Clinical trials: Hypercholesterolaemia
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
Dyslipidemias, High Cholesterol
Study to Evaluate the Effect of Obicetrapib in Combination With Ezetimibe as an Adjunct to HIS Therapy
This study will be a placebo-controlled, double-blind, randomized, phase 2 study to evaluate the efficacy, safety, and tolerability of obicetrapib 10 mg, both in combination with ezetimibe 10 mg and as monotherapy, as an adjunct…
- Conditions
- Dyslipidemias, High Cholesterol, Hypercholesterolemia
- Trial name
- ROSE2 (NCT05266586)
- Testing
- Obicetrapib, Ezetimibe 10mg
- Where
- 16 sites in United States
- Volunteers
- 119 people
- Sponsor
- NewAmsterdam Pharma
Hypercholesteremia
Efficacy and Safety of Gemcabene in Patients With Homozygous Familial Hypercholesterolemia on Stable, Lipid-Lowering Therapy (COBALT-1)
The purpose of this study was to assess the efficacy, safety, and tolerability of multiple doses of Gemcabene in patients with HoFH on stable, lipid-lowering therapy.
- Trial name
- NCT02722408
- Testing
- Gemcabene
- Where
- 7 sites in United States, Canada and 1 more
- Volunteers
- 8 people
- Sponsor
- NeuroBo Pharmaceuticals Inc.
Dyslipidemias, High Cholesterol
Randomized Study of Obicetrapib in Combination With Ezetimibe
This study will be a placebo-controlled, double-blind, randomized, phase 2 study in participants with mild dyslipidemia to evaluate the efficacy, safety, and tolerability of obicetrapib and ezetimibe combination therapy.
- Conditions
- Dyslipidemias, High Cholesterol, Hypercholesterolemia
- Trial name
- OCEAN (NCT04770389)
- Testing
- Obicetrapib 5mg, Ezetimibe 10mg
- Where
- 9 sites in United States, Netherlands
- Volunteers
- 112 people
- Sponsor
- NewAmsterdam Pharma
Hypercholesterolemia
A Study to Evaluate the Effects of Extended Release (ER) Niacin/Laropiprant, Laropiprant, ER Niacin, and Placebo on Urinary Prostanoid Metabolites in Subjects With High Cholesterol (0524A-075)(COMPLETED)
The purpose of this study is to evaluate the potential effects of ER niacin/laropiprant, ER niacin, laropiprant, and placebo over the course of seven days on urinary levels of a metabolite of thromboxane A2 (TxA2), as a marker of…
- Trial name
- NCT00769132
- Testing
- Comparator: niacin + laropiprant, Comparator: niacin, Comparator: laropiprant
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Hypercholesterolemia, Atherosclerotic Cardiovascular Diseases
Evaluation of Long-Term Safety and Tolerability of ETC-1002 in High-Risk Patients With Hyperlipidemia and High CV Risk (CLEAR Harmony)
The purpose of this study is to see if ETC-1002 (bempedoic acid) is safe and well-tolerated versus placebo in patients with high cardiovascular risk and elevated LDL cholesterol that is not adequately controlled by their current…
- Trial name
- NCT02666664
- Testing
- ETC-1002
- Where
- 104 sites in United States, Canada and 4 more
- Volunteers
- 2,230 people
- Sponsor
- Esperion Therapeutics, Inc.
Hypercholesterolemia With Concomitant Type 2 Diabetes
LIpid Lowering With Highly Potent Statins in Hyperlipidaemia With Type 2 Diabetes patiENts
The purpose of this study is to compare the effect of rosuvastatin and atorvastatin on lipid lowering effect and glucose metabolism in hypercholesterolemia patients with diabetes mellitus.
- Trial name
- LISTEN (NCT01544309)
- Testing
- Atorvastatin, Rosuvastatin
- Where
- 133 sites in Japan
- Volunteers
- 1,049 people
- Sponsor
- Listen Trial Group
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
Obesity, Hypercholesterolemia
Feasibility and Acceptability of a Beverage Intervention for Hispanic Adults
This study aims to 1) assess the feasibility and acceptability of a prescribed beverage intervention in 50 obese Hispanic adults ages 18-64 years over 6 weeks; and 2) assess preliminary effects of the beverage intervention on…
- Conditions
- Obesity, Hypercholesterolemia, Hyperglycemia, Hypertriglyceridemia
- Trial name
- NCT02911753
- Testing
- Mediterranean Lemonade, Green Tea, Flavored Water
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- University of Arizona
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
Homozygous Familial Hypercholesterolemia
Study of REGN1500 in Participants With Homozygous Familial Hypercholesterolemia (HoFH)
This is an open-label, single-arm study to assess the reduction of low-density lipoprotein cholesterol (LDL-C) by REGN1500 in patients with homozygous familial hypercholesterolemia (HoFH).
- Trial name
- NCT02265952
- Testing
- REGN1500 250 mg SC/15 mg/kg IV/450 mg SC
- Where
- 5 sites in United States, Canada and 1 more
- Volunteers
- 9 people
- Sponsor
- Regeneron Pharmaceuticals
Hypercholesterolemia
Durable Effect of PCSK9 Antibody CompARed wiTh placEbo Study
To evaluate the efficacy, safety, and tolerability of 52 weeks of subcutaneous (SC) evolocumab (AMG 145) compared with placebo when added to assigned background lipid-lowering therapy.
- Trial name
- DESCARTES (NCT01516879)
- Testing
- Evolocumab, Atorvastatin, Ezetimibe
- Where
- 96 sites in United States, Australia and 7 more
- Volunteers
- 905 people
- Sponsor
- Amgen
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
Hyperlipidemia
LDL-C Assessment With PCSK9 Monoclonal Antibody Inhibition Combined With Statin Therapy-2
The primary objective was to evaluate the effect of 12 weeks of evolocumab administered subcutaneously every 2 weeks (Q2W) and monthly (QM) when used in combination with a statin, compared with placebo, on percent change from…
- Trial name
- LAPLACE-2 (NCT01763866)
- Testing
- Evolocumab, Ezetimibe, Atorvastatin
- Where
- 244 sites in United States, Australia and 19 more
- Volunteers
- 2,067 people
- Sponsor
- Amgen
Diabetes, Hypertension
Pharmacy Home Adherence Reporting and Monitoring Outcomes Study
This study is a pilot test of an intervention that delivers timely diagnostic information about medication nonadherence to doctors, and then offers the services of clinical pharmacists to treat these nonadherence problems.
- Conditions
- Diabetes, Hypertension, Hypercholesterolemia
- Trial name
- PHARxMOS (NCT02306122)
- Testing
- Pharmacist calls patient unless physician cancels call, Patient nonadherence information sent to physician, Pharmacist calls patient if physician requests call
- Where
- United States
- Volunteers
- 2,697 people
- Sponsor
- Brown University
Mood Disorders, Hypertension
One-Day Acceptance and Commitment Training Intervention in Primary Care Patients
The goal of this study is to 1) examine the feasibility and acceptability of a one-day Acceptance and Commitment Training + Illness Management (ACT-IM) intervention in patients with comorbid vascular disease risk factors and…
- Conditions
- Mood Disorders, Hypertension, Diabetes, Hypercholesterolemia
- Trial name
- NCT01879800
- Testing
- Acceptance and Commitment Therapy plus Illness Management
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- Lilian N. Dindo
Hypercholesterolemia, Atherosclerotic Cardiovascular Disease
Assessment of the Long-Term Safety and Efficacy of Bempedoic Acid (CLEAR Harmony OLE)
The purpose of this study is to see if bempedoic acid (ETC-1002) is safe and well-tolerated in patients with high cardiovascular risk and elevated LDL cholesterol that is not adequately controlled by their current therapy.
- Trial name
- NCT03067441
- Testing
- bempedoic acid
- Where
- 3 sites in United States
- Volunteers
- 1,462 people
- Sponsor
- Esperion Therapeutics, Inc.
Familial Hypercholesterolemia
Long Term, Follow-on Study of Lomitapide in Patients With Homozygous Familial Hypercholesterolemia
This was a long term follow on study to assess the continued long term safety and efficacy of lomitapide in patients with homozygous familial hypercholesterolemia.
- Trial name
- NCT00943306
- Testing
- lomitapide
- Where
- 10 sites in United States, Canada and 2 more
- Volunteers
- 19 people
- Sponsor
- Aegerion Pharmaceuticals, Inc.
Hereditary Breast and Ovarian Cancer Syndrome, Lynch Syndrome
Pediatric Reporting of Adult-Onset Genomic Results
The Investigators will conduct a longitudinal, mixed-methods cohort study to assess primary and secondary psychosocial outcomes among MyCode adolescent participants and their parents, and health behaviors of children who received…
- Conditions
- Hereditary Breast and Ovarian Cancer Syndrome, Lynch Syndrome, Familial Hypercholesterolemia
- Trial name
- NCT03832985
- Testing
- Child(ren) receive an adult-onset result, Child(ren) received a pediatric-onset result, Control - Negative Result
- Where
- United States
- Volunteers
- 162 people, healthy volunteers welcome
- Sponsor
- Geisinger Clinic
Familial Hypercholesterolemia - Homozygous
Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Homozygous Familial Hypercholesterolemia
This was a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in adolescents with homozygous familial hypercholesterolemia (HoFH) and elevated low density lipoprotein cholesterol (LDL-C).
- Trial name
- ORION-13 (NCT04659863)
- Testing
- Inclisiran
- Where
- 11 sites in United States, Canada and 6 more
- Volunteers
- 13 people
- Sponsor
- Novartis Pharmaceuticals