Clinical trials: High Cholesterol
Hypercholesterolemia
Open Label Study of Long Term Evaluation Against LDL-C Trial
The primary clinical hypothesis is that long-term exposure of evolocumab (AMG 145) will be safe and well tolerated in adults with hypercholesterolemia.
- Trial name
- OSLER (NCT01439880)
- Testing
- Evolocumab, Standard of care
- Where
- 187 sites in United States, Australia and 16 more
- Volunteers
- 1,324 people
- Sponsor
- Amgen
Hypercholesterolemia
Study to Evaluate the Efficacy and Safety of an Every Four Weeks Treatment Regimen of Alirocumab (REGN727/ SAR236553) in Patients With Primary Hypercholesterolemia (ODYSSEY CHOICE 1)
To determine the efficacy, long-term safety, and tolerability of alirocumab 300 mg every 4 weeks (Q4W), in comparison with placebo, as well as its potential as a starting regimen.
- Trial name
- NCT01926782
- Testing
- Alirocumab, Statin
- Where
- 83 sites in United States, Bulgaria and 6 more
- Volunteers
- 803 people
- Sponsor
- Regeneron Pharmaceuticals
Hypercholesterolemia
Effect of a Treatment With a Nutraceutical Combination on Sub-optimal LDL Cholesterol Levels
High cholesterol is one of the major controllable risk factor for coronary heart disease. It is well demonstrated that drugs that reduce the intestinal absorption of cholesterol or block the synthesis of cholesterol or the…
- Trial name
- NATCOL (NCT03739242)
- Testing
- Nutraceutical combination
- Where
- Italy
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- A. Menarini Industrie Farmaceutiche Riunite S.r.l.
Amyotrophic Lateral Sclerosis
High Fat/High Calorie Trial in Amyotrophic Lateral Sclerosis
The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of long-term use of high fat/high calorie and high calorie diets in people with amyotrophic lateral sclerosis (ALS) (Lou Gehrig's…
- Trial name
- NCT00983983
- Testing
- Oxepa, Jevity 1.5, Jevity 1.0
- Where
- 13 sites in United States
- Volunteers
- 28 people
- Sponsor
- Massachusetts General Hospital
Hypercholesterolemia
Evaluating Effect of the Study Drug Praluent (Alirocumab) on Neurocognitive Function When Compared to Placebo
The main purpose of this study is to evaluate the effect on mental state (known as "neurocognitive function") with use of Praluent.
- Trial name
- NCT02957682
- Testing
- Praluent (Alirocumab)
- Where
- 188 sites in United States, Bulgaria and 7 more
- Volunteers
- 2,176 people
- Sponsor
- Regeneron Pharmaceuticals
Hypercholesterolemia
A Patient-Spouse Intervention for Self-Managing High Cholesterol
We examined the effect of a patient-spouse intervention to lower LDL-C by increasing patient treatment adherence. A randomized controlled trial compared a one-year, telephone-based patient-spouse intervention to usual care.
- Trial name
- CouPLES (NCT00321789)
- Testing
- spouse-assisted intervention
- Where
- United States
- Volunteers
- 255 people, healthy volunteers welcome
- Sponsor
- US Department of Veterans Affairs
Cardiovascular Disease
Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction - DOSE Finding Study
Evaluate the effect of olpasiran administered subcutaneously (SC) compared with placebo, on percent change from baseline in lipoprotein(a) (Lp[a]).
- Trial name
- NCT04270760
- Testing
- Olpasiran
- Where
- 36 sites in United States, Australia and 5 more
- Volunteers
- 281 people
- Sponsor
- Amgen
Homozygous Familial Hypercholesterolemia
Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia
The primary objectives of the study are: To evaluate the long-term safety and tolerability of evinacumab in patients with Homozygous Familial Hypercholesterolemia (HoFH) To evaluate the long-term safety and tolerability of…
- Trial name
- NCT03409744
- Testing
- evinacumab
- Where
- 38 sites in United States, Australia and 10 more
- Volunteers
- 116 people
- Sponsor
- Regeneron Pharmaceuticals
Metabolic Diseases, Hyperlipidemias
Safety and Efficacy Study of ISIS 301012 (Mipomersen) Administration in High Risk Statin Intolerant Subjects
The purpose of this study is to determine safety and efficacy of mipomersen (ISIS 301012) in the reduction of total cholesterol, low density lipoprotein cholesterol (LDL-C), and apolipoprotein B (apoB) in high risk subjects…
- Conditions
- Metabolic Diseases, Hyperlipidemias, Metabolic Disorder, Hypercholesterolemia
- Trial name
- ASSIST (NCT00707746)
- Testing
- mipomersen
- Where
- Netherlands
- Volunteers
- 34 people
- Sponsor
- Kastle Therapeutics, LLC
Dyslipidemias, High Cholesterol
Study to Evaluate the Effect of Obicetrapib in Combination With Ezetimibe as an Adjunct to HIS Therapy
This study will be a placebo-controlled, double-blind, randomized, phase 2 study to evaluate the efficacy, safety, and tolerability of obicetrapib 10 mg, both in combination with ezetimibe 10 mg and as monotherapy, as an adjunct…
- Conditions
- Dyslipidemias, High Cholesterol, Hypercholesterolemia
- Trial name
- ROSE2 (NCT05266586)
- Testing
- Obicetrapib, Ezetimibe 10mg
- Where
- 16 sites in United States
- Volunteers
- 119 people
- Sponsor
- NewAmsterdam Pharma
Hypercholesterolemia
Effects of Vytorin Versus Placebo in Subjects With Primary Hypercholesterolemia (Study P04420)
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase 3 study of Vytorin 10/10 (ezetimibe 10 mg with simvastatin 10 mg), Vytorin 10/20 (ezetimibe 10 mg with simvastatin 20 mg), and Vytorin…
- Trial name
- NCT00413972
- Testing
- ezetimibe with simvastatin
- Volunteers
- 392 people
- Sponsor
- Organon and Co
Hyperlipidemia
LAPLACE-TIMI 57: Low-density Lipoprotein Cholesterol (LDL-C) Assessment With PCSK9 monoclonaL Antibody Inhibition Combined With Statin thErapy
To evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab (AMG 145) administered every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on percent change from baseline in LDL-C when used in addition to a…
- Trial name
- LAPLACE (NCT01380730)
- Testing
- Evolocumab
- Where
- 100 sites in United States, Canada and 3 more
- Volunteers
- 631 people
- Sponsor
- Amgen
Subjects With Hyperlipidemia, Dyslipidemia and HIV Infection
Safety, Tolerability and Efficacy on Low Density Lipoprotein Cholesterol (LDL-C) of Evolocumab in Participants With Human Immunodeficiency Virus (HIV) and Hyperlipidemia/Mixed Dyslipidemia
The study is divided into 2 parts. The first part of the study will be double-blinded and will last for 24 weeks. During this time, participants will be randomized in a ratio of 2:1 to receive either evolocumab once monthly (QM)…
- Trial name
- NCT02833844
- Testing
- Evolocumab
- Where
- 78 sites in United States, Australia and 13 more
- Volunteers
- 467 people
- Sponsor
- Amgen
Cardiovascular Diseases, Hypercholesterolemia
Vascular Lifestyle-Intervention and Screening in Pharmacy
The overall goal of the present project is to contribute to new knowledge about the effect of a low threshold population screening system for cardiovascular risk factors in Norway.
- Conditions
- Cardiovascular Diseases, Hypercholesterolemia, Dyslipidemia, Hypertensive Disease
- Trial name
- VISA (NCT02223793)
- Testing
- Information on high risk factor levels and lifestyle advice, No information on high risk factor levels but lifestyle advice, No information on high risk factor levels, nor lifestyle advice
- Where
- Norway
- Volunteers
- 582 people, healthy volunteers welcome
- Sponsor
- University of Oslo
Primary Hypercholesterolemia, Mixed Dyslipidemia
Efficacy and Safety of Extended-Release Niacin/ Laropiprant/Simvastatin Tablets in Participants With Hypercholesterolemia or Mixed Dyslipidemia (MK-0524B-143)
This study is being done to find out if tablets containing extended release (ER) niacin, laropiprant, and simvastatin (ERN/LRPT/SIM) are as effective as tablets containing ER niacin and laropiprant taken with simvastatin tablets…
- Trial name
- NCT01335997
- Testing
- ER niacin/laropiprant (ERN/LRPT), ER niacin/laropiprant/simvastatin (ERN/LRPT/SIM), Simvastatin (SIM)
- Volunteers
- 1,139 people
- Sponsor
- Merck Sharp & Dohme LLC
Hypercholesterolemia
Comparison of Simvastatin Versus Simvastatin/Ezetimibe on Small Dense Low -Density Lipoprotein (LDL)
Both simvastatin 40 mg and simvastatin/ezetimibe 10/10 mg result in low-density lipoprotein cholesterol (LDL-C) reductions of approximately the same magnitude.
- Trial name
- NCT00932620
- Testing
- SIMVASTATIN 40 mg, SIMVASTATIN/EZETIMIBE 10/10 mg
- Where
- Greece
- Volunteers
- 100 people
- Sponsor
- University of Ioannina
Atherosclerosis, Hypercholesterolemia
Randomized Trial of Imaging Versus Risk Factor-Based Therapy for Plaque Regression
Background: Atherosclerosis (thickening of the artery walls caused by cholesterol and other deposits) commonly occurs in the heart vessels and carotid (neck) arteries of adults.
- Trial name
- NCT01212900
- Testing
- Statins, HMG CoA
- Where
- United States
- Volunteers
- 230 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Hyperlipidemias
Trial of Antroquinonol in Patients With Hypercholesterolemia and Hyperlipidemia
Identified the efficacy of Antroquinonol (Hocena 50mg) in triglyceride, lipid-lowering and fatty liver.
- Trial name
- NCT02719028
- Testing
- Antroquinonol
- Where
- 6 sites in Taiwan
- Volunteers
- 120 people
- Sponsor
- Golden Biotechnology Corporation
Hypercholesterolemia, Familial
Reduction of Low-Density Lipoprotein Cholesterol (LDL-C) With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder Study
The primary objective of this study was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145), compared with placebo, on percent change from baseline in LDL-C in adults with heterozygous familial…
- Trial name
- RUTHERFORD (NCT01375751)
- Testing
- Evolocumab
- Volunteers
- 168 people
- Sponsor
- Amgen
Hypercholesterolemia
Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-4
The primary objective of the study was to evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in…
- Trial name
- GAUSS-4 (NCT02634580)
- Testing
- Evolocumab, Ezetimibe
- Where
- 35 sites in Japan
- Volunteers
- 61 people
- Sponsor
- Amgen