Clinical trials: Lipid Disorders
Hypercholesterolemia
Efficacy and Safety of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-lowering Therapy.
CKJX839D12304 was a research study to determine if the study treatment, called inclisiran, in comparison to placebo and ezetimibe effectively reduces Low-Density Lipoprotein Cholesterol (LDL-C) as measured by percentage change…
- Trial name
- V-Mono (NCT05763875)
- Testing
- Inclisiran, Ezetimibe
- Where
- 42 sites in United States, Colombia and 3 more
- Volunteers
- 350 people
- Sponsor
- Novartis Pharmaceuticals
Subjects With Hyperlipidemia, Dyslipidemia
Effects of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition on Arterial Wall Inflammation in Patients With Elevated Lipoprotein(a) (Lp(a))
A study to assess the effects of proprotein convertase subtilisin/ kexin type 9 (PCSK9) inhibition on the arterial wall inflammation in patients with elevated lipoprotein(a).
- Trial name
- ANITSCHKOW (NCT02729025)
- Testing
- Evolocumab
- Where
- 15 sites in United States, Canada and 1 more
- Volunteers
- 129 people
- Sponsor
- Amgen
Morbid Obesity
An Analysis of Lipid and Glucose Metabolism Following Bariatric Surgery
Bariatric surgery induce remarkable weight loss and improvement or resolution of type 2 diabetes. Obesity is the primary risk factor for type 2 diabetes, and 90% of all type 2 diabetics are obese.
- Trial name
- NCT02067585
- Testing
- Standardized Lipid meals
- Where
- Canada
- Volunteers
- 48 people
- Sponsor
- University of Alberta
Diabetes Mellitus
Efficacy Study of Pioglitazone Compared to Glimepiride on Coronary Atherosclerotic Disease Progression in Subjects With Type 2 Diabetes Mellitus
The purpose of this study was to determine the efficacy of pioglitazone, once daily (QD), compared to glimepiride on atherosclerotic disease measured by intravascular ultrasound.
- Trial name
- PERISCOPE (NCT00225277)
- Testing
- Pioglitazone, Glimepiride
- Where
- 79 sites in United States, Argentina and 2 more
- Volunteers
- 547 people
- Sponsor
- Takeda
Tay-Sachs Disease, Sandhoff Disease
A Multinational, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Pharmacodynamics, Pharmacokinetics, and Safety of Venglustat in Late-onset GM2
Primary Objectives: Primary population (adult participants with late-onset GM2 gangliosidosis): To assess the efficacy and pharmacodynamics (PD) of daily oral dosing of venglustat when administered over a 104-week period…
- Trial name
- AMETHIST (NCT04221451)
- Testing
- venglustat GZ402671
- Where
- 23 sites in United States, Argentina and 11 more
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Genzyme, a Sanofi Company
Parenteral Nutrition
Study Comparing a Soybean Oil-Based With an Olive Oil-Based Lipid Emulsion in ICU Patients Requiring TPN
Many hospitalized patients who are malnourished or not eating receive intravenous feeding or total parenteral nutrition (TPN). Despite improving nutrition, TPN may increase the risk of infections and hospital complications.
- Trial name
- TPN2 (NCT00672854)
- Testing
- ClinOleic 20% Intravenous Emulsion, Intralipid, 20% Intravenous Emulsion
- Where
- 2 sites in United States
- Volunteers
- 100 people
- Sponsor
- Emory University
Dyslipidemias
Lipitor Korean Atorvastatin Goal Achievement Across Risk Levels Study
To evaluate the percentage of Korean dyslipidemic subjects in the total group and each cardiovascular risk group achieving LDL-C target as defined by NCEP ATP Ⅲ criteria at starting doses of 10mg, 20mg and 40mg of atorvastatin…
- Trial name
- AT GOAL (NCT00540293)
- Testing
- Atorvastatin
- Where
- 20 sites in South Korea
- Volunteers
- 425 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Acute Coronary Syndrome, Lipid Disorder
Polypill in Acute Coronary Syndrome
Acute coronary syndromes (ACS) represent a major contributor to mortality, morbidity, and healthcare costs. Effective therapies are widely available; however, adherence is low.
- Conditions
- Acute Coronary Syndrome, Lipid Disorder, Coronary Artery Disease
- Trial name
- POLY-ACS (NCT05514938)
- Testing
- Polypill, Usual Care (individual medications prescribed by primary cardiologist)
- Where
- 2 sites in United States
- Volunteers
- 140 people
- Sponsor
- University of Texas Southwestern Medical Center
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
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
Hypercholesterolemia
Evaluate Safety and Efficacy of AEGR-733 and Atorvastatin vs Atorvastatin Monotherapy in Hypercholesterolemia
Evaluate the efficacy of combination therapy AEGR-733 plus atorvastatin 20 mg versus monotherapy on serum lipoproteins over 4 and 8 weeks of therapy.
- Trial name
- NCT00690443
- Testing
- Atorvastatin, AEGR-733
- Where
- 5 sites in United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Aegerion Pharmaceuticals, Inc.
Gaucher Disease, Type 1
A Study of Eliglustat Tartrate (Genz-112638) in Patients With Gaucher Disease Who Have Reached Therapeutic Goals With Enzyme Replacement Therapy (ENCORE)
This Phase 3 study was designed to confirm the efficacy and safety of eliglustat tartrate (Genz-112638) in participants with Gaucher disease type 1 who had reached therapeutic goals with enzyme replacement therapy (ERT).
- Trial name
- ENCORE (NCT00943111)
- Testing
- Eliglustat tartrate, Imiglucerase
- Where
- 34 sites in United States, Argentina and 10 more
- Volunteers
- 160 people
- Sponsor
- Genzyme, a Sanofi Company
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
Chronic Diseases
A Cluster-randomized Controlled Knowledge Translation Feasibility Study in Alberta Community Pharmacies
Background: Despite evidence of benefit for pharmacist involvement in chronic disease management, the provision of these services in community pharmacy has been suboptimal.
- Trial name
- NCT02191111
- Testing
- Task-focused facilitation
- Where
- Canada
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- University of Alberta
Hypercholesterolemia
A Multiple Ascending Dose Study of HTD1801 in Adults With Hypercholesterolemia
This is a randomized, double-blind, placebo-controlled, multicenter, multiple ascending dose (MAD) study to evaluate the safety and tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of HTD1801 in overweight to…
- Trial name
- NCT03381287
- Testing
- HTD1801 Tablets, 500 mg, HTD1801 Tablets, 1000 mg, HTD1801 Tablets, 2000 mg
- Where
- 3 sites in Australia
- Volunteers
- 50 people
- Sponsor
- HighTide Therapeutics (Hong Kong) Limited
Fabry Disease
A Safety and Efficacy Study of Fabrazyme® Replacement Therapy in Patients With Cardiac Fabry Disease
This is a multi-center, open label, phase IV study conducted to evaluate the efficacy and safety of agalsidase beta (Fabrazyme [recombinant form]) administered by intravenous drip infusion in participants with cardiac Fabry…
- Trial name
- NCT00140621
- Testing
- Agalsidase beta
- Where
- 7 sites in Japan
- Volunteers
- 6 people
- Sponsor
- Genzyme, a Sanofi Company
Dry Eye Syndrome
SYSTANE® BALANCE Symptoms (OSDI) & Inflammatory Biomarkers
The purpose of this study is to evaluate the ability of SYSTANE® BALANCE and SYSTANE® Gel to improve comfort in subjects with dry eyes.
- Trial name
- NCT01733732
- Testing
- SYSTANE® BALANCE Lubricant Eye Drops, SYSTANE® Gel
- Volunteers
- 54 people
- Sponsor
- Alcon Research
Hypercholesterolemia, Coronary Heart Disease
Phytosterols, Ezetimibe, and Cholesterol Metabolism
Phytosterols and ezetimibe each reduce intestinal cholesterol absorption by 30-55% but appear to have different mechanisms of action.
- Trial name
- Phyteaux-III (NCT00863265)
- Testing
- Ezetimibe, Phytosterols + ezetimibe
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Washington University School of Medicine
Refractive Error
Formula Identification (FID) 114657 in Contact Lens Wearers
The purpose of this study is to evaluate the thickness of the pre-lens tear lipid layer after 2 hours of lens wear with use of FID 114657 compared to saline control.
- Trial name
- NCT02293538
- Testing
- FID 114657 eye drops (10 ml), Saline control eye drops (15 ml), Habitual contact lenses
- Volunteers
- 234 people
- Sponsor
- Alcon Research
Hypercholesterolaemia
Efficacy and Safety of Alirocumab Versus Placebo on Top of Maximally Tolerated Lipid Lowering Therapy in Patients With Hypercholesterolemia Who Have Type 1 or Type 2 Diabetes and Are Treated With Insulin (ODYSSEY DM - Insulin)
Primary Objectives: To demonstrate the superiority of alirocumab in comparison with placebo in the reduction of calculated low-density lipoprotein cholesterol (LDL-C) in participants with diabetes treated with insulin and with…
- Trial name
- NCT02585778
- Testing
- Alirocumab, Lipid-Modifying Therapy (LMT), Antihyperglycemic Drug
- Where
- 110 sites in United States, Austria and 8 more
- Volunteers
- 517 people
- Sponsor
- Sanofi