Clinical trials: Familial Hypercholesterolaemia
Mixed Dyslipidemia, Hypercholesterolaemia
Phase 3 Clinical Study Evaluating Efficacy, Safety, and Tolerability of Obicetrapib Vs Bempedoic Acid to Treat Dyslipidemia in Adults With Primary Non-familial Hypercholesterolemia or Mixed Dyslipidemia at High to Very High Cardiovascular Risk, During a Treatment Period of Approximately 84 Days
This Phase 3, randomized, double-blind, active-controlled study evaluates the efficacy and safety of obicetrapib (OBI) compared to bempedoic acid (BPA) in participants with dyslipidemia at high or very high cardiovascular risk.
- Trial name
- MEDICI (NCT07614958)
- Where
- United Kingdom
- Volunteers
- 426 people
- Sponsor
- A. Menarini International Licensing S.A.
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
Heterozygous Familial Hypercholesterolemia
Study of MGL-3196 in Patients With Heterozygous Familial Hypercholesterolemia (HeFH)
The primary objective of this study is to determine the effect of once-daily oral MGL-3196 on the percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in participants with Heterozygous Familial…
- Trial name
- NCT03038022
- Testing
- MGL-3196 (resmetirom)
- Where
- 13 sites in Denmark, Netherlands and 1 more
- Volunteers
- 116 people
- Sponsor
- Madrigal Pharmaceuticals, Inc.
Lipid Metabolism, Inborn Errors, Hypercholesterolemia, Autosomal Dominant
Study to Assess the Safety and Efficacy of ISIS 301012 (Mipomersen) in Homozygous Familial Hypercholesterolemia
The purpose of this study is to evaluate the safety and efficacy of mipomersen (ISIS 301012) in subjects with homozygous familial hypercholesterolemia on lipid-lowering therapy.
- Conditions
- Lipid Metabolism, Inborn Errors, Hypercholesterolemia, Autosomal Dominant, Hyperlipidemias, Metabolic Diseases
- Trial name
- RADICHOL 1 (NCT00607373)
- Testing
- mipomersen
- Where
- 10 sites in United States, Brazil and 5 more
- Volunteers
- 51 people
- Sponsor
- Kastle Therapeutics, LLC
Atherosclerosis, Heterozygous Familial Hypercholesterolemia
Efficacy and Safety of the ACAT Inhibitor CS-505 (Pactimibe) for Reducing the Progression of Carotid Artery Disease. This Study is Also Known as CAPTIVATE.
The effects of pactimibe versus placebo on the progression of atherosclerosis in the carotid arteries will be assessed using standard ultrasound techniques.
- Trial name
- NCT00151788
- Testing
- Pactimibe sulfate
- Where
- 37 sites in United States, Canada and 7 more
- Volunteers
- 796 people
- Sponsor
- Daiichi Sankyo
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
Low-Density Lipoprotein (LDL) Apheresis Using H.E.L.P. Therapy
The objectives of this post-surveillance study are to continue to evaluate the safety and effectiveness of the H.E.L.P. System. The safety and effectiveness will be assessed by evaluating the occurrence of death, cardiovascular…
- Trial name
- Secura (NCT00916643)
- Testing
- HELP Secura (apheresis treatment)
- Volunteers
- 113 people
- Sponsor
- B. Braun Medical Inc.
Homozygous Familial Hypercholesterolemia
Evaluate the Efficacy and Safety of SHR-1918 in Patients With Homozygous Familial Hypercholesterolemia
This is a single-arm, open-label study to assess the reduction of low-density lipoprotein cholesterol (LDL-C) by SHR-1918 in patients with homozygous familial hypercholesterolemia (HoFH).
- Trial name
- NCT06009393
- Testing
- SHR-1918
- Where
- China
- Volunteers
- 26 people
- Sponsor
- Beijing Suncadia Pharmaceuticals Co., Ltd
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
Type II Hyperlipidaemia
Efficacy and Safety of JTT-705 300, 600 And 900mg in Comparison With Placebo in Patients With Type II Hyperlipidaemia
To demonstrate the effect of JTT-705 doses from 300 mg to 900 mg on the elevation of HDL-C and on the inhibition of CETP activity versus placebo, in patients presenting with mild dyslipidaemia.
- Trial name
- NCT00686010
- Testing
- JTT-705 300mg, JTT-705 600mg, JTT-705 900mg
- Where
- Netherlands
- Volunteers
- 198 people
- Sponsor
- Japan Tobacco 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
Atherosclerotic Cardiovascular Disease, Familial Hypercholesterolemia
Patterns of Inclisiran Use in the Real World: An Analysis of US Databases
This was a retrospective observational cohort study of patients who initiated inclisiran, alirocumab, or evolocumab in a real-world setting in the United States.
- Trial name
- NCT07023445
- Where
- United States
- Volunteers
- 37,688 people
- Sponsor
- Novartis Pharmaceuticals
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.
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
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
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
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
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
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