Clinical trials: Elevated LDL-C
Primary Hypercholesterolemia, Mixed Dyslipidemia
Study to Assess in Home Use of Evolocumab (AMG 145) Administration Using Either an Automated Mini-doser or a Prefilled Autoinjector/Pen
The primary objective of this study was to assess users' ability to administer a full dose of evolocumab in a home-use setting using either an automated mini-doser (AMD) or autoinjector/pen (AI/pen).
- Trial name
- NCT01879319
- Testing
- Evolocumab AMD, Evolocumab AI/pen
- Where
- 27 sites in United States, Canada
- Volunteers
- 164 people
- Sponsor
- Amgen
ASCVD, Risk Factor, Cardiovascular
Inclisiran for Subjects With ASCVD or ASCVD-Risk Equivalents and Elevated Low-density Lipoprotein Cholesterol
This is a Phase III, placebo-controlled, double-blind, randomized study in participants with ASCVD or ASCVD-Risk equivalents and elevated LDL-C despite maximum tolerated dose of LDL-C lowering therapies to evaluate the efficacy…
- Conditions
- ASCVD, Risk Factor, Cardiovascular, Elevated Cholesterol
- Trial name
- ORION-11 (NCT03400800)
- Testing
- Inclisiran Sodium
- Where
- 70 sites in Czechia, Germany and 5 more
- Volunteers
- 1,617 people
- Sponsor
- The Medicines Company
Primary Hypercholesterolemia or Mixed Hyperlipidemia
Study of QLC7401 in the Treatment of Primary Hypercholesterolemia or Mixed Hyperlipidemia With Elevated LDL Cholesterol
To evaluate the efficacy, safety, pharmacodynamics and immunogenicity of QLC7401 subcutaneous administration in patients with primary hypercholesterolemia or mixed hyperlipidemia with poorly controlled LDL-C elevated on optimized…
- Trial name
- NCT06750341
- Testing
- QLC7401
- Volunteers
- 156 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Hypercholesteremia
A 12-Week, Phase 2 Study of Gemcabene in Hypercholesterolemia Patients on Stable Moderate and High-Intensity Statins
The purpose of this study was to assess the efficacy, safety, and tolerability of multiple doses of gemcabene 600 mg QD compared to placebo in patients with hypercholesterolemia not adequately controlled on high-intensity or…
- Trial name
- ROYAL-1 (NCT02634151)
- Testing
- Gemcabene
- Where
- 24 sites in United States
- Volunteers
- 105 people
- Sponsor
- NeuroBo Pharmaceuticals Inc.
Coronary Arteriosclerosis, Diabetes Mellitus, Type 2
Benefits Of Using Various Starting Doses Of Atorvastatin On Achievement Of Cholesterol Targets
European physicians tend to always use the lowest dose of statins to initiate therapy even in subjects who require large reductions in cholesterol.
- Conditions
- Coronary Arteriosclerosis, Diabetes Mellitus, Type 2, Cerebrovascular Accident, Dyslipidemia
- Trial name
- ACTFAST 2 (NCT00442325)
- Testing
- Atorvastatin (Lipitor)
- Where
- 32 sites in Greece, Hungary and 6 more
- Volunteers
- 595 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Fatty Liver, Dyslipidemias
Atorvastatin Versus Vitamin E in Treatment of Non-alcoholic Fatty Liver Disease
The purpose of the study is to compare the impact of atorvastatin 20mg qd and Vitamin E 300mg qd therapy on liver fat content in patients with type 2 diabetes associated with high LDL-C and non-alcoholic fatty liver disease.
- Conditions
- Fatty Liver, Dyslipidemias, Diabetes Mellitus
- Trial name
- NCT01720719
- Testing
- atorvastatin, Vitamin E
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Xin Gao
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
Hyperlipidemia
Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects
The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145), compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in patients with…
- Trial name
- GAUSS (NCT01375764)
- Testing
- Evolocumab, Ezetimibe
- Where
- 42 sites in United States, Australia and 6 more
- Volunteers
- 160 people
- Sponsor
- Amgen
Macular Edema, Diabetes Mellitus
Laser and Antioxidant Treatment of Diabetic Macular Edema
This study will compare the side effects of two laser treatments for diabetic macular edema, a common condition in patients with diabetes.
- Trial name
- NCT00055042
- Testing
- Vitamin E
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- National Eye Institute (NEI)
Healthy Participants, Dyslipidemia
A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4954 in Healthy Adult Participants With or Without Elevated Lipoprotein (a) (Lp[a]) Levels, and Participants With Dyslipidemia
The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple ascending doses of AZD4954 in healthy participants with or without elevated Lipoprotein(a)…
- Trial name
- NCT06980428
- Testing
- AZD4954
- Where
- 6 sites in United States
- Volunteers
- 136 people
- Sponsor
- AstraZeneca
Hypercholesterolemia
Study in High Risk Patients Switched From Higher Doses of Other Statins to Crestor on the Percentage of Patients Reaching the New LDL-C Target Goal
The purpose of this study is to determine the efficacy of Crestor in high risk patients switched from higher doses of other statins in obtaining the new European Atherosclerosis Society (EAS) low-density lipoprotein cholesterol…
- Trial name
- NCT00240344
- Where
- 75 sites in Netherlands
- Volunteers
- 2,650 people
- Sponsor
- AstraZeneca
Dyslipidemias
Investigation Into the RAtio of LDL-CHolestEroL to HDL-Cholesterol Improvement After Statin Treatment in Korean Patients
An observational, non-interventional, multi-centre study to provide further information on the ratio of LDL-C to HDL-C improvement after statin treatment in Korean patients group.
- Trial name
- RACHEL (NCT00931320)
- Volunteers
- 3,000 people
- Sponsor
- AstraZeneca
Dyslipidemias, High Cholesterol
Randomized Study of Obicetrapib as an Adjunct to Statin Therapy
This study will be a placebo-controlled, double-blind, randomized, phase 2 dose-finding study to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to high-intensity statin therapy.
- Conditions
- Dyslipidemias, High Cholesterol, Hypercholesterolemia
- Trial name
- ROSE (NCT04753606)
- Testing
- Obicetrapib
- Where
- 19 sites in United States
- Volunteers
- 120 people
- Sponsor
- NewAmsterdam Pharma
Hyperlipidemia or Mixed Dyslipidemia at High Risk for Cardiovascular Events
Study of Low-Density Lipoprotein Cholesterol (LDL-C) Reduction Using Evolocumab (AMG 145) in Japanese Patients With Advanced Cardiovascular Risk
The primary objective of the study was to evaluate the effect of 12 weeks of subcutaneous evolocumab administered every 2 weeks and once a month, compared with placebo, on percent change from baseline in LDL-C when used in…
- Trial name
- AMG145 (NCT01953328)
- Testing
- Atorvastatin, Evolocumab
- Where
- 54 sites in Japan
- Volunteers
- 409 people
- Sponsor
- Amgen
Hypercholesterolemia
Compare the Efficacy of Rosuvastatin to Atorvastatin in High Risk Patients With Hypercholesterolemia
This trial is to compare the efficacy, safety and tolerability of Rosuvastatin with Atorvastatin by assessing the change of LDL-C in patients with hypercholesterolemia and history of coronary heart disease (CHD) or risk…
- Trial name
- NCT00683618
- Testing
- Rosuvastatin, Atorvastatin
- Where
- 6 sites in China
- Volunteers
- 934 people
- Sponsor
- AstraZeneca
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
Elevated High-sensitivity C-Reactive Protein (hsCRP)
JUPITER - Crestor 20mg Versus Placebo in Prevention of Cardiovascular (CV) Events
The purpose of this study is to determine the safety and effectiveness of long-term therapy with rosuvastatin compared with a placebo, and to evaluate whether treatment with rosuvastatin might be effective in reducing the risk of…
- Trial name
- NCT00239681
- Testing
- Rosuvastatin
- Where
- 856 sites in United States, Argentina and 25 more
- Volunteers
- 17,802 people
- Sponsor
- AstraZeneca
Hyperlipidemia
Monoclonal Antibody Against PCSK9 to Reduce Elevated Low-density Lipoprotein Cholesterol (LDL-C) in Adults Currently Not Receiving Drug Therapy for Easing Lipid Levels
The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145) every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on the percent change from baseline in LDL-C when used as…
- Trial name
- MENDEL (NCT01375777)
- Testing
- Evolocumab, Ezetimibe
- Where
- 58 sites in United States, Australia and 3 more
- Volunteers
- 411 people
- Sponsor
- Amgen
Hypercholesterolaemia
LATAM LOWERS LDL-C
This is an open label, patient-level 1:1 randomized clinical trial in a multi-country study aiming to evaluate the real-world impact of inclisiran + Usual Care (UC) vs UC alone on LDL-C lowering, patient-reported outcomes, and…
- Trial name
- NCT06501443
- Testing
- Usual care, KJX839
- Where
- 11 sites in Argentina, Brazil
- Volunteers
- 520 people
- Sponsor
- Novartis Pharmaceuticals
Mild to Moderate Hypertension and Elevated Low-Density Lipoprotein Cholesterol
A Study of BEBT-701 in Patients With Mild to Moderate Hypertension and Elevated Low-Density Lipoprotein Cholesterol（LDL-C）
This Phase I/II clinical trial is designed to evaluate, through a single-dose Phase I segment and a multiple-dose Phase II segment, the safety/tolerability, pharmacokinetic (PK) profile, and pharmacodynamic (PD) characteristics…
- Trial name
- NCT07368608
- Testing
- BEBT-701 Injection
- Where
- China
- Volunteers
- 340 people
- Sponsor
- BeBetter Med Inc