Clinical trials: Familial Hypercholesterolemia
Homozygous Familial Hypercholesterolemia
Safety, Tolerability and Efficacy of Microsomal Triglyceride Protein (MTP) Inhibitor
The primary objective of this study is to evaluate the safety and tolerability of 4 doses of lomitapide (AEGR-733; BMS-201038) given as an initial low dose and then escalated through an additional 3 dose levels over a 16-week…
- Trial name
- NCT01556906
- Testing
- Lomitapide
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Aegerion Pharmaceuticals, Inc.
Familial Hypercholesterolemia
Ezetimibe (SCH 58235) Taken With Either Atorvastatin or Simvastatin in Participants With Familial Hypercholesterolemia (MK-0653-018)
The primary objective of this study is to evaluate the efficacy and the safety of ezetimibe (SCH 58235) co-administered with either atorvastatin or simvastatin in participants with homozygous familial hypercholesterolemia (FH).
- Trial name
- NCT03884452
- Testing
- Atorvastatin, Simvastatin, Ezetimibe
- Volunteers
- 50 people
- Sponsor
- Organon and Co
Hypercholesterolemia, Familial, Hyperlipidemia
Study To Evaluate The Safety And Efficacy Of Torcetrapib/Atorvastatin In Subjects With Familial Hypercholerolemia
The Torcetrapib project was terminated on December 2, 2006 due to safety findings. To evaluate the efficacy and safety of torcetrapib/atorvastatin compared to atorvastatin alone in patients with heterozygous familial…
- Trial name
- NCT00134485
- Testing
- torcetrapib/atorvastatin, atorvastatin
- Where
- 41 sites in United States, Australia and 7 more
- Volunteers
- 400 people
- Sponsor
- Pfizer
Homozygous Familial Hypercholesterolemia
Phase 3 Study to Evaluate the Efficacy and Safety of LIB003 With Evolocumab in HoFH
To compare the safety, tolerability and LDL-C response after 24 Weeks of monthly (every 4 weeks [Q4W]) subcutaneous (SC) dosing of LIB003 300 mg with monthly (Q4W) SC dosing of 420 mg evolocumab (Repatha®) in patients with HoFH…
- Trial name
- NCT04034485
- Testing
- lerodalcibep, evolocumab
- Where
- 12 sites in United States, India and 4 more
- Volunteers
- 65 people
- Sponsor
- LIB Therapeutics LLC
Familial Hypercholesterolemia - Homozygous, Lipid Metabolism Disorders
Evaluate the Efficacy and Safety of IBI306 in Subjects With Homozygous Familial Hypercholesterolemia
IBI306 is a bio-innovative drug against proprotein convertase subtilisin 9 (PCSK-9) monoclonal antibody. Currently, cholesterol-lowering drugs with multiple mechanisms of action are on the market or under development.
- Conditions
- Familial Hypercholesterolemia - Homozygous, Lipid Metabolism Disorders, Proprotein Convertase Subtilisin/Kexin 9
- Trial name
- NCT04948008
- Testing
- IBI306
- Where
- China
- Volunteers
- 8 people
- Sponsor
- Shenzhen People's Hospital
Heterozygous Familial Hypercholesterolemia
Early-phase Study of ART002g1 Injection in HeFH: Safety, Tolerability and Preliminary Efficacy
This study is an open-label, single ascending dose (SAD) study designed to evaluate the safety and tolerability of ART002g1 in patients with heterozygous familial hypercholesterolemia (HeFH) who require further reduction in…
- Trial name
- NCT07353398
- Testing
- ART002g1 Injection
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Familial Hypercholesterolaemia
The Spanish Familial Hypercholesterolaemia Cohort Study
SAFEHEART is a large, on-going registry study in molecularly defined patients with heterozygous FH treated in Spain.
- Trial name
- SAFEHEART (NCT02693548)
- Where
- Spain
- Volunteers
- 4,141 people, healthy volunteers welcome
- Sponsor
- Fundación Hipercolesterolemia Familiar
Homozygous Familial Hypercholesterolemic
Cardiovascular Evaluation of Patients With High Cholesterol and Normal Volunteers
Homozygous familial hypercholesterolemia is a rare inherited disease of metabolism. It occurs in less than 1 in 1 million people within the United States.
- Trial name
- NCT00001204
- Where
- United States
- Volunteers
- 73 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Hypercholesterolemia
Study of Awareness and Detection of Familial Hypercholesterolemia
The CASCADE-FH Registry is a national, multi-center initiative that will track the therapy, clinical outcomes, and patient-reported outcomes over time.
- Trial name
- CASCADE-FH (NCT01960244)
- Where
- United States
- Volunteers
- 5,000 people
- Sponsor
- The Familial Hypercholesterolemia Foundation
Familial Hypercholesterolemia
Atorvastatin Three Year Pediatric Study
The purpose of this study is to characterize three year descriptive growth and development (ie, height, weight, body mass index, Tanner Stage) and efficacy of cholesterol reduction in pediatric subjects with Heterozygous Familial…
- Trial name
- NCT00827606
- Testing
- atorvastatin
- Where
- 40 sites in United States, Belgium and 13 more
- Volunteers
- 272 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Familial or Severe Hypercholesterolemia
Flaxseed Compared With Placebo in Patients With Hypercholesterolemia
The aim of this study is to determine if thirty grams per day of flaxseed consumption for 4 weeks could potentially reduce the serum lipid levels in children and adolescents with familial or severe hypercholesterolemia compared…
- Trial name
- NCT01007344
- Testing
- flaxseed, whole wheat flour
- Where
- Canada
- Volunteers
- 30 people
- Sponsor
- The Hospital for Sick Children
LDL - Low Density Lipoprotein Receptor Disorder, Rosuvastatin
Impact of Rosuvastatin Doses on LDL Levels, CPK Levels and Aspartate Aminotransferase Levels
Particpants were divided into groups based on doses of rosuvastatin and were assessed and for CPK, LDL and AST levels
- Trial name
- NCT06910098
- Testing
- Rosuvastatin
- Where
- Pakistan
- Volunteers
- 195 people, healthy volunteers welcome
- Sponsor
- Central Park Medical College
Familial Hypercholesterolemia
PMMHRI - Familial Hypercholesterolemia Registry
The registry is maintained at the Regional Centre for Rare Diseases, established in 2016, within Polish Mother's Memorial Hospital Research Institute.
- Trial name
- FH-Registry (NCT06571630)
- Where
- Poland
- Volunteers
- 300 people
- Sponsor
- Polish Mother Memorial Hospital Research Institute
Homozygous Familial Hypercholesterolemia
A Safety and Efficacy Study of AEGR-733 to Treat Homozygous Familial Hypercholesterolemia (FH)
The goal of this trial is to study the effects of AEGR-733 on LDL cholesterol, other lipids as well as measures of safety over the long-term.
- Trial name
- NCT00730236
- Testing
- AEGR-733
- Where
- 10 sites in United States, Canada and 2 more
- Volunteers
- 29 people
- Sponsor
- Aegerion Pharmaceuticals, Inc.
Hypercholesterolemia
Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy
Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9).
- Trial name
- ODYSSEY FH I (NCT01623115)
- Testing
- Alirocumab, Lipid Modifying Therapy (LMT)
- Where
- 91 sites in United States, Austria and 12 more
- Volunteers
- 486 people
- Sponsor
- Sanofi
Atherosclerotic Vascular Disease, Heterozygous Familial Hypercholesterolemia
Inclisiran (Leqvio®) in Patients With Atherosclerotic Vascular Disease and/or Heterozygous Familial Hypercholesterolemia Treated in Spain: the INSPIRE Study
This study aims to address several key questions regarding the use of inclisiran in real-world clinical practice in Spain.
- Trial name
- INSPIRE (NCT06958315)
- Testing
- Inclisiran
- Where
- 20 sites in Spain
- Volunteers
- 219 people
- Sponsor
- Novartis Pharmaceuticals
Heterozygous Familial Hypercholesterolemia, Coronary Artery Disease
Efficacy and Safety Study of ISIS 301012 (Mipomersen) as Add-on in Familial Hypercholesterolemic Patients With Coronary Artery Disease
The purpose of this study is to determine whether mipomersen safely and effectively lowers low-density lipoprotein cholesterol (LDL-C) in patients with Heterozygous Familial Hypercholesterolemia (HeFH) and coronary artery disease…
- Trial name
- RADICHOL II (NCT00706849)
- Testing
- mipomersen sodium
- Where
- 48 sites in United States, Canada
- Volunteers
- 124 people
- Sponsor
- Kastle Therapeutics, LLC
Familial Hypercholesterolaemia
An Study to Evaluate Rosuvastatin in Children and Adolescents With Familial Hypercholesterolaemia
This study is being carried out to see if the study medication, rosuvastatin, is effective in treating familial hypercholesterolaemia in children and adolescents, and to determine the long term (over 2 years) safety, tolerability…
- Trial name
- NCT01078675
- Testing
- rosuvastatin calcium
- Where
- 15 sites in United States, Belgium and 3 more
- Volunteers
- 315 people
- Sponsor
- AstraZeneca
Pediatric Homozygous Familial Hypercholesterolemia (HoFH), Severe Hypertriglyceridemia (HTG)
Compassionate Use of Evinacumab
Provide compassionate use of evinacumab
- Conditions
- Pediatric Homozygous Familial Hypercholesterolemia (HoFH), Severe Hypertriglyceridemia (HTG), Dysbetalipoproteinemia (DBL)
- Trial name
- NCT06500598
- Testing
- Evinacumab
- Sponsor
- Regeneron Pharmaceuticals
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