Clinical trials: Familial Hypercholesterolaemia
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
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.
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
Hypercholesterolemia, Familial
Reduction of Low-Density Lipoprotein Cholesterol (LDL-C) With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder Study
The primary objective of this study was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145), compared with placebo, on percent change from baseline in LDL-C in adults with heterozygous familial…
- Trial name
- RUTHERFORD (NCT01375751)
- Testing
- Evolocumab
- Volunteers
- 168 people
- Sponsor
- Amgen
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
Familial Hypercholesterolemia
Penn Family Screening for Familial Hypercholesterolemia
The goal of this clinical trial is to test two implementation strategies (automated health system [Penn Medicine]-mediated strategy vs.
- Trial name
- NHLBI-R33 (NCT05750667)
- Testing
- Cascade screening
- Where
- United States
- Volunteers
- 800 people
- Sponsor
- Northwestern University
Refractory Hypercholesterolemia, Familial Hypercholesterolemia
Safety and Efficacy Study of NGGT006 in Refractory Hypercholesterolemia Patients
This is an early phase 1, open-label, single-center, dose-escalation pilot trial to evaluate the safety and efficacy of an intravenous infusion of NGGT006 in patients with refractory Hypercholesterolemia diagnosed by gene testing…
- Trial name
- NCT06293729
- Testing
- NGGT006
- Volunteers
- 9 people
- Sponsor
- Suzhou Municipal Hospital
Atherosclerosis, Hypercholesterolemia
Effect of Ezetimibe Plus Simvastatin Versus Simvastatin Alone on Atherosclerosis in the Carotid Artery (ENHANCE)(P02578)
The purpose of the study is to determine whether ezetimibe plus simvastatin will be more effective than simvastatin alone in preventing progression of atherosclerosis of the inner layer of the carotid artery.
- Conditions
- Atherosclerosis, Hypercholesterolemia, Hyperlipoproteinemia Type II
- Trial name
- ENHANCE (NCT00552097)
- Testing
- ezetimibe (plus simvastatin)
- Volunteers
- 720 people
- Sponsor
- Organon and Co
Healthy, Hypercholesterolemia
In Vitro Demonstration of Direct Platelet-Related Effects of PCSK9 Enzyme
Proprotein convertase subtilisin/kexin type 9 (PCSK9) has evolved as a pivotal enzyme in lipid metabolism and therapeutic target for hypercholesterolemia and atherosclerotic cardiovascular disease (CVD).
- Conditions
- Healthy, Hypercholesterolemia, Hypertension, Overweight
- Trial name
- NCT06675994
- Testing
- PCSK9 Antibody, PCSK9 Enzyme
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- LifeBridge Health
Familial Hypercholesterolemia - Homozygous
Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Homozygous Familial Hypercholesterolemia
This was a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in adolescents with homozygous familial hypercholesterolemia (HoFH) and elevated low density lipoprotein cholesterol (LDL-C).
- Trial name
- ORION-13 (NCT04659863)
- Testing
- Inclisiran
- Where
- 11 sites in United States, Canada and 6 more
- Volunteers
- 13 people
- Sponsor
- Novartis Pharmaceuticals
Hypercholesterolemia, Hypercholesterolemia, Familial
Evaluating the Efficacy of Pediatric Lipid Screening Alerts
The purpose of the study is to evaluate prospectively the impact of different system alerts on the prescription of lipid panels to pediatric Geisinger patients (9-11 years old), as per the now-universal guidelines.
- Conditions
- Hypercholesterolemia, Hypercholesterolemia, Familial, Hypercholesteremia in Children, Hyperlipidemia in Children
- Trial name
- NCT04118348
- Testing
- Best Practice Alert, Health Maintenance Topic
- Where
- United States
- Volunteers
- 13,340 people
- Sponsor
- Geisinger Clinic
Homozygous Familial Hypercholesterolemia
The Rogosin Institute Homozygous Familial Hypercholesterolemia Repository
This repository will establish for the first time a system to carefully assess and monitor over time the general health and the amount of cholesterol in the arteries of U.S.
- Trial name
- NCT01109368
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- The Rogosin Institute
Familiar Hypercholesterolemia
High Intensity Interval Training in the Treatment of Familial Hypercholesterolemia (UPPA-FH)
This study has one main objective: a) To assess the impact of two different supervised exercise interventions on cardiorespiratory fitness and markers of subclinical atherosclerosis in patients with Familiar Hipercolesterolemia…
- Trial name
- UPPA-FH (NCT06833944)
- Testing
- HIIT intervention program, MICT intervention program
- Where
- Spain
- Volunteers
- 75 people
- Sponsor
- Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
Familial Hypercholesterolemia
Phase I Study of Ex Vivo Liver-Directed Gene Therapy for Familial Hypercholesterolemia
OBJECTIVES: I. Develop an approach for treating patients with homozygous familial hypercholesterolemia using gene therapy with autologous hepatocytes transduced with a normal low-density lipoprotein receptor gene.
- Trial name
- NCT00004809
- Testing
- gene therapy
- Volunteers
- 5 people
- Sponsor
- National Center for Research Resources (NCRR)
Atherosclerotic Cardiovascular Disease, Hypercholesterolemia
A Real-world Study of Inclisiran Adherence, Treatment Patterns, Patient Characteristics, and Effectiveness in ASCVD Patients With Hypercholesterolemia, ASCVD-risk Equivalent Patients With Hypercholesterolemia and Familial Hypercholesterolemia
This was a descriptive, non-interventional, retrospective cohort study among patients with atherosclerotic cardiovascular disease (ASCVD) and hypercholesterolemia, ASCVD-risk equivalent (ASCVD-RE) or familial hypercholesterolemia…
- Trial name
- NCT06507852
- Where
- United States
- Volunteers
- 95 people
- Sponsor
- Novartis
Hypercholesterolemia, Familial, Calcification; Heart
Diet Quality and Coronary Artery Calcification in Adults With Heterozygous Familial Hypercholesterolemia
The overarching objective is to evaluate the relationship between diet and coronary artery calcification in patients with heterozygous familial hypercholesterolemia (HeFH). We will recruit adults with HeFH.
- Conditions
- Hypercholesterolemia, Familial, Calcification; Heart, Diet Habit
- Trial name
- FH-CAC (NCT04837638)
- Testing
- Diet
- Where
- Canada
- Volunteers
- 258 people, healthy volunteers welcome
- Sponsor
- Laval University
Dyslipidaemia
48-wk Open Label Phase IIIb to Evaluate Efficacy and Safety
The purpose of this study is to assess the efficacy and safety of rosuvastatin in reducing low density lipoprotein cholesterol levels to internationally recognised goals in subjects with dyslipidaemia.
- Trial name
- NCT00654602
- Testing
- Rosuvastatin, Maintenance of specific diet
- Volunteers
- 1,500 people
- Sponsor
- AstraZeneca
Familial Hypercholesterolemia
IN-TANDEM Familial Hypercholesterolemia Pilot Study
The purpose of this study is to validate the use of the FH Foundation FIND FH® Algorithm as a clinical decision support tool. FIND FH (Flag/Identify/Network/Engage) is a national initiative that utilizes machine learning and data…
- Trial name
- NCT03253432
- Testing
- Genetic testing
- Where
- 2 sites in United States
- Volunteers
- 378 people, healthy volunteers welcome
- Sponsor
- University of Pennsylvania
Familial Hypercholesterolemia
A Study of the Safety and Efficacy of Patients With Familial Hypercholesterolaemia Taking Colesevelam as add-on Therapy to Their Existing Medication
This study is designed to assess whether colesevelam given as third line treatment added to a maximal tolerated and stable dose of a statin and ezetimibe is able to further decrease the level of LDL cholesterol in a safe and…
- Trial name
- NCT00655265
- Testing
- Colesevelam hydrochloride film-coated tablets
- Where
- 8 sites in France, Germany and 3 more
- Volunteers
- 86 people
- Sponsor
- Genzyme, a Sanofi Company
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