Clinical trials: Cholesterol
Lysosomal Acid Lipase Deficiency, Wolman Disease
Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Sebelipase Alfa in Children With Growth Failure Due to Lysosomal Acid Lipase Deficiency
This was an open-label, repeat-dose, intra-participant dose-escalation study of SBC-102 (sebelipase alfa) in children with growth failure due to lysosomal acid lipase (LAL) Deficiency.
- Trial name
- NCT01371825
- Testing
- Sebelipase alfa (SBC-102)
- Where
- 7 sites in United States, Egypt and 3 more
- Volunteers
- 9 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Hypercholesterolemia
A Study to Evaluate the Effects of Ezetimibe (MK-0653) on the Postprandial (Following a Meal) Lipoprotein Response in Participants With Primary Hypercholesterolemia (High Cholesterol) (MK-0653-072)(COMPLETED)
A study to evaluate the cholesterol-lowering effects of ezetimibe in participants with primary hypercholesterolemia (high cholesterol) after eating a meal that is high in cholesterol.
- Trial name
- NCT00101439
- Testing
- ezetimibe
- Volunteers
- 58 people
- Sponsor
- Organon and Co
Hypercholesterolemia
Evolocumab Compared to LDL-C Apheresis in Patients Receiving LDL-C Apheresis Prior to Study Enrollment
To evaluate the efficacy of subcutaneous (SC) evolocumab, compared to regularly scheduled low-density lipoprotein cholesterol (LDL-C) apheresis, on reducing the need for future apheresis.
- Trial name
- NCT02585895
- Testing
- Evolocumab, Low-density Lipoprotein Cholesterol (LDL-C) Apheresis
- Where
- 17 sites in United States, Australia and 6 more
- Volunteers
- 39 people
- Sponsor
- Amgen
Atherosclerotic Cardiovascular Disease
A Research Study Looking at How NNC0385-0434 Tablets Work to Lower Blood Cholesterol in People With Heart Disease or a High Risk of Heart Disease
This study looks at how well a new medicine, NNC0385-0434, works to lower blood cholesterol levels. Participants will either get NNC0385-0434 as a tablet (a potential new medicine), or placebo as a tablet (a dummy medicine that…
- Trial name
- NCT04992065
- Testing
- NNC0385-0434 A 15 mg, NNC0385-0434 A 40 mg, NNC0385-0434 A 100 mg
- Where
- 44 sites in United States, Belgium and 5 more
- Volunteers
- 267 people
- Sponsor
- Novo Nordisk A/S
Familial Hypercholesterolemia - Heterozygous
Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Heterozygous Familial Hypercholesterolemia
This was a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in adolescents with heterozygous familial hypercholesterolemia (HeFH) and elevated low density lipoprotein cholesterol…
- Trial name
- ORION-16 (NCT04652726)
- Testing
- Inclisiran
- Where
- 59 sites in United States, Argentina and 24 more
- Volunteers
- 141 people
- Sponsor
- Novartis Pharmaceuticals
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
Lysosomal Acid Lipase Deficiency
Safety and Efficacy Study of Sebelipase Alfa in Participants With Lysosomal Acid Lipase Deficiency
This study evaluated the safety and efficacy of sebelipase alfa in a broad population of participants with lysosomal acid lipase deficiency (LAL-D).
- Trial name
- NCT02112994
- Testing
- Sebelipase Alfa
- Where
- 19 sites in United States, Australia and 13 more
- Volunteers
- 31 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Hypercholesterolemia, Dyslipidemia
A Multiple Dose Study Of PF-04950615 (RN316) In Subjects On Maximum Doses Of Statins
PF-04950615 is a new investigational hypercholesterolemic agent that is being tested in this study to evaluate if it can lower LDL cholesterol.
- Trial name
- NCT01350141
- Testing
- PF-04950615 (RN316)
- Where
- 35 sites in United States, Canada
- Volunteers
- 46 people
- Sponsor
- Pfizer
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.
Dyslipidemias, High Cholesterol
Randomized Study to Evaluate the Effect of Obicetrapib on Top of Maximum Tolerated Lipid-Modifying Therapies
This study will be a placebo-controlled, double-blind, randomized, phase 3 study in participants with underlying heterozygous familial hypercholesterolemia (HeFH) and/or ASCVD to evaluate the efficacy, safety, and tolerability of…
- Conditions
- Dyslipidemias, High Cholesterol, Hypercholesterolemia, Familial Hypercholesterolemia
- Trial name
- BROADWAY (NCT05142722)
- Testing
- Obicetrapib
- Where
- 181 sites in United States, China and 6 more
- Volunteers
- 2,530 people
- Sponsor
- NewAmsterdam Pharma
Hyperlipidemia and Mixed Dyslipidemia
Open-label Extension Study of Evolocumab (AMG 145) in Adults With Hyperlipidemia and Mixed Dyslipidemia
This study will contribute to the evaluation of long-term safety, tolerability and efficacy of evolocumab (AMG 145) in adults with hyperlipidemia and adults with mixed dyslipidemia.
- Trial name
- OSLER-2 (NCT01854918)
- Testing
- Evolocumab, Standard of Care
- Where
- 363 sites in United States, Australia and 23 more
- Volunteers
- 3,681 people
- Sponsor
- Amgen
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
Infection, Human Immunodeficiency Virus I, HIV-1 Infection
HIV-1 Infection Study of Once a Day Versus Twice a Day Protease Inhibitor in Antiretroviral Treatment Naive Adults
This is a Phase IIIB, 48 Week, multicentre, randomized, open-label, parallel group study comparing the safety and efficacy of fosamprenavir plus ritonavir 1400mg/100mg once-daily to fosamprenavir plus ritonavir 700mg/100mg…
- Trial name
- NCT00450580
- Testing
- fosamprenavir/ritonavir
- Where
- 69 sites in Belgium, France and 7 more
- Volunteers
- 212 people
- Sponsor
- ViiV Healthcare
Hypercholesterolemia, Heterozygous Familial
A Study of the Safety and Efficacy of Two Different Regimens of Mipomersen in Patients With Familial Hypercholesterolemia and Inadequately Controlled Low-Density Lipoprotein Cholesterol
Primary objective: Determine whether mipomersen (ISIS 301012) significantly reduces atherogenic lipid levels in patients with severe heterozygous familial hypercholesterolemia (severe HeFH), defined as low-density lipoprotein…
- Trial name
- FOCUS FH (NCT01475825)
- Testing
- mipomersen sodium 200 mg, mipomersen sodium 70 mg
- Where
- 113 sites in United States, Argentina and 28 more
- Volunteers
- 309 people
- Sponsor
- Kastle Therapeutics, LLC
Lysosomal Acid Lipase Deficiency
Acid Lipase Replacement Investigating Safety and Efficacy (ARISE) in Participants With Lysosomal Acid Lipase Deficiency
This Phase 3 study evaluated the efficacy and safety of 1 milligram/kilogram (mg/kg) intravenous (IV) infusions of SBC-102 (sebelipase alfa) administered every other week (qow) in participants with late onset lysosomal acid…
- Trial name
- ARISE (NCT01757184)
- Testing
- Sebelipase Alfa
- Where
- 40 sites in United States, Argentina and 13 more
- Volunteers
- 66 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Hyperlipidemia
Monoclonal Antibody Against PCSK9 to Reduce Elevated Low-density Lipoprotein Cholesterol (LDL-C) in Adults Currently Not Receiving Drug Therapy for Easing Lipid Levels
The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145) every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on the percent change from baseline in LDL-C when used as…
- Trial name
- MENDEL (NCT01375777)
- Testing
- Evolocumab, Ezetimibe
- Where
- 58 sites in United States, Australia and 3 more
- Volunteers
- 411 people
- Sponsor
- Amgen
Hyperlipidemias, Hypertension
The Effect of Farlong® NotoGinseng™ (Ginseng Plus®) on Cholesterol and Blood Pressure
In this randomized, placebo-controlled, double-blind parallel study in human participants with elevated LDL-C and elevated BP described here, the clinical benefits of Farlong NotoGinseng™ (Farlong Ginseng Plus® Panax Notoginseng…
- Trial name
- NCT04069715
- Testing
- Farlong NotoGinseng™ (Farlong Ginseng Plus® Panax Notoginseng extract)
- Volunteers
- 95 people, healthy volunteers welcome
- Sponsor
- LongStar HealthPro, Inc. DBA Farlong Pharmaceutical
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.
Dyslipidemia
Effect of Plant Sterols Esterified to Fish Oil Fatty Acids on Plasma Lipid Levels
The purpose of this study is to determine whether plant sterols esterified to fish oil fatty acids in a fish oil matrix improve the lipid profile, predominantly LDL-cholesterol and TG concentrations in healthy hyperlipidemic…
- Trial name
- NCT00441480
- Testing
- Plant sterols esters
- Where
- Israel
- Volunteers
- 91 people, healthy volunteers welcome
- Sponsor
- Enzymotec
Dyslipidemia
A Study to Assess the Efficacy, Safety and Tolerability of Different Doses of AZD0780 in Patients With Dyslipidemia
The primary purpose of this study is to measure the effect of different daily doses of AZD0780 on Low-Density Lipoprotein (LDL-C) levels compared with placebo in participants with dyslipidemia.
- Trial name
- PURSUIT (NCT06173570)
- Testing
- AZD0780
- Where
- 55 sites in United States, Canada and 6 more
- Volunteers
- 428 people
- Sponsor
- AstraZeneca