Clinical trials: Elevated Cholesterol
Hypercholesterolemia
Efficacy and Safety of Alirocumab in Patients With Hypercholesterolemia Not Adequately Controlled With Non-statin Lipid Modifying Therapy or the Lowest Strength of Statin
Primary Objective: To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab administration as add-on therapy to non-statin lipid modifying therapy (LMT) including diet therapy alone or the lowest…
- Trial name
- ODYSSEY-NIPPON (NCT02584504)
- Testing
- Alirocumab, Atorvastatin, Non-statin Lipid-Modifying Therapy
- Where
- 30 sites in Japan
- Volunteers
- 163 people
- Sponsor
- Sanofi
High Triglycerides, Hypercholesterolemia
Omega-3 Fatty Acids (Lovaza) for Second Generation Antipsychotic-Associated Hypertriglyceridemia
This is an open-label pilot study of omega-3 fatty acids (Lovaza) for hypertriglyceridemia in subjects who have been on an atypical (second-generation) antipsychotic medication.
- Conditions
- High Triglycerides, Hypercholesterolemia, Schizophrenia, Schizoaffective Disorder
- Trial name
- NCT00833976
- Testing
- Lovaza
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- Massachusetts General Hospital
Hypercholesterolemia
Ezetimibe/Simvastatin (10 mg/40 mg) vs. the Doubling of Atorvastatin in High Risk Participants (MK-0653A-134 AM1)(COMPLETED)
Participants currently taking atorvastatin 20 mg will be switched to either atorvastatin 40 mg or ezetimibe/simvastatin 10 mg/40 mg (10/40).
- Trial name
- NCT00782184
- Testing
- ezetimibe/simvastatin 10/40, atorvastatin 40 mg, atorvastatin 20 mg
- Volunteers
- 250 people
- Sponsor
- Organon and Co
Hypercholesterolemia, Dyslipidemias
Study of Pitavastatin in Elderly Patients With Primary Hypercholesterolemia or Combined Dyslipidemia
This is an open-label extension study of NK-104-306 (NCT00257686) for elderly patients with hypercholesterolemia or combined dyslipidemia.
- Trial name
- NCT00330876
- Testing
- Pitavastatin
- Where
- 59 sites in Denmark, Germany and 3 more
- Volunteers
- 545 people
- Sponsor
- Kowa Research Europe
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
Hypercholesterolemia
Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe in Patients With Hypercholesterolemia
Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9).
- Trial name
- ODYSSEY MONO (NCT01644474)
- Testing
- Alirocumab, Ezetimibe
- Where
- 8 sites in United States, Belgium and 2 more
- Volunteers
- 103 people
- Sponsor
- Sanofi
Type IIa and IIb Hypercholesterolaemia
Evaluation of the Efficacy and Safety of Rosuvastatin 5 mg Versus Pravastatin 40 mg and Atorvastatin 10 mg in Type IIa and IIb Hypercholesterolaemic Patients
The purpose of this study is to evaluate the efficacy and safety of Rosuvastatin 5 mg as an hypercholesterolemia treatment comparatively at 2 other statins: Pravastatin 40 mg and Atorvastatin 10 mg.
- Trial name
- CAP-Chol (NCT00631189)
- Testing
- Rosuvastatin, Pravastatin, Atorvastatin
- Where
- 170 sites in France
- Volunteers
- 668 people
- Sponsor
- AstraZeneca
Hypercholesterolemia
A Clinical Study in Children With Heterozygous Familial Hypercholesterolemia (HeFH) Aged 6 to 17 Treated Once Daily With Bempedoic Acid Oral Dosing (CLEAR Path 1)
Multiple-dose study to measure pharmacokinetics, pharmacodynamics and safety of bempedoic acid in pediatric participants 6 to 17 years of age with HeFH.
- Trial name
- CLEAR Path 1 (NCT05694260)
- Testing
- Bempedoic acid
- Where
- 24 sites in United States, Canada and 4 more
- Volunteers
- 31 people
- Sponsor
- Esperion Therapeutics, Inc.
Hypercholesterolemia, Familial, Heterozygous Familial Hypercholesterolemia
A Study of Extended-release (ER) Niacin/Laropiprant in Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0524A-158)
The purpose of this study is to determine the pharmacokinetics of laropiprant following administration of a single dose of 1 (Panel A) and 2 (Panel B) combination tablets of MK-0524A in adolescents with heterozygous familial…
- Trial name
- NCT01583647
- Testing
- MK-0524A
- Volunteers
- 10 people
- Sponsor
- Merck Sharp & Dohme LLC
High Cholesterol
Technology-Assisted Cholesterol Trial in Consumers (TACTiC)
The purpose of this AUS is to evaluate the extent to which participants can safely and effectively self-select, purchase, and use Crestor OTC 5 mg for a 6-month period according to the label.
- Trial name
- TACTiC (NCT04964544)
- Testing
- 5 mg rosuvastatin calcium with a Web App (combination product)
- Where
- United States
- Volunteers
- 1,196 people
- Sponsor
- AstraZeneca
Hypercholesterolemia
Open-label Extension (OLE) Study to Assess Safety and Efficacy of Evolocumab
The purpose of this study was to characterize the safety and tolerability of long-term administration of evolocumab in adults with known coronary artery disease and hypercholesterolemia.
- Trial name
- NCT02304484
- Testing
- Evolocumab
- Where
- 126 sites in United States, Argentina and 27 more
- Volunteers
- 770 people
- Sponsor
- Amgen
Elevated LDL Cholesterol
A Pharmacodynamic Study to Evaluate the Effect of a Fixed Dose Combination Pill on Low Density Lipoprotein (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
- NCT01004705
- Testing
- Cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin and ramipril),, Simvastatin
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Ferrer Internacional S.A.
Dyslipidemia
Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk Open-label Extension
The primary clinical hypothesis is that long-term exposure of evolocumab will be safe and well tolerated in subjects with clinically evident atherosclerotic cardiovascular disease (CVD).
- Trial name
- FOURIER OLE (NCT02867813)
- Testing
- Evolocumab
- Where
- 198 sites in United States, Czechia and 5 more
- Volunteers
- 5,035 people
- Sponsor
- Amgen
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
Study in Participants With Homozygous Familial Hypercholesterolemia (HoFH)
The primary objective of the study is to demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) with alirocumab subcutaneous (SC) every 2 weeks (Q2W) in comparison to placebo after 12 weeks of treatment.
- Trial name
- ODYSSEY HoFH (NCT03156621)
- Testing
- Alirocumab
- Where
- 28 sites in United States, Austria and 11 more
- Volunteers
- 69 people
- Sponsor
- Regeneron Pharmaceuticals
Hypercholesterolemia, Atherosclerotic Cardiovascular Disease
Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia and Statin Intolerant
The purpose of this study is to determine if bempedoic acid (ETC-1002) is effective and safe versus placebo in patients with elevated LDL cholesterol and who are statin-intolerant.
- Conditions
- Hypercholesterolemia, Atherosclerotic Cardiovascular Disease, Statin Adverse Reaction
- Trial name
- CLEAR Serenity (NCT02988115)
- Testing
- bempedoic acid
- Where
- 67 sites in United States, Canada
- Volunteers
- 345 people
- Sponsor
- Esperion Therapeutics, Inc.
Hypercholesterolemia
A Dose-finding Trial of ETC-1002(Bempedoic Acid) in Patients With Hypercholesterolemia
The purpose of this study is to assess the low-density lipoprotein cholesterol (LDL-C)-lowering efficacy and safety of ETC-1002(bempedoic acid) 60 mg, 120 mg and 180 mg versus placebo added to ongoing stable statin therapy or…
- Trial name
- NCT04784442
- Testing
- 180mg of ETC-1002(bempedoic acid), 120mg of ETC-1002(bempedoic acid), 60mg of ETC-1002(bempedoic acid)
- Where
- Japan
- Volunteers
- 188 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
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
Hypercholesterolemia and High Risk for Cardiovascular Events
A Study to Evaluate Tolerability and Efficacy of Evolocumab (AMG 145) in Japanese Subjects
The primary objective is to evaluate the effect of 12 weeks of subcutaneous evolocumab every 2 weeks or every 4 weeks, compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) when…
- Trial name
- AMG145 (NCT01652703)
- Testing
- Evolocumab
- Where
- 42 sites in Japan
- Volunteers
- 310 people
- Sponsor
- Amgen
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