Clinical trials: Hypercholesterolemia
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
Dyslipidemia
Evaluating PCSK9 Binding antiBody Influence oN coGnitive HeAlth in High cardiovascUlar Risk Subjects
This study evaluated change over time in neurocognitive testing in patients receiving statin therapy in combination with evolocumab (AMG 145), compared with patients receiving statin therapy in combination with placebo.
- Trial name
- EBBINGHAUS (NCT02207634)
- Testing
- Evolocumab, Background Statin Therapy
- Where
- 416 sites in United States, Australia and 28 more
- Volunteers
- 1,974 people
- Sponsor
- Amgen
ASCVD, Risk Factor, Cardiovascular
Inclisiran for Subjects With ASCVD or ASCVD-Risk Equivalents and Elevated Low-density Lipoprotein Cholesterol
This is a Phase III, placebo-controlled, double-blind, randomized study in participants with ASCVD or ASCVD-Risk equivalents and elevated LDL-C despite maximum tolerated dose of LDL-C lowering therapies to evaluate the efficacy…
- Conditions
- ASCVD, Risk Factor, Cardiovascular, Elevated Cholesterol
- Trial name
- ORION-11 (NCT03400800)
- Testing
- Inclisiran Sodium
- Where
- 70 sites in Czechia, Germany and 5 more
- Volunteers
- 1,617 people
- Sponsor
- The Medicines Company
Diabetes Mellitus, Metabolic Syndrome X
Effect of Statins on Oxidative Stress and Endothelial Progenitor Cells
Thirty-six subjects with hyperlipidemia and metabolic syndrome and/or diabetes were randomized in a double-blind manner to either pravastatin 80 mg or atorvastatin 10 mg daily.
- Conditions
- Diabetes Mellitus, Metabolic Syndrome X, Hypercholesterolemia
- Trial name
- STOPCAP (NCT00166036)
- Testing
- Atorvastatin, Pravastatin
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Emory University
Hypercholesterolemia
Study of Evinacumab (REGN1500) in Participants With Persistent Hypercholesterolemia
The primary objective of the study is to evaluate the reduction of LDL-C by evinacumab in comparison to placebo after 16 weeks in patients with primary hypercholesterolemia (HeFH, or non-HeFH with a history of clinical ASCVD)…
- Trial name
- NCT03175367
- Testing
- Evinacumab, Background Lipid Modifying Therapy (LMT)
- Where
- 95 sites in United States, Australia and 18 more
- Volunteers
- 272 people
- Sponsor
- Regeneron Pharmaceuticals
Inflammation, Atherosclerosis
Anti-inflammatory Effects of Simvastatin
The purpose of this research study is to determine which of the two ingredients of Vytorin (Simvastatin or Ezetimibe) is responsible for the anti-inflammatory effects of Vytorin
- Conditions
- Inflammation, Atherosclerosis, Hypercholesterolemia
- Trial name
- NCT04638400
- Testing
- Simvastatin 40mg, Ezetimibe 10mg
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- paresh Dandona
Hypercholesteremia
A 12-Week, Phase 2 Study of Gemcabene in Hypercholesterolemia Patients on Stable Moderate and High-Intensity Statins
The purpose of this study was to assess the efficacy, safety, and tolerability of multiple doses of gemcabene 600 mg QD compared to placebo in patients with hypercholesterolemia not adequately controlled on high-intensity or…
- Trial name
- ROYAL-1 (NCT02634151)
- Testing
- Gemcabene
- Where
- 24 sites in United States
- Volunteers
- 105 people
- Sponsor
- NeuroBo Pharmaceuticals Inc.
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
Hypercholesterolemia
Study of Alirocumab (REGN727/SAR236553) in Patients With Primary Hypercholesterolemia and Moderate, High, or Very High Cardiovascular (CV) Risk, Who Are Intolerant to Statins (ODYSSEY ALTERNATIVE)
This is a randomized, double-blind, double-dummy, active-controlled, parallel-group, multi-national, multi-center study to compare alirocumab (REGN727/SAR236553) versus ezetimibe in participants with primary hypercholesterolemia…
- Trial name
- NCT01709513
- Testing
- Atorvastatin, Ezetimibe, Alirocumab
- Where
- 70 sites in United States, Austria and 6 more
- Volunteers
- 314 people
- Sponsor
- Regeneron Pharmaceuticals
Hypercholesterolemia, Heterozygous Familial Hypercholesterolemia
A Clinical Trial to Assess the Long Term Safety and Tolerability of MK-0653C in Japanese Participants With Hypercholesterolemia (MK-0653C-384)
This study will assess the safety and tolerability of Ezetimibe (EZ) 10 mg/Atorvastatin (Atora) 10 mg and EZ 10mg/Atora 20 mg fixed-dose combination (FDC) in Japanese participants with hypercholesterolemia uncontrolled with…
- Trial name
- NCT02460159
- Testing
- EZ 10 mg/Atorva 20 mg FDC, EZ 10 mg/Atorva 10 mg FDC
- Volunteers
- 135 people
- Sponsor
- Organon and Co
Triglycerides, Weight Gain Trajectory
Effects of RDX-002 on Postprandial Triglycerides in Patients Discontinuing GLP-1 Agonists
The goal of this clinical trial is to learn if drug RDX-002 works to treat high levels of fat (known as triglycerides, or TGs) in the blood in adults. It will also learn about the safety of drug RDX-002.
- Conditions
- Triglycerides, Weight Gain Trajectory, Cholesterol, Elevated
- Trial name
- NCT06640972
- Testing
- RDX-002
- Where
- United States
- Volunteers
- 68 people
- Sponsor
- Response Pharmaceuticals
Familial Hypercholesterolemia
Low-Density Lipoprotein (LDL) Apheresis Using H.E.L.P. Therapy
The objectives of this post-surveillance study are to continue to evaluate the safety and effectiveness of the H.E.L.P. System. The safety and effectiveness will be assessed by evaluating the occurrence of death, cardiovascular…
- Trial name
- Secura (NCT00916643)
- Testing
- HELP Secura (apheresis treatment)
- Volunteers
- 113 people
- Sponsor
- B. Braun Medical Inc.
Hypercholesterolemia
Actual Use Trial of Atorvastatin Calcium 10 mg
The purpose of this actual use study is to simulate the over the counter use of atorvastatin calcium 10 mg.
- Trial name
- NCT01964326
- Testing
- Atorvastatin calcium 10 mg
- Where
- 37 sites in United States
- Volunteers
- 1,311 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Hypercholesterolemia
A Study to Determine the Number of Patients Who Reach Optimal Cholesterol Levels on Each of Three Different Treatments (0653A-121)
To evaluate the percentage of patients with either established cardiovascular disease (CVD), at "high risk" of developing CVD or with diabetes who are on simvastatin 40mg, with fasting LDL-C > 2mmol/l, who are able to attain the…
- Trial name
- NCT00462748
- Testing
- ezetimibe (+) simvastatin, Comparator: atorvastatin, Comparator: rosuvastatin
- Volunteers
- 786 people
- Sponsor
- Organon and Co
Hypercholesterolemia, Dyslipidemias
Dose-ranging Efficacy and Pharmacokinetics Study of Intravenous Atorvastatin in Hypercholesterolemic Patients
Open-label study will titrate doses of intravenous atorvastatin and monitor respective LDL-C levels in hypercholesterolemic patients previously controlled on oral atorvastatin.
- Trial name
- NCT03611010
- Testing
- Atorvastatin injection
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Cumberland Pharmaceuticals
Hypercholesterolemia, Familial
Carotid IMT (Intima Media Thickening) Study (0524A-041)(TERMINATED)
This is a 105-week clinical study in patients with heterozygous familial hypercholesterolemia on intensive Low Density Lipoprotein-cholesterol (LDL-C) lowering therapy intended to assess the affects of MK0524A on carotid intima…
- Trial name
- ACHIEVE (NCT00384293)
- Testing
- Comparator: niacin (+) laropiprant (MK0524A)
- Volunteers
- 937 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Hypercholesterolemia
Bioequivalence Study Comparing A New 80 Mg Atorvastatin Tablet To A 80 Mg Atorvastatin Commercial Tablet
To determine whether new 80 mg atorvastatin tablets are bioequivalent to 80 mg commercial atorvastatin tablets (Lipitor®).
- Trial name
- NCT00917644
- Testing
- Atorvastatin
- Where
- United States
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Hypercholesterolemia
Comparison of the Effect of Vytorin 10/80 Tablet Split Into 4 and Simvastatin 20 Milligrams on Low-density Lipoprotein (LDL) Cholesterol
The purpose of this study is to compare the efficacy of a Vytorin 10/80 tablet, an approved agent for the treatment of elevated LDL cholesterol which combines the cholesterol absorption inhibitor Ezetimibe 10 mg and simvastatin…
- Trial name
- NCT00762164
- Testing
- Vytorin, Simvastatin
- Where
- United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Bronx VA Medical Center
Hypercholesterolemia, Familial Hypercholesterolemia
A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Heterozygous Familial Hypercholesterolemia (MK-0616-017/CORALreef HeFH)
The goal of this study is to evaluate the efficacy, safety, and tolerability of enlicitide decanoate in adult participants with heterozygous familial hypercholesterolemia.
- Trial name
- NCT05952869
- Testing
- Enlicitide Decanoate
- Where
- 59 sites in United States, Australia and 15 more
- Volunteers
- 303 people
- Sponsor
- Merck Sharp & Dohme LLC
Familial Hypercholesterolemia
Atorvastatin Three Year Pediatric Study
The purpose of this study is to characterize three year descriptive growth and development (ie, height, weight, body mass index, Tanner Stage) and efficacy of cholesterol reduction in pediatric subjects with Heterozygous Familial…
- Trial name
- NCT00827606
- Testing
- atorvastatin
- Where
- 40 sites in United States, Belgium and 13 more
- Volunteers
- 272 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.