Clinical trials: Statin Therapy
Hypercholesterolemia and High Risk for Cardiovascular Events
A Study to Evaluate Tolerability and Efficacy of Evolocumab (AMG 145) in Japanese Subjects
The primary objective is to evaluate the effect of 12 weeks of subcutaneous evolocumab every 2 weeks or every 4 weeks, compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) when…
- Trial name
- AMG145 (NCT01652703)
- Testing
- Evolocumab
- Where
- 42 sites in Japan
- Volunteers
- 310 people
- Sponsor
- Amgen
Hypercholesterolemia
Evaluation of ETC-1002 vs Placebo in Patients Receiving Ongoing Statin Therapy
The purpose of this research study is to see how ETC-1002 is tolerated in the body and how ETC-1002 affects the levels of LDL-C (bad cholesterol) in patients receiving ongoing statin therapy.
- Trial name
- NCT02072161
- Testing
- ETC-1002, Statin Therapy
- Where
- 40 sites in United States
- Volunteers
- 133 people
- Sponsor
- Esperion Therapeutics, Inc.
Primary Hypercholesterolemia
A Study of SCH 58235 (Ezetimibe) When Added to Ongoing Therapy With a Statin in Participants With Primary Hypercholesterolemia, Known Coronary Heart Disease, or Multiple Cardiovascular Risk Factors (P02173)
This is a study to evaluate the lipid-altering efficacy, safety, and tolerability of ezetimibe when added to ongoing therapy with an 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase inhibitor (statin) in participants…
- Trial name
- NCT03882905
- Testing
- Ezetimibe, Simivastatin, Statin
- Volunteers
- 769 people
- Sponsor
- Organon and Co
Dyslipidemias
Cinical Trial to Explore the Efficacy of Statin/Choline Fenofibrate Combination Therapy vs Statin Monotherapy in Patients With Inadequately Controlled TG Despite Receiving Statin Monotherapy
A Multi-center, Randomized, Double-blind, Parallel Phase Ⅳ Study to Explore the Efficacy of Statin/Choline Fenofibrate Combination Therapy vs Statin Monotherapy in Patients With Inadequately Controlled TG Despite Receiving Statin…
- Trial name
- NCT03874260
- Testing
- Fenofibrate
- Where
- South Korea
- Volunteers
- 180 people
- Sponsor
- Daewon Pharmaceutical Co., Ltd.
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.
Hypercholesterolemia
Cross-Over Study to Compare the Pharmacokinetics and Pharmacodynamics of LIB003 Process 1 and Process 2 Drug Product
To compare the pharmacokinetics (PK), and pharmacodynamics (PD) of single subcutaneous (SC) doses of 300 mg LIB003 Process 1 (P1) and Process 2 (P2) drug product in subjects with or without statin therapy
- Trial name
- NCT05234775
- Testing
- lerodalcibep
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- LIB Therapeutics LLC
Hyperlipidemia or Mixed Dyslipidemia at High Risk for Cardiovascular Events
Study of Low-Density Lipoprotein Cholesterol (LDL-C) Reduction Using Evolocumab (AMG 145) in Japanese Patients With Advanced Cardiovascular Risk
The primary objective of the study was to evaluate the effect of 12 weeks of subcutaneous evolocumab administered every 2 weeks and once a month, compared with placebo, on percent change from baseline in LDL-C when used in…
- Trial name
- AMG145 (NCT01953328)
- Testing
- Atorvastatin, Evolocumab
- Where
- 54 sites in Japan
- Volunteers
- 409 people
- Sponsor
- Amgen
Lipid Metabolism Disorder
Open Label Study Evaluating The Use Of Combination Therapy Of Ezetimibe And Statins In Patients With Dyslipidemia In Colombia (0653-141)(COMPLETED)
Gather additional efficacy and safety (pharmacovigilance) information in the usual daily care in patients with Dyslipidemia on ezetimibe under real conditions in Colombia associated with statins.
- Trial name
- NCT00651963
- Testing
- ezetimibe
- Volunteers
- 80 people
- Sponsor
- Organon and Co
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
Nonalcoholic Steatohepatitis
Combination Obeticholic Acid (OCA) and Statins for Monitoring of Lipids (CONTROL)
This Phase 2, double-blind, randomized, placebo-controlled, multicenter study, with an open-label long-term safety extension (LTSE), will evaluate the effect of Obeticholic Acid, and the subsequent addition of statin therapy, on…
- Trial name
- CONTROL (NCT02633956)
- Testing
- Obeticholic Acid, Atorvastatin
- Where
- 22 sites in United States
- Volunteers
- 84 people
- Sponsor
- Intercept Pharmaceuticals
Hyperlipidemia
Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects -2
The primary objective was to evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab every 2 weeks (Q2W) and monthly (QM), compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol…
- Trial name
- GAUSS-2 (NCT01763905)
- Testing
- Evolocumab, Ezetimibe
- Where
- 58 sites in United States, Australia and 12 more
- Volunteers
- 307 people
- Sponsor
- Amgen
Cardiovascular Disease
An Observational Study of Statin Treatment Induced HDL Changes
The aim with this study is to investigate the effect of statin induced changes in HDL-C on all cause mortality and CVD with adjustment for changes in other blood lipids and clinical parameters in Sweden, UK and the Netherlands.
- Trial name
- SIRIUS (NCT01551784)
- Volunteers
- 120,000 people
- Sponsor
- AstraZeneca
Dyslipidemia
TA-8995: Its Use in Patients With Mild Dyslipidaemia (TULIP)
The primary objective of this study is to evaluate the efficacy of different doses of TA-8995, a cholesteryl ester transfer protein (CETP) inhibitor, on the elevation of high-density lipoprotein cholesterol (HDL-C) and reduction…
- Trial name
- TULIP (NCT01970215)
- Testing
- TA-8995, Atorvastatin, Rosuvastatin
- Where
- 17 sites in Denmark, Netherlands
- Volunteers
- 364 people
- Sponsor
- Xention Ltd
Dyslipidemia, Coronary Heart Disease
Comparative Efficacy Evaluation of Lipids When Treated With Niaspan & Statin or Other Lipid-Modifying Therapies-COMPELL
The purpose of this study is to evaluate the effectiveness of first-line treatment using Niaspan (an extended release version of niacin) and statins versus other drugs that lower lipid levels, in subjects with elevated fat levels…
- Conditions
- Dyslipidemia, Coronary Heart Disease, Atherosclerosis, Stroke
- Trial name
- NCT00079638
- Testing
- Niacin, Atorvastatin, Simvastatin
- Volunteers
- 300 people
- Sponsor
- Kos Pharmaceuticals
Dyslipidemia, Coronary Artery Disease
Characterization of Multi-dose RVX000222 in Combination With Statin Treatment in Dyslipidemia
This study is designed to characterize the pharmacokinetics of multi-dose RVX000222 and atorvastatin and rosuvastatin when either statin is administered in combination with RVX000222 in subjects with dyslipidemia.
- Trial name
- NCT01863225
- Testing
- RVX000222, Rosuvastatin, Atorvastatin
- Where
- Australia
- Volunteers
- 13 people
- Sponsor
- Resverlogix Corp
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
Hypercholesterolemia
A Study of the Safety and Efficacy of Anacetrapib (MK-0859) Among Participants With Hypercholesterolemia When Added to Ongoing Statin Therapy (MK-0859-022)
This study will evaluate the effects of anacetrapib on low-density lipoprotein-cholesterol (LDL-C) and high-density lipoprotein cholesterol (HDL-C) in participants with hypercholesterolemia when added to an existing statin…
- Trial name
- NCT01860729
- Testing
- Anacetrapib
- Volunteers
- 589 people
- Sponsor
- Merck Sharp & Dohme LLC
Dyslipidemias
Evaluation of Dyslipidemia Management After Statin and Ezetimibe Complex Treatment
This study is a large-scale, prospective, multi-site, and non-interventional observational study to observe the change and safety of dyslipidemia management status when administering statin+etimib complex drugs in patients with…
- Trial name
- NCT05614765
- Testing
- Statin+Ezetimibe compound
- Where
- South Korea
- Volunteers
- 18,000 people
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
Hypercholesterolemia
Effect of Ezetimibe Treatment on Low-density Lipoprotein Cholesterol (LDL-C) Levels in Participants With Coronary Heart Disease (CHD) Already Treated With a Statin (MK-0653A-205 AM1)
This non-interventional longitudinal study is a follow-up of the Austrian Cholesterol Screening and Treatment project (ACT I), which assessed the cholesterol status, including achievement of the target levels applicable at that…
- Trial name
- ACT II (NCT01381679)
- Testing
- Ezetimibe
- Volunteers
- 1,682 people
- Sponsor
- Organon and Co
Cardiovascular Risk
C2 -CORVUS Cholesterol-Control (C2) Controlled Targets for High Vascular Risk Patients Using Effective Statins (CORVUS)
To demonstrate a higher percent rate of achieved target lipid goals among patients at high cardiovascular risk using more potent lipid-lowering treatment options including high-potency statins and combination therapies.
- Trial name
- C2 -CORVUS (NCT00921752)
- Where
- 26 sites in Hungary
- Volunteers
- 1,500 people
- Sponsor
- AstraZeneca