Clinical trials: Familial Hypercholesterolemia
Hypercholesterolemia
Evaluating Effect of the Study Drug Praluent (Alirocumab) on Neurocognitive Function When Compared to Placebo
The main purpose of this study is to evaluate the effect on mental state (known as "neurocognitive function") with use of Praluent.
- Trial name
- NCT02957682
- Testing
- Praluent (Alirocumab)
- Where
- 188 sites in United States, Bulgaria and 7 more
- Volunteers
- 2,176 people
- Sponsor
- Regeneron Pharmaceuticals
Hypercholesterolemia, Atherosclerotic Cardiovascular Disease
Assessment of the Long-Term Safety and Efficacy of Bempedoic Acid (CLEAR Harmony OLE)
The purpose of this study is to see if bempedoic acid (ETC-1002) is safe and well-tolerated in patients with high cardiovascular risk and elevated LDL cholesterol that is not adequately controlled by their current therapy.
- Trial name
- NCT03067441
- Testing
- bempedoic acid
- Where
- 3 sites in United States
- Volunteers
- 1,462 people
- Sponsor
- Esperion Therapeutics, Inc.
Hypercholesterolemia
Open Label Study of Long Term Safety Evaluation of Alirocumab
Primary Objective: To assess the long-term safety of alirocumab (SAR236553/REGN727) when added to lipid-lowering therapy in participants with heterozygous familial hypercholesterolemia (heFH) who had completed EFC12492…
- Trial name
- ODYSSEY OLE (NCT01954394)
- Testing
- Alirocumab, Lipid-Modifying Therapy (LMT)
- Where
- 177 sites in United States, Argentina and 22 more
- Volunteers
- 986 people
- Sponsor
- Sanofi
Familial Hypercholesterolemia
A Study to Determine the Safety, Tolerability, and Efficacy of SHR-1209 in Patients With Familial Hypercholesterolemia
The study is being conducted to evaluate the efficacy, safety and tolerability of SHR-1209 in subjects with familial hypercholesterolemia.
- Trial name
- NCT04455581
- Testing
- SHR-1209
- Volunteers
- 8 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Hypercholesterolemia
Efficacy and Safety Evaluation of Alirocumab in Patients With Heterozygous Familial Hypercholesterolemia or High Cardiovascular Risk Patients With Hypercholesterolemia on Lipid Modifying Therapy (ODYSSEY JAPAN)
Primary Objective: To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable daily statin therapy with or without other lipid modifying therapy in comparison with…
- Trial name
- NCT02107898
- Testing
- Alirocumab, Lipid-Modifying Therapy (LMT)
- Where
- 32 sites in Japan
- Volunteers
- 216 people
- Sponsor
- Sanofi
Familial Hypercholesterolemia - Homozygous
Study to Evaluate Safety, Tolerability and Efficacy of Inclisiran in Children With Homozygous Familial Hypercholesterolemia
This is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in children (aged 2 to <12 years) with homozygous familial hypercholesterolemia (HoFH) and elevated low density lipoprotein…
- Trial name
- ORION-19 (NCT06597006)
- Testing
- Inclisiran
- Where
- 19 sites in United States, Austria and 9 more
- Volunteers
- 9 people
- Sponsor
- Novartis Pharmaceuticals
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.
Hypercholesterolemia
Safety and Efficacy of IBI306 in Chinese Subjects With Non-familial Hypercholesterolemia
IBI306 is a fully human monoclonal antibody that binds proprotein convertase substilisin/kexin type 9 (PCSK-9), preventing its interaction with the low-density lipoprotein cholesterol receptor (LDL-R) and thereby restoring LDL-R…
- Trial name
- NCT04289285
- Testing
- IBI306 450mg SC Q4W, IBI306 600mg SC Q6W
- Where
- China
- Volunteers
- 804 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Hypercholesterolemia, Heterozygous Familial Hypercholesterolemia
Open-Label Extension of Study R727-CL-1003 (NCT01266876) to Evaluate the Long-Term Safety and Efficacy of Alirocumab (REGN727) in Participants With Heterozygous Familial Hypercholesterolemia (HeFH)
The primary objective of the study was to assess the long-term safety and tolerability of alirocumab in patients with heFH who were receiving concomitant treatment with hydroxymethyl glutaryl-coenzyme A (HMG-CoA) reductase…
- Trial name
- NCT01576484
- Testing
- Alirocumab
- Where
- 14 sites in United States, Canada
- Volunteers
- 58 people
- Sponsor
- Regeneron Pharmaceuticals
Hyperlipoproteinemia Type II, Homozygous Familial Hypercholesterolemia
Efficacy and Tolerability of Anacetrapib Added to Ongoing Lipid-Lowering Therapy in Adult Participants With Homozygous Familial Hypercholesterolemia (HoFH) (MK-0859-042)
This study will evaluate the safety and effect of anacetrapib on low-density lipoprotein-cholesterol (LDL-C) when added to ongoing lipid-lowering therapy.
- Trial name
- NCT01841684
- Testing
- Anacetrapib
- Volunteers
- 2 people
- Sponsor
- Merck Sharp & Dohme LLC
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
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
Type II Hyperlipidemia
A Safety and Efficacy Study of DRL-17822, a Cholesteryl Ester Transfer Protein (CETP) Inhibitor, in Patients With Abnormal Cholesterol Levels
The purpose of this study is to determine if a new drug, DRL-17822, is safe and effective in elevating high density lipoprotein cholesterol (HDL-C) and reducing low density lipoprotein cholesterol (LDL-C) in people with abnormal…
- Trial name
- NCT01388816
- Where
- 12 sites in Italy, Poland and 1 more
- Volunteers
- 176 people
- Sponsor
- Dr. Reddy's Laboratories Limited
Heterozygous Familial Hypercholesterolemia
Study of Alirocumab (REGN727/SAR236553) in Patients With heFH (Heterozygous Familial Hypercholesterolemia) Who Are Not Adequately Controlled With Their LMT (Lipid-Modifying Therapy)
This is a randomized, double-blind, placebo-controlled, parallel-group, multi-national study alirocumab (REGN727/SAR236553) in patients with Heterozygous Familial Hypercholesterolemia (heFH) who are not adequately controlled with…
- Trial name
- ODYSSEY FH II (NCT01709500)
- Testing
- LMT (atorvastatin, simvastatin, or rosuvastatin), alirocumab
- Where
- 24 sites in Czechia, Netherlands and 2 more
- Volunteers
- 249 people
- Sponsor
- Regeneron Pharmaceuticals
Hypercholesterolemia, Familial Hypercholesterolemia
Long Term Post Marketing Specified Drug Use Result Survey for Evolocumab in Japan
The purpose of this post-marketing survey is to obtain real-world information on the safety and effectiveness of evolocumab in Japan.
- Trial name
- NCT02808403
- Testing
- No intervention
- Where
- 138 sites in Japan
- Volunteers
- 6,000 people
- Sponsor
- Amgen
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.
Healthy
A Study to Assess Any Potential Interaction Between Colesevelam and Ciclosporin in Healthy Volunteers
This study is designed to assess any potential interaction between colesevelam and ciclosporin in healthy volunteers.
- Trial name
- NCT00692250
- Testing
- Colesevelam hydrochloride film-coated tablets (Cholestagel)
- Where
- Netherlands
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Genzyme, a Sanofi Company
Hyperlipidemia
Reduction of LDL-C With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder Study-2
The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneously once every 2 weeks (Q2W) and once monthly (QM), compared with placebo, on percent change from baseline in low-density lipoprotein…
- Trial name
- RUTHERFORD-2 (NCT01763918)
- Testing
- Evolocumab
- Where
- 39 sites in United States, Australia and 12 more
- Volunteers
- 331 people
- Sponsor
- Amgen
Heterozygous Familial Hypercholesterolemia
Exploratory Study of Plaque Regression
Despite the availability of several classes of very effective drugs available to treat heterozygous Familial Hypercholesterolemia (HeFH), there remains a large unmet medical need for new, effective and well tolerated therapies.
- Trial name
- EXPRESS (NCT01515241)
- Testing
- CER-001
- Where
- Canada
- Volunteers
- 10 people
- Sponsor
- Cerenis Therapeutics, SA
Hypercholesterolemia
Efficacy of Lapaquistat Acetate Co-Administered With Current Lipid-Lowering Treatment on Blood Cholesterol Levels in Subjects With Homozygous Familial Hypercholesterolemia
The purpose of the study is to determine the efficacy of lapaquistat acetate, once daily (QD), to lower cholesterol in subjects with homozygous familial hypercholesterolemia undergoing lipid-lowering treatment.
- Trial name
- NCT00263081
- Testing
- Lapaquistat acetate and current lipid-lowering treatment, Current lipid-lowering treatment
- Where
- 10 sites in United States, Canada and 4 more
- Volunteers
- 44 people
- Sponsor
- Takeda