Clinical trials: Lipid Disorders
Hypertriglyceridemia
Efficacy of TAK-085 in Participants With Hypertriglyceridemia
The purpose of this study was to determine the efficacy and safety 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
- NCT01350973
- Testing
- Omega-3-acid ethyl esters 90 (TAK-085), Eicosapentaenoic acid-ethyl (EPA-E)
- Volunteers
- 611 people
- Sponsor
- Takeda
Dry Eye
Clinical Outcomes Following Treatment With SYSTANE® BALANCE
The purpose of this study is to evaluate the clinical effectiveness of SYSTANE® BALANCE compared to REFRESH OPTIVE® Advanced in subjects with lipid-deficient dry eye.
- Trial name
- NCT02776670
- Testing
- Propylene glycol, 0.6% eye drops, Lubricant eye drops
- Volunteers
- 308 people
- Sponsor
- Alcon Research
Hyperlipidemia
Safety and Benefit of MBX-8025 With and Without Commonly Used Statins in Moderately Overweight Patients With High Cholesterol
A Multicenter Randomized, Double-Blind, Placebo-Controlled Study to evaluate the efficacy, safety and tolerability of MBX-8025, a novel PPAR-d agonist to treat hyperlipidemia, insulin resistance and obesity in overweight…
- Trial name
- MBX-8025 (NCT00701883)
- Testing
- MBX-8025, Atorvastatin
- Where
- 28 sites in United States
- Volunteers
- 183 people
- Sponsor
- Gilead Sciences
Dyslipidemias
A Study Of The Efficacy Of Atorvastatin For Lowering Cholesterol In High-Risk Patients With High Cholesterol
The purpose of the study is to evaluate the effectiveness of atorvastatin in lowering cholesterol and getting these high risk patients to their goals of LDL <115 mg/dl across starting doses of 10 mg, 20 mg, or 40 mg with one step…
- Trial name
- NCT00644670
- Testing
- Atorvastatin
- Where
- 17 sites in Belgium
- Volunteers
- 232 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Hypercholesterolemia, Hypertriglyceridemia
Efficacy and Safety of Gemcabene in Patients With Low HDL-C and Either Normal or Elevated Triglycerides
The purpose of this study is to evaluate the effect of gemcabene on HDL-C, LDL-C, TG, and other lipid levels in patients with low HDL-C
- Trial name
- NCT02585869
- Testing
- Gemcabene 150 mg, Gemcabene 300 mg, Gemcabene 600 mg
- Volunteers
- 161 people
- Sponsor
- NeuroBo Pharmaceuticals Inc.
Fed
Bioequivalence Study of Etodolac Tablet USP 500 mg Under Fed Condition
This is a open Label, balanced, randomized, single dose, two-treatment, two-sequence, two-period, crossover pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding…
- Trial name
- NCT01735383
- Testing
- Etodolac Tablets USP 500mg, Etodolac Tablets USP 500 mg
- Where
- India
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- IPCA Laboratories Ltd.
Gaucher Disease
Multicenter Extension Study of Velaglucerase Alfa in Japanese Patients With Gaucher Disease
Gaucher disease is an inherited deficiency of the lysosomal enzyme glucocerebrosidase (GCB) that leads to progressive accumulation of glucocerebroside within macrophages and subsequent tissue and organ damage; typically of the…
- Trial name
- NCT01842841
- Testing
- velaglucerase alfa
- Where
- 5 sites in Japan
- Volunteers
- 5 people
- Sponsor
- Shire
Hypercholesterolemia
Actual Use Trial of Atorvastatin Calcium 10 mg
The purpose of this actual use study is to simulate the over the counter use of atorvastatin calcium 10 mg.
- Trial name
- NCT01964326
- Testing
- Atorvastatin calcium 10 mg
- Where
- 37 sites in United States
- Volunteers
- 1,311 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Hypertriglyceridemia
Long-term Safety and Efficacy Study of MND-2119 in Patients With Hypertriglyceridemia
The purpose of this study is to evaluate the safety and efficacy of MND-2119 at a dose of 2g/day or 4g/day for 52 weeks in patients with hypertriglyceridemia.
- Trial name
- NCT04221217
- Testing
- Icosapent
- Where
- Japan
- Volunteers
- 120 people
- Sponsor
- Mochida Pharmaceutical Company, Ltd.
Gaucher Disease
A Safety and Efficacy Study of Two Dose Levels of Taliglucerase Alfa in Pediatric Subjects With Gaucher Disease
This is a multi-center, double-blind trial to assess the safety and efficacy of taliglucerase alfa in untreated subjects (2 to <18 years old) with Gaucher disease randomly assigned to treatment with one of two doses, 30 or 60…
- Trial name
- NCT01132690
- Testing
- Taliglucerase alfa
- Where
- 3 sites in Israel, Paraguay and 1 more
- Volunteers
- 11 people
- Sponsor
- Pfizer
Fabry Disease
A Study to Assess the Absorption, Metabolism and Excretion of Migalastat Hydrochloride (AT1001-014)
This study is designed to describe the metabolism of AT1001 (migalastat HCl) and the contribution of metabolism and urinary excretion to its overall elimination as part of the continuing assessment of the safety and effectiveness…
- Trial name
- NCT01730482
- Testing
- [14C] AT1001
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Amicus Therapeutics
Type 1 Gaucher Disease
A Study in Type 1 Gaucher Patients to Evaluate the Pharmacokinetics, Safety and Pharmacodynamics of AT2101
This is an open-label study designed to assess if AT2101 is safe in patients with Gaucher disease and how AT2101 gets through the body after it is taken by mouth.
- Trial name
- NCT00875160
- Testing
- AT2101
- Where
- 2 sites in United States, United Kingdom
- Volunteers
- 1 people
- Sponsor
- Amicus Therapeutics
Hypercholesterolemia, Dyslipidemia
Follow-on Protocol of Pitavastatin Versus Simvastatin in Patients With Hypercholesterolemia or Dyslipidemia and Coronary Heart Disease Risk Factors
This is a sixteen-week follow-on and 28 week single-blind extension study for patients who participated in study NK-104-304.
- Conditions
- Hypercholesterolemia, Dyslipidemia, Coronary Heart Disease
- Trial name
- NCT00344175
- Testing
- pitavastatin, simvastatin
- Where
- 28 sites in Denmark, Netherlands and 2 more
- Volunteers
- 178 people
- Sponsor
- Kowa Research Europe
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
Diabetes Mellitus
Efficacy of Pioglitazone on Macrovascular Outcome in Patients With Type 2 Diabetes
The purpose of this study is to determine whether pioglitazone, once daily (QD), can delay the time to death, heart attack, acute coronary syndrome, heart bypass surgery, stroke, leg bypass surgery or amputation in patients with…
- Trial name
- PROactive (NCT00174993)
- Testing
- Pioglitazone
- Where
- 19 sites in Austria, Belgium and 17 more
- Volunteers
- 4,373 people
- Sponsor
- Takeda
CTX
Study to Evaluate Patients With Cerebrotendinous Xanthomatosis (RESTORE)
The study is made up of two cohorts: a randomized double-blind crossover (placebo withdrawal with rescue) study among patients ≥ 16 years of age (adult cohort) and an open-label dose titration study among pediatric patients ≥1…
- Trial name
- NCT04270682
- Testing
- Blinded CDCA 250 mg TID, Open-Label CDCA 250 mg TID, Rescue Medication CDCA 250 mg TID
- Where
- 12 sites in United States, Brazil
- Volunteers
- 19 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Severe Hypertriglyceridemia
Study of Plozasiran in Adults With Severe Hypertriglyceridemia
This Phase 3 study will evaluate the safety and efficacy of plozasiran injection (ARO-APOC3) in adult participants with severe hypertriglyceridemia (SHTG).
- Trial name
- SHASTA-4 (NCT06347016)
- Testing
- Plozasiran Injection
- Where
- 149 sites in United States, Argentina and 14 more
- Volunteers
- 311 people
- Sponsor
- Arrowhead Pharmaceuticals
Healthy Participants
A First-in-Human, Single- and Multiple-Ascending Dose Study of YH35995 in Healthy Adult Male Participants
This is a randomized, double-blind, first-in-human study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple oral doses of YH35995
- Trial name
- NCT06517914
- Testing
- YH35995
- Where
- South Korea
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Yuhan Corporation
Hypercholesterolemia
Investigating Effects of a Novel Nutraceutical on Hypercholesterolaemia in Australian Adults
To evaluate the effects of daily consumption of 3 capsules of Swisse Nutra+ Cholesterol Balance on serum LDL-cholesterol in adults with hypercholesterolaemia compared to placebo over four months.
- Trial name
- CLoNE (NCT04783714)
- Testing
- Swisse Nutra+ Cholesterol Balance
- Where
- Australia
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Swisse Wellness Pty Ltd
Hypercholesterolemia
Efficacy and Safety Evaluation of Alirocumab in Patients With Heterozygous Familial Hypercholesterolemia or High Cardiovascular Risk Patients With Hypercholesterolemia on Lipid Modifying Therapy (ODYSSEY JAPAN)
Primary Objective: To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable daily statin therapy with or without other lipid modifying therapy in comparison with…
- Trial name
- NCT02107898
- Testing
- Alirocumab, Lipid-Modifying Therapy (LMT)
- Where
- 32 sites in Japan
- Volunteers
- 216 people
- Sponsor
- Sanofi
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