Clinical trials: Familial Hypercholesterolemia - Heterozygous
Hypercholesterolemia, Familial
Carotid IMT (Intima Media Thickening) Study (0524A-041)(TERMINATED)
This is a 105-week clinical study in patients with heterozygous familial hypercholesterolemia on intensive Low Density Lipoprotein-cholesterol (LDL-C) lowering therapy intended to assess the affects of MK0524A on carotid intima…
- Trial name
- ACHIEVE (NCT00384293)
- Testing
- Comparator: niacin (+) laropiprant (MK0524A)
- Volunteers
- 937 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Hypercholesterolemia
Open Label Study of Long Term Safety Evaluation of Alirocumab
Primary Objective: To assess the long-term safety of alirocumab (SAR236553/REGN727) when added to lipid-lowering therapy in participants with heterozygous familial hypercholesterolemia (heFH) who had completed EFC12492…
- Trial name
- ODYSSEY OLE (NCT01954394)
- Testing
- Alirocumab, Lipid-Modifying Therapy (LMT)
- Where
- 177 sites in United States, Argentina and 22 more
- Volunteers
- 986 people
- Sponsor
- Sanofi
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
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
Heterozygous Familial Hypercholesterolemia
Trial Assessing Efficacy, Safety and Tolerability of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition in Paediatric Subjects With Genetic Low-Density Lipoprotein (LDL) Disorders
A study to assess safety and efficacy of evolocumab (AMG-145) in paediatric subjects aged 10-17 years diagnosed with heterozygous familial hypercholesterolemia.
- Trial name
- HAUSER-RCT (NCT02392559)
- Testing
- Evolocumab
- Where
- 66 sites in United States, Australia and 24 more
- Volunteers
- 158 people
- Sponsor
- Amgen
Dyslipidemias, Hypercholesterolemia
Study of Obicetrapib & Ezetimibe Fixed Dose Combination on Top of Maximum Tolerated Lipid-Modifying Therapies
The study is a placebo-controlled, double-blind, randomized, phase 3 study in participants with heterozygous familial hypercholesterolemia (HeFH) and/or atherosclerotic cardiovascular disease (ASCVD) or multiple ASCVD risk…
- Conditions
- Dyslipidemias, Hypercholesterolemia, Familial Hypercholesterolemia, ASCVD
- Trial name
- TANDEM (NCT06005597)
- Testing
- Combination Therapy, Monotherapy obicetrapib, Monotherapy ezetimibe
- Where
- 45 sites in United States
- Volunteers
- 407 people
- Sponsor
- NewAmsterdam Pharma
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
Hypercholesterolemia, Heterozygous Familial Hypercholesterolemia
Open-Label Extension of Study R727-CL-1003 (NCT01266876) to Evaluate the Long-Term Safety and Efficacy of Alirocumab (REGN727) in Participants With Heterozygous Familial Hypercholesterolemia (HeFH)
The primary objective of the study was to assess the long-term safety and tolerability of alirocumab in patients with heFH who were receiving concomitant treatment with hydroxymethyl glutaryl-coenzyme A (HMG-CoA) reductase…
- Trial name
- NCT01576484
- Testing
- Alirocumab
- Where
- 14 sites in United States, Canada
- Volunteers
- 58 people
- Sponsor
- Regeneron Pharmaceuticals
Heterozygous Familial Hypercholesterolemia (HeFH)
A Study to Evaluate the SYH2053 Injection in Patients With Heterozygous Familial Hypercholesterolemia (HeFH)
Heterozygous Familial Hypercholesterolemia (HeFH) is an autosomal dominant disorder characterized by markedly elevated low-density lipoprotein cholesterol (LDL-C) and increased risk of atherosclerotic cardiovascular disease…
- Trial name
- NCT07465263
- Testing
- SYH2053 Injection
- Where
- China
- Volunteers
- 135 people, healthy volunteers welcome
- Sponsor
- CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
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 - Heterozygous
Study of Coronary Calcification in Subjects With Autosomal Dominant Familial Hypercholesterolemia Heterozygous
Familial hypercholesterolemia (FH) is an autosomal dominant genetic disorder characterized by elevated plasma levels of LDL-C cholesterol.
- Trial name
- FH-CALC (NCT03501875)
- Testing
- CAC Score
- Where
- France
- Volunteers
- 270 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Familial Hypercholesterolemia
Safety, Tolerability and Efficacy of Evolocumab (AMG 145) in Children With Inherited Elevated Low-density Lipoprotein Cholesterol (Familial Hypercholesterolemia)
The main purpose of this study is to describe the safety and tolerability of 80 weeks of subcutaneous (SC) evolocumab when added to standard of care in children 10 to 17 years of age with familial hypercholesterolemia.
- Trial name
- HAUSER-OLE (NCT02624869)
- Testing
- Evolocumab
- Where
- 46 sites in United States, Australia and 21 more
- Volunteers
- 163 people
- Sponsor
- Amgen
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
Cardiovascular, Metabolic Disease
A Safety and Tolerability Trial Evaluating CTX310 in Participants With Refractory Dyslipidemias
This is a single-arm, open-label, multicenter, ascending dose Phase 1 trial that will enroll participants 18 to 75 years of age with dyslipidemias that are refractory to available treatments.
- Conditions
- Cardiovascular, Metabolic Disease, Dyslipidemias, Lipid Disorder
- Trial name
- NCT07491172
- Testing
- CTX310
- Where
- 17 sites in United States, Australia and 2 more
- Volunteers
- 90 people
- Sponsor
- CRISPR Therapeutics AG
Hypercholesterolemia, Familial, Hyperlipidemia
Carotid B-Mode Ultrasound Study to Compare Anti-Atherosclerotic Effect of Torcetrpib/Atorvastatin to Atorvastatin Alone.
The Torcetrapib project was terminated on December 2, 2006 due to safety findings. To look at ultrasound images taken in the carotid arteries and to look at various lipids in the blood of people with heterozygous familial…
- Trial name
- RADIANCE 1 (NCT00136981)
- Testing
- torcetrapib/atorvastatin, atorvastatin
- Where
- 34 sites in United States, Canada and 6 more
- Volunteers
- 800 people
- Sponsor
- Pfizer
Hypercholesterolemia, Heterozygous Familial Hypercholesterolemia
A Clinical Trial to Assess the Long Term Safety and Tolerability of MK-0653C in Japanese Participants With Hypercholesterolemia (MK-0653C-384)
This study will assess the safety and tolerability of Ezetimibe (EZ) 10 mg/Atorvastatin (Atora) 10 mg and EZ 10mg/Atora 20 mg fixed-dose combination (FDC) in Japanese participants with hypercholesterolemia uncontrolled with…
- Trial name
- NCT02460159
- Testing
- EZ 10 mg/Atorva 20 mg FDC, EZ 10 mg/Atorva 10 mg FDC
- Volunteers
- 135 people
- Sponsor
- Organon and Co
Familial Hypercholesterolemia, Familial Hypercholesterolemia Due to Genetic Defect of Apolipoprotein B
Advancing Cardiac Care Unit-based Rapid Assessment and Treatment of hypErcholesterolemia
ACCURATE will test the hypothesis that opportunistic genetic testing for Familial Hypercholesterolemia (FH) in patients admitted to hospital with an acute coronary syndrome will increase the diagnosis of FH and will impact…
- Conditions
- Familial Hypercholesterolemia, Familial Hypercholesterolemia Due to Genetic Defect of Apolipoprotein B, Familial Hypercholesterolemia Due to Heterozygous LDL Receptor Mutation, Familial Hypercholesterolemia - Heterozygous
- Trial name
- ACCURATE (NCT05218005)
- Testing
- Research-based genetic test for Familial Hypercholesterolemia
- Where
- 2 sites in Canada
- Volunteers
- 140 people
- Sponsor
- University of British Columbia
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
Heterozygous Familial Hypercholesterolemia, Premature Coronary Heart Disease
A Study of VERVE-102 in Patients With Familial Hypercholesterolemia or Premature Coronary Artery Disease
VT-10201 is an Open-label, Phase 1b, Single-ascending Dose Study That Will Evaluate the Safety of VERVE-102 Administered to Patients With Heterozygous Familial Hypercholesterolemia (HeFH) or Premature Coronary Artery Disease…
- Trial name
- NCT06164730
- Testing
- VERVE-102
- Where
- 27 sites in United States, Australia and 4 more
- Volunteers
- 85 people
- Sponsor
- Verve Therapeutics, Inc.
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.