Clinical trials: High Cholesterol/Hyperlipidemia
Dyslipidemias, Hypercholesterolemia
Effect On Serum Cholesterol Of Dairy Products With Addition Of Esterified Phytosterols
Hypercholesterolemia is an important risk factor for cardiovascular disease, asociated primarily with high plasma levels of LDL lipoprotein, which in turn depend on the endogenous hepatic synthesis of cholesterol and its…
- Trial name
- ACTICOL (NCT02644109)
- Testing
- Phytosterol
- Where
- 2 sites in Chile
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- University of Chile
High Cholesterol, Coronary Artery Disease
Ezetimibe in Patients Hypo-responsive to Statins
Response to statin therapy for elevated low density lipoprotein is variable and may be influenced by cholesterol absorption. This study will evaluate whether combination therapy with atorvastatin/ezetimibe will be superior to…
- Trial name
- NCT00965055
- Testing
- Ezetimibe, Atorvastatin
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- University of California, San Diego
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
Hypercholesterolemia
A Study to Evaluate the Efficacy and Safety of Enlicitide (MK-0616, Oral PCSK9 Inhibitor) Compared With Ezetimibe or Bempedoic Acid or Ezetimibe and Bempedoic Acid in Adults With Hypercholesterolemia (MK-0616-018/CORALreef AddOn)
The main purpose of this study is to assess whether enlicitide is superior to ezetimibe or bempedoic acid or ezetimibe + bempedoic acid in reducing low-density lipoprotein cholesterol (LDL-C) in participants with…
- Trial name
- NCT06450366
- Testing
- Enlicitide, Ezetimibe, Bempedoic Acid
- Where
- 35 sites in United States, Argentina and 6 more
- Volunteers
- 301 people
- Sponsor
- Merck Sharp & Dohme LLC
Hypercholesterolemia
AEGR-733 and Atorvastatin 20 mg vs. Monotherapy in Moderate Hypercholesterolemia
The purpose of this study is to test the effectiveness of the study drug, AEGR-733 alone and in combination with the medication, atorvastatin (Lipitor), on cholesterol in volunteers with moderately high cholesterol.
- Trial name
- NCT00474240
- Testing
- Atorvastatin 20 mg, AEGR-733 5 mg, AEGR-733 10 mg
- Where
- 17 sites in United States
- Volunteers
- 157 people
- Sponsor
- Aegerion Pharmaceuticals, Inc.
Hypercholesterolemia
Evaluation of Alirocumab Versus Ezetimibe on Top of Statin in Asia in High Cardiovascular Risk Patients With Hypercholesterolemia
Primary Objective: To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable maximally tolerated daily statin therapy in comparison to ezetimibe 10 mg daily after 24…
- Trial name
- ODYSSEY EAST (NCT02715726)
- Testing
- Alirocumab, ezetimibe, atorvastatin
- Where
- 62 sites in China, India and 1 more
- Volunteers
- 615 people
- Sponsor
- Sanofi
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
Hypercholesterolemia
A Study to Assess the Cholesterol Lowering Effect of an Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Patients With High Cholesterol and With High Cardiovascular Risk (0653A-809)(COMPLETED)
This is a multicenter study to evaluate the safety and efficacy of ezetimibe/simvastatin versus rosuvastatin in participants with high cholesterol.
- Trial name
- NCT00479713
- Testing
- ezetimibe (+) simvastatin, Comparator : rosuvastatin calcium
- Volunteers
- 618 people
- Sponsor
- Organon and Co
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
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, Statin-Associated Myopathy
Safety of Red Yeast Rice for High Cholesterol in Individuals With Statin Intolerance
This study will examine the effect of red yeast rice extract compared to pravastatin on muscle related complaints in individuals with high cholesterol who have previously been unable to tolerate statin medications due to muscle…
- Trial name
- NCT00639223
- Testing
- Red Yeast Rice, Pravastatin, Lifestyle modification program
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- University of Pennsylvania
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.
Homozygous Familial Hypercholesterolemia
A Study of Inclisiran in Participants With Homozygous Familial Hypercholesterolemia (HoFH)
This study was a Phase III,A two-part (double-blind placebo-controlled/open-label) multicenter study to evaluate safety, tolerability, and efficacy of inclisiran in subjects with homozygous familial hypercholesterolemia (HoFH).
- Trial name
- ORION-5 (NCT03851705)
- Testing
- Inclisiran Sodium for injection
- Where
- 13 sites in Hong Kong, Israel and 6 more
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Hypercholesterolemia
Bioavailability Study for New Atorvastatin Formulation
The purpose of this study is to estimate the relative bioavailability of the commercial tablet with one prototype extemporaneous preparation suspension formulation, to assist with internal decision making on formulation…
- Trial name
- NCT00844376
- Testing
- Atorvastatin suspension, Lipitor
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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
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
Hypertension, Angina Pectoris
Amlodipine/Atorvastatin (Caduet®) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)
In this survey, to collect the safety and efficacy information of Amlodipine /Atorvastatin (Caduet® Combination Tablets) in daily medical practice will be examined.
- Conditions
- Hypertension, Angina Pectoris, Hypercholesterolemia, Familial Hypercholesterolemia
- Trial name
- NCT01107743
- Testing
- Amlodipine/Atorvastatin
- Volunteers
- 1,291 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Hypercholesterolemia
Evaluate Safety and Efficacy of AEGR-733 and Atorvastatin vs Atorvastatin Monotherapy in Hypercholesterolemia
Evaluate the efficacy of combination therapy AEGR-733 plus atorvastatin 20 mg versus monotherapy on serum lipoproteins over 4 and 8 weeks of therapy.
- Trial name
- NCT00690443
- Testing
- Atorvastatin, AEGR-733
- Where
- 5 sites in United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Aegerion Pharmaceuticals, Inc.
Dyslipidemia
Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk
The primary objective was to evaluate the effect of treatment with evolocumab, compared with placebo, on the risk for cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary…
- Trial name
- FOURIER (NCT01764633)
- Testing
- Evolocumab
- Where
- 1,284 sites in United States, Argentina and 47 more
- Volunteers
- 27,564 people
- Sponsor
- Amgen
Hypercholesterolemia, Coronary Heart Disease
Phytosterols, Ezetimibe, and Cholesterol Metabolism
Phytosterols and ezetimibe each reduce intestinal cholesterol absorption by 30-55% but appear to have different mechanisms of action.
- Trial name
- Phyteaux-III (NCT00863265)
- Testing
- Ezetimibe, Phytosterols + ezetimibe
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Washington University School of Medicine