Clinical trials: Hypercholesterolaemia
High Cholesterol, Coronary Artery Disease
Ezetimibe in Patients Hypo-responsive to Statins
Response to statin therapy for elevated low density lipoprotein is variable and may be influenced by cholesterol absorption. This study will evaluate whether combination therapy with atorvastatin/ezetimibe will be superior to…
- Trial name
- NCT00965055
- Testing
- Ezetimibe, Atorvastatin
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- University of California, San Diego
Hypercholesterolemia
Long-term Safety and Tolerability of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY Long Term)
Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9).
- Trial name
- NCT01507831
- Testing
- Alirocumab, Lipid-Modifying Therapy (LMT)
- Where
- 320 sites in United States, Argentina and 25 more
- Volunteers
- 2,341 people
- Sponsor
- Sanofi
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
Type IIa and IIb Hypercholesterolaemia
Evaluation of the Efficacy and Safety of Rosuvastatin 5 mg Versus Pravastatin 40 mg and Atorvastatin 10 mg in Type IIa and IIb Hypercholesterolaemic Patients
The purpose of this study is to evaluate the efficacy and safety of Rosuvastatin 5 mg as an hypercholesterolemia treatment comparatively at 2 other statins: Pravastatin 40 mg and Atorvastatin 10 mg.
- Trial name
- CAP-Chol (NCT00631189)
- Testing
- Rosuvastatin, Pravastatin, Atorvastatin
- Where
- 170 sites in France
- Volunteers
- 668 people
- Sponsor
- AstraZeneca
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
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
Comparison of Simvastatin Versus Simvastatin/Ezetimibe on Small Dense Low -Density Lipoprotein (LDL)
Both simvastatin 40 mg and simvastatin/ezetimibe 10/10 mg result in low-density lipoprotein cholesterol (LDL-C) reductions of approximately the same magnitude.
- Trial name
- NCT00932620
- Testing
- SIMVASTATIN 40 mg, SIMVASTATIN/EZETIMIBE 10/10 mg
- Where
- Greece
- Volunteers
- 100 people
- Sponsor
- University of Ioannina
Hypercholesterolemia
Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe on Top of Statin in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY COMBO II)
Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9).
- Trial name
- NCT01644188
- Testing
- Alirocumab, Ezetimibe, Lipid Modifying Therapy (LMT)
- Where
- 126 sites in United States, Canada and 8 more
- Volunteers
- 720 people
- Sponsor
- Sanofi
Homozygous Familial Hypercholesterolaemia (HoFH)
Efficacy and Safety of Lomitapide in Paediatric Patients With Homozygous Familial Hypercholesterolaemia (HoFH)
This is a single arm, open label, multi centre phase III study to evaluate the efficacy and long term safety of lomitapide in paediatric patients with HoFH receiving stable lipid lowering therapy (LLT) (including lipoprotein…
- Trial name
- NCT04681170
- Testing
- Lomitapide
- Where
- 12 sites in Germany, Israel and 4 more
- Volunteers
- 46 people
- Sponsor
- Amryt Pharma
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
Primary Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH)
Vytorin Reexamination Study (0653A-174)
This survey is conducted for preparing application material for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of VYTORIN through collecting…
- Trial name
- NCT01070966
- Volunteers
- 2,089 people
- Sponsor
- Organon and Co
Hypercholesterolemia
Bioequivalence Study Comparing A New 10 Mg Atorvastatin Tablet To A 10 Mg Atorvastatin Commercial Tablet
To determine whether new 10 mg atorvastatin tablets are bioequivalent to 10 mg commercial atorvastatin tablets (Lipitor®).
- Trial name
- NCT00917579
- Testing
- Atorvastatin
- Where
- United States
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Primary Hypercholesterolemia, Mixed Hyperlipidemia
Phase 2 Dose-Ranging Efficacy and Safety Trial of SCH 900271 in Participants With Primary Hypercholesterolemia or Mixed Hyperlipidemia (P05675)
The purpose of this study is to evaluate the effect of SCH 900271 compared to placebo on the reduction of low-density lipoprotein cholesterol (LDL-C) from baseline to 8 weeks of treatment in participants with primary…
- Trial name
- NCT00941603
- Testing
- SCH 900271 15mg, SCH 900271
- Volunteers
- 619 people
- Sponsor
- Merck Sharp & Dohme LLC
High Cholesterol
Technology-Assisted Cholesterol Trial in Consumers (TACTiC)
The purpose of this AUS is to evaluate the extent to which participants can safely and effectively self-select, purchase, and use Crestor OTC 5 mg for a 6-month period according to the label.
- Trial name
- TACTiC (NCT04964544)
- Testing
- 5 mg rosuvastatin calcium with a Web App (combination product)
- Where
- United States
- Volunteers
- 1,196 people
- Sponsor
- AstraZeneca
Diabetes Mellitus, Metabolic Syndrome X
Effect of Statins on Oxidative Stress and Endothelial Progenitor Cells
Thirty-six subjects with hyperlipidemia and metabolic syndrome and/or diabetes were randomized in a double-blind manner to either pravastatin 80 mg or atorvastatin 10 mg daily.
- Conditions
- Diabetes Mellitus, Metabolic Syndrome X, Hypercholesterolemia
- Trial name
- STOPCAP (NCT00166036)
- Testing
- Atorvastatin, Pravastatin
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Emory University
Hypercholesterolemia
Evaluation of the LDL-C Lowering Effects of Ezetimibe Achieved in Co-administration Therapy With Statins in an Indonesian Population (Study P04276)(COMPLETED)
The purpose of this study is to evaluate the safety and tolerability of the low-density lipoprotein-cholesterol (LDL-C) lowering in an Indonesian population treated with ezetimibe co-administered with a statin in routine daily…
- Trial name
- NCT00705081
- Testing
- ezetimibe, statin
- Volunteers
- 453 people
- Sponsor
- Organon and Co
Hypercholesterolemia
Effects of Ezetimibe on the Absorption of Oxidized Cholesterol
The purpose of this study is to test the effects of Zetia™ (ezetimibe) 10 milligrams (mg) on the absorption of oxysterol into the blood following a meal containing oxysterol.
- Trial name
- NCT00794677
- Testing
- ezetimibe
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- UCSF Benioff Children's Hospital Oakland
Hypercholesterolemia, Myocardial Infarction
IMPROVE-IT: Examining Outcomes in Subjects With Acute Coronary Syndrome: Vytorin (Ezetimibe/Simvastatin) vs Simvastatin (P04103)
This is a randomized, active-control, double-blind study of subjects with stabilized high-risk acute coronary syndrome (ACS). The primary objective is to evaluate the clinical benefit of Ezetimibe/Simvastatin Combination 10/40…
- Trial name
- NCT00202878
- Testing
- ezetimibe/simvastatin, simvastatin
- Volunteers
- 18,144 people
- Sponsor
- Organon and Co
Hypercholesterolemia, Dyslipidemias
A Pharmacokinetic and Pharmacodynamic Study of PF-04950615 (RN316) in Subjects With Hypercholesterolemia
This Phase 1 study has been designed to evaluate the absolute bioavailability of PF-04950615 (RN316) in subjects with hypercholesterolemia who are not currently on lipid-lowering therapy.
- Conditions
- Hypercholesterolemia, Dyslipidemias, Hyperlipidemias, Lipid Metabolism Disorders
- Trial name
- NCT01435382
- Testing
- PF-04950615 (RN316)
- Where
- 7 sites in United States
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Pfizer
Hypertension, Hypercholesterolemia
A Randomized Study To Evaluate Efficacy And Safety Of A Fixed Combination Therapy Of Amlodipine And Atorvastatin
To assess the changes in the trough Systolic Blood Pressure (SBP) and the percent changes in Low Density Lipoprotein-Cholesterol (LDL-C) from baseline at Week 8 in the treatment period
- Trial name
- NCT00530946
- Testing
- Amlodipine 2.5mg/Atorvastatin 5mg, Amlodipine 2.5mg/Atorvastatin 10mg, Amlodipine 5mg/Atorvastatin 5mg
- Where
- 17 sites in Japan
- Volunteers
- 165 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.