen.
- Trial name
- NCT01849497
- Testing
- Evolocumab Pre-filled Syringe, Evolocumab AI/pen
- Where
- 26 sites in United States, Canada
- Volunteers
- 149 people
- Sponsor
- Amgen
Hyperlipidemia, Glucose Metabolism Disorders
The Effect of Hypocol® on Lipids in Subjects With Mild Hypercholesterolemia and Mildly Elevated Blood Glucose
The purpose of this study is to determine to what degree Hypocol® (Red Yeast Rice) may lower low density lipoprotein (LDL)-cholesterol in a European population.
- Trial name
- NCT00114855
- Testing
- HYPOCOL®
- Where
- Norway
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Oslo University Hospital
Elevated LDL Cholesterol
Pharmacodynamic Clinical Trial of Cardiovascular Polypill on LDL Cholesterol
This study evaluates the effect on LDL cholesterol of the 3 drugs given together in the cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin, and ramipril) as compared to the effect on LDL cholesterol of…
- Trial name
- NCT01362218
- Testing
- Cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin and ramipril), Simvastatin, ramipril, acetylsalicylic acid
- Where
- Spain
- Volunteers
- 107 people
- Sponsor
- Ferrer Internacional S.A.
Hypercholesterolemia, Atherosclerotic Cardiovascular Disease
Evaluation of Long-Term Efficacy of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia at High Cardiovascular Risk
The purpose of this study is to see if bemedoic acid (ETC-1002) is effective versus placebo in patients with high cardiovascular risk and elevated LDL cholesterol not adequately controlled by their current therapy.
- Trial name
- CLEAR Wisdom (NCT02991118)
- Testing
- bempedoic acid
- Where
- 2 sites in United States
- Volunteers
- 779 people
- Sponsor
- Esperion Therapeutics, Inc.
Obesity, Hypertension
The Effects of Metformin on Blood Vessel Structure and Function
The purpose of this study is to evaluate whether the drug Metformin has beneficial effects on the blood vessels of individuals with the Metabolic Syndrome (MeS).
- Conditions
- Obesity, Hypertension, Hypercholesterolemia, Hyperglycemia
- Trial name
- NCT00105066
- Testing
- Metformin
- Where
- United States
- Volunteers
- 77 people
- Sponsor
- National Institute on Aging (NIA)
High LDL-cholesterol Levels
Red-fleshed Apple as a Novel Anthocyanin-biofortified Food to Improve Cardiometabolic Risk Factors.
The primary aim is to evaluate the added health value of the presence of anthocyanins in the redlove apple, versus a green apple with a similar matrix, on cardiometabolic risk, and compare the matrix effect on the bioavailability…
- Trial name
- AppleCor (NCT03795324)
- Testing
- Redlove Apple intervention, Green Apple intervention, Aronia drink intervention
- Where
- Spain
- Volunteers
- 120 people
- Sponsor
- University Rovira i Virgili
Acute Coronary Syndrome
Comparison of High and Moderate Intensity Statins in Achieving the Target LDL-C Level After Acute Coronary Syndrome
This study evaluates the effectiveness of high- and moderate-intensity statins in achieving target low-density lipoprotein cholesterol (LDL-C) levels in patients with acute coronary syndrome (ACS).
- Trial name
- NCT06782243
- Testing
- Moderate-Intensity Statins, High-Intensity Statins
- Where
- Pakistan
- Volunteers
- 190 people
- Sponsor
- Khyber Medical University Peshawar