Clinical trials: Hyperlipidemia
Hypertriglyceridemia, Atherosclerotic Cardiovascular Disease
A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) in Adults With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease (Established or at Increased Risk for), and/or With Severe Hypertriglyceridemia
The purpose of the study was to evaluate the effect of olezarsen on percent change in fasting triglyceride (TG) levels compared to placebo at Months 6 and 12 and the proportion of participants who achieve different thresholds in…
- Conditions
- Hypertriglyceridemia, Atherosclerotic Cardiovascular Disease, Severe Hypertriglyceridemia
- Trial name
- NCT05355402
- Testing
- Olezarsen
- Where
- 24 sites in United States, Canada
- Volunteers
- 154 people
- Sponsor
- Ionis Pharmaceuticals, Inc.
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
Hypertension, Hyperlipidemia
Prioritized Clinical Decision Support (CDS) to Reduce Cardiovascular Risk
The objective of this project is to develop and implement sophisticated point-of-care Electronic Health Record (EHR)-based clinical decision support that (a) identifies and (b) prioritizes all available evidence-based treatment…
- Conditions
- Hypertension, Hyperlipidemia, Diabetes, Smoking
- Trial name
- NCT01420016
- Testing
- Prioritized Clinical Decision Support
- Volunteers
- 7,914 people, healthy volunteers welcome
- Sponsor
- HealthPartners Institute
High Triglycerides, Hypercholesterolemia
Omega-3 Fatty Acids (Lovaza) for Second Generation Antipsychotic-Associated Hypertriglyceridemia
This is an open-label pilot study of omega-3 fatty acids (Lovaza) for hypertriglyceridemia in subjects who have been on an atypical (second-generation) antipsychotic medication.
- Conditions
- High Triglycerides, Hypercholesterolemia, Schizophrenia, Schizoaffective Disorder
- Trial name
- NCT00833976
- Testing
- Lovaza
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- Massachusetts General Hospital
Hypercholesterolemia
Ezetimibe/Simvastatin (10 mg/40 mg) vs. the Doubling of Atorvastatin in High Risk Participants (MK-0653A-134 AM1)(COMPLETED)
Participants currently taking atorvastatin 20 mg will be switched to either atorvastatin 40 mg or ezetimibe/simvastatin 10 mg/40 mg (10/40).
- Trial name
- NCT00782184
- Testing
- ezetimibe/simvastatin 10/40, atorvastatin 40 mg, atorvastatin 20 mg
- Volunteers
- 250 people
- Sponsor
- Organon and Co
Hypercholesterolemia, Dyslipidemias
Study of Pitavastatin in Elderly Patients With Primary Hypercholesterolemia or Combined Dyslipidemia
This is an open-label extension study of NK-104-306 (NCT00257686) for elderly patients with hypercholesterolemia or combined dyslipidemia.
- Trial name
- NCT00330876
- Testing
- Pitavastatin
- Where
- 59 sites in Denmark, Germany and 3 more
- Volunteers
- 545 people
- Sponsor
- Kowa Research Europe
Cardiovascular Disease
The Evaluation of Bococizumab (PF-04950615;RN316) in Reducing the Occurrence of Major Cardiovascular Events in High Risk Subjects
This study evaluates the PCSK9 inhibitor, Bococizumab (PF-04950615;RN316), compared to placebo, in reducing the occurrence of major cardiovascular events, including cardiovascular death, myocardial infarction, stroke, and…
- Trial name
- SPIRE-1 (NCT01975376)
- Testing
- bococizumab (PF-04950615)
- Where
- 1,745 sites in United States, Argentina and 34 more
- Volunteers
- 16,784 people
- Sponsor
- Pfizer
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
Hypercholesterolemia
Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe in Patients With Hypercholesterolemia
Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9).
- Trial name
- ODYSSEY MONO (NCT01644474)
- Testing
- Alirocumab, Ezetimibe
- Where
- 8 sites in United States, Belgium and 2 more
- Volunteers
- 103 people
- Sponsor
- Sanofi
Hypercholesterolemia
A Clinical Study in Children With Heterozygous Familial Hypercholesterolemia (HeFH) Aged 6 to 17 Treated Once Daily With Bempedoic Acid Oral Dosing (CLEAR Path 1)
Multiple-dose study to measure pharmacokinetics, pharmacodynamics and safety of bempedoic acid in pediatric participants 6 to 17 years of age with HeFH.
- Trial name
- CLEAR Path 1 (NCT05694260)
- Testing
- Bempedoic acid
- Where
- 24 sites in United States, Canada and 4 more
- Volunteers
- 31 people
- Sponsor
- Esperion Therapeutics, Inc.
Cardiovascular Disease
The Evaluation of Bococizumab (PF-04950615; RN316) in Reducing the Occurrence of Major Cardiovascular Events in High Risk Subjects
This study evaluates the PCSK9 inhibitor, Bococizumab (PF-04950615;RN316), compared to placebo, in reducing the occurrrence of major cardiovascular events, including cardiovascular death, myocardial infarction, stroke, and…
- Trial name
- SPIRE-2 (NCT01975389)
- Testing
- bococizumab (PF-04950615)
- Where
- 1,595 sites in United States, Argentina and 33 more
- Volunteers
- 10,564 people
- Sponsor
- Pfizer
Hypercholesterolemia, Familial, Heterozygous Familial Hypercholesterolemia
A Study of Extended-release (ER) Niacin/Laropiprant in Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0524A-158)
The purpose of this study is to determine the pharmacokinetics of laropiprant following administration of a single dose of 1 (Panel A) and 2 (Panel B) combination tablets of MK-0524A in adolescents with heterozygous familial…
- Trial name
- NCT01583647
- Testing
- MK-0524A
- Volunteers
- 10 people
- Sponsor
- Merck Sharp & Dohme LLC
High Cholesterol
Technology-Assisted Cholesterol Trial in Consumers (TACTiC)
The purpose of this AUS is to evaluate the extent to which participants can safely and effectively self-select, purchase, and use Crestor OTC 5 mg for a 6-month period according to the label.
- Trial name
- TACTiC (NCT04964544)
- Testing
- 5 mg rosuvastatin calcium with a Web App (combination product)
- Where
- United States
- Volunteers
- 1,196 people
- Sponsor
- AstraZeneca
Hypertriglyceridemia
Long-term Efficacy and Safety Study of TAK-085 in Participants With Hypertriglyceridemia
The purpose of this study is to determine the safety and efficacy of TAK-085, once daily (QD) or twice daily (BID), compared to ethyl eicosapentaenoate (EPA-E), three times daily (TID) in participants with hypertriglyceridemia…
- Trial name
- NCT01350999
- Testing
- omega-3-acid ethyl esters 90 (TAK-085), Eicosapentaenoic acid-ethyl (EPA)
- Volunteers
- 503 people
- Sponsor
- Takeda
Hypercholesterolemia
Open-label Extension (OLE) Study to Assess Safety and Efficacy of Evolocumab
The purpose of this study was to characterize the safety and tolerability of long-term administration of evolocumab in adults with known coronary artery disease and hypercholesterolemia.
- Trial name
- NCT02304484
- Testing
- Evolocumab
- Where
- 126 sites in United States, Argentina and 27 more
- Volunteers
- 770 people
- Sponsor
- Amgen
Hyperlipidemia
Randomized Clinical Trial Of Bococizumab (PF-04950615; RN316) In Subjects With Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events
This study is a multicenter, randomized study in subjects with high cholesterol receiving highly effective statins to assess the efficacy, safety and tolerability of Bococizumab (PF-04950615;RN316) to lower LDL-C.
- Trial name
- SPIRE-HR (NCT01968954)
- Testing
- Bococizumab (PF-04950615;RN316)
- Where
- 103 sites in United States, Australia and 7 more
- Volunteers
- 711 people
- Sponsor
- Pfizer
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.
Dyslipidemia
Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk Open-label Extension
The primary clinical hypothesis is that long-term exposure of evolocumab will be safe and well tolerated in subjects with clinically evident atherosclerotic cardiovascular disease (CVD).
- Trial name
- FOURIER OLE (NCT02867813)
- Testing
- Evolocumab
- Where
- 198 sites in United States, Czechia and 5 more
- Volunteers
- 5,035 people
- Sponsor
- Amgen
Cardiovascular Disease
Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction - DOSE Finding Study
Evaluate the effect of olpasiran administered subcutaneously (SC) compared with placebo, on percent change from baseline in lipoprotein(a) (Lp[a]).
- Trial name
- NCT04270760
- Testing
- Olpasiran
- Where
- 36 sites in United States, Australia and 5 more
- Volunteers
- 281 people
- Sponsor
- Amgen
Gestational Diabetes, Hyperlipidemia
Lipid Metabolism in Gestational Diabetes
The purpose of this pilot study is to determine if, during pregnancy, women with GDM have an exaggerated lipid response compared to non-gestational diabetics.
- Trial name
- NCT00534105
- Testing
- Total Cholesterol, Triglyceride, HDL
- Where
- United States
- Volunteers
- 106 people
- Sponsor
- Baystate Medical Center