Clinical trials: Statin
Atherosclerotic Vascular Disease
Evaluate the Utility of 18FDG-PET as a Tool to Quantify Atherosclerotic Plaque (MK-0000-081 AM3)(COMPLETED)
The purpose of this study is to evaluate the utility of 18Fluorine Fluorodeoxyglucose Positron Emission Tomography (18FDG-PET) as a tool to quantify atherosclerotic plaque.
- Trial name
- NCT00703261
- Testing
- atorvastatin
- Volunteers
- 83 people
- Sponsor
- Merck Sharp & Dohme LLC
Hypercholesterolemia
Coadministration of Ezetimibe and Simvastatin in Patients With Primary Hypercholesterolemia (P05457)
Evaluate the safety of the long-term (1 year) coadministration of ezetimibe and simvastatin in patients with hypercholesterolemia who have not reached low density lipoprotein (LDL)-cholesterol target with…
- Trial name
- NCT00653523
- Testing
- Ezetimibe, Simvastatin
- Volunteers
- 151 people
- Sponsor
- Organon and Co
Hyperlipidemia
Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-3
The primary objective of this study was to evaluate the effect of 24 weeks of evolocumab administered subcutaneously (SC) every month, compared with ezetimibe, on low-density lipoprotein cholesterol (LDL-C) levels in adults with…
- Trial name
- GAUSS-3 (NCT01984424)
- Testing
- Atorvastatin, Ezetimibe
- Where
- 58 sites in United States, Australia and 11 more
- Volunteers
- 511 people
- Sponsor
- Amgen
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
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
Healthy Volunteers, Hypercholesterolemia
A Study of LY3015014 in Healthy Participants With High Cholesterol
This is a study in healthy participants with high levels of "bad" cholesterol who are already taking a popular type of cholesterol-lowering medication called statins.
- Trial name
- NCT01671085
- Testing
- LY3015014
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Dyslipidemias, High Cholesterol
Randomized Study of Obicetrapib in Combination With Ezetimibe
This study will be a placebo-controlled, double-blind, randomized, phase 2 study in participants with mild dyslipidemia to evaluate the efficacy, safety, and tolerability of obicetrapib and ezetimibe combination therapy.
- Conditions
- Dyslipidemias, High Cholesterol, Hypercholesterolemia
- Trial name
- OCEAN (NCT04770389)
- Testing
- Obicetrapib 5mg, Ezetimibe 10mg
- Where
- 9 sites in United States, Netherlands
- Volunteers
- 112 people
- Sponsor
- NewAmsterdam Pharma
Dyslipidemia, Hypercholesterolemia
A Dose-Finding Study in Japanese Patients to Evaluate the Effect of Obicetrapib as an Adjunct to Stable Statin Therapy.
This study will be a placebo-controlled, double-blind, randomized, phase 2 dose-finding study in Japanese patients to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to stable statin therapy.
- Conditions
- Dyslipidemia, Hypercholesterolemia, High Cholesterol
- Trial name
- NCT05421078
- Testing
- Obicetrapib
- Where
- 10 sites in Japan
- Volunteers
- 102 people
- Sponsor
- NewAmsterdam Pharma
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.
Hypercholesterolemia, Acute Coronary Syndrome
Evaluation of Effect of Alirocumab on Coronary Atheroma Volume in Japanese Patients Hospitalized for Acute Coronary Syndrome With Hypercholesterolemia
Primary Objective: To compare the efficacy of alirocumab (Praluent®) with standard of care (SoC) on coronary atheroma progression (percent change in normalized total atheroma volume [TAV]) after 9 months of treatment in…
- Trial name
- ODYSSEY J-IVUS (NCT02984982)
- Testing
- Alirocumab SAR236553, Atorvastatin, Rosuvastatin
- Where
- 39 sites in Japan
- Volunteers
- 206 people
- Sponsor
- Sanofi
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
Dyslipidemia
Efficacy and Safety of Alirocumab Versus Usual Care on Top of Maximally Tolerated Statin Therapy in Patients With Type 2 Diabetes and Mixed Dyslipidemia (ODYSSEY DM-Dyslipidemia)
Primary Objective: To demonstrate the superiority of alirocumab in comparison with usual care in the reduction of non-high-density lipoprotein cholesterol (non-HDL-C) in participants with type 2 diabetes and mixed dyslipidemia at…
- Trial name
- NCT02642159
- Testing
- Alirocumab, Statins, Ezetimibe
- Where
- 119 sites in United States, Australia and 13 more
- Volunteers
- 413 people
- Sponsor
- Sanofi
Hypercholesterolemia
Phase 2a Study to Assess CIVI 007 in Patients on a Background of Statin Therapy
Evaluation of the clinical profile (lipid efficacy, safety and PK) across a number of doses of CIVI 007, a PCSK9 inhibitor. Patients to be evaluated will be on a stable background of statin therapy with or without ezetimibe.
- Trial name
- NCT04164888
- Testing
- CIVI 007
- Where
- 7 sites in United States
- Volunteers
- 49 people
- Sponsor
- Civi Biopharma, Inc.
Hypercholesterolemia
Comparison of Ezetimibe Added to Ongoing Statin Therapy Versus Doubling the Dose of Statin in the Treatment of Hypercholesterolemia (P04355)
This is a randomized, open label, parallel group comparison study. Following a 1-week screening period, patients will be randomized to 1 of 2 treatment groups: ezetimibe added to ongoing statin treatment (ezetimibe plus…
- Trial name
- NCT00652327
- Testing
- Ezetimibe + Statin (simvastatin, atorvastatin, or pravastatin), Double Statin (simvastatin, atorvastatin, or pravastatin)
- Volunteers
- 83 people
- Sponsor
- Organon and Co
Hypercholesterolemia, Atherosclerosis
Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) as Add-on to Ezetimibe Therapy in Patients With Elevated LDL-C (CLEAR Tranquility)
The purpose of this study is to determine if bempedoic acid (ETC-1002) added-on to ezetimibe therapy is effective and safe versus placebo in patients with elevated LDL cholesterol.
- Conditions
- Hypercholesterolemia, Atherosclerosis, Statin Adverse Reaction
- Trial name
- NCT03001076
- Testing
- Bempedoic acid, Ezetimibe
- Where
- United States
- Volunteers
- 269 people
- Sponsor
- Esperion Therapeutics, Inc.
Diabetes, Hyperlipidemia, Mixed Dyslipidemia
Safety and Efficacy of Evolocumab in Combination With Statin Therapy in Adults With Diabetes and Hyperlipidemia or Mixed Dyslipidemia
The primary objective of this study was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145) in combination with statin therapy (atorvastatin) on percent change from baseline in low-density lipoprotein…
- Trial name
- BERSON (NCT02662569)
- Testing
- Evolocumab, Atorvastatin
- Where
- 110 sites in United States, Argentina and 8 more
- Volunteers
- 986 people
- Sponsor
- Amgen
Hyperlipidemia
Ascending Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Evolocumab (AMG 145) in Adults With Hyperlipidemia on Stable Doses of a Statin
The purpose of the study is to evaluate the safety and tolerability of multiple doses of evolocumab when given as an add-on to stable statin therapy.
- Trial name
- NCT01133522
- Testing
- Evolocumab
- Volunteers
- 60 people
- Sponsor
- Amgen
Hypercholesterolemia, Atherosclerotic Cardiovascular Disease
Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia and Statin Intolerant
The purpose of this study is to determine if bempedoic acid (ETC-1002) is effective and safe versus placebo in patients with elevated LDL cholesterol and who are statin-intolerant.
- Conditions
- Hypercholesterolemia, Atherosclerotic Cardiovascular Disease, Statin Adverse Reaction
- Trial name
- CLEAR Serenity (NCT02988115)
- Testing
- bempedoic acid
- Where
- 67 sites in United States, Canada
- Volunteers
- 345 people
- Sponsor
- Esperion Therapeutics, Inc.
Hypertriglyceridemia, Cardiovascular Disease
[E]PANOVA Combined With a [S]TATIN in [P]ATIENTS With HYPERT[R]IGLYCER[I]DEMIA to Reduce Non-HDL CHOLES[T]EROL
The primary objective is to evaluate the efficacy of adding Epanova (2 g or 4 g daily) to an optimal statin monotherapy for lowering non-high-density lipoprotein (non-HDL) cholesterol in subjects with persistent…
- Trial name
- ESPRIT (NCT01408303)
- Testing
- Olive oil, 4g, omega-3-carboxylic acids, 2g, omega-3-carboxylic acids, 4g
- Where
- 89 sites in United States
- Volunteers
- 646 people
- Sponsor
- AstraZeneca
Dyslipidemias, Hyperlipidemias
A Dose-Ranging Study With Vupanorsen (TRANSLATE-TIMI 70)
This is a multicenter, Phase 2b, double-blind, placebo-controlled, parallel group study to provide data on efficacy, safety, tolerability, and pharmacokinetics (PK) of PF-07285557 (hereafter, vupanorsen) administered…
- Conditions
- Dyslipidemias, Hyperlipidemias, Hyperlipoproteinemias
- Trial name
- NCT04516291
- Testing
- Vupanorsen
- Where
- 114 sites in United States, Canada and 1 more
- Volunteers
- 286 people
- Sponsor
- Pfizer