Clinical trials: Hypercholesterolemia
Hypercholesterolemia, Mixed Dyslipidemia
Evaluation of Evolocumab (AMG 145) Efficacy in Diabetic Adults With Hypercholesterolemia/Mixed Dyslipidemia
The purpose of this study is to evaluate the effect of 12 weeks of subcutaneous evolocumab taken monthly compared with subcutaneous placebo taken monthly on low density lipoprotein cholesterol (LDL-C) in adults with type 2…
- Conditions
- Hypercholesterolemia, Mixed Dyslipidemia, Type 2 Diabetes
- Trial name
- BANTING (NCT02739984)
- Testing
- Evolocumab
- Where
- 66 sites in United States, Belgium and 5 more
- Volunteers
- 424 people
- Sponsor
- Amgen
Hypercholesterolemia
A Study of the Efficacy and Safety of ETC-1002 in Participants With Statin Intolerance
This study will assess the Low-Density Lipoprotein-Cholesterol (LDL-C) lowering efficacy and safety of ETC-1002 versus placebo in participants with hypercholesterolemia and a history of statin intolerance.
- Trial name
- NCT01751984
- Testing
- ETC-1002
- Where
- 5 sites in United States
- Volunteers
- 56 people
- Sponsor
- Esperion Therapeutics, Inc.
Diabetes Mellitus, Insulin-Dependent, Hypercholesterolemia
Statins in Children With Type 1 Diabetes and Hypercholesterolemia
Children with type1 diabetes (T1DM) have increased risk for cardiovascular disease (CVD) due to chronic increase in the blood sugars and inflammation.
- Trial name
- NCT01236365
- Testing
- Atorvastatin
- Where
- 5 sites in United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Nemours Children's Clinic
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
Atherosclerosis, Cardiovascular Diseases
Action to Control Cardiovascular Risk in Diabetes (ACCORD)
The purpose of this study is to prevent major cardiovascular events (heart attack, stroke, or cardiovascular death) in adults with type 2 diabetes mellitus using intensive glycemic control, intensive blood pressure control, and…
- Conditions
- Atherosclerosis, Cardiovascular Diseases, Hypercholesterolemia, Hypertension
- Trial name
- ACCORD (NCT00000620)
- Testing
- Anti-hyperglycemic Agents, Anti-hypertensive Agents
- Where
- 7 sites in United States, Canada
- Volunteers
- 10,251 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Heterozygous Familial Hypercholesterolemia
Study of Alirocumab (REGN727/SAR236553) in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) Undergoing Low-density Lipoprotein (LDL) Apheresis Therapy
The primary objective of the study is to evaluate the effect of alirocumab 150 mg every 2 weeks (Q2W) in comparison with placebo on the frequency of low-density lipoprotein (LDL) apheresis treatments in participants with…
- Trial name
- ODYSSEY ESCAPE (NCT02326220)
- Testing
- Alirocumab
- Where
- 13 sites in United States, Germany
- Volunteers
- 62 people
- Sponsor
- Regeneron Pharmaceuticals
Hyperlipidemias
Effect of Rice Bran and Cooked Navy Beans on Cholesterol Levels in Healthy Children
A multidisciplinary team of clinicians and researchers will conduct a pilot feasibility study to evaluate whether dietary intake of dry bean powder or rice bran or a combination is a helpful dietary recommendation to reduce total…
- Trial name
- NCT01911390
- Testing
- Bean powder, Rice bran, Control arm
- Where
- 2 sites in United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Poudre Valley Health System
Homozygous Familial Hypercholesterolemia (HoFH)
A Study to Evaluate the Efficacy and Safety of Rosuvastatin in Children and Adolescents With Homozygous Familial Hypercholesterolemia
The purpose of the study is to establish the efficacy, safety and tolerability of rosuvastatin in children and adolescents with homozygous familial hypercholesterolemia.
- Trial name
- HYDRA (NCT02226198)
- Testing
- Rosuvastatin 20mg
- Where
- 9 sites in Belgium, Canada and 5 more
- Volunteers
- 20 people
- Sponsor
- AstraZeneca
Hypercholesterolemia
Efficacy and Safety Evaluation of Alirocumab in Patients With Heterozygous Familial Hypercholesterolemia or High Cardiovascular Risk Patients With Hypercholesterolemia on Lipid Modifying Therapy (ODYSSEY JAPAN)
Primary Objective: To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable daily statin therapy with or without other lipid modifying therapy in comparison with…
- Trial name
- NCT02107898
- Testing
- Alirocumab, Lipid-Modifying Therapy (LMT)
- Where
- 32 sites in Japan
- Volunteers
- 216 people
- Sponsor
- Sanofi
Hypercholesterolemia
Ezetimibe Plus (+) Simvastatin Versus Atorvastatin Comparative Study (0653A-092)(COMPLETED)
This is an efficacy and safety study of Vytorin (ezetimibe (+) simvastatin) compared to atorvastatin (ezetimibe/simvastatin) at week 6 in primary hypercholesterolemia patients in Korea.
- Trial name
- NCT00166504
- Testing
- ezetimibe (+) simvastatin, atorvastatin
- Volunteers
- 203 people
- Sponsor
- Organon and Co
Hyperlipidemia
Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-3
The primary objective of this study was to evaluate the effect of 24 weeks of evolocumab administered subcutaneously (SC) every month, compared with ezetimibe, on low-density lipoprotein cholesterol (LDL-C) levels in adults with…
- Trial name
- GAUSS-3 (NCT01984424)
- Testing
- Atorvastatin, Ezetimibe
- Where
- 58 sites in United States, Australia and 11 more
- Volunteers
- 511 people
- Sponsor
- Amgen
Hypercholesterolemia
Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) When Co-administered With High Dose of Atorvastatin in Patients With Primary Hypercholesterolemia
Primary Objective: To evaluate the effect of alirocumab (SAR236553/REGN727) on low-density lipoprotein cholesterol (LDL-C) levels compared with placebo when co-administered with 80 mg of atorvastatin after 8 weeks of treatment in…
- Trial name
- NCT01288469
- Testing
- Alirocumab, Atorvastatin
- Where
- 20 sites in United States
- Volunteers
- 92 people
- Sponsor
- Sanofi
Hypercholesterolemia
Effects of Ezetimibe on the Absorption of Oxidized Cholesterol
The purpose of this study is to test the effects of Zetia™ (ezetimibe) 10 milligrams (mg) on the absorption of oxysterol into the blood following a meal containing oxysterol.
- Trial name
- NCT00794677
- Testing
- ezetimibe
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- UCSF Benioff Children's Hospital Oakland
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
Hyperlipoproteinemia Type II, Hypercholesterolemia, Familial
Study to Assess the Tolerability and Efficacy of Anacetrapib (MK-0859) Co-Administered With Statin in Participants With Heterozygous Familial Hypercholesterolemia (MK-0859-020)
The objective of this study is to evaluate the efficacy and tolerability of adding anacetrapib to ongoing statin therapy in participants with heterozygous familial hypercholesterolemia (HeFH).
- Trial name
- REALIZE (NCT01524289)
- Testing
- Anacetrapib
- Volunteers
- 306 people
- Sponsor
- Merck Sharp & Dohme LLC
Hypercholesterolemia
Cholesterol Medication Packaging Study
The purpose of the overall study is to improve medication use rates among veterans by looking at the risk factors of low-density lipoprotein cholesterol (LDL).
- Trial name
- MWV_CAPS (NCT01744977)
- Testing
- packaging
- Where
- 2 sites in United States
- Volunteers
- 240 people
- Sponsor
- Durham VA Medical Center
Hypercholesterolemia, Diabetes Mellitus, Type 2
Ezetimibe and Simvastatin in Primary Hypercholesterolemia, Diabetes Mellitus Type 2, and Coronary Heart Disease (COMPLETED)
This multicenter, randomized, double-blind, placebo-controlled study will assess, after 6 weeks of dosing, whether co-administration of ezetimibe 10 mg with simvastatin 20 mg will be more effective than treatment with doubling…
- Conditions
- Hypercholesterolemia, Diabetes Mellitus, Type 2, Coronary Disease
- Trial name
- NCT00423488
- Testing
- Ezetimibe 10 mg, Simvastatin 20 mg
- Volunteers
- 93 people
- Sponsor
- Organon and Co
Hypercholesterolemia
A Study to Evaluate the Effectiveness of Ezetimibe/Atorvastatin 10 mg/40 mg Combination Tablet Compared to Marketed Ezetimibe 10 mg and Atorvastatin 40 mg Tablets in Participants With High Cholesterol (MK-0653C-190 AM1)
The purpose of this study is to determine whether ezetimibe/atorvastatin 10 mg/40 mg combination tablet is equivalent to the coadministration of ezetimibe 10 mg and atorvastatin 40 mg in lowering…
- Trial name
- NCT01370603
- Testing
- Atorvastatin, Ezetimibe, Ezetimibe/atorvastatin
- Volunteers
- 328 people
- Sponsor
- Organon and Co
Type 2 Diabetes Mellitus, Hypercholesterolemia
Effects of Metformin Hydrochloride (HCl) in Combination With Colesevelam HCl, Compared to Metformin HCl Alone, in Patients With Type 2 Diabetes Mellitus and the Effects of Colesevelam HCl on Lipids and Glucose on Pre-diabetic Patients.
This is a 16-week double-blind, placebo-controlled (for colesevelam hydrochloride (HCl)) study in the type 2 diabetic subjects and pre-diabetic subjects.
- Conditions
- Type 2 Diabetes Mellitus, Hypercholesterolemia, Pre-diabetes
- Trial name
- NCT00570739
- Testing
- Metformin HCl tablets and Colesevelam tablets, Colesevelam
- Where
- 31 sites in United States, Colombia and 2 more
- Volunteers
- 502 people
- Sponsor
- Daiichi Sankyo
Hypercholesterolaemia
Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Renal Impairment Study (MK-0616-020)
The primary objective of the study is to compare the plasma pharmacokinetics (PK) of enlicitide decanoate following a single 20 mg dose in participants on a background of statin therapy with varying degrees of renal impairment…
- Trial name
- NCT05934292
- Testing
- Enlicitide Decanoate
- Where
- 5 sites in United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC