Clinical trials: Lipid Disorders
Hypercholesterolemia
Coadministration of Ezetimibe and Simvastatin in Patients With Primary Hypercholesterolemia (P05457)
Evaluate the safety of the long-term (1 year) coadministration of ezetimibe and simvastatin in patients with hypercholesterolemia who have not reached low density lipoprotein (LDL)-cholesterol target with…
- Trial name
- NCT00653523
- Testing
- Ezetimibe, Simvastatin
- Volunteers
- 151 people
- Sponsor
- Organon and Co
Fabry Disease
Study to Compare the Efficacy and Safety of Oral AT1001 and Enzyme Replacement Therapy in Patients With Fabry Disease
Study to compare the efficacy and safety of migalastat and enzyme replacement therapy (ERT) in male and female participants with Fabry disease who are currently receiving ERT and who have an alpha galactosidase-A (α Gal-A)…
- Trial name
- NCT01218659
- Testing
- migalastat hydrochloride, agalsidase
- Where
- 25 sites in United States, Australia and 8 more
- Volunteers
- 68 people
- Sponsor
- Amicus Therapeutics
Cardiovascular Diseases
A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High-Risk Patients With Hypertriglyceridemia and on Statin
AMR101 (icosapent ethyl [ethyl-EPA]) is a highly purified ethyl ester of eicosapentaenoic acid (EPA) developed by Amarin Pharma Inc.
- Trial name
- REDUCE-IT (NCT01492361)
- Testing
- AMR101, Statin therapy
- Where
- 410 sites in United States, Australia and 9 more
- Volunteers
- 8,179 people
- Sponsor
- Amarin Pharma Inc.
Gastrointestinal Hemorrhage, Clostridium Difficile Colitis
Enteral Nutrition as Stress Ulcer Prophylaxis in Critically Ill Patients.
study is to determine if proton pump inhibitors plus enteral nutrition is superior to enteral nutrition alone as a stress ulcer prophylaxis strategy in critically ill patients in terms of incidence of overt and significant GI…
- Trial name
- NCT01477320
- Testing
- Pantoprazole 40 mg IV daily and tube feed.
- Where
- United States
- Volunteers
- 124 people
- Sponsor
- Mohamed Saad
Dyslipidemias, Hypercholesterolemia
Study of Obicetrapib & Ezetimibe Fixed Dose Combination on Top of Maximum Tolerated Lipid-Modifying Therapies
The study is a placebo-controlled, double-blind, randomized, phase 3 study in participants with heterozygous familial hypercholesterolemia (HeFH) and/or atherosclerotic cardiovascular disease (ASCVD) or multiple ASCVD risk…
- Conditions
- Dyslipidemias, Hypercholesterolemia, Familial Hypercholesterolemia, ASCVD
- Trial name
- TANDEM (NCT06005597)
- Testing
- Combination Therapy, Monotherapy obicetrapib, Monotherapy ezetimibe
- Where
- 45 sites in United States
- Volunteers
- 407 people
- Sponsor
- NewAmsterdam Pharma
Cardiovascular, Dyslipidemia
Cardiovascular Events Based On Statin Initiation In The Elderly
The purpose of this study is to compare rates and risk of primary cardiovascular events among elderly patients newly initiating therapy with atorvastatin or simvastatin.
- Trial name
- NCT01304641
- Testing
- Atorvastatin Initiators, Simvastatin Initiators
- Volunteers
- 31,603 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Hypercholesterolemia
A Study of Ezetimibe Added On to Rosuvastatin Versus Up Titration of Rosuvastatin in Patients With Hypercholesterolemia (MK0653-139)
A study to evaluate the low-density lipoprotein cholesterol (LDL-C) lowering efficacy of the addition of ezetimibe to rosuvastatin compared with doubling dose of rosuvastatin in participants treated with rosuvastatin alone and…
- Trial name
- NCT00783263
- Testing
- Comparator: rosuvastatin 5 mg + ezetimibe 10 mg, Comparator: rosuvastatin 10 mg, Comparator: rosuvastatin 10 mg + ezetimibe 10 mg
- Volunteers
- 440 people
- Sponsor
- Organon and Co
Angina Pectoris, Angina, Unstable
SPECTACL: SPECTroscopic Assessment of Coronary Lipid
The purpose of this study is to evaluate a near-infrared (NIR) spectroscopy system that has been designed to identify the chemical composition of coronary artery plaques in patients undergoing a percutaneous coronary intervention…
- Conditions
- Angina Pectoris, Angina, Unstable, Myocardial Infarction
- Trial name
- SPECTACL (NCT00330928)
- Testing
- Near Infrared Spectroscopy (NIRS) Imaging, intravascular ultrasound (IVUS)
- Where
- 6 sites in United States, Canada
- Volunteers
- 106 people
- Sponsor
- Infraredx
GM2 Gangliosidosis, Tay-Sachs Disease
N-Acetyl-L-Leucine for GM2 Gangliosidosis (Tay-Sachs and Sandhoff Disease)
This is a multinational, multicenter, open-label, rater-blinded prospective Phase II study which will assess the safety and efficacy of N-Acetyl-L-Leucine (IB1001) for the treatment of GM2 Gangliosidosis (Tay-Sachs and Sandhoff…
- Conditions
- GM2 Gangliosidosis, Tay-Sachs Disease, Sandhoff Disease
- Trial name
- NCT03759665
- Testing
- IB1001
- Where
- 8 sites in United States, Germany and 2 more
- Volunteers
- 30 people
- Sponsor
- IntraBio Inc
Hypertension, Hypercholesterolemia
Clinical Trial of Protein and Blood Pressure
The purpose of this randomized, double-blind, controlled trial is to examine the effect of soybean protein supplementation on blood pressure in persons with prehypertension or stage-1 hypertension.
- Trial name
- ProBP (NCT00107744)
- Testing
- Soy protein-milk protein-carbohydrate, Milk protein-carbohydrate-soy protein, Carbohydrate-soy protein-milk protein
- Volunteers
- 352 people, healthy volunteers welcome
- Sponsor
- Tulane University
Hyperlipidemia
Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects
The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145), compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in patients with…
- Trial name
- GAUSS (NCT01375764)
- Testing
- Evolocumab, Ezetimibe
- Where
- 42 sites in United States, Australia and 6 more
- Volunteers
- 160 people
- Sponsor
- Amgen
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
Hyperlipidemia, Blood Pressure
Effect of Pterostilbene on Cholesterol, Blood Pressure and Oxidative Stress
Pterostilbene is one of several stilbenes found in certain berries, particularly blueberries, that have demonstrated pre-clinical benefit to cholesterol, blood pressure, and oxidative stress.
- Conditions
- Hyperlipidemia, Blood Pressure, Oxidative Stress
- Trial name
- NCT01267227
- Testing
- Pterostilbene 50 mg twice daily, Grape Extract, Pterostilbene 125 mg twice daily
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- University of Mississippi Medical Center
Fabry Disease
Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Migalastat in Pediatric Subjects (Aged 12 to <18 Years)
This was an open-label study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of migalastat treatment in pediatric participants 12 to <18 years of age with Fabry disease and amenable gene…
- Trial name
- NCT03500094
- Testing
- Migalastat HCl 150 mg
- Where
- 8 sites in United States, United Kingdom
- Volunteers
- 22 people
- Sponsor
- Amicus Therapeutics
Batten Disease
An Open-label Safety, Pharmacokinetic, and Efficacy Study of Miglustat for the Treatment of Subjects With Batten Ceroid Lipofuscinosis, Neuronal 3 (CLN3) Disease
This is an open label study in approximately 6 subjects in 2 centers to assess the safety, PK, and efficacy of the maximum tolerable dose (MTD) of oral miglustat (100 mg once daily [QD] to 200 mg 3 times daily [TID]) in subjects…
- Trial name
- NCT05174039
- Testing
- Miglustat 100 milligrams (mg) Oral Capsule
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Beyond Batten Disease Foundation
Type 2 Diabetes Mellitus
The Effects of Soy Isoflavones to Improve the Metabolism of Glucose and Lipids
Many studies showed that soy foods or soy isoflavones can lower the risk of cardiovascular disease (CVD), osteoporosis and some cancers, but few human studies assessed effects of purified isoflavone components (genistein and…
- Trial name
- NCT00951912
- Testing
- Daidzein, Genistein
- Where
- China
- Volunteers
- 165 people
- Sponsor
- Sun Yat-sen University
Hypercholesterolemia
To Evaluate Ezetimibe Plus Atorvastatin Versus Atorvastatin in Patients With High Cholesterol Not Controlled on Atorvastatin 20 mg (0653-079)(COMPLETED)
The purpose of this study is to evaluate and compare the efficacy and safety of ezetimibe plus atorvastatin versus atorvastatin in hypercholesterolemic patients at moderately high risk for coronary heart disease not adequately…
- Trial name
- NCT00276458
- Testing
- Comparator: atorvastatin, Comparator: ezetimibe
- Volunteers
- 196 people
- Sponsor
- Organon and Co
Hyperlipidemia
Sitagliptin Regulation of Intestinal and Hepatic Lipoprotein Particle and Hepatic Glucose Production in Humans
Recent studies in both animals and humans has demonstrated that the hormone GLP-1 (glucagon like peptide 1) reduces intestinal production of lipoprotein particles.
- Trial name
- NCT01600703
- Testing
- Sitagliptin
- Where
- Canada
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- University Health Network, Toronto
Accelerated Phase Chronic Myelogenous Leukemia, Adult Acute Lymphoblastic Leukemia in Remission
Fludarabine Phosphate, Melphalan, and Low-Dose Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies
This phase II trial studies how well giving fludarabine phosphate, melphalan, and low-dose total-body irradiation (TBI) followed by donor peripheral blood stem cell transplant (PBSCT) works in treating patients with hematologic…
- Conditions
- Accelerated Phase Chronic Myelogenous Leukemia, Adult Acute Lymphoblastic Leukemia in Remission, Adult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
- Trial name
- NCT01529827
- Testing
- fludarabine phosphate, melphalan, total-body irradiation
- Where
- United States
- Volunteers
- 94 people
- Sponsor
- Roswell Park Cancer Institute
Obesity, Sedentary Lifestyle
Exercise After Clinically Significant Weight Loss
The Prescribed Exercise to Reduce Recidivism After Weight Loss Pilot (PREVAIL-P) study will evaluate the effect of aerobic exercise training amount on weight maintenance following clinically significant weight loss.
- Conditions
- Obesity, Sedentary Lifestyle, Insulin Resistance
- Trial name
- PREVAIL-P (NCT03685123)
- Testing
- Physical activity recommendations, Weight maintenance recommendations, OPTIFAST weight loss
- Where
- United States
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- East Carolina University