Clinical trials: High Cholesterol/Hyperlipidemia
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
Hypercholesterolemia
LDL-Cholesterol Lowering Effect of KB2115 as Add on to Ezetimibe
Eprotirome (KB2115) is a liver selective thyroid hormone that can induce hyperthyroidism in the liver, while an euthyroid state is preserved in the extrahepatic tissue.
- Trial name
- NCT00677248
- Testing
- Eprotirome and ezetimibe
- Where
- Sweden
- Volunteers
- 120 people
- Sponsor
- Karo Bio AB
Hypercholesterolemia
A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous (SC) Administered Alirocumab in Healthy Chinese Subjects
Primary Objective: To assess the safety and tolerability of ascending single SC doses of alirocumab in Chinese healthy subjects. Secondary Objectives: To assess the pharmacokinetic profile of a single SC dose of alirocumab.
- Trial name
- NCT02979015
- Testing
- alirocumab SAR236553 (REGN727)
- Where
- China
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Sanofi
Hypercholesterolemia, Heterozygous Familial Hypercholesterolemia
Study of Efficacy and Safety of Inclisiran in Japanese Participants With High Cardiovascular Risk and Elevated LDL-C
This was a placebo-controlled, double-blind, randomized trial in Japanese participants with history of coronary artery disease (CAD) or participants categorized in 'high risk' by JAS 2017 guideline, or Japanese participants with…
- Trial name
- ORION-15 (NCT04666298)
- Testing
- Inclisiran sodium
- Where
- 42 sites in Japan
- Volunteers
- 312 people
- Sponsor
- Novartis Pharmaceuticals
Hypercholesterolemia, Atherosclerosis
Switching to Rosuvastatin Versus Adding Ezetimibe to Atorvastatin Versus Doubling the Dose of Atorvastatin in Patients With Hypercholesterolemia and Risk Factors (P03708)
This study assesses whether adding ezetimibe 10 mg/d to ongoing treatment with atorvastatin 10 mg/d is more effective than switching the subject to treatment with rosuvastatin 10 mg/d or doubling the dose of atorvastatin to 20…
- Conditions
- Hypercholesterolemia, Atherosclerosis, Coronary Artery Disease
- Trial name
- NCT00651378
- Testing
- Rosuvastatin, Ezetimibe + Atorvastatin, Double Atorvastatin
- Volunteers
- 87 people
- Sponsor
- Organon and Co
Hypercholesteremia, Coronary Artery Disease
Lipitor Phase 4 Clinical Trial in Hypercholesteremia Patients With Yellow Coronary Plaque
To evaluate the efficacy of intensive lipid-lowering therapy with Lipitor on the changes of characteristics of yellow coronary plaque in subjects with hypercholesteremia accompanying coronary artery disease
- Trial name
- NCT00408382
- Testing
- atorvastatin, Lipitor
- Where
- 2 sites in Japan
- Volunteers
- 50 people
- Sponsor
- Astellas Pharma Inc
Vascular Diseases, Hypercholesterolemia
The Effect of Plant Sterols on Vascular Function
The main aim of the study is to investigate, in humans, the effect of plant sterols on vascular function by measuring flow-mediated dilation (FMD).
- Trial name
- NCT01803178
- Testing
- Plant Sterols
- Where
- Germany
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Unilever R&D
Atherosclerosis, Hypercholesterolemia
Comparison of Co-administration of Ezetimibe Plus Simvastatin Versus Simvastatin Alone in Primary Hypercholesterolemia (P03476)
This study will assess whether the daily co-administration of ezetimibe 10 mg with ongoing treatment of simvastatin 20 mg will be more effective than treatment with simvastatin 20 mg alone in further reducing LDL-C concentrations.
- Conditions
- Atherosclerosis, Hypercholesterolemia, Coronary Heart Disease
- Trial name
- NCT00651274
- Testing
- Ezetimibe
- Volunteers
- 144 people
- Sponsor
- Organon and Co
Hypercholesterolemia
Effect of L. Reuteri NCIMB 30242 on Plasma Bile Acid Profile
Background: In recent years, probiotics have shown promise in treating a variety of diseases. Previously, the investigators have reported on the clinical efficacy of bile salt hydrolase active Lactobacillus reuteri NCIMB 30242 in…
- Trial name
- NCT02216825
- Testing
- Delayed release capsule, L. reuteri NCIMB 30242, escalated dose, Standard vegetarian capsule, L. reuteri NCIMB 30242, escalated dose
- Volunteers
- 10 people
- Sponsor
- Micropharma Limited
Coronary Artery Disease, Hypercholesterolemia, Hypertension
Atorvastatin Effectiveness and Safety in Cardiology Patients in Real World Setting
The study is to verify atorvastatin effectiveness and safety in Chinese population, and explore the optimal atorvastatin regimens in high-to-moderate risk for ASCVD。
- Trial name
- ATTENTION (NCT02565615)
- Testing
- No intervention
- Where
- 54 sites in China
- Volunteers
- 5,115 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Hyperlipemia
A Single and Multiple Ascending Doses Study to Evaluate the Safety, Tolerability and Pharmacokinetics of RBD7022
This is a randomized, single blind, placebo controlled, single center phase I study to evaluate the safety, tolerability, pharmacokinetics, and preliminary pharmacodynamics of single and multiple ascending doses of subcutaneously…
- Trial name
- NCT05912296
- Testing
- RBD7022
- Where
- China
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Suzhou Ribo Life Science Co. Ltd.
Hypercholesterolemia
To Evaluate Ezetimibe Plus Atorvastatin Versus Atorvastatin in Patients With High Cholesterol Not Controlled on Atorvastatin 40 mg (0653-090)
To Evaluate and Compare the Efficacy and Safety of Ezetimibe Plus Atorvastatin Versus Atorvastatin in Hypercholesterolemic Patients at High Risk for Coronary Heart Disease Not Adequately Controlled on Atorvastatin 40 mg.
- Trial name
- NCT00276484
- Testing
- atorvastatin, ezetimibe
- Volunteers
- 579 people
- Sponsor
- Organon and Co
Dyslipidemias, Hypercholesterolemia
Cholesterol-lowering Effects of Plant Stanol Ester
Efficacy of plant stanols as esters on LDL-cholesterol reduction is well documented. LDL-cholesterol lowering efficacy of the ingredient administered in a smoothie is less well known.
- Conditions
- Dyslipidemias, Hypercholesterolemia, Hyperlipidemias
- Trial name
- NCT02316808
- Testing
- Plant stanol ester
- Volunteers
- 91 people, healthy volunteers welcome
- Sponsor
- Raisio Group
Hypercholesterolemia, Coronary Heart Disease
Evaluation of the Efficacy of Rosuvastatin in Daily Practice in Untreated High Risk Patients (CHALLENGE)
In an observational multi-centre study (CHALLENGE), the effects were assessed of starting treatment with low doses of rosuvastatin in statin naive patients with a history of coronary heart disease (CHD), peripheral vascular…
- Conditions
- Hypercholesterolemia, Coronary Heart Disease, Peripheral Vascular Disease, CVA
- Trial name
- CHALLENGE (NCT00574782)
- Volunteers
- 2,660 people
- Sponsor
- AstraZeneca
Hypercholesterolemia
Study to Evaluate the Safety, PK, and Pharmacodynamics of LIB003
Randomized, double-blind, placebo-controlled, single ascending dose study in nine (9) separate and sequential dose cohorts (7 SC and 2 IV cohorts) to assess the safety and tolerability, pharmacokinetics and pharmacodynamics of…
- Trial name
- LIB003SAD (NCT03545438)
- Testing
- LIB003
- Where
- United States
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- LIB Therapeutics LLC
Hypercholesterolemia
A Study to Assess the Safety and Efficacy of CAT-2054 in Combination With Atorvastatin in Patients With Hypercholesterolemia
The purpose of this placebo-controlled, double-blind study is to assess the effect of several doses of CAT-2054 on LDL-C in hypercholesterolemic patients on a stable dose of high-intensity statin, and to evaluate the safety and…
- Trial name
- NCT02608697
- Testing
- CAT-2054, Atorvastatin
- Where
- 34 sites in United States
- Volunteers
- 153 people
- Sponsor
- Catabasis Pharmaceuticals
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
Hypercholesterolaemia, Atherosclerosis
Ezetimibe Plus Simvastatin Versus Simvastatin in Untreated Subjects With High Cholesterol (P03435)
This study will assess whether co-administration of ezetimibe 10 mg with simvastatin 20 mg will be more effective than treatment with simvastatin 20 mg alone in reducing LDL-C concentrations when administered for 6 weeks.
- Trial name
- NCT00653835
- Testing
- Ezetimibe + Simvastatin, Simvastatin
- Volunteers
- 153 people
- Sponsor
- Organon and Co
Homozygous Familial Hypercholesterolemia
A Study to Evaluate the Safety and Efficacy of the PCSK9 Inhibitor AK102 in Patients With HoFH
AK102 is being developed for the treatment of HoFH. The study will be conducted in 2 parts, part 1 is open label, single arm study to evaluate the safety, tolerability and efficacy of PCSK9 inhibitor AK102, and part 2 is double…
- Trial name
- NCT03933293
- Testing
- AK102, Statins, Ezetimibe
- Where
- 2 sites in China
- Volunteers
- 10 people
- Sponsor
- Akeso
Hypercholesterolemia
Effect of the Food Supplement TOTUM-070 on Lipid Metabolism
This clinical trial is to confirm the effects of TOTUM-070, a mix of 5 plants extracts, consumed at the daily regimen of two times per day, on fasting blood LDL cholesterol concentrations in moderately hypercholesterolemic…
- Trial name
- HEARTII (NCT06243484)
- Testing
- TOTUM-070
- Where
- Germany
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Valbiotis