Clinical trials: LDL-C
Dyslipidemia
The Effect of 3-Week Consumption of Soya Beverage Enriched With Plant Sterols on Serum LDL-C
This is a local, single-center, two-arm, randomized, double-blind, placebo-controlled clinical trial that examines the LDL-C-lowering effect of the consumption of a soya beverage enriched with plant sterol for 3 weeks.
- Trial name
- NCT02881658
- Testing
- Plant sterols-enriched soya beverage provided by Vitasoy, Soya beverage provided by Vitasoy
- Where
- Hong Kong
- Volunteers
- 201 people, healthy volunteers welcome
- Sponsor
- The University of Hong Kong
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
Diabetes Mellitus, Type 2
A Study In Patients With Type 2 Diabetes Mellitus
This study evaluates the effect of medicines for type 2 diabetes and lipids control. This study will require about 6 office visits for lab tests and examinations.
- Trial name
- NCT00256867
- Testing
- GSK523338
- Where
- 85 sites in United States, Australia and 4 more
- Volunteers
- 369 people
- Sponsor
- GlaxoSmithKline
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 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
Hypercholesterolemia
(H.E.L.P.)Apheresis Therapy to Compare the Reduction of LDL (Low Density Lipoprotein) Cholesterol
The primary objective of the study is to demonstrate that the performance of the modified Plasmat® Futura H.E.L.P. Apheresis System is non-inferior to the current FDA approved Plasmat® Secura H.E.L.P Apheresis System for use…
- Trial name
- FUTURA (NCT00526058)
- Testing
- Secura then Futura, Futura then Secura
- Where
- 2 sites in United States
- Volunteers
- 18 people
- Sponsor
- B. Braun Medical Inc.
Lipoprotein Metabolism, PCSK9
Comparison of EPA and DHA-Rich Fish Oils on Lipoprotein Metabolism In Adults
Background: Metabolism is what the body does to turn food into energy. Omega-3 fatty acids are substances found in foods such as cold-water fish and shellfish that are essential for good health.
- Conditions
- Lipoprotein Metabolism, PCSK9, Proteomics
- Trial name
- NCT02514070
- Testing
- EPA-rich fish oil, DHA-rich fish oil
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Primary Hypercholesterolemia
Effects of Prescription Omega-3 on LDL-C in Primary Hypercholesterolemia
The objectives of this study are to assess the effects of 4 g/d P-OM3, compared with placebo, on LDL-C and other aspects of the fasting lipid profile in subjects with primary hypercholesterolemia.
- Trial name
- NCT00746811
- Testing
- P-OM3
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Provident Clinical Research
Diabetes Mellitus, Type 2
Dulce Digital-Me: An Adaptive mHealth Intervention for Underserved Hispanics With Diabetes
This study will compare Dulce Digital (i.e., the investigators' proven-effective combination of "one-size-fits-all" educational text messages and nurse monitoring of patient-transmitted blood glucose values) and Dulce Digital-Me…
- Trial name
- DD-Me (NCT03130699)
- Testing
- Dulce Digital, Dulce Digital-Me (Automated Delivery), Dulce Digital-Me (Medical Assistant)
- Where
- 2 sites in United States
- Volunteers
- 310 people
- Sponsor
- Scripps Whittier Diabetes Institute
Healthy Volunteers
A Study of LY3015014 in Otherwise Healthy Participants With High Low-density Lipoprotein (LDL) Cholesterol
This is a phase 1 study in otherwise healthy participants with high LDL cholesterol. Following multiple doses of LY3015014, the safety and tolerability of the drug, how the body handles the drug, and the drug's effect on the body…
- Trial name
- NCT01618916
- Testing
- LY3015014
- Where
- 2 sites in United States
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Atherosclerotic Cardiovascular Disease, Symptomatic Atherosclerosis
An Extension Trial of Inclisiran in Participants With Cardiovascular Disease and High Cholesterol
This clinical study was designed to assess the efficacy, safety, and tolerability of long-term dosing of inclisiran and evolocumab given as subcutaneous injections in participants with high cardiovascular risk and elevated…
- Conditions
- Atherosclerotic Cardiovascular Disease, Symptomatic Atherosclerosis, Type2 Diabetes, Familial Hypercholesterolemia
- Trial name
- ORION-3 (NCT03060577)
- Testing
- Inclisiran, Evolocumab
- Where
- 52 sites in United States, Canada and 3 more
- Volunteers
- 382 people
- Sponsor
- Novartis Pharmaceuticals
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
Diabetes, Diabetes Mellitus, Type 2
Bempedoic Acid + Ezetimibe Fixed-Dose Combination (FDC) Study in Patients With Type 2 Diabetes and Elevated LDL-C
12 week study to assess the LDL-C lowering efficacy, other lipid and glycemic measures, and safety of bempedoic acid/ezetimibe FDC compared to ezetimibe and placebo in patients with type 2 diabetes (T2D) and elevated LDL-C
- Conditions
- Diabetes, Diabetes Mellitus, Type 2, Cholesterolemia
- Trial name
- NCT03531905
- Testing
- Bempedoic acid + Ezetimibe FDC Oral Tablet, Ezetimibe 10 mg Oral Tablet
- Where
- 4 sites in United States
- Volunteers
- 242 people
- Sponsor
- Esperion Therapeutics, Inc.
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
Hypercholesterolemia
Open Label Study of Long Term Evaluation Against LDL-C Trial
The primary clinical hypothesis is that long-term exposure of evolocumab (AMG 145) will be safe and well tolerated in adults with hypercholesterolemia.
- Trial name
- OSLER (NCT01439880)
- Testing
- Evolocumab, Standard of care
- Where
- 187 sites in United States, Australia and 16 more
- Volunteers
- 1,324 people
- Sponsor
- Amgen
Overweight; Hyperlipidemia
Efficacy and Safety of Fermented Barley on Decrement of Body Fat in Obese Subjects
Barley, like oats, is a rich source of the soluble fibre β-glucan, which has been shown to significantly lower LDL-cholesterol (LDL-C). However, barley foods have been less widely studied.
- Trial name
- NCT01402128
- Testing
- Barley beta-glucan(3.0g)
- Where
- South Korea
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Chonbuk National University Hospital
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, Familial Hypercholesterolemia
A Clinical Trial to Assess the Long Term Safety and Tolerability of MK-0653H in Japanese Participants With Hypercholesterolemia (MK-0653H-833)
The study will assess the safety and tolerability of Ezetimibe 10 mg+ Rosuvastatin 2.5 mg and Ezetimibe 10 mg+ Rosuvastatin 5.0 mg for up to 52 weeks in Japanese participants with hypercholesterolemia uncontrolled with…
- Trial name
- NCT02748057
- Testing
- Ezetimibe, Rosuvastatin
- Volunteers
- 135 people
- Sponsor
- Organon and Co
Hyperlipidemia
Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects
The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145), compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in patients with…
- Trial name
- GAUSS (NCT01375764)
- Testing
- Evolocumab, Ezetimibe
- Where
- 42 sites in United States, Australia and 6 more
- Volunteers
- 160 people
- Sponsor
- Amgen
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