Clinical trials: Hyperlipidemia
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
Hyperlipidemia, Hypercholesterolemia
A Prospective, Open Label Comparison of Ezetimibe, Niacin, and Colestipol as Adjunct Therapy in Lipid Reduction
To compare LDL reduction compared to baseline in patients using maximum tolerated HMG CoA Reductase inhibitor (statin) therapy with adjunctive therapy with ezetimibe, colestipol, or niacin.
- Trial name
- NCT00203476
- Testing
- Niacin, Colestipol, Ezetimibe
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Tuscaloosa Research & Education Advancement Corporation
Hypertriglyceridemia
Epanova® for Lowering Very High Triglycerides II (EVOLVE II)
This is a double-blind, randomized, olive oil-controlled study to investigate the efficacy and safety of Epanova as an adjunct therapy to diet for reduction of TG levels in subjects with severe hypertriglyceridemia.
- Trial name
- EVOLVEII (NCT02009865)
- Testing
- Epanova, Olive Oil
- Where
- 40 sites in United States, Canada and 5 more
- Volunteers
- 379 people
- Sponsor
- AstraZeneca
Homozygous Familial Hypercholesterolemia
Study in Participants With Homozygous Familial Hypercholesterolemia (HoFH)
The primary objective of the study is to demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) with alirocumab subcutaneous (SC) every 2 weeks (Q2W) in comparison to placebo after 12 weeks of treatment.
- Trial name
- ODYSSEY HoFH (NCT03156621)
- Testing
- Alirocumab
- Where
- 28 sites in United States, Austria and 11 more
- Volunteers
- 69 people
- Sponsor
- Regeneron Pharmaceuticals
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
Hypercholesterolemia
Monthly And Twice Monthly Subcutaneous Dosing Of PF-04950615 (RN316) In Hypercholesterolemic Subjects On A Statin
To evaluate the Low Density Lipoprotein-Cholesterol (LDL-C) lowering effect of PF-04950615 administered subcutaneously at monthly intervals, or twice monthly intervals in subjects with high cholesterol whose LDL-cholesterol is…
- Trial name
- NCT01592240
- Testing
- PBO, 200mg PF-04950615 (RN316), 300mg PF-04950615 (RN316)
- Where
- 74 sites in United States
- Volunteers
- 354 people
- Sponsor
- Pfizer
Hypercholesterolemia, Dyslipidemia
A Multicenter Study Comparing the Safety and Efficacy of ABT-335 and Rosuvastatin Calcium Combination Therapy to Monotherapy in Subjects With Dyslipidemia
The purpose of this study is to evaluate the safety and efficacy of ABT-335 and rosuvastatin calcium combination therapy to monotherapy in subjects with dyslipidemia.
- Trial name
- NCT00463606
- Testing
- ABT-335 and rosuvastatin calcium, ABT-335, rosuvastatin calcium
- Where
- 168 sites in United States
- Volunteers
- 760 people
- Sponsor
- AstraZeneca
Elevated Lipoprotein(a), Cardiovascular Disease
Phase 2 Study of ISIS 681257 (AKCEA-APO(a)-LRx) in Participants With Hyperlipoproteinemia(a) and Cardiovascular Disease
This is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the safety, including tolerability, of ISIS 681257 and to assess the efficacy of different doses and dosing regimens of ISIS…
- Trial name
- NCT03070782
- Testing
- ISIS 681257
- Where
- 32 sites in United States, Canada and 3 more
- Volunteers
- 286 people
- Sponsor
- Akcea Therapeutics
Hypercholesterolemia
Study to Evaluate the Efficacy and Safety of an Every Four Weeks Treatment Regimen of Alirocumab (REGN727/ SAR236553) in Patients With Primary Hypercholesterolemia (ODYSSEY CHOICE 1)
To determine the efficacy, long-term safety, and tolerability of alirocumab 300 mg every 4 weeks (Q4W), in comparison with placebo, as well as its potential as a starting regimen.
- Trial name
- NCT01926782
- Testing
- Alirocumab, Statin
- Where
- 83 sites in United States, Bulgaria and 6 more
- Volunteers
- 803 people
- Sponsor
- Regeneron Pharmaceuticals
Diabetes Mellitus
Prospective Evaluation of Proteinuria and Renal Function in Diabetic Patients With Progressive Renal Disease
The purpose of this study is to evaluate the effects of Crestor (rosuvastatin) and (Lipitor) atorvastatin on urinary protein excretion over 1 year in patients with Type 1 or 2 diabetes with moderate proteinuria and…
- Trial name
- PLANET 1 (NCT00296374)
- Testing
- Rosuvastatin, Atorvastatin
- Where
- 116 sites in United States, Argentina and 9 more
- Volunteers
- 353 people
- Sponsor
- AstraZeneca
Hyperlipidemia
Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Subjects Currently Not Receiving Drug Therapy for Easing Lipid Levels-2
The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneous (SC) monotherapy every 2 weeks (Q2W) and monthly (QM), compared with placebo and ezetimibe, on percent change from baseline in low-density…
- Trial name
- MENDEL-2 (NCT01763827)
- Testing
- Evolocumab, Ezetimibe
- Where
- 83 sites in United States, Australia and 8 more
- Volunteers
- 615 people
- Sponsor
- Amgen
Hypercholesterolemia, Dyslipidemias
Dose-ranging Efficacy and Pharmacokinetics Study of Intravenous Atorvastatin in Hypercholesterolemic Patients
Open-label study will titrate doses of intravenous atorvastatin and monitor respective LDL-C levels in hypercholesterolemic patients previously controlled on oral atorvastatin.
- Trial name
- NCT03611010
- Testing
- Atorvastatin injection
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Cumberland Pharmaceuticals
Hypercholesterolemia, Coronary Heart Disease
12-week Open-label, Phase IIIb Comparing Efficacy and Safety of Rosuvastatin (CRESTOR™) in Combination With Ezetimibe
The purpose of this study is to determine whether treatment of Rosuvastatin (CRESTOR™) or Simvastatin given as monotherapy or given in combination with Ezetimibe, will lower the Low Density Lipoprotein Cholesterol (LDL-C) in…
- Conditions
- Hypercholesterolemia, Coronary Heart Disease, Atherosclerosis
- Trial name
- GRAVITY (NCT00525824)
- Testing
- Rosuvastatin (Crestor), Ezetimibe, Simvastatin
- Where
- 9 sites in United States, Argentina and 7 more
- Volunteers
- 1,743 people
- Sponsor
- AstraZeneca
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
Insulin Resistance, Hypertriglyceridemia
Comparing Tricor, Avandia, or Weight Loss to Lower Cardiovascular Risk Factors in People With High Triglycerides.
Approximately 1/4 of the US population has insulin resistance and the associated risk factors such as elevated lipid levels -triglycerides (type of fat from what we eat and what the liver produces and low HDL cholesterol which is…
- Trial name
- NCT00186537
- Testing
- Rosiglitazone, Fenofibrate, Weight Loss
- Where
- United States
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Stanford University
Dyslipidemias, High Cholesterol
Evaluate the Effect of Obicetrapib in Patients With HeFH on Top of Maximum Tolerated Lipid-Modifying Therapies.
This study will be a placebo-controlled, double-blind, randomized, phase 3 study to Evaluate the Efficacy, Safety, and Tolerability of Obicetrapib in Participants with a History of Heterozygous Familial Hypercholesterolemia…
- Conditions
- Dyslipidemias, High Cholesterol, Hypercholesterolemia, Familial Hypercholesterolemia
- Trial name
- BROOKLYN (NCT05425745)
- Testing
- Obicetrapib
- Where
- 96 sites in United States, Canada and 8 more
- Volunteers
- 354 people
- Sponsor
- NewAmsterdam Pharma
Diabetes Mellitus, Postprandial Lipemia
Effects of Sitagliptin on Postprandial Lipemia in Men With Type 2 Diabetes
Sitagliptin is a potent and selective inhibitor of dipeptidyl peptidase IV (DPP-4), and has been shown to reduce fasting and postprandial glucose levels in patients with type 2 diabetes mainly through incretin hormone-mediated…
- Trial name
- NCT00660075
- Testing
- Sitagliptin
- Where
- Canada
- Volunteers
- 36 people
- Sponsor
- Laval University
Familial Hypercholesterolaemia
An Study to Evaluate Rosuvastatin in Children and Adolescents With Familial Hypercholesterolaemia
This study is being carried out to see if the study medication, rosuvastatin, is effective in treating familial hypercholesterolaemia in children and adolescents, and to determine the long term (over 2 years) safety, tolerability…
- Trial name
- NCT01078675
- Testing
- rosuvastatin calcium
- Where
- 15 sites in United States, Belgium and 3 more
- Volunteers
- 315 people
- Sponsor
- AstraZeneca
Primary Hyperlipidemia and Mixed Dyslipidemia
Effects on Lipoprotein Metabolism From PCSK9 Inhibition Utilizing a Monoclonal Antibody
This is a randomized, double-blind, placebo-controlled trial to evaluate the effect of evolocumab, atorvastatin, and combination therapy on lipoprotein kinetics.
- Trial name
- FLOREY (NCT02189837)
- Testing
- Evolocumab, Atorvastatin
- Where
- 2 sites in Australia
- Volunteers
- 89 people, healthy volunteers welcome
- Sponsor
- Amgen
Hypercholesterolemia, Hyperlipoproteinemia Type II
Safety Study of AEM-28 to Treat Refractory Hypercholesterolemia
The purpose of the first part of this study is to determine the safety and tolerability of a single dose of AEM-28, an apolipoprotein E mimetic, in subjects with high total cholesterol who are otherwise healthy subjects.
- Trial name
- NCT02100839
- Testing
- AEM-28, Normal Saline
- Where
- Australia
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- LipimetiX Development, LLC