Clinical trials: Hypercholesterolemia
Hyperlipidemia, Hypercholesterolemia
A Prospective, Open Label Comparison of Ezetimibe, Niacin, and Colestipol as Adjunct Therapy in Lipid Reduction
To compare LDL reduction compared to baseline in patients using maximum tolerated HMG CoA Reductase inhibitor (statin) therapy with adjunctive therapy with ezetimibe, colestipol, or niacin.
- Trial name
- NCT00203476
- Testing
- Niacin, Colestipol, Ezetimibe
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Tuscaloosa Research & Education Advancement Corporation
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.
Dyslipidemia
A Study to Assess the Efficacy and Safety of ETC-1002 in Subjects With Elevated Blood Cholesterol and Either Normal or Elevated Triglycerides
This Phase 2 proof-of-concept study will assess the lipid regulating efficacy and safety of ETC-1002 in subjects with hypercholesterolemia and either normal or elevated triglycerides.
- Trial name
- NCT01262638
- Testing
- ETC-1002
- Where
- 11 sites in United States
- Volunteers
- 177 people
- Sponsor
- Esperion Therapeutics, Inc.
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
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.
Atherosclerotic Cardiovascular Disease, Familial Hypercholesterolemia
Trial to Evaluate the Effect of ALN-PCSSC Treatment on Low Density Lipoprotein Cholesterol (LDL-C)
This study is a Phase II, placebo-controlled, double-blind, randomized trial in 480 participants with atherosclerotic cardiovascular disease (ASCVD) or ASCVD-risk equivalents (for example, diabetes and familial…
- Conditions
- Atherosclerotic Cardiovascular Disease, Familial Hypercholesterolemia, Diabetes
- Trial name
- ORION-1 (NCT02597127)
- Testing
- ALN-PCSSC, Normal Saline
- Where
- 54 sites in United States, Canada and 3 more
- Volunteers
- 501 people
- Sponsor
- The Medicines Company
Hypercholesterolemia
Ezetimibe (EZ)/Atorvastatin (Ator) (MK-0653C) vs. Ator in Chinese Hypercholesterolemic Participants (MK-0653C-439)
This study will evaluate the EZ/Ator fixed-dose combination (FDC) tablet (MK-0653C) as second line Low-Density Lipoprotein - Cholesterol (LDL-C) treatment in Chinese participants.
- Trial name
- NCT03768427
- Testing
- EZ 10 mg/Ator 10 mg, EZ 10 mg/Ator 20 mg, Atorvastatin
- Where
- 30 sites in China
- Volunteers
- 454 people
- Sponsor
- Organon and Co
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
Familial Hypercholesterolemia
Atorvastatin Three Year Pediatric Study
The purpose of this study is to characterize three year descriptive growth and development (ie, height, weight, body mass index, Tanner Stage) and efficacy of cholesterol reduction in pediatric subjects with Heterozygous Familial…
- Trial name
- NCT00827606
- Testing
- atorvastatin
- Where
- 40 sites in United States, Belgium and 13 more
- Volunteers
- 272 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ASCVD, Elevated Cholesterol
Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol
This is a Phase III, placebo-controlled, double-blind, randomized study in participants with ASCVD and elevated LDL-C despite maximum tolerated dose of LDL-C lowering therapies to evaluate the efficacy, safety, and tolerability…
- Trial name
- ORION-10 (NCT03399370)
- Testing
- Inclisiran Sodium
- Where
- 145 sites in United States
- Volunteers
- 1,561 people
- Sponsor
- The Medicines Company
High Cholesterol, High Blood Pressure
Online Trial Examining Validity and Reliability of the Shared Decision Making Process Survey
The purpose of this study is to survey a sample of adults who have recently made a decision about treatment of high cholesterol or high blood pressure or a decision about screening for colorectal cancer, breast cancer, or…
- Conditions
- High Cholesterol, High Blood Pressure, Colorectal Cancer, Breast Cancer
- Trial name
- NCT04317690
- Where
- United States
- Volunteers
- 539 people
- Sponsor
- Massachusetts General Hospital
Primary Hypercholesterolemia
Effects of Prescription Omega-3 on LDL-C in Primary Hypercholesterolemia
The objectives of this study are to assess the effects of 4 g/d P-OM3, compared with placebo, on LDL-C and other aspects of the fasting lipid profile in subjects with primary hypercholesterolemia.
- Trial name
- NCT00746811
- Testing
- P-OM3
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Provident Clinical Research
Lipid Metabolism Disorders
Efficacy and Safety of Fluvastatin Sodium Extended Release Tablets 80 mg Once Daily in Chinese Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
This study is to demonstrate therapeutic comparability of Fluvastatin sodium Extended Release Tablets 80 mg QD and Fluvastatin sodium Immediate Release Capsules 40 mg BID in LDL-C lowering from baseline to week 12 (endpoint) in…
- Trial name
- NCT01551173
- Testing
- Fluvastatin sodium
- Where
- China
- Volunteers
- 436 people
- Sponsor
- Novartis Pharmaceuticals
Hypercholesterolemia, Mixed Dyslipidemia
Evaluation of Evolocumab (AMG 145) Efficacy in Diabetic Adults With Hypercholesterolemia/Mixed Dyslipidemia
The purpose of this study is to evaluate the effect of 12 weeks of subcutaneous evolocumab taken monthly compared with subcutaneous placebo taken monthly on low density lipoprotein cholesterol (LDL-C) in adults with type 2…
- Conditions
- Hypercholesterolemia, Mixed Dyslipidemia, Type 2 Diabetes
- Trial name
- BANTING (NCT02739984)
- Testing
- Evolocumab
- Where
- 66 sites in United States, Belgium and 5 more
- Volunteers
- 424 people
- Sponsor
- Amgen
Atherosclerotic Cardiovascular Disease
A Randomized Study to Evaluate the Effect of an "Inclisiran First" Implementation Strategy Compared to Usual Care in Patients With Atherosclerotic Cardiovascular Disease and Elevated LDL-C Despite Receiving Maximally Tolerated Statin Therapy (VICTORION-INITIATE)
The purpose of this study was to assess the effectiveness of an "inclisiran first" implementation strategy (addition of inclisiran to maximally tolerated statin therapy immediately upon failure to achieve acceptable LDL-C with…
- Trial name
- V-INITIATE (NCT04929249)
- Testing
- Inclisiran
- Where
- 43 sites in United States
- Volunteers
- 450 people
- Sponsor
- Novartis Pharmaceuticals
Myopathy, HMG COA Reductase Inhibitor Adverse Reaction
Evaluation of Ubiquinol on Mitochondrial Oxidative Capacity in Statin Patients Using 31PMRS
It is our primary hypothesis that statin drugs impair skeletal muscle mitochondrial function and that ubiquinol (the reduced active form of CoQ10) supplementation will block impairment of PCr recovery kinetics in patients using…
- Conditions
- Myopathy, HMG COA Reductase Inhibitor Adverse Reaction, Hypercholesterolemia
- Trial name
- NCT01702987
- Testing
- ubiquinol, statin
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Beth Israel Deaconess Medical Center
Homozygous Familial Hypercholesterolemia (HoFH)
A Study to Evaluate the Efficacy and Safety of Rosuvastatin in Children and Adolescents With Homozygous Familial Hypercholesterolemia
The purpose of the study is to establish the efficacy, safety and tolerability of rosuvastatin in children and adolescents with homozygous familial hypercholesterolemia.
- Trial name
- HYDRA (NCT02226198)
- Testing
- Rosuvastatin 20mg
- Where
- 9 sites in Belgium, Canada and 5 more
- Volunteers
- 20 people
- Sponsor
- AstraZeneca
Hypercholesterolemia
Open Label Study of Long Term Evaluation Against LDL-C Trial
The primary clinical hypothesis is that long-term exposure of evolocumab (AMG 145) will be safe and well tolerated in adults with hypercholesterolemia.
- Trial name
- OSLER (NCT01439880)
- Testing
- Evolocumab, Standard of care
- Where
- 187 sites in United States, Australia and 16 more
- Volunteers
- 1,324 people
- Sponsor
- Amgen
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
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.