Clinical trials: Heterozygous Familial Hypercholesterolemia
Pediatric Heterozygous Hypercholesterolemia
8-Week PK/PD Atorvastatin Study In Children And Adolescents With Heterozygous Familial Hypercholesterolemia
To evaluate pharmacokinetics, pharmacodynamics, safety and tolerability of atorvastatin in children and adolescents with heterozygous familial hypercholesterolemia
- Trial name
- NCT00739999
- Testing
- Atorvastatin
- Where
- 3 sites in Canada, Greece and 1 more
- Volunteers
- 39 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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
Heterozygous Familial Hypercholesterolemia, Mixed Dyslipidemia
Efficacy and Safety of Fluvastatin in Children With Heterozygous Familial Hypercholesterolemia
The purpose of the study is to assess the safety and efficacy of fluvastatin in children diagnosed with heterozygous familial hypercholesterolemia
- Trial name
- NCT00171236
- Testing
- Fluvastatin
- Where
- Switzerland
- Volunteers
- 84 people
- Sponsor
- Novartis
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
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
Hypercholesterolemia
Evaluating Effect of the Study Drug Praluent (Alirocumab) on Neurocognitive Function When Compared to Placebo
The main purpose of this study is to evaluate the effect on mental state (known as "neurocognitive function") with use of Praluent.
- Trial name
- NCT02957682
- Testing
- Praluent (Alirocumab)
- Where
- 188 sites in United States, Bulgaria and 7 more
- Volunteers
- 2,176 people
- Sponsor
- Regeneron Pharmaceuticals
Heterozygous Familial Hypercholesterolemia (HeFH), Homozygous Familial Hypercholesterolemia (HoFH)
The ORIGIN-FH Study
The goal of this clinical trial is to identify different types of Familial Hypercholesterolemia (FH) in infants and newborns. Participants will: undergo a cheek swab for genetic testing (parents only) have 5 blood samples…
- Conditions
- Heterozygous Familial Hypercholesterolemia (HeFH), Homozygous Familial Hypercholesterolemia (HoFH), Familial Hypercholesterolemia
- Trial name
- ORIGIN-FH (NCT07470723)
- Testing
- Screening for FH
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- University of Wisconsin, Madison
Heterozygous Familial Hypercholesterolemia, Non-familial Hypercholesterolemia
Long Term Safety Study of PRALUENT
The primary objective of the study was to evaluate the long term safety of PRALUENT in participants with heterozygous familial hypercholesterolemia (heFH) or non-familial hypercholesterolemia (FH) participants at high or very…
- Trial name
- NCT03694197
- Testing
- Praluent
- Where
- 123 sites in United States, Bulgaria and 4 more
- Volunteers
- 1,389 people
- Sponsor
- Regeneron Pharmaceuticals
Hypercholesterolaemia
Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia (ODYSSEY HIGH FH)
Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9).
- Trial name
- NCT01617655
- Testing
- Alirocumab, Lipid Modifying Therapy (LMT)
- Where
- 35 sites in United States, Canada and 3 more
- Volunteers
- 107 people
- Sponsor
- Sanofi
Heterozygous Familial Hypercholesterolemia
Study to Assess the Efficacy and Safety of LIB003 in HeFH Patients on Oral Lipid Therapy Needing Further LDL-C Reduction
This study is to assess LDL-C reductions at Week 24 and the mean of Weeks 22 and 24 with monthly Q4W (≤31 days) dosing of LIB003 300 mg administered subcutaneously (SC) compared to placebo in patients 18 years or older with…
- Trial name
- LIBerate-FH (NCT04797104)
- Testing
- lerodalcibep
- Where
- 7 sites in United States, Israel and 3 more
- Volunteers
- 478 people
- Sponsor
- LIB Therapeutics LLC
Familial Hypercholesterolemia
PLUTO: Pediatric Lipid-redUction Trial of rOsuvastatin
The primary objective of this study is to determine the efficacy of once-daily rosuvastatin in reducing LDL-C in children and adolescents aged 10-17 years with HeFH from baseline (Day 0) to the end of the 12-week double-blind…
- Trial name
- NCT00355615
- Testing
- Rosuvastatin
- Where
- 20 sites in United States, Canada and 3 more
- Volunteers
- 173 people
- Sponsor
- AstraZeneca
Lipid Metabolism, Inborn Errors, Hypercholesterolemia, Autosomal Dominant
An Open-label Extension Study to Assess the Long-term Safety and Efficacy of ISIS 301012 (Mipomersen) in Patients With Familial Hypercholesterolemia or Severe-Hypercholesterolemia
To evaluate the safety and efficacy of extended dosing with mipomersen (ISIS 301012) in participants with familial hypercholesterolemia or severe hypercholesterolemia on lipid-lowering therapy who had completed either the…
- Conditions
- Lipid Metabolism, Inborn Errors, Hypercholesterolemia, Autosomal Dominant, Hyperlipidemias, Metabolic Diseases
- Trial name
- NCT00694109
- Testing
- Mipomersen Sodium
- Where
- 33 sites in United States, Brazil and 5 more
- Volunteers
- 144 people
- Sponsor
- Kastle Therapeutics, LLC
Primary Hypercholesterolemia
Pediatric Study to Evaluate the Efficacy and Safety of Ezetimibe Monotherapy in Children With Primary Hypercholesterolemia (P05522)
The purpose of this study is to determine the effect of ezetimibe 10 mg/day compared to placebo on the reduction of low-density lipoprotein cholesterol (LDL-C) from baseline to 12 weeks of treatment in children >=6 to <=10 years…
- Trial name
- NCT00867165
- Testing
- ezetimibe
- Volunteers
- 138 people
- Sponsor
- Organon and Co
Heterozygous or Homozygous Familial Hypercholesterolemia
Long-term Safety and Tolerability of Inclisiran in Participants With HeFH or HoFH Who Have Completed the Pediatric ORION-16, ORION-13, ORION-20, or ORION-19 Studies
The purpose of this open-label, single arm, multicenter extension study is to evaluate the long-term safety and tolerability of inclisiran in participants with HeFH or HoFH who have completed the ORION-16 (CKJX839C12301)…
- Trial name
- V-PEDS-OLE (NCT05682378)
- Testing
- Inclisiran
- Where
- 52 sites in United States, Argentina and 24 more
- Volunteers
- 195 people
- Sponsor
- Novartis Pharmaceuticals
Heterozygous Familial Hypercholesterolemia
Safety and Efficacy of IBI306 in HeFH Patients
IBI306 is a fully human monoclonal antibody that binds proprotein convertase substilisin/kexin type 9 (PCSK-9), preventing its interaction with the low-density lipoprotein cholesterol receptor (LDL-R) and thereby restoring LDL-R…
- Trial name
- NCT04179669
- Testing
- IBI306
- Where
- China
- Volunteers
- 149 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Heterozygous Familial Hypercholesterolemia
Lp(a) and Aortic Valve Calcification
Aortic valve stenosis (AVS), the most common form of valve disease in the western world, afflicts more than 1 million individuals in North America [1] and the burden of AVS is high and is expected to double within the next 50…
- Trial name
- FHLPA (NCT02976818)
- Where
- Canada
- Volunteers
- 173 people
- Sponsor
- Laval University
Heterozygous Familial Hypercholesterolemia
Effects of Soy Protein on Cholesterol Levels in Children Affected With Familial Hypercholesterolemia
Familial hypercholesterolemia (FH) is an inheritable, autosomal dominant disorder leading to pathologically increased levels of low-density-lipoprotein cholesterol (LDL-C).
- Trial name
- SOYFIT (NCT03563547)
- Testing
- Dietary counseling (fat modifed diet), Dietary Counseling (fat modified + soy enriched diet)
- Where
- Austria
- Volunteers
- 34 people
- Sponsor
- Austrian Academic Institute for Clinical Nutrition
Familial Hypercholesterolemia - Heterozygous
Study to Evaluate Efficacy and Safety of Inclisiran in Children With Heterozygous Familial Hypercholesterolemia
This is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in children (aged 6 to <12 years) with heterozygous familial hypercholesterolemia (HeFH) and elevated low density lipoprotein…
- Trial name
- ORION-20 (NCT06597019)
- Testing
- Inclisiran
- Where
- 66 sites in United States, Argentina and 21 more
- Volunteers
- 60 people
- Sponsor
- Novartis Pharmaceuticals
Hypercholesterolemia
A Study of LY3015014 in Participants With High Cholesterol
This study is designed to define the amount and duration of cholesterol lowering and to assess the safety and tolerability of different dose regimens of LY3015014 in participants with high cholesterol.
- Trial name
- NCT01890967
- Testing
- LY3015014, Statin, Ezetimibe
- Where
- 49 sites in United States, Canada and 6 more
- Volunteers
- 527 people
- Sponsor
- Eli Lilly and Company
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