Clinical trials: Statin Therapy
Dyslipidemia, Coronary Heart Disease
Study to Evaluate the Long-Term Safety and Efficacy of ABT-335, in Combination With Three Different Statins in Subjects With Mixed Dyslipidemia.
The primary purpose of this study is to test the safety and the effects of using an investigational drug regimen; once daily ABT-335 (Investigational drug) administered in combination with once daily atorvastatin calcium…
- Conditions
- Dyslipidemia, Coronary Heart Disease, Mixed Dyslipidemia
- Trial name
- NCT00300430
- Testing
- ABT-335 and rosuvastatin calcium, ABT-335 and atorvastatin calcium, ABT-335 and simvastatin
- Where
- United States
- Volunteers
- 1,911 people
- Sponsor
- Abbott
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
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.
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
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.
Hypercholesterolemia
Efficacy and Safety of Colesevelam in Pediatric Patients With Genetic High Cholesterol
This study will evaluate the lipid-lowering effect and safety of colesevelam therapy administered to heterozygous familial pediatric patients 10 through 17 years of age who are on a stable dose of a pediatric-approved statin…
- Trial name
- NCT00145574
- Testing
- colesevelam HCl
- Where
- 25 sites in United States, Australia and 6 more
- Volunteers
- 194 people
- Sponsor
- Daiichi Sankyo
Hypercholesterolemia
Efficacy and Safety of Alirocumab in Patients With Hypercholesterolemia Not Adequately Controlled With Non-statin Lipid Modifying Therapy or the Lowest Strength of Statin
Primary Objective: To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab administration as add-on therapy to non-statin lipid modifying therapy (LMT) including diet therapy alone or the lowest…
- Trial name
- ODYSSEY-NIPPON (NCT02584504)
- Testing
- Alirocumab, Atorvastatin, Non-statin Lipid-Modifying Therapy
- Where
- 30 sites in Japan
- Volunteers
- 163 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
Dyslipidemias, Hypercholesterolemia
Effect of Statins on Lipid Levels Following the First Acute Coronary Event (MK-0000-204)
The current study is proposed to investigate the pattern of dyslipidemia and of lipid treatment practices in patients in India experiencing their first acute cardiovascular event and the extent of residual dyslipidemia after 12…
- Conditions
- Dyslipidemias, Hypercholesterolemia, Hypertriglyceridemia, High LDL-C
- Trial name
- REMAINS (NCT01245738)
- Volunteers
- 635 people
- Sponsor
- Merck Sharp & Dohme LLC
Hyperlipidemia
LAPLACE-TIMI 57: Low-density Lipoprotein Cholesterol (LDL-C) Assessment With PCSK9 monoclonaL Antibody Inhibition Combined With Statin thErapy
To evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab (AMG 145) administered every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on percent change from baseline in LDL-C when used in addition to a…
- Trial name
- LAPLACE (NCT01380730)
- Testing
- Evolocumab
- Where
- 100 sites in United States, Canada and 3 more
- Volunteers
- 631 people
- Sponsor
- Amgen
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.
Carotid Atherosclerosis
Merck Carotid Atherosclerosis Trial (MK-0000-111)(COMPLETED)
This study will examine the effect of statin and niacin therapy on carotid plaque biomarkers
- Trial name
- MCAT (NCT00804843)
- Testing
- Atorvastatin/niacin extended-release, Atorvastatin, Simvastatin
- Volunteers
- 100 people
- Sponsor
- Merck Sharp & Dohme LLC
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
Hyperlipoproteinemia Type II, Hypercholesterolemia, Familial
Study to Assess the Tolerability and Efficacy of Anacetrapib (MK-0859) Co-Administered With Statin in Participants With Heterozygous Familial Hypercholesterolemia (MK-0859-020)
The objective of this study is to evaluate the efficacy and tolerability of adding anacetrapib to ongoing statin therapy in participants with heterozygous familial hypercholesterolemia (HeFH).
- Trial name
- REALIZE (NCT01524289)
- Testing
- Anacetrapib
- Volunteers
- 306 people
- Sponsor
- Merck Sharp & Dohme LLC
Dyslipidemias, Cardiovascular Diseases
A Study to Evaluate Fenofibrate Combination With Statin in Chinese Patients With Dyslipidemic
Atherogenic dyslipidemia includes patients who have coronary heart disease (CHD) or CHD risk equivalents, whose TG level is not adequately controlled after statin monotherapy.
- Conditions
- Dyslipidemias, Cardiovascular Diseases, Hypertriglyceridemia
- Trial name
- NCT01462877
- Testing
- fenofibrate
- Where
- China
- Volunteers
- 506 people
- Sponsor
- Abbott
Dyslipidemia
Evaluating PCSK9 Binding antiBody Influence oN coGnitive HeAlth in High cardiovascUlar Risk Subjects
This study evaluated change over time in neurocognitive testing in patients receiving statin therapy in combination with evolocumab (AMG 145), compared with patients receiving statin therapy in combination with placebo.
- Trial name
- EBBINGHAUS (NCT02207634)
- Testing
- Evolocumab, Background Statin Therapy
- Where
- 416 sites in United States, Australia and 28 more
- Volunteers
- 1,974 people
- Sponsor
- Amgen
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.
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
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
Dyslipidemia
Observational Study On Compliance Of Statin Treatment Of Patients With High Blood Cholesterol Levels
The purpose of the study is to show the compliance rates of the patients to statin treatment and the reasons of non-compliance.
- Trial name
- NCT00673660
- Testing
- Patient Compliance
- Where
- 5 sites in Turkey (Türkiye)
- Volunteers
- 375 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.