Clinical trials: Low-density-lipoprotein-type
Hypercholesterolemia
Evolocumab Compared to LDL-C Apheresis in Patients Receiving LDL-C Apheresis Prior to Study Enrollment
To evaluate the efficacy of subcutaneous (SC) evolocumab, compared to regularly scheduled low-density lipoprotein cholesterol (LDL-C) apheresis, on reducing the need for future apheresis.
- Trial name
- NCT02585895
- Testing
- Evolocumab, Low-density Lipoprotein Cholesterol (LDL-C) Apheresis
- Where
- 17 sites in United States, Australia and 6 more
- Volunteers
- 39 people
- Sponsor
- Amgen
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.
Hyperlipidemia
Monoclonal Antibody Against PCSK9 to Reduce Elevated Low-density Lipoprotein Cholesterol (LDL-C) in Adults Currently Not Receiving Drug Therapy for Easing Lipid Levels
The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145) every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on the percent change from baseline in LDL-C when used as…
- Trial name
- MENDEL (NCT01375777)
- Testing
- Evolocumab, Ezetimibe
- Where
- 58 sites in United States, Australia and 3 more
- Volunteers
- 411 people
- Sponsor
- Amgen
Hypercholesterolemia, Familial
Reduction of Low-Density Lipoprotein Cholesterol (LDL-C) With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder Study
The primary objective of this study was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145), compared with placebo, on percent change from baseline in LDL-C in adults with heterozygous familial…
- Trial name
- RUTHERFORD (NCT01375751)
- Testing
- Evolocumab
- Volunteers
- 168 people
- Sponsor
- Amgen
Subjects With Hyperlipidemia, Dyslipidemia and HIV Infection
Safety, Tolerability and Efficacy on Low Density Lipoprotein Cholesterol (LDL-C) of Evolocumab in Participants With Human Immunodeficiency Virus (HIV) and Hyperlipidemia/Mixed Dyslipidemia
The study is divided into 2 parts. The first part of the study will be double-blinded and will last for 24 weeks. During this time, participants will be randomized in a ratio of 2:1 to receive either evolocumab once monthly (QM)…
- Trial name
- NCT02833844
- Testing
- Evolocumab
- Where
- 78 sites in United States, Australia and 13 more
- Volunteers
- 467 people
- Sponsor
- Amgen
Cardiovascular Risk Factor, Type2 Diabetes Mellitus
Orange Juice And Sugar Intervention Study
The objectives of this proposal are to address the gaps in knowledge regarding the metabolic effects of consuming orange juice, the most frequently consumed fruit juice in this country, compared to sugar-sweetened beverage.
- Conditions
- Cardiovascular Risk Factor, Type2 Diabetes Mellitus, Insulin Sensitivity, Metabolic Syndrome
- Trial name
- OASIS (NCT03527277)
- Testing
- Naturally-sweetened orange juice, Sugar-sweetened beverage
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- University of California, Davis
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
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
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
Type 2 Diabetes
A Diabetes Study to Treat A Population Previously Not at Target
This study will assess if customizing the start dose of rosuvastatin appropriate for the degree of LDL-C reduction required, would achieve LDL-C target of ≤ 2.0 mmol/L quickly with either no titration or just one titration step…
- Trial name
- ADAPT (NCT00747149)
- Testing
- Rosuvastatin
- Where
- 84 sites in Canada
- Volunteers
- 598 people
- Sponsor
- AstraZeneca
Homozygous Familial Hypercholesterolemia (HoFH)
A Gene Therapy Study for Homozygous Familial Hypercholesterolemia (HoFH)
This first-in-human study is intended to evaluate the safety and preliminary effectiveness of AAV (Adeno-associated virus)-based liver-directed gene therapy in the treatment of adults with Homozygous Familial Hypercholesterolemia…
- Trial name
- NCT02651675
- Testing
- AAV directed hLDLR gene therapy
- Where
- 9 sites in United States, Canada and 2 more
- Volunteers
- 9 people
- Sponsor
- REGENXBIO Inc.
Familial Hypercholesterolemia
Low-Density Lipoprotein (LDL) Apheresis Using H.E.L.P. Therapy
The objectives of this post-surveillance study are to continue to evaluate the safety and effectiveness of the H.E.L.P. System. The safety and effectiveness will be assessed by evaluating the occurrence of death, cardiovascular…
- Trial name
- Secura (NCT00916643)
- Testing
- HELP Secura (apheresis treatment)
- Volunteers
- 113 people
- Sponsor
- B. Braun Medical Inc.
Heart Transplant
Impact of Evolocumab in Cardiac Transplant Patients With CAV
Coronary allograft vasculopathy (CAV) is diffusely accelerated atherosclerosis of a transplanted heart. Evolocumab (Repatha) is an FDA-approved drug for lowering low density lipoprotein (LDL) in patients who have not received a…
- Trial name
- NCT03944577
- Testing
- Evolocumab
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- University of Nebraska
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
Hypercholesterolemia
An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Homozygous Familial Hypercholesterolemia
Primary Objective: To evaluate the efficacy of alirocumab (75 or 150 milligrams [mg] depending on body weight [BW]), administered every 2 weeks (Q2W), on low-density lipoprotein cholesterol (LDL-C) levels at Week 12 of treatment…
- Trial name
- NCT03510715
- Testing
- Alirocumab SAR236553 (REGN727), Atorvastatin, Simvastatin
- Where
- 10 sites in Brazil, Canada and 8 more
- Volunteers
- 18 people
- Sponsor
- Sanofi