Clinical trials: Elevated LDL Cholesterol
Hypercholesterolemia
Evaluation of the Safety & Efficacy of a Combination of Niacin ER & Simvastatin in Patients With Dyslipidemia (OCEANS)
The purpose of this 24 week study is to compare the effectiveness and safety of different doses of Niacin ER/Simvastatin (NS) in subjects with elevated fat levels in their blood (dyslipidemia).
- Trial name
- NCT00080275
- Testing
- Niacin Extended-Release and simvastatin Tablets
- Volunteers
- 600 people
- Sponsor
- Kos Pharmaceuticals
Hypertriglyceridemia
Effect of AMR101 (Ethyl Icosapentate) on Triglyceride (Tg) Levels in Patients on Statins With High Tg Levels (≥ 200 and < 500 mg/dL)
The primary objective is to determine the efficacy of AMR101 (ethyl icosapentate) compared to placebo in lowering high fasting triglyceride levels in patients with high risk for cardiovascular disease and fasting triglyceride…
- Trial name
- ANCHOR (NCT01047501)
- Testing
- AMR101 (ethyl icosapentate) - 4 g/day, AMR101 (ethyl icosapentate) - 2 g/day
- Where
- 80 sites in United States
- Volunteers
- 702 people
- Sponsor
- Amarin Pharma Inc.
Familial Hypercholesterolemia
Safety, Tolerability and Efficacy of Evolocumab (AMG 145) in Children With Inherited Elevated Low-density Lipoprotein Cholesterol (Familial Hypercholesterolemia)
The main purpose of this study is to describe the safety and tolerability of 80 weeks of subcutaneous (SC) evolocumab when added to standard of care in children 10 to 17 years of age with familial hypercholesterolemia.
- Trial name
- HAUSER-OLE (NCT02624869)
- Testing
- Evolocumab
- Where
- 46 sites in United States, Australia and 21 more
- Volunteers
- 163 people
- Sponsor
- Amgen
ASCVD, Elevated Cholesterol
Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol
This is a Phase III, placebo-controlled, double-blind, randomized study in participants with ASCVD and elevated LDL-C despite maximum tolerated dose of LDL-C lowering therapies to evaluate the efficacy, safety, and tolerability…
- Trial name
- ORION-10 (NCT03399370)
- Testing
- Inclisiran Sodium
- Where
- 145 sites in United States
- Volunteers
- 1,561 people
- Sponsor
- The Medicines Company
Cardiovascular Disease With Mention of Arteriosclerosis, Elevated Cholesterol
Long-term Efficacy and Safety of OLE LIB003 in HoFH, HeFH, and High-risk CVD Patients Requiring Further LDL-C Reduction
The study is to assess the long-term safety, tolerability, and efficacy after 48 and 72 weeks with monthly (Q4W [<31 days]) dosing of subcutaneous (SC) LIB003 300 mg administered in patients with CVD or at high risk for CVD…
- Conditions
- Cardiovascular Disease With Mention of Arteriosclerosis, Elevated Cholesterol, Familial Hypercholesterolemia
- Trial name
- LIBerate-OLE (NCT04798430)
- Testing
- lerodalcibep
- Where
- 12 sites in United States, India and 4 more
- Volunteers
- 2,000 people
- Sponsor
- LIB Therapeutics LLC
Dyslipidaemias, Dyslipidaemia
GW501516 In Subjects Who Have Low Level Of High-Density Lipoprotein Cholesterol
The purpose of this clinical research study is to compare up to 3 doses of an investigational drug GW501516 to placebo (an inactive pill that looks like GW501516) to see if it is safe, well tolerated and effective in improving…
- Trial name
- NCT00158899
- Testing
- GW501516 oral tablets
- Where
- 64 sites in Belgium, Denmark and 9 more
- Volunteers
- 424 people
- Sponsor
- GlaxoSmithKline
Atherosclerotic Cardiovascular Disease, Symptomatic Atherosclerosis
An Extension Trial of Inclisiran in Participants With Cardiovascular Disease and High Cholesterol
This clinical study was designed to assess the efficacy, safety, and tolerability of long-term dosing of inclisiran and evolocumab given as subcutaneous injections in participants with high cardiovascular risk and elevated…
- Conditions
- Atherosclerotic Cardiovascular Disease, Symptomatic Atherosclerosis, Type2 Diabetes, Familial Hypercholesterolemia
- Trial name
- ORION-3 (NCT03060577)
- Testing
- Inclisiran, Evolocumab
- Where
- 52 sites in United States, Canada and 3 more
- Volunteers
- 382 people
- Sponsor
- Novartis Pharmaceuticals
Coronary Arteriosclerosis, Diabetes Mellitus, Type 2
Establish The Benefits Of Using Various Starting Doses Of Atorvastatin On Achievement Of Cholesterol Targets (ACTFAST)
Physicians tend to always use the lowest dose of statins to initiate therapy even in subjects who require large reductions in cholesterol.
- Conditions
- Coronary Arteriosclerosis, Diabetes Mellitus, Type 2, Cerebrovascular Accident, Dyslipidemia
- Trial name
- ACTFAST (NCT00442845)
- Testing
- Atorvastatin (Lipitor)
- Where
- 121 sites in Cameroon, Canada and 3 more
- Volunteers
- 2,080 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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
Hypercholesterolemia, Dyslipidemia
A Multiple Dose Study Of PF-04950615 (RN316) In Subjects On Maximum Doses Of Statins
PF-04950615 is a new investigational hypercholesterolemic agent that is being tested in this study to evaluate if it can lower LDL cholesterol.
- Trial name
- NCT01350141
- Testing
- PF-04950615 (RN316)
- Where
- 35 sites in United States, Canada
- Volunteers
- 46 people
- Sponsor
- Pfizer
Hypercholesteremia
Direct Statin Comparison of LDL-C Values: an Evaluation of Rosuvastatin Therapy
The primary objective of the study is to compare the efficacy of rosuvastatin 10 mg with atorvastatin 10 mg by assessment of the percentage of subjects who reach EAS LDL-C target goals after 12 weeks of therapy.
- Trial name
- NCT00239330
- Testing
- Rosuvastatin, Atorvastatin
- Where
- 26 sites in Belgium
- Volunteers
- 824 people
- Sponsor
- AstraZeneca
Dyslipidemia
Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk
The primary objective was to evaluate the effect of treatment with evolocumab, compared with placebo, on the risk for cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary…
- Trial name
- FOURIER (NCT01764633)
- Testing
- Evolocumab
- Where
- 1,284 sites in United States, Argentina and 47 more
- Volunteers
- 27,564 people
- Sponsor
- Amgen
Hypercholesterolemia
A Study to See How Safe and Effective Alirocumab is When Given Weekly to Adult Participants Who Have Hypercholesterolemia
This study is researching an experimental drug called alirocumab, referred to as "study drug". In the United States, alirocumab is approved for the treatment of hypercholesterolemia (high blood cholesterol levels).
- Trial name
- ASCEND-QW (NCT07477704)
- Testing
- Alirocumab
- Where
- 34 sites in United States
- Volunteers
- 438 people
- Sponsor
- Regeneron Pharmaceuticals
Atherosclerotic Cardiovascular Disease
A Research Study Looking at How NNC0385-0434 Tablets Work to Lower Blood Cholesterol in People With Heart Disease or a High Risk of Heart Disease
This study looks at how well a new medicine, NNC0385-0434, works to lower blood cholesterol levels. Participants will either get NNC0385-0434 as a tablet (a potential new medicine), or placebo as a tablet (a dummy medicine that…
- Trial name
- NCT04992065
- Testing
- NNC0385-0434 A 15 mg, NNC0385-0434 A 40 mg, NNC0385-0434 A 100 mg
- Where
- 44 sites in United States, Belgium and 5 more
- Volunteers
- 267 people
- Sponsor
- Novo Nordisk A/S
Hypercholesterolemia
Open Label Study of Long Term Evaluation Against LDL-C Trial
The primary clinical hypothesis is that long-term exposure of evolocumab (AMG 145) will be safe and well tolerated in adults with hypercholesterolemia.
- Trial name
- OSLER (NCT01439880)
- Testing
- Evolocumab, Standard of care
- Where
- 187 sites in United States, Australia and 16 more
- Volunteers
- 1,324 people
- Sponsor
- Amgen
Hyperlipidemia
LDL-C Assessment With PCSK9 Monoclonal Antibody Inhibition Combined With Statin Therapy-2
The primary objective was to evaluate the effect of 12 weeks of evolocumab administered subcutaneously every 2 weeks (Q2W) and monthly (QM) when used in combination with a statin, compared with placebo, on percent change from…
- Trial name
- LAPLACE-2 (NCT01763866)
- Testing
- Evolocumab, Ezetimibe, Atorvastatin
- Where
- 244 sites in United States, Australia and 19 more
- Volunteers
- 2,067 people
- Sponsor
- Amgen
Metabolic Syndrome X
ROMEO (Rosuvastatin in Metabolic syndrOme)
The primary objective of this study is to compare the effect of rosuvastatin 10mg with atorvastatin 10mg after 6 weeks of treatment in the ratio of ApoB/ApoA1 in subjects with metabolic syndrome.
- Trial name
- NCT00395486
- Testing
- Rosuvastatin, Atorvastatin
- Where
- 3 sites in South Korea
- Volunteers
- 258 people
- Sponsor
- AstraZeneca
Primary Hypercholesterolemia or Mixed Dyslipidemia
Efficacy and Safety of Inclisiran as Monotherapy in Chinese Adults With Low or Moderate ASCVD Risk and Elevated Low-density Lipoprotein Cholesterol.
The purpose of this study was to evaluate the efficacy and safety of inclisiran as a monotherapy in Chinese adults with low or moderate atherosclerotic cardiovascular disease (ASCVD) risk and elevated low-density lipoprotein…
- Trial name
- V-Mono China (NCT05888103)
- Testing
- Inclisiran
- Where
- 28 sites in China
- Volunteers
- 207 people
- Sponsor
- Novartis Pharmaceuticals
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.