Clinical trials: Lipid Metabolism Disorders
Familial Chylomicronemia Syndrome, Lipoprotein Lipase Deficiency
The Approach Open Label Study: A Study of Volanesorsen (Formerly IONIS-APOCIIIRx) in Participants With Familial Chylomicronemia Syndrome
An open-label study of volanesorsen (ISIS 304801) administered subcutaneously to participants with FCS.
- Conditions
- Familial Chylomicronemia Syndrome, Lipoprotein Lipase Deficiency, Hyperlipoproteinemia Type 1
- Trial name
- NCT02658175
- Testing
- Volanesorsen
- Where
- 34 sites in United States, Brazil and 9 more
- Volunteers
- 68 people
- Sponsor
- Akcea Therapeutics
Hypercholesterolemia
Safety and Tolerability of Varying Load and Dose of ISIS 301012 in People With Elevated LDL-cholesterol Levels
The aim of this study is to assess the safety and tolerability of varying dose and load regimens of ISIS 301012 in people who have elevated LDL-cholesterol levels.
- Trial name
- NCT00216463
- Where
- Germany
- Volunteers
- 50 people
- Sponsor
- Kastle Therapeutics, LLC
ASCVD, Risk Factor, Cardiovascular
Inclisiran for Subjects With ASCVD or ASCVD-Risk Equivalents and Elevated Low-density Lipoprotein Cholesterol
This is a Phase III, placebo-controlled, double-blind, randomized study in participants with ASCVD or ASCVD-Risk equivalents and elevated LDL-C despite maximum tolerated dose of LDL-C lowering therapies to evaluate the efficacy…
- Conditions
- ASCVD, Risk Factor, Cardiovascular, Elevated Cholesterol
- Trial name
- ORION-11 (NCT03400800)
- Testing
- Inclisiran Sodium
- Where
- 70 sites in Czechia, Germany and 5 more
- Volunteers
- 1,617 people
- Sponsor
- The Medicines Company
Hypercholesterolaemia
Non-interventional Study (NIS) to Assess Reaching of Cholesterol Target Values in Patients Treated With HMG-CoA Reductase Inhibitors
This is a multi-centre non-interventional study of patients who are treated with any HMGCoA reductase inhibitor available in Croatia (rosuvastatin, simvastatin, atorvastatin and fluvastatin) for at least 6 months.
- Trial name
- NCT01257971
- Where
- 27 sites in Croatia
- Volunteers
- 1,868 people
- Sponsor
- AstraZeneca
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
Gaucher Disease
A Multicenter Extension Study of Taliglucerase Alfa in Pediatric Subjects With Gaucher Disease
A protocol to extend the assessment of the safety and efficacy of taliglucerase alfa in pediatric subjects (2 to <18 years old) with symptoms and clinical manifestations of Gaucher disease who completed treatment in Protocols…
- Trial name
- NCT01411228
- Testing
- Taliglucerase alfa
- Where
- 3 sites in Israel, Paraguay and 1 more
- Volunteers
- 15 people
- Sponsor
- Pfizer
Fabry Disease
French Prospective, Observational Cohort Study of Patients With Fabry Disease Treated With Migalastat
This is a noninterventional cohort study to evaluate the effects of migalastat, on long-term safety, effectiveness, and quality of life (QOL) in patients with Fabry disease.
- Trial name
- NCT04602364
- Testing
- Noninterventional
- Where
- 13 sites in France
- Volunteers
- 48 people
- Sponsor
- Amicus Therapeutics France SAS
Primary Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH)
Vytorin Reexamination Study (0653A-174)
This survey is conducted for preparing application material for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of VYTORIN through collecting…
- Trial name
- NCT01070966
- Volunteers
- 2,089 people
- Sponsor
- Organon and Co
Hypercholesterolemia
Study of Alirocumab (REGN727/SAR236553) added-on to Rosuvastatin Versus Other Lipid Modifying Treatments (LMT) (ODYSSEY OPTIONS II)
To evaluate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab (REGN727/SAR236553) as an add-on therapy to other LMT in patients with hypercholesterolemia at high cardiovascular (CV) risk.
- Trial name
- NCT01730053
- Testing
- Alirocumab, Rosuvastatin, Ezetimibe
- Where
- 93 sites in United States, Australia and 7 more
- Volunteers
- 305 people
- Sponsor
- Regeneron Pharmaceuticals
HIV Infections
A Study of the Effects of Amprenavir, a Protease Inhibitor, on Carbohydrate and Fat Metabolism in HIV-Infected Patients
The purpose of this study is to evaluate the effects of a 3-drug anti-HIV regimen, amprenavir (APV) plus abacavir (ABC) plus lamivudine (3TC), on the way carbohydrates (sugars) and fats are metabolized (processed by the body) in…
- Trial name
- NCT00002245
- Testing
- Abacavir sulfate, Amprenavir, Lamivudine
- Where
- United States
- Sponsor
- Glaxo Wellcome
Fabry Disease
A Study of Replagal in Treatment-naïve Adults With Fabry Disease
In this study, adults with Fabry Disease who have not had any treatment for this condition will be treated with Replagal. The main aim of the study is to check if Replagal improves kidney function and heart structure of…
- Trial name
- NCT04840667
- Testing
- REPLAGAL
- Where
- 28 sites in Canada, Finland and 6 more
- Volunteers
- 17 people
- Sponsor
- Shire
Hyperlipidemia
A Comparison Study to Evaluate the Pharmacokinetics and Safety of NK-104-CR in Healthy Adult Volunteers
The purpose of this study is to compare the pharmacokinetics and safety of a controlled release (CR) version of pitavastatin (also referred to as NK-104) to immediate release (IR) pitavastatin in healthy adult volunteers.
- Trial name
- NCT02634034
- Testing
- A: NK-104-CR 8 mg, B: Pitavastatin IR 4 mg, C: Pitavastatin IR 8 mg
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Kowa Research Institute, Inc.
Hyperlipidemia
A Trial to Evaluate the Efficacy and Safety of SHR-1918 in Patients With Hyperlipidemia
The study is being conducted to evaluate the efficacy, and safety of SHR-1918 in reducing serum low-density lipoprotein cholesterol (LDL-C) and total triglycerides (TG) in patients with hyperlipidemia compared with placebo, and…
- Trial name
- NCT07230730
- Testing
- SHR-1918
- Where
- China
- Volunteers
- 900 people
- Sponsor
- Beijing Suncadia Pharmaceuticals Co., Ltd
Gaucher Disease, Gaucher Disease, Type 1
A Clinical Trial of PR001 (LY3884961) in Patients With Peripheral Manifestations of Gaucher Disease (PROCEED)
Study J3Z-MC-OJAE is a Phase 1/2, multicenter, open-label, dose-finding study of LY3884961 evaluating the safety and tolerability in adults with peripheral manifestations of GD.
- Trial name
- NCT05487599
- Testing
- LY3884961
- Where
- 5 sites in United States, Australia and 2 more
- Volunteers
- 8 people
- Sponsor
- Prevail Therapeutics
Overweight and Obesity
Policaptil Gel Retard® in Overweight and Mild Obese Subjects
This is a randomized, double blind, placebo controlled, interventional clinical study aimed at evaluating the effects of the medical device Libramed (Policaptil Gel Retard®) on the glycemic, lipid and weight profile in overweight…
- Trial name
- NCT03423368
- Testing
- Libramed
- Where
- Italy
- Volunteers
- 67 people
- Sponsor
- Aboca Spa Societa' Agricola
Hypertriglyceridemia, Severe Hypertriglyceridemia
A Study to Assess the Safety, Tolerability and Efficacy of ION775
The main objective of this study is to evaluate the effect of ION775 on fasting triglyceride (TG) levels in participants with hypertriglyceridemia (HTG) and severe hypertriglyceridemia (sHTG).
- Trial name
- NCT07604974
- Testing
- ION775
- Where
- 18 sites in United States, Canada
- Volunteers
- 72 people
- Sponsor
- Ionis Pharmaceuticals, Inc.
Niemann-Pick Type C Disease
Miglustat in Niemann-Pick Type C Disease
This is a phase II randomized controlled study of miglustat in adult and juvenile patients with Niemann-Pick Type C disease. Up to 42 patients will be randomised in a 2:1 ratio to either treatment with miglustat or to a…
- Trial name
- NCT00517153
- Testing
- miglustat
- Volunteers
- 29 people
- Sponsor
- Actelion
Cardiovascular Diseases, Diabetes Mellitus
Vytorin Treating Uncontrolled Lipids (VyTUL) Study (0653A-122)
To compare the effectiveness of ezetimibe/simvastatin 10/40 daily to atorvastatin 80 daily in reducing the concentration of ldl-c at endpoint after 6 weeks of treatment.
- Trial name
- NCT00395603
- Testing
- MK0653A, ezetimibe (+) simvastatin / Duration of Treatment: 6 Weeks, Comparator: atorvastatin / Duration of Treatment: 6 Weeks
- Volunteers
- 550 people
- Sponsor
- Organon and Co
Hypercholesterolemia
A Long-term Study of AK102 in Patients With Hypercholesterolemia
This is a phase II, open-label, non-controlled, extended study. The main objective of this study is to evaluate the long-term efficacy and safety of AK102 in combination with basic lipid-lowering therapy in patients with…
- Trial name
- NCT04173403
- Testing
- 450mg AK102, 300mg AK102, 150mg AK102
- Where
- China
- Volunteers
- 796 people
- Sponsor
- Akeso
Hypercholesterolemia
Efficacy and Safety of Pitavastatin in a Real-world Setting
The prospective, observational, non-comparative trial in South Korea was designed to evaluate the efficacy and safety of pitavastatin (Livalo) in clinical practice in 28,343 patients.
- Trial name
- PROOF (NCT04402112)
- Testing
- Pitavastatin
- Volunteers
- 28,343 people
- Sponsor
- JW Pharmaceutical
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