Clinical trials: Hyperlipoproteinemia Type II
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.
Hyperlipidemia, Insulin Resistance
Relationship Between Insulin Resistance and Statin Induced Type 2 Diabetes, and Integrative Personal Omics Profiling
Background: There is general agreement that statin-treatment of patients to lower plasma cholesterol levels can increase the incidence of type 2 diabetes mellitus (T2D) in some individuals1-5.
- Conditions
- Hyperlipidemia, Insulin Resistance, Type 2 Diabetes
- Trial name
- NCT02437084
- Testing
- Atorvastatin
- Where
- United States
- Volunteers
- 115 people, healthy volunteers welcome
- Sponsor
- Stanford University
Familial Hypercholesterolemia, Lipid Disorder
Familial Hypercholesterolemia Canada / Hypercholesterolemie Familiale Canada
Familial hypercholesterolemia (FH) is the most frequent genetic lipoprotein disorder associated with premature CAD. In Canada, the burden of disease is estimated to be approximately 83,500 patients.
- Trial name
- FHCanada (NCT02009345)
- Where
- Canada
- Volunteers
- 6,000 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Hypercholesterolemia, Familial, LIPOPROTEIN TYPES--Lp SYSTEM Lp(a) HYPERLIPOPROTEINEMIA
Safety and Efficacy of the DALI LDL-adsorber and MONET Lipoprotein Filter
Low Density Lipoprotein (LDL)-apheresis refers to a procedure in which blood taken from a patient's vein is cleaned from pathogenic substances, e.g. cholesterol, outside the body and then given back to the patient.
- Trial name
- LINET (NCT01753232)
- Testing
- DALI-adsorber, MONET-Lipoprotein filter
- Where
- 11 sites in Germany
- Volunteers
- 108 people
- Sponsor
- Fresenius Medical Care Deutschland GmbH
Heterozygous Familial Hypercholesterolemia
A Study of PCSK9 Inhibitor AK102 in Patients With Heterozygous Familial Hypercholesterolemia (HeFH)
This is a double-blind, randomized, placebo-controlled, multicenter study to evaluate the safety and efficacy of AK102 in patients with heterozygous familial hypercholesterolemia (HeFH).The primary objective of this study is to…
- Trial name
- NCT04173793
- Testing
- AK102, Statins and/or Ezetimibe
- Where
- 2 sites in China
- Volunteers
- 109 people
- Sponsor
- Akeso
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.
Familial Hypercholesterolemias, Atherosclerotic Cardiovascular Disease (ASCVD)
Study of the Determinants of Coronary Atherosclerosis in Familial Hypercholesterolemia (ATHERO-FH Study)
The goal of this study (interventional clinical research not involving a health product) is to assess the prevalence of subclinical coronary atherosclerosis diagnosed by coronary CT angiography in heart failure patients in…
- Trial name
- ATHERO-FH (NCT06960902)
- Testing
- Coronary CT scan with CAC score measurement
- Where
- 9 sites in France
- Volunteers
- 600 people
- Sponsor
- Nantes University Hospital
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
Familial Hypercholesterolemia
Russian Familial Hypercholesterolemia Registry
True prevalence of FH in the Russian Federation is unknown which leads to low percentage of diagnosed and treated cases. Research is needed to determine the prevalence of FH, specific diagnostic algorithms and optimal treatment…
- Trial name
- RuFH (NCT02208869)
- Where
- 5 sites in Russia
- Volunteers
- 1,000 people
- Sponsor
- Russian Cardiology Research and Production Center
Homozygous Familial Hypercholesterolemia, HoFH
HDL Acute Lipid Optimization in Homozygous Familial Hypercholesterolemia
Assess the effect on coronary atheroma of serial infusions of autologous selectively delipidated HDL/preβ enriched plasma following use of HDL Therapeutics PDS-2™ System
- Trial name
- NCT03135184
- Testing
- HDL Therapeutics PDS-2 System
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- HDL Therapeutics
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
Mixed Hyperlipidemia
Comparison of the Efficacy and Safety of AtorVastatin mOnotherapy vs. Combination Atorvastatin/Fenofibric Acid
The purpose of this study is to compare combination atorvastatin/fenofibric acid 10/135mg with atorvastatin 20mg monotherapy in the mixed hyperlipidemia who were not at lipid goals with atorvastatin 10mg monotherapy.
- Trial name
- AVOCADO (NCT01974297)
- Testing
- Atorvastatin 10mg, fenofibric acid 135mg, atorvastatin 20mg
- Where
- South Korea
- Volunteers
- 194 people
- Sponsor
- Sang Hak Lee
Hypertriglyceridemia, Familial Hypercholesterolemia
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IONIS ANGPTL3-LRx in Healthy Volunteers With Elevated Triglycerides and Participants With Familial Hypercholesterolemia
The purpose is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of IONIS ANGPTL3-LRx (ISIS 703802) given to healthy volunteer subjects with elevated triglycerides and subjects with familial…
- Trial name
- NCT02709850
- Testing
- IONIS ANGPTL3-LRx
- Where
- Canada
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Ionis Pharmaceuticals, Inc.
Coronary Artery Disease
Prevalence of Familial Hypercholesterolaemia (FH) in Italian Patients With Coronary Artery Disease
Evaluate the prevalence of familial hypercholesterolemia (FH) in patients with documented coronary artery disease (CAD) event [acute myocardial infarction (AMI), acute coronary syndrome (ACS), coronary artery bypass graft (CABG)…
- Trial name
- POSTER (NCT03520140)
- Where
- 81 sites in Italy
- Volunteers
- 5,415 people
- Sponsor
- Heart Care Foundation
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.
Type 2 Diabetes, Hypertension
Controlling Hypertension in Diabetes- Feasibility Study
Many primary care patients, especially in inner-city settings, do not achieve targets for blood pressure and glycemic control. There is an urgent need to enhance treatment for those who do not reach goals within the usual…
- Conditions
- Type 2 Diabetes, Hypertension, Hyperlipidemia
- Trial name
- COACH-D (NCT01145742)
- Testing
- home health/primary care collaboration
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- Albert Einstein College of Medicine
Metabolic Syndrome, Insulin Resistance
Study of How Exercise or Weight Loss Effects Metabolic Syndrome
The Metabolic Syndrome (MS) is prevalent in the American population and is strongly associated with premature coronary disease. Lifestyle intervention, primarily exercise and dietary changes, are foundational treatment strategies…
- Conditions
- Metabolic Syndrome, Insulin Resistance, Obesity
- Trial name
- NCT00292994
- Testing
- Exercise, Weight Loss
- Where
- United States
- Volunteers
- 130 people, healthy volunteers welcome
- Sponsor
- Yankton Clinical Research Alliance
Primary Hypercholesterolemia or Mixed Hyperlipidemia
QLC7401 Monotherapy in Non-familial Hypercholesterolemia or Mixed Dyslipidemia
This Phase III clinical trial aims to assess the efficacy and safety of QLC7401 monotherapy in adults with non-familial primary hypercholesterolemia or mixed dyslipidemia who are not receiving lipid-lowering therapy.
- Trial name
- NCT07444086
- Testing
- QLC7401
- Volunteers
- 510 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Hypercholesterolemia, Familial Hypercholesterolemia
A 12-week Post-marketing, Observational Study to Confirm the Safety and Efficacy of Zetia Alone or in Combination With Other Lipid-lowering Drugs in Japanese Subjects With Hypercholesterolemia (Study P05244)
This study is a non-interventional (observational) study in Japan to confirm the safety and efficacy of Zetia when administered alone or in combination with other lipid-lowering drugs in daily medical practice throughout a…
- Conditions
- Hypercholesterolemia, Familial Hypercholesterolemia, Homozygous Sitosterolemia
- Trial name
- NCT00704444
- Testing
- Ezetimibe, Ezetimibe + other lipid-lowering medication(s)
- Volunteers
- 11,332 people
- Sponsor
- Organon and Co
Homozygous Familial Hypercholesterolemia (HoFH)
Identifying and Genotyping Homozygous Familial Hypercholesterolemia (HoFH) Patients
This study is designed to help identify patients with HoFH due to mutations in the LDLR as confirmed by genotyping.
- Trial name
- NCT04148001
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- REGENXBIO Inc.