Clinical trials: Hypercholesterolaemia
Primary Hypercholesterolaemia
A Study to Evaluate the Safety and Pharmacokinetics of AD-228A Compared to Coadministration of AD-2281 and AD-2282
Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of AD-228A in healthy subjects.
- Trial name
- NCT06858865
- Testing
- AD-228A, AD-2281 and AD-2282
- Where
- South Korea
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Addpharma Inc.
Hypercholesterolaemia
Bioequivalence Study of Bempedoic Acid 180 mg Film Coated Tablet and Nilemdo® (Bempedoic Acid) 180 mg Film-coated Tablets
Single dose oral bioequivalence study of Bempedoic Acid 180 mg Film Coated Tablet and Nilemdo® (Bempedoic Acid) 180 mg Film-coated tablets in healthy adult human subjects under fasting conditions.
- Trial name
- NCT07170852
- Testing
- Bempedoic acid film coated tablet, Nilemdo® Film-coated tablets
- Where
- India
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
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
Kidney Transplant, Familial Hypercholesterolaemia
Cardiovascular Risk in Children With Chronic Conditions Study
Children living with chronic health conditions face a higher risk of developing cardiovascular diseases than their peers, largely due to the accelerated aging of the heart and blood vessels.
- Conditions
- Kidney Transplant, Familial Hypercholesterolaemia, Type 1 Diabetes Mellitus (T1DM), Type 2 Diabetes Mellitus (T2DM)
- Trial name
- CR3C (NCT07086989)
- Where
- 3 sites in Hungary
- Volunteers
- 300 people
- Sponsor
- Semmelweis University
HIV, Hypercholesterolaemia
Treatment With Rosuvastatin Versus Switching PI (Protease Inhibitor) in Patients HIV With High Cholesterol Levels
To compare the effect of rosuvastatin to protease inhibitor switching on fasting total cholesterol over 12 weeks.
- Trial name
- SOS (NCT01935674)
- Testing
- Switch ritonavir-boosted PI, Continue Ritonavir-boosted PI+Rosuvastatin
- Where
- Spain
- Volunteers
- 43 people
- Sponsor
- Juan A. Arnaiz
Hypertension, Primary Hypercholesterolaemia
To Evaluate the Efficacy and Safety of Co-administrated HODO-2224-1 and HODO-2224-2 in Patients With Essential Hypertension and Primary Hypercholesterolemia
A Multicenter, Randomized, Double-blind, Active-controlled, Parallel group, Phase 3 trial to Evaluate the Efficacy and Safety of Co-administrated HODO-2224-1 and HODO-2224-2 in Patients with Essential Hypertension and Primary…
- Trial name
- HODO-2224 (NCT06646354)
- Testing
- Ezetimibe/Rosuvastatin/Candesartan/Amlodipine, Candesartan/Amlodipine, Candesartan/Rosuvastatin/Ezetimibe
- Where
- South Korea
- Volunteers
- 125 people
- Sponsor
- Hyundai Pharm
Hypercholesterolaemia, Mixed Dyslipidaemia
Single Dose Oral Bioequivalence Study of Bempedoic Acid 180 mg Film Coated Tablet and Nilemdo® (Bempedoic Acid) 180 mg Film-coated Tablets in Healthy Adult Human Subjects Under Fasting Conditions.
Single dose oral bioequivalence study of Bempedoic Acid 180 mg Film Coated Tablet and Nilemdo® (Bempedoic Acid) 180 mg Film-coated tablets in healthy adult human subjects under fasting conditions.
- Conditions
- Hypercholesterolaemia, Mixed Dyslipidaemia, Cardiovascular Diseases
- Trial name
- NCT06923956
- Testing
- Bempedoic Acid Film Coated Tablet, Nilemdo® (Bempedoic Acid) Film-coated tablets
- Where
- India
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Primary Hypercholesterolaemia and Mixed Dyslipidaemia, Atherosclerotic Cardiovascular Disease
Non-interventional Study on the Monthly Administration of 300 mg AliRocumab (PRALUENT®) With the 2 ml SYDNEY Auto-injector
Primary objectives: To assess the effectiveness of the PRALUENT® 2 ml SYDNEY auto-injector as measured by the lipid-lowering effect of alirocumab after approx.
- Trial name
- MARS (NCT05129241)
- Where
- Germany
- Volunteers
- 163 people
- Sponsor
- Sanofi
Primary Hypercholesterolaemia
A Study to Compare PK Characteristics and Safety Profiles Between AD-228B and AD-2284
Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of AD-228B in healthy subjects.
- Trial name
- NCT06884098
- Testing
- AD-228B, AD-2284
- Where
- South Korea
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Addpharma Inc.
Hypercholesterolaemia
A Study of PCSK9 Inhibitor AK102 in Healthy Subjects
This is a first-in-human,randomized, double-blind, placebo-controlled, single dose escalation, phase 1 study to evaluate the safety, tolerability, PK/PD and immunogenicity of AK102 administered subcutaneously in healthy subjects.
- Trial name
- NCT04169386
- Testing
- AK102
- Where
- China
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Akeso
Primary Hypercholesterolaemia and Mixed Dyslipidemia
Efficacy and Safety of JS002 as Monotherapy in Patients With Primary Hypercholesterolaemia and Mixed Dyslipidemia
JS002 is a recombinant humanized anti-PCSK9 monoclonal antibody. This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, PK/PD profile, immunogenicity as well as complete delivery of…
- Trial name
- NCT05621070
- Testing
- JS002
- Where
- China
- Volunteers
- 582 people
- Sponsor
- Shanghai Junshi Bioscience Co., Ltd.
Hypercholesterolaemia, Hyperlipidaemia
TWICE (Ezetimibe Together With Any Statin Cholesterol Enhancement)(0653-060)
In patients with primary hypercholesterolemia treated with a statin and with ldl-c above the recommended target goal (esc 2003 recommendations ldl>=1.15 g/l) to compare the efficacy and the safety of ezetrol added to ongoing…
- Trial name
- NCT00328523
- Testing
- MK-0653, ezetimibe, Duration of Treatment: 3 months
- Volunteers
- 1,496 people
- Sponsor
- Organon and Co
Hypercholesterolaemia, Atherosclerosis
Ezetimibe Plus Simvastatin Versus Simvastatin in Untreated Subjects With High Cholesterol (P03435)
This study will assess whether co-administration of ezetimibe 10 mg with simvastatin 20 mg will be more effective than treatment with simvastatin 20 mg alone in reducing LDL-C concentrations when administered for 6 weeks.
- Trial name
- NCT00653835
- Testing
- Ezetimibe + Simvastatin, Simvastatin
- Volunteers
- 153 people
- Sponsor
- Organon and Co
Hypercholesterolaemia
Chart Review of Repatha® in Subjects With Hyperlipidaemia
Review of clinical characteristics of patients who are prescribed Repatha® and how their treatment is managed.
- Trial name
- HEYMANS (NCT02770131)
- Where
- 183 sites in Austria, Belgium and 10 more
- Volunteers
- 1,986 people
- Sponsor
- Amgen
Familial Hypercholesterolemia, Polygenic Hypercholesterolaemia
Universal Familial Hypercholesterolemia Screening in Children
30 million individuals globally with undiagnosed familial hypercholesterolemia (FH) are at a substantial cardiovascular disease (CVD) risk, which could be normalized by early diagnosis and treatment.
- Trial name
- NCT04507984
- Testing
- Genetic analysis, Lipid levels measurement
- Where
- 2 sites in Germany, Slovenia
- Volunteers
- 17,000 people
- Sponsor
- University of Ljubljana, Faculty of Medicine
Hypercholesterolaemia
An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia
Primary Objective: To evaluate the efficacy of alirocumab administered every 2 weeks (Q2W) and every 4 weeks (Q4W) versus placebo after 24 weeks of double-blind (DB) treatment on low-density lipoprotein cholesterol (LDL-C) levels…
- Trial name
- NCT03510884
- Testing
- Alirocumab SAR236553 (REGN727), Rosuvastatin, Atorvastatin
- Where
- 43 sites in United States, Argentina and 22 more
- Volunteers
- 153 people
- Sponsor
- Sanofi
Familial Hypercholesterolaemia
Pilot Project of Familial Hypercholesterolemia Screening in Newborns in the Czech Republic
The project is a national, prospective, multicenter, non-interventional pilot project of screening for the disease Familial hypercholesterolaemia (FH) in newborns in the Czech Republic.
- Trial name
- CzeCH-IN (NCT05638022)
- Testing
- Total cholesterol (TC) level test and direct Low density lipoprotein cholesterol (LDL-C) level test, DNA testing
- Where
- 11 sites in Czechia
- Volunteers
- 10,000 people, healthy volunteers welcome
- Sponsor
- Institute of Health Information and Statistics of the Czech Republic
Healthy Volunteers, Hypercholesterolaemia
A Research Study Investigating How NNC0385-0434 is Tolerated in People With or Without High Cholesterol Levels
In this study, there are two study medicines: NNC0385-0434 (the new medicine being tested) and placebo (a 'dummy' medicine). Participants will only get one of these medicines - which one is decided by chance.
- Trial name
- NCT04058834
- Testing
- NNC0385-0434
- Where
- United Kingdom
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Hypercholesterolaemia
Carotid Atorvastatin Study in Hyperlipidemic Post-Menopausal Women
To evaluate the effect of atorvastatin 80 mg, versus placebo, given for 12 months on carotid intima-media thickness in postmenopausal women with moderate hypercholesterolemia.
- Trial name
- NCT00163163
- Testing
- Echographic measurements, Blood samples
- Where
- 69 sites in Belgium, France and 1 more
- Volunteers
- 400 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Hypercholesterolaemia, Pregnancy
Study to Evaluate the Safety of Repatha® in Pregnancy
To evaluate pregnancy and infant outcomes among females diagnosed with familial hypercholesterolaemia (FH), exposed to Repatha® during pregnancy. This includes follow-up of their infants to the age of 12 months
- Trial name
- NCT02906124
- Where
- 48 sites in Australia, Austria and 12 more
- Volunteers
- 4 people
- Sponsor
- Amgen