Clinical trials: Hyperlipoproteinemia Type II
Familial Hypercholesterolemia, Lipid Disorder
Familial Hypercholesterolemia Canada / Hypercholesterolemie Familiale Canada
Familial hypercholesterolemia (FH) is the most frequent genetic lipoprotein disorder associated with premature CAD. In Canada, the burden of disease is estimated to be approximately 83,500 patients.
- Trial name
- FHCanada (NCT02009345)
- Where
- Canada
- Volunteers
- 6,000 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
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
Cardiovascular Disease With Mention of Arteriosclerosis, Elevated Cholesterol
Long-term Efficacy and Safety of OLE LIB003 in HoFH, HeFH, and High-risk CVD Patients Requiring Further LDL-C Reduction
The study is to assess the long-term safety, tolerability, and efficacy after 48 and 72 weeks with monthly (Q4W [<31 days]) dosing of subcutaneous (SC) LIB003 300 mg administered in patients with CVD or at high risk for CVD…
- Conditions
- Cardiovascular Disease With Mention of Arteriosclerosis, Elevated Cholesterol, Familial Hypercholesterolemia
- Trial name
- LIBerate-OLE (NCT04798430)
- Testing
- lerodalcibep
- Where
- 12 sites in United States, India and 4 more
- Volunteers
- 2,000 people
- Sponsor
- LIB Therapeutics LLC
Primary Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH)
Vytorin Reexamination Study (0653A-174)
This survey is conducted for preparing application material for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of VYTORIN through collecting…
- Trial name
- NCT01070966
- Volunteers
- 2,089 people
- Sponsor
- Organon and Co
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
Hypercholesterolemia, Familial Hypercholesterolemia
A 52-week Post-marketing, Observational Study to Confirm the Safety and Efficacy of Zetia Alone or in Combination With Other Lipid-lowering Drugs in Japanese Subjects With Hypercholesterolemia (Study P05245)
This study is a non-interventional (observational) study in Japan to confirm the safety and efficacy of Zetia when administered alone or in combination with other lipid-lowering drugs in daily medical practice throughout a…
- Conditions
- Hypercholesterolemia, Familial Hypercholesterolemia, Homozygous Sitosterolemia
- Trial name
- NCT00705211
- Testing
- Ezetimibe, Ezetimibe + other lipid-lowering medication(s)
- Volunteers
- 1,794 people
- Sponsor
- Organon and Co
Familial Hypercholesterolemia
EAS Familial Hypercholesterolaemia Studies Collaboration
Familial hypercholesterolaemia (FH) is a common genetic disorder resulting in marked elevations in low-density lipoprotein cholesterol (LDL-C).
- Trial name
- FHSC (NCT04272697)
- Where
- United Kingdom
- Volunteers
- 75,000 people, healthy volunteers welcome
- Sponsor
- Imperial College London
Homozygous Familial Hypercholesterolemia (HoFH)
A Study to Evaluate the Safety of Rosuvastatin in Children and Adolescents With Homozygous Familial Hypercholesterolemia
The purpose of the study is to evaluate the safety of Rosuvastatin in Children and Adolescents with Homozygous Familial Hypercholesterolemia.
- Trial name
- NCT02434497
- Testing
- Rosuvastatin 20mg
- Where
- 6 sites in Belgium, Canada and 4 more
- Volunteers
- 9 people
- Sponsor
- AstraZeneca
Familial Hypercholesterolemia
Implitapide in Patients With Homozygous Familial Hypercholesterolemia (HoFH) 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
- NCT00079846
- Testing
- Implitapide
- Where
- 6 sites in United States, Canada and 3 more
- Volunteers
- 60 people
- Sponsor
- Medical Research Laboratories International
Familial Hypercholesterolaemia, Hypercholesterolaemia
Specified Drug-use Survey of Leqvio for s.c. Injection.
The objective of this study is to evaluate the long-term safety of Leqvio in patients with familial hypercholesterolaemia or hypercholesterolaemia in post-marketing clinical practice
- Trial name
- NCT06275724
- Testing
- inclisiran
- Where
- 107 sites in Japan
- Volunteers
- 585 people
- Sponsor
- Novartis Pharmaceuticals
Hypercholesterolemia, Familial
Is Family Screening Improved by Genetic Testing of Familial Hypercholesterolemia
To test the hypothesis that in patients with a clinical diagnosis of familial hypercholesterolemia (FH), genetic testing and identification of a causative mutation might enhance the success of family-based cascade screening.
- Trial name
- IFIGhTFH (NCT04526457)
- Testing
- Standard of Care, Genetic Testing
- Volunteers
- 240 people
- Sponsor
- University of Pennsylvania
Hypercholesterolemia
Safety and Tolerability Study of Ezetimibe (SCH 058235/MK-0653) Plus Atorvastatin or Simvastatin in Homozygous Familial Hypercholesterolemia (P01417/MK-0653-019)
The primary purpose of this study is to evaluate the long-term safety and tolerability of ezetimibe (SCH 058235/MK-0653) 10 mg dosed daily and co-administered with either atorvastatin or simvastatin for up to 24 months in…
- Trial name
- NCT03885921
- Testing
- Ezetimibe, Atorvastatin, Simvastatin
- Volunteers
- 44 people
- Sponsor
- Organon and Co
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
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
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
Developing and Implementing Familial Hypercholesterolemia Registry
Familial hypercholesterolemia (FH) is a most prevalent genetic disorder define as high cholesterol level and premature death. The prevalence of FH reported in few countries however unknown in Iran.
- Trial name
- NCT02865694
- Testing
- Cascade
- Where
- Iran
- Volunteers
- 500 people
- Sponsor
- Isfahan University of Medical Sciences
Familial Hypercholesterolemia - Heterozygous
Study to Evaluate the Efficacy and Safety of Lerodalcibep in Children 6 to 17 Years, With Heterozygous FH
The goal of this clinical trial is to assess the LDL-Cholesterol reductions at Week 12 and Week 24 with monthly dosing of lerodalcibep (Lerochol) 300 mg administered subcutaneously by auto-injector (AI)/pre-filled pen (PFP)…
- Trial name
- LIBerateKids (NCT07102511)
- Testing
- lerodalcibep 300 mg Monthly SC
- Where
- 7 sites in United States, Israel and 4 more
- Volunteers
- 150 people
- Sponsor
- LIB Therapeutics LLC
Lysosomal Acid Lipase Deficiency
A Study to Identify and Characterize LAL-D Patients in High-risk Populations
The objective of this study is to determine the frequency of Lysosomal Acid Lipase Deficiency (LAL D) by lysosomal acid lipase (LAL) enzyme activity assay in patients who are considered to be at risk.
- Trial name
- NCT02345421
- Where
- 15 sites in United States
- Volunteers
- 640 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
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
Homozygous Familial Hypercholesterolemia
Effect of CER-001 on Plaque Volume in Homozygous Familial Hypercholesterolemia (HoFH) Subjects
The available medications used to treat HoFH are targeted at reducing circulating levels of total and LDL-cholesterol. These measures can retard the progression of cardiovascular disease, however, they are unlikely to regress…
- Trial name
- MODE (NCT01412034)
- Testing
- CER-001
- Where
- 9 sites in United States, Canada and 3 more
- Volunteers
- 23 people
- Sponsor
- Cerenis Therapeutics, SA