Clinical trials: Hypercholesterolaemia
Hypercholesterolemia, Dyslipidemias
Study of Pitavastatin in Elderly Patients With Primary Hypercholesterolemia or Combined Dyslipidemia
This is an open-label extension study of NK-104-306 (NCT00257686) for elderly patients with hypercholesterolemia or combined dyslipidemia.
- Trial name
- NCT00330876
- Testing
- Pitavastatin
- Where
- 59 sites in Denmark, Germany and 3 more
- Volunteers
- 545 people
- Sponsor
- Kowa Research Europe
Hypercholesterolemia
Evaluation of Alirocumab in Addition to Lipid-Modifying Therapy in Patients With High Cardiovascular Risk and Hypercholesterolemia in South Korea and Taiwan
Primary Objective: To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable maximally tolerated daily statin therapy with or without other lipid-modifying therapy (LMT)…
- Trial name
- NCT02289963
- Testing
- Alirocumab, Lipid-Modifying Therapy (LMT)
- Where
- 27 sites in South Korea, Taiwan
- Volunteers
- 199 people
- Sponsor
- Sanofi
Primary Hypercholesterolemia, Mixed Dyslipidemia
Safety and Efficacy of Evolocumab in Addition to Optimal Stable Background Statin Therapy in Chinese Participants With Primary Hypercholesterolemia and Mixed Dyslipidemia
This study is being done to learn more about evolocumab in Chinese people with primary hypercholesterolemia or mixed dyslipidemia.
- Trial name
- NCT03433755
- Testing
- evolocumab
- Where
- 31 sites in China
- Volunteers
- 259 people
- Sponsor
- Amgen
Familial Hypercholesterolemia - Heterozygous
Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Heterozygous Familial Hypercholesterolemia
This was a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in adolescents with heterozygous familial hypercholesterolemia (HeFH) and elevated low density lipoprotein cholesterol…
- Trial name
- ORION-16 (NCT04652726)
- Testing
- Inclisiran
- Where
- 59 sites in United States, Argentina and 24 more
- Volunteers
- 141 people
- Sponsor
- Novartis Pharmaceuticals
Heterozygous Familial Hypercholesterolemia
Study to Assess the Efficacy and Safety of LIB003 in HeFH Patients on Oral Lipid Therapy Needing Further LDL-C Reduction
This study is to assess LDL-C reductions at Week 24 and the mean of Weeks 22 and 24 with monthly Q4W (≤31 days) dosing of LIB003 300 mg administered subcutaneously (SC) compared to placebo in patients 18 years or older with…
- Trial name
- LIBerate-FH (NCT04797104)
- Testing
- lerodalcibep
- Where
- 7 sites in United States, Israel and 3 more
- Volunteers
- 478 people
- Sponsor
- LIB Therapeutics LLC
Hypercholesterolemia
Effect of a Treatment With a Nutraceutical Combination on Sub-optimal LDL Cholesterol Levels
High cholesterol is one of the major controllable risk factor for coronary heart disease. It is well demonstrated that drugs that reduce the intestinal absorption of cholesterol or block the synthesis of cholesterol or the…
- Trial name
- NATCOL (NCT03739242)
- Testing
- Nutraceutical combination
- Where
- Italy
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- A. Menarini Industrie Farmaceutiche Riunite S.r.l.
Primary Hypercholesterolemia
Evaluation of Ezetimibe and Atorvastatin Coadministration Versus Atorvastatin or Rosuvastatin Monotherapy in Japanese Patients With Hypercholesterolemia (Study P06027)(COMPLETED)
The purpose of this study is to evaluate the efficacy and safety of atorvastatin 10 mg and ezetimibe 10 mg coadministration in Japanese participants with hypercholesterolemia whose low-density lipoprotein (LDL)-cholesterol levels…
- Trial name
- NCT00871351
- Testing
- Ezetimibe, Atorvastatin, Rosuvastatin
- Volunteers
- 125 people
- Sponsor
- Organon and Co
Primary Hyperlipidemia and Mixed Dyslipidemia
Effects on Lipoprotein Metabolism From PCSK9 Inhibition Utilizing a Monoclonal Antibody
This is a randomized, double-blind, placebo-controlled trial to evaluate the effect of evolocumab, atorvastatin, and combination therapy on lipoprotein kinetics.
- Trial name
- FLOREY (NCT02189837)
- Testing
- Evolocumab, Atorvastatin
- Where
- 2 sites in Australia
- Volunteers
- 89 people, healthy volunteers welcome
- Sponsor
- Amgen
Dyslipidemias, High Cholesterol
Randomized Study to Evaluate the Effect of Obicetrapib on Top of Maximum Tolerated Lipid-Modifying Therapies
This study will be a placebo-controlled, double-blind, randomized, phase 3 study in participants with underlying heterozygous familial hypercholesterolemia (HeFH) and/or ASCVD to evaluate the efficacy, safety, and tolerability of…
- Conditions
- Dyslipidemias, High Cholesterol, Hypercholesterolemia, Familial Hypercholesterolemia
- Trial name
- BROADWAY (NCT05142722)
- Testing
- Obicetrapib
- Where
- 181 sites in United States, China and 6 more
- Volunteers
- 2,530 people
- Sponsor
- NewAmsterdam Pharma
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
Hypercholesterolemia
Study of Efficacy, Safety, Tolerability and Quality of Life of Inclisiran (KJX839) vs Placebo, on Top of Ongoing Individually Optimized Lipid-lowering Therapy, in Participants With Hypercholesterolemia
Study of efficacy, safety, tolerability and quality of life of inclisiran (KJX839) vs placebo, on top of ongoing individually optimized lipid-lowering therapy, in participants with hypercholesterolemia
- Trial name
- V-DIFFERENCE (NCT05192941)
- Testing
- Inclisiran Sodium
- Where
- 136 sites in Bulgaria, Czechia and 6 more
- Volunteers
- 1,770 people
- Sponsor
- Novartis Pharmaceuticals
Hyperlipidemia
Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Subjects Currently Not Receiving Drug Therapy for Easing Lipid Levels-2
The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneous (SC) monotherapy every 2 weeks (Q2W) and monthly (QM), compared with placebo and ezetimibe, on percent change from baseline in low-density…
- Trial name
- MENDEL-2 (NCT01763827)
- Testing
- Evolocumab, Ezetimibe
- Where
- 83 sites in United States, Australia and 8 more
- Volunteers
- 615 people
- Sponsor
- Amgen
Hypercholesterolemia, Statin-Associated Myopathy
Safety of Red Yeast Rice for High Cholesterol in Individuals With Statin Intolerance
This study will examine the effect of red yeast rice extract compared to pravastatin on muscle related complaints in individuals with high cholesterol who have previously been unable to tolerate statin medications due to muscle…
- Trial name
- NCT00639223
- Testing
- Red Yeast Rice, Pravastatin, Lifestyle modification program
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- University of Pennsylvania
Hypercholesterolemia
Phase III Study To Evaluate Alirocumab in Patients With Hypercholesterolemia Not Treated With a Statin (ODYSSEY CHOICE II)
Primary Objective: To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by a regimen of Alirocumab including a starting dose of 150 mg every 4 weeks (Q4W) as add-on to non-statin lipid modifying background…
- Trial name
- NCT02023879
- Testing
- Alirocumab, Non-statin LMT, Diet Alone
- Where
- 43 sites in United States, Australia and 6 more
- Volunteers
- 233 people
- Sponsor
- Sanofi
Severe Familial Hypercholesterolemia
Trial Assessing Long Term USe of PCSK9 Inhibition in Subjects With Genetic LDL Disorders
A study to assess the long term safety and tolerability of evolocumab (AMG 145) in adolescents and adults with severe familial hypercholesterolemia.
- Trial name
- TAUSSIG (NCT01624142)
- Testing
- Evolocumab
- Where
- 44 sites in United States, Australia and 16 more
- Volunteers
- 300 people
- Sponsor
- Amgen
Hypercholesterolemia, Dyslipidemia
Long-Term Extension Study of Pitavastatin in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia
This study is a long-term follow-up protocol for patients who participated in study NK-104-3.01EU or study NK-104-3.02EU.
- Trial name
- NCT00325780
- Testing
- Pitavastatin
- Where
- 186 sites in Denmark, Finland and 11 more
- Volunteers
- 1,355 people
- Sponsor
- Kowa Research Europe
Hypercholesterolemia
AEGR-733 and Atorvastatin 20 mg vs. Monotherapy in Moderate Hypercholesterolemia
The purpose of this study is to test the effectiveness of the study drug, AEGR-733 alone and in combination with the medication, atorvastatin (Lipitor), on cholesterol in volunteers with moderately high cholesterol.
- Trial name
- NCT00474240
- Testing
- Atorvastatin 20 mg, AEGR-733 5 mg, AEGR-733 10 mg
- Where
- 17 sites in United States
- Volunteers
- 157 people
- Sponsor
- Aegerion Pharmaceuticals, Inc.
Hypercholesterolemia
Vytorin (10/20 Or 10/40) Compared to Atorvastatin (10 mg or 20 mg) in Patients With Coronary Artery Disease (0653A-126)(COMPLETED)
Evaluate the proportion of hyperlipaemic persons with known coronary heart disease achieving ldl-c goal as defined by the national cholesterol education program (NCEP) adult treatment panel (ATP) III guidelines
- Trial name
- NCT00442897
- Testing
- simvastatin (+) ezetimibe, Comparator: atorvastatin
- Volunteers
- 229 people
- Sponsor
- Organon and Co
Hypercholesterolemia
Study to Evaluate the Efficacy and Safety of an Every Four Weeks Treatment Regimen of Alirocumab (REGN727/ SAR236553) in Patients With Primary Hypercholesterolemia (ODYSSEY CHOICE 1)
To determine the efficacy, long-term safety, and tolerability of alirocumab 300 mg every 4 weeks (Q4W), in comparison with placebo, as well as its potential as a starting regimen.
- Trial name
- NCT01926782
- Testing
- Alirocumab, Statin
- Where
- 83 sites in United States, Bulgaria and 6 more
- Volunteers
- 803 people
- Sponsor
- Regeneron Pharmaceuticals
Hypercholesterolemia, Dyslipidemias
Dose-ranging Efficacy and Pharmacokinetics Study of Intravenous Atorvastatin in Hypercholesterolemic Patients
Open-label study will titrate doses of intravenous atorvastatin and monitor respective LDL-C levels in hypercholesterolemic patients previously controlled on oral atorvastatin.
- Trial name
- NCT03611010
- Testing
- Atorvastatin injection
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Cumberland Pharmaceuticals