Clinical trials: Hypercholesterolemia, Autosomal Dominant
Lipid Metabolism, Inborn Errors, Hypercholesterolemia, Autosomal Dominant
Open Label Extension of ISIS 301012 (Mipomersen) to Treat Familial Hypercholesterolemia
The purpose of this study is to evaluate the safety and efficacy of extended dosing of mipomersen in patients with familial hypercholesterolemia on lipid-lowering therapy who have completed either the 301012-CS8 (NCT00280995) or…
- Conditions
- Lipid Metabolism, Inborn Errors, Hypercholesterolemia, Autosomal Dominant, Hyperlipidemias, Metabolic Diseases
- Trial name
- NCT00477594
- Testing
- mipomersen sodium
- Where
- 5 sites in United States
- Volunteers
- 21 people
- Sponsor
- Kastle Therapeutics, LLC
Dyslipidemias, Familial Hypercholesterolemia
A VSA003 Phase 1 Study in Chinese Adult Healthy Volunteers
This is a randomized, double blinded, phase 1 study. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single dose of VSA003 in healthy adult volunteerst
- Conditions
- Dyslipidemias, Familial Hypercholesterolemia, Hypertriglyceridemia
- Trial name
- NCT05851066
- Testing
- VSA003, 0.9% NaCl
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Visirna Therapeutics HK Limited
Heterozygous Familial Hypercholesterolemia
A Study to Evaluate the Efficacy and Safety of JS002 in Patients With Heterozygous Familial Hypercholesterolemia (HeFH).
JS002 is a recombinant human anti-PCSK9 monoclonal antibody.The study is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study in Chinese patients with heterozygous familial hypercholesterolemia…
- Trial name
- NCT05325203
- Testing
- Ongericimab
- Where
- China
- Volunteers
- 135 people
- Sponsor
- Shanghai Junshi Bioscience Co., Ltd.
Familial Hypercholesterolemia
Effects of Low-density Lipoprotein (LDL) Apheresis on Inflammatory and Lipid Markers
The primary objective of this study is to measure how LDL apheresis affects levels of inflammatory and cholesterol markers in human beings.
- Trial name
- INFLAME (NCT01138371)
- Testing
- LDL Apheresis
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Emory University
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
Familial Hypercholesterolemia
Effect of Omega-3 Fatty Acid on Endothelial Function
Background Familial hypercholesterolemia (FH) is an inherited disease in which the level of bad cholesterol (LDL-cholesterol) is increased, leading to an increase in coronary heart disease even if adequately treated with…
- Trial name
- NCT01813006
- Testing
- Omega-3
- Where
- Norway
- Volunteers
- 34 people
- Sponsor
- Nordlandssykehuset HF
Familial Hypercholesterolemia
French Observatory of Familial Hypercholesterolemia in Cardiology
The Family Hypercholesterolemia remains poorly diagnosed disease with an outlet sometimes suboptimal care. However, the Family Hypercholesterolemia exposes patients concerned at increased cardiovascular risk.
- Trial name
- FH Care (NCT02013713)
- Where
- France
- Volunteers
- 31 people
- Sponsor
- French Cardiology Society
Heterozygous Familial Hypercholesterolemia
Study of Alirocumab (REGN727/SAR236553) in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) Undergoing Low-density Lipoprotein (LDL) Apheresis Therapy
The primary objective of the study is to evaluate the effect of alirocumab 150 mg every 2 weeks (Q2W) in comparison with placebo on the frequency of low-density lipoprotein (LDL) apheresis treatments in participants with…
- Trial name
- ODYSSEY ESCAPE (NCT02326220)
- Testing
- Alirocumab
- Where
- 13 sites in United States, Germany
- Volunteers
- 62 people
- Sponsor
- Regeneron Pharmaceuticals
Myalgia, Hypercholesterolemia
Study of the Safety and Tolerability Associated With PPD10558 Versus Atorvastatin in Patients Previously Intolerant to Statins Due to Statin-associated Myalgia (SAM)
The purpose of this study is to assess the incidence of statin-associated myalgia (SAM) with treatment with PPD10558 versus atorvastatin in patients previously intolerant to statins.
- Conditions
- Myalgia, Hypercholesterolemia, Hyperlipidemia
- Trial name
- NCT01279590
- Testing
- PPD10558, Atorvastatin
- Where
- 67 sites in United States
- Volunteers
- 282 people
- Sponsor
- Furiex Pharmaceuticals, Inc
Hypercholesterolemia, Familial
Study of ISIS 301012 (Mipomersen) in Heterozygous Familial Hypercholesterolemia Subjects on Lipid Lowering Therapy
The aim of this study is to assess the safety and efficacy of varying doses of ISIS 301012 (mipomersen) as add-on therapy in subjects with Heterozygous Familial Hypercholesterolemia
- Trial name
- NCT00281008
- Where
- 8 sites in United States, Netherlands
- Volunteers
- 44 people
- Sponsor
- Kastle Therapeutics, LLC
Homozygous Familial Hypercholesterolemia (HoFH)
A Long-term Follow-up Study to Evaluate the Safety and Efficacy of RGX-501
This long-term observational study is designed to follow subjects who, during another Clinical Study, received gene therapy treatment used to treat their Homozygous Familial Hypercholesterolemia (HoFH) disease.
- Trial name
- NCT04080050
- Testing
- Single intravenous (IV) dose of human Low Density Lipoprotein Receptor (LDLR) Gene Therapy
- Where
- 6 sites in United States, Canada and 1 more
- Volunteers
- 8 people
- Sponsor
- REGENXBIO Inc.
Homozygous Familial Hypercholesterolemia (HoFH)
A Study to Evaluate the Efficacy and Safety of Rosuvastatin in Children and Adolescents With Homozygous Familial Hypercholesterolemia
The purpose of the study is to establish the efficacy, safety and tolerability of rosuvastatin in children and adolescents with homozygous familial hypercholesterolemia.
- Trial name
- HYDRA (NCT02226198)
- Testing
- Rosuvastatin 20mg
- Where
- 9 sites in Belgium, Canada and 5 more
- Volunteers
- 20 people
- Sponsor
- AstraZeneca
Hypercholesterolemia
Efficacy and Safety Evaluation of Alirocumab in Patients With Heterozygous Familial Hypercholesterolemia or High Cardiovascular Risk Patients With Hypercholesterolemia on Lipid Modifying Therapy (ODYSSEY JAPAN)
Primary Objective: To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable daily statin therapy with or without other lipid modifying therapy in comparison with…
- Trial name
- NCT02107898
- Testing
- Alirocumab, Lipid-Modifying Therapy (LMT)
- Where
- 32 sites in Japan
- Volunteers
- 216 people
- Sponsor
- Sanofi
Homozygous Familial Hypercholesterolemia (HoFH), Major Adverse Cardiovascular Events (MACE)
Evaluation of the Effect of Lomitapide Treatment on Major Adverse Cardiovascular Events (MACE) in Patients With Homozygous Familial Hypercholesterolemia
This observational, multicenter, retrospective and prospective study aims to evaluate the effect of lomitapide treatment on Major Adverse Cardiovascular Events (MACE) in patients with Homozygous Familial Hypercholesterolemia…
- Conditions
- Homozygous Familial Hypercholesterolemia (HoFH), Major Adverse Cardiovascular Events (MACE), Dyslipidemia
- Trial name
- LILITH (NCT06832371)
- Where
- 30 sites in France, Greece and 3 more
- Volunteers
- 73 people
- Sponsor
- Fondazione SISA (Societa Italiana per lo Studio della Arteriosclerosi)
Familial Hypercholesterolemia, Familial Hypercholesterolemia - Heterozygous
Early Detection of Familial Hypercholesterolemia in Children
Heterozigous FH is an underdiagnosed disease in the paediatric population. Its early detection, would allow us to initiate lifestyle therapeutical changes and early pharmacological therapy if necessary.
- Conditions
- Familial Hypercholesterolemia, Familial Hypercholesterolemia - Heterozygous, Familial Hypercholesterolemia - Homozygous
- Trial name
- DECOPIN (NCT04370899)
- Testing
- lifestyle assessment
- Where
- 2 sites in Spain
- Volunteers
- 400 people
- Sponsor
- Institut Investigacio Sanitaria Pere Virgili
Familial Hypercholesterolemia - Homozygous
Study to Evaluate Safety, Tolerability and Efficacy of Inclisiran in Children With Homozygous Familial Hypercholesterolemia
This is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in children (aged 2 to <12 years) with homozygous familial hypercholesterolemia (HoFH) and elevated low density lipoprotein…
- Trial name
- ORION-19 (NCT06597006)
- Testing
- Inclisiran
- Where
- 19 sites in United States, Austria and 9 more
- Volunteers
- 9 people
- Sponsor
- Novartis Pharmaceuticals
Familial Hypercholesterolaemia
Computerized Decision Support for Identification and Management of Familial Hypercholesterolemia
The goal of this clinical trial is to learn if a computer alert can aid clinicians in identifying patients with a genetic type of high cholesterol, called Familial Hypercholesterolemia.
- Trial name
- FH-ALERT (NCT06743659)
- Testing
- Alert-based computerized decision support
- Where
- United States
- Volunteers
- 450 people
- Sponsor
- Brigham and Women's Hospital
Familial Hypercholesterolemia
Pilot Study for a National Screening for Familial Hypercholesterolemia
A pilot study to study the feasibility of the screening of familial hypercholesterolemia within the setting of the legal medical visits at primary school.
- Trial name
- EARLIE (NCT05271305)
- Where
- Luxembourg
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier du Luxembourg
Familial Hypercholesterolemia
Implitapide in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) on Maximal Concurrent Lipid-Lowering Therapy
The purpose of this study is to determine if implitapide, used in conjunction with other lipid-lowering therapies, is safe and effective when compared to placebo in lowering low-density lipoprotein cholesterol (LDL-C) in patients…
- Trial name
- NCT00079859
- Testing
- Implitapide
- Where
- 6 sites in United States, Netherlands and 1 more
- Volunteers
- 120 people
- Sponsor
- Medical Research Laboratories International
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