Clinical trials: Elevated Low Density Lipoprotein Cholesterol
- Condition Elevated Low Density Lipoprotein Cholesterol
- Funder type Industry (pharma, biotech, devices)
- Has posted results yes
Hypercholesterolemia
Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) When Co-administered With High Dose of Atorvastatin in Patients With Primary Hypercholesterolemia
Primary Objective: To evaluate the effect of alirocumab (SAR236553/REGN727) on low-density lipoprotein cholesterol (LDL-C) levels compared with placebo when co-administered with 80 mg of atorvastatin after 8 weeks of treatment in…
- Trial name
- NCT01288469
- Testing
- Alirocumab, Atorvastatin
- Where
- 20 sites in United States
- Volunteers
- 92 people
- Sponsor
- Sanofi
Cardiovascular Diseases
Study of the Effectiveness and Safety of Niaspan ® in the Treatment of Lipid Abnormalities in Latin America
Post-Marketing Observational study of Niaspan® tablet in accordance with each country regulations. This study will be conducted in a prospective, single-arm, multi-center format.
- Trial name
- NCT01200160
- Testing
- Niacin
- Where
- 22 sites in Colombia, Mexico and 1 more
- Volunteers
- 128 people, healthy volunteers welcome
- Sponsor
- Abbott
Atherosclerotic Cardiovascular Disease, Familial Hypercholesterolemia
Trial to Evaluate the Effect of ALN-PCSSC Treatment on Low Density Lipoprotein Cholesterol (LDL-C)
This study is a Phase II, placebo-controlled, double-blind, randomized trial in 480 participants with atherosclerotic cardiovascular disease (ASCVD) or ASCVD-risk equivalents (for example, diabetes and familial…
- Conditions
- Atherosclerotic Cardiovascular Disease, Familial Hypercholesterolemia, Diabetes
- Trial name
- ORION-1 (NCT02597127)
- Testing
- ALN-PCSSC, Normal Saline
- Where
- 54 sites in United States, Canada and 3 more
- Volunteers
- 501 people
- Sponsor
- The Medicines Company
Elevated LDL Cholesterol
A Pharmacodynamic Study to Evaluate the Effect of a Fixed Dose Combination Pill on Low Density Lipoprotein (LDL) Cholesterol
This study evaluates the effect on LDL cholesterol of the 3 drugs given together in the cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin, and ramipril) as compared to the effect on LDL cholesterol of…
- Trial name
- NCT01004705
- Testing
- Cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin and ramipril),, Simvastatin
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Ferrer Internacional S.A.
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
Atherosclerotic Cardiovascular Disease
A Randomized Study to Evaluate the Effect of an "Inclisiran First" Implementation Strategy Compared to Usual Care in Patients With Atherosclerotic Cardiovascular Disease and Elevated LDL-C Despite Receiving Maximally Tolerated Statin Therapy (VICTORION-INITIATE)
The purpose of this study was to assess the effectiveness of an "inclisiran first" implementation strategy (addition of inclisiran to maximally tolerated statin therapy immediately upon failure to achieve acceptable LDL-C with…
- Trial name
- V-INITIATE (NCT04929249)
- Testing
- Inclisiran
- Where
- 43 sites in United States
- Volunteers
- 450 people
- Sponsor
- Novartis Pharmaceuticals
Primary Hypercholesterolemia, Mixed Dyslipidemia
Efficacy and Safety of Extended-Release Niacin/ Laropiprant/Simvastatin Tablets in Participants With Hypercholesterolemia or Mixed Dyslipidemia (MK-0524B-143)
This study is being done to find out if tablets containing extended release (ER) niacin, laropiprant, and simvastatin (ERN/LRPT/SIM) are as effective as tablets containing ER niacin and laropiprant taken with simvastatin tablets…
- Trial name
- NCT01335997
- Testing
- ER niacin/laropiprant (ERN/LRPT), ER niacin/laropiprant/simvastatin (ERN/LRPT/SIM), Simvastatin (SIM)
- Volunteers
- 1,139 people
- Sponsor
- Merck Sharp & Dohme 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
ASCVD, Risk Factor, Cardiovascular
Inclisiran for Subjects With ASCVD or ASCVD-Risk Equivalents and Elevated Low-density Lipoprotein Cholesterol
This is a Phase III, placebo-controlled, double-blind, randomized study in participants with ASCVD or ASCVD-Risk equivalents and elevated LDL-C despite maximum tolerated dose of LDL-C lowering therapies to evaluate the efficacy…
- Conditions
- ASCVD, Risk Factor, Cardiovascular, Elevated Cholesterol
- Trial name
- ORION-11 (NCT03400800)
- Testing
- Inclisiran Sodium
- Where
- 70 sites in Czechia, Germany and 5 more
- Volunteers
- 1,617 people
- Sponsor
- The Medicines Company
Atherosclerotic Cardiovascular Disease, Atherosclerotic Cardiovascular Disease Risk Equivelents
Study in Primary Care Evaluating Inclisiran Delivery Implementation + Enhanced Support
The purpose of this study was to evaluate the implementation of inclisiran in a regional primary care setting in the UK Inclisiran, also known as KJX839, is a medication made to reduce the level of "bad" cholesterol…
- Conditions
- Atherosclerotic Cardiovascular Disease, Atherosclerotic Cardiovascular Disease Risk Equivelents, Elevated Low Density Lipoprotein Cholesterol
- Trial name
- SPIRIT (NCT04807400)
- Testing
- Inclisiran, Behavioural Support, Background lipid lowering therapy
- Where
- 17 sites in United Kingdom
- Volunteers
- 892 people
- Sponsor
- Novartis Pharmaceuticals
Diabetes, Diabetes Mellitus, Type 2
Bempedoic Acid + Ezetimibe Fixed-Dose Combination (FDC) Study in Patients With Type 2 Diabetes and Elevated LDL-C
12 week study to assess the LDL-C lowering efficacy, other lipid and glycemic measures, and safety of bempedoic acid/ezetimibe FDC compared to ezetimibe and placebo in patients with type 2 diabetes (T2D) and elevated LDL-C
- Conditions
- Diabetes, Diabetes Mellitus, Type 2, Cholesterolemia
- Trial name
- NCT03531905
- Testing
- Bempedoic acid + Ezetimibe FDC Oral Tablet, Ezetimibe 10 mg Oral Tablet
- Where
- 4 sites in United States
- Volunteers
- 242 people
- Sponsor
- Esperion Therapeutics, Inc.
Dyslipidemia
A Study to Assess the Effect of RO4607381 in Patients With Relatively Low Levels of High Density Lipoprotein-Cholesterol (HDL-C)
This 4 arm study will evaluate the efficacy and safety of RO4607381 when co-administered with pravastatin in patients with low or relatively low HDL-C levels.
- Trial name
- NCT00697203
- Testing
- Pravastatin, Dalcetrapib
- Where
- 33 sites in United States
- Volunteers
- 292 people
- Sponsor
- Hoffmann-La Roche
Healthy Participants
A Study of LY2484595 on Pharmacokinetics in Healthy Participants
This is a 2-part study. Part 1 is to determine the safety and tolerability in healthy participants of increasing daily doses of LY2484595 for 14 days to achieve a blood level of LY2484595 much higher than what is needed for…
- Trial name
- NCT01448824
- Testing
- LY2484595, Ketoconazole
- Where
- 2 sites in United States
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia
Safety and Efficacy Study Comparing ABT-143 to Simvastatin in Subjects With Elevated Levels of Low Density Lipoprotein Cholesterol ("Bad Cholesterol") and Triglycerides
The primary purpose of this study is to test the effect and safety of three different doses of ABT-143 compared to simvastatin in subjects with elevated levels of low density lipoprotein cholesterol ("bad cholesterol") and…
- Trial name
- NCT00812955
- Testing
- ABT-143, simvastatin
- Where
- 129 sites in United States
- Volunteers
- 474 people
- Sponsor
- AstraZeneca
Familial Hypercholesterolemia - Homozygous
Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Homozygous Familial Hypercholesterolemia
This was a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in adolescents with homozygous familial hypercholesterolemia (HoFH) and elevated low density lipoprotein cholesterol (LDL-C).
- Trial name
- ORION-13 (NCT04659863)
- Testing
- Inclisiran
- Where
- 11 sites in United States, Canada and 6 more
- Volunteers
- 13 people
- Sponsor
- Novartis Pharmaceuticals
Familial Hypercholesterolemia - Heterozygous
Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Heterozygous Familial Hypercholesterolemia
This was a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in adolescents with heterozygous familial hypercholesterolemia (HeFH) and elevated low density lipoprotein cholesterol…
- Trial name
- ORION-16 (NCT04652726)
- Testing
- Inclisiran
- Where
- 59 sites in United States, Argentina and 24 more
- Volunteers
- 141 people
- Sponsor
- Novartis Pharmaceuticals
Heterozygous Familial Hypercholesterolemia
Trial Assessing Efficacy, Safety and Tolerability of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition in Paediatric Subjects With Genetic Low-Density Lipoprotein (LDL) Disorders
A study to assess safety and efficacy of evolocumab (AMG-145) in paediatric subjects aged 10-17 years diagnosed with heterozygous familial hypercholesterolemia.
- Trial name
- HAUSER-RCT (NCT02392559)
- Testing
- Evolocumab
- Where
- 66 sites in United States, Australia and 24 more
- Volunteers
- 158 people
- Sponsor
- Amgen
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
Dyslipidemia
Niacin/Laropiprant Tablet for South and Southeast Asians With Low High-Density Lipoprotein Cholesterol (LDL-C) at Risk for Cardiovascular Disease (MK-0524A-108)
The study will evaluate the use of extended release niacin/laropiprant (ERN/LRPT) combination tablets in a primary prevention population currently not taking or eligible for lipid-modifying therapy (LMT); the population will…
- Trial name
- NCT01414166
- Testing
- ERN/LRPT
- Volunteers
- 244 people
- Sponsor
- Merck Sharp & Dohme LLC
Heterozygous Familial Hypercholesterolemia, Elevated Cholesterol
Trial to Evaluate the Effect of Inclisiran Treatment on Low Density Lipoprotein Cholesterol (LDL-C) in Subjects With Heterozygous Familial Hypercholesterolemia (HeFH)
This is a Phase III, placebo-controlled, double-blind, randomized study in participants with HeFH and elevated LDL-C to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) injection(s) of inclisiran.
- Trial name
- ORION-9 (NCT03397121)
- Testing
- Inclisiran
- Where
- 45 sites in United States, Canada and 6 more
- Volunteers
- 482 people
- Sponsor
- The Medicines Company