Clinical trials: Hypercholesterolemia, Familial
Hypercholesterolemia
A Clinical Study in Children With Heterozygous Familial Hypercholesterolemia (HeFH) Aged 6 to 17 Treated Once Daily With Bempedoic Acid Oral Dosing (CLEAR Path 1)
Multiple-dose study to measure pharmacokinetics, pharmacodynamics and safety of bempedoic acid in pediatric participants 6 to 17 years of age with HeFH.
- Trial name
- CLEAR Path 1 (NCT05694260)
- Testing
- Bempedoic acid
- Where
- 24 sites in United States, Canada and 4 more
- Volunteers
- 31 people
- Sponsor
- Esperion Therapeutics, Inc.
Hypercholesterolemia, Familial, Heterozygous Familial Hypercholesterolemia
A Study of Extended-release (ER) Niacin/Laropiprant in Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0524A-158)
The purpose of this study is to determine the pharmacokinetics of laropiprant following administration of a single dose of 1 (Panel A) and 2 (Panel B) combination tablets of MK-0524A in adolescents with heterozygous familial…
- Trial name
- NCT01583647
- Testing
- MK-0524A
- Volunteers
- 10 people
- Sponsor
- Merck Sharp & Dohme LLC
Homozygous Familial Hypercholesterolemia
Study in Participants With Homozygous Familial Hypercholesterolemia (HoFH)
The primary objective of the study is to demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) with alirocumab subcutaneous (SC) every 2 weeks (Q2W) in comparison to placebo after 12 weeks of treatment.
- Trial name
- ODYSSEY HoFH (NCT03156621)
- Testing
- Alirocumab
- Where
- 28 sites in United States, Austria and 11 more
- Volunteers
- 69 people
- Sponsor
- Regeneron Pharmaceuticals
Hypercholesterolemia, Atherosclerotic Cardiovascular Disease
Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia and Statin Intolerant
The purpose of this study is to determine if bempedoic acid (ETC-1002) is effective and safe versus placebo in patients with elevated LDL cholesterol and who are statin-intolerant.
- Conditions
- Hypercholesterolemia, Atherosclerotic Cardiovascular Disease, Statin Adverse Reaction
- Trial name
- CLEAR Serenity (NCT02988115)
- Testing
- bempedoic acid
- Where
- 67 sites in United States, Canada
- Volunteers
- 345 people
- Sponsor
- Esperion Therapeutics, Inc.
Homozygous Familial Hypercholesterolemia HoFH
Safety and Tolerability of Repatha® (Evolocumab) in Indian Participants With Homozygous Familial Hypercholesterolemia
To describe the safety and tolerability of evolocumab in participants with homozygous familial hypercholesterolemia (HoFH) in India. All participants will receive evolocumab over an 8-week period.
- Trial name
- RAMAN (NCT03403374)
- Testing
- evolocumab
- Where
- 12 sites in India
- Volunteers
- 30 people
- Sponsor
- Amgen
Hypercholesterolemia, Heterozygous Familial
A Study of the Safety and Efficacy of Two Different Regimens of Mipomersen in Patients With Familial Hypercholesterolemia and Inadequately Controlled Low-Density Lipoprotein Cholesterol
Primary objective: Determine whether mipomersen (ISIS 301012) significantly reduces atherogenic lipid levels in patients with severe heterozygous familial hypercholesterolemia (severe HeFH), defined as low-density lipoprotein…
- Trial name
- FOCUS FH (NCT01475825)
- Testing
- mipomersen sodium 200 mg, mipomersen sodium 70 mg
- Where
- 113 sites in United States, Argentina and 28 more
- Volunteers
- 309 people
- Sponsor
- Kastle Therapeutics, LLC
Hyperlipidemias
A Study Evaluating the Safety and Efficacy of Bempedoic Acid Plus Ezetimibe Fixed-Dose Combination Compared to Bempedoic Acid, Ezetimibe, and Placebo in Patients Treated With Maximally Tolerated Statin Therapy
The purpose of this study is to determine if Bempedoic Acid (BA) + Ezetimibe (EZE) in a fixed-dose combination (FDC) is effective and safe versus its individual components and placebo in patients with elevated LDL cholesterol…
- Trial name
- NCT03337308
- Testing
- Bempedoic Acid + Ezetimibe Fixed-Dose Combination, Bempedoic Acid, Ezetimibe
- Where
- 5 sites in United States
- Volunteers
- 382 people
- Sponsor
- Esperion Therapeutics, Inc.
Homozygous Familial Hypercholesterolaemia (HoFH)
Efficacy and Safety of Lomitapide in Paediatric Patients With Homozygous Familial Hypercholesterolaemia (HoFH)
This is a single arm, open label, multi centre phase III study to evaluate the efficacy and long term safety of lomitapide in paediatric patients with HoFH receiving stable lipid lowering therapy (LLT) (including lipoprotein…
- Trial name
- NCT04681170
- Testing
- Lomitapide
- Where
- 12 sites in Germany, Israel and 4 more
- Volunteers
- 46 people
- Sponsor
- Amryt Pharma
Homozygous Familial Hypercholesterolemia
Gene Analysis and Treatment Optimization in Chinese Homozygous Familial Hypercholesterolemia
Identify new or novel genes which may impact on cholesterol level, and establish the relationship between those gene mutations with atherosclerosis, as well as responses to lipid-lowering drugs.
- Trial name
- NCT01878604
- Testing
- Gene analysis, Historical data of lipid-lowering drug administration, Historical data of plasma lipids, xanthoma changes
- Where
- China
- Volunteers
- 5 people
- Sponsor
- Central South University
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
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.
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
Hypercholesterolemia, Familial Hypercholesterolemia
A Study of the Efficacy and Safety of Enclitide Chloride (MK-0616 Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-008)
The purpose of this study is to evaluate the efficacy and safety of enclitide chloride, an oral PCSK9 inhibitor, in lowering low-density lipoprotein cholesterol (LDL-C) in participants with hypercholesterolemia.
- Trial name
- NCT05261126
- Testing
- Enclitide Chloride
- Where
- 63 sites in United States, Germany and 6 more
- Volunteers
- 381 people
- Sponsor
- Merck Sharp & Dohme LLC
Hypercholesterolemia
Evolocumab Compared to LDL-C Apheresis in Patients Receiving LDL-C Apheresis Prior to Study Enrollment
To evaluate the efficacy of subcutaneous (SC) evolocumab, compared to regularly scheduled low-density lipoprotein cholesterol (LDL-C) apheresis, on reducing the need for future apheresis.
- Trial name
- NCT02585895
- Testing
- Evolocumab, Low-density Lipoprotein Cholesterol (LDL-C) Apheresis
- Where
- 17 sites in United States, Australia and 6 more
- Volunteers
- 39 people
- Sponsor
- Amgen
Hypercholesterolaemia
An 8-Week Dose-Finding Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia
Primary Objective: To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 8 weeks of treatment in heterozygous familial hypercholesterolemia (heFH) participants aged of 8 to 17 years…
- Trial name
- ODYSSEY KIDS (NCT02890992)
- Testing
- alirocumab SAR236553 (REGN727), statins, ezetimibe
- Where
- 16 sites in United States, Canada and 8 more
- Volunteers
- 42 people
- Sponsor
- Sanofi
Homozygous Familial Hypercholesterolemia
Evaluate the Efficacy and Safety of Evinacumab in Pediatric Patients With Homozygous Familial Hypercholesterolemia
The primary objective for Part A of the study is to assess the pharmacokinetics (PK) of evinacumab in pediatric patients with homozygous familial hypercholesterolemia (HoFH).
- Trial name
- NCT04233918
- Testing
- Evinacumab
- Where
- 11 sites in United States, Australia and 4 more
- Volunteers
- 20 people
- Sponsor
- Regeneron Pharmaceuticals
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.
Familial Hypercholesterolemia
Long Term, Follow-on Study of Lomitapide in Patients With Homozygous Familial Hypercholesterolemia
This was a long term follow on study to assess the continued long term safety and efficacy of lomitapide in patients with homozygous familial hypercholesterolemia.
- Trial name
- NCT00943306
- Testing
- lomitapide
- Where
- 10 sites in United States, Canada and 2 more
- Volunteers
- 19 people
- Sponsor
- Aegerion Pharmaceuticals, Inc.
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.
Hypercholesterolemia, Familial Hypercholesterolemia
A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Heterozygous Familial Hypercholesterolemia (MK-0616-017/CORALreef HeFH)
The goal of this study is to evaluate the efficacy, safety, and tolerability of enlicitide decanoate in adult participants with heterozygous familial hypercholesterolemia.
- Trial name
- NCT05952869
- Testing
- Enlicitide Decanoate
- Where
- 59 sites in United States, Australia and 15 more
- Volunteers
- 303 people
- Sponsor
- Merck Sharp & Dohme LLC