Clinical trials: Lipid Metabolism Disorders
Fed
Bioequivalence Study of Lisinopril Tablets 40 mg Under Fed Condition
This is a randomized, balanced, open Label, two-treatment, two-period, two-sequence, single dose, crossover pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding…
- Trial name
- NCT01735344
- Testing
- Lisinopril Tablets 40 mg, Lisinopril
- Where
- India
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- IPCA Laboratories Ltd.
Familial Lipoprotein Lipase Deficiency
Safety and Efficacy in LPL-Deficient Subjects of AMT-011, an Adeno-Associated Viral Vector Expressing Human Lipoprotein Lipase [S447X]
LPLD is a rare autosomal recessive disorder, characterized by the presence of marked chylomicronemia and hence hypertriglyceridemia.
- Trial name
- NCT01109498
- Testing
- Alipogene Tiparvovec (AMT-011), Human LPL [S447X], Mycophenolate mofetil, cyclosporine
- Where
- Canada
- Volunteers
- 14 people
- Sponsor
- Amsterdam Molecular Therapeutics
Hyperlipidemia
A Study of Evacetrapib (LY2484595) in Participants With High Cholesterol
The purpose of the ACCENTUATE study is to evaluate whether the study drug known as evacetrapib is effective in treating participants with high cholesterol and atherosclerotic cardiovascular disease (ASCVD) and/or diabetes.
- Trial name
- ACCENTUATE (NCT02227784)
- Testing
- Evacetrapib, Atorvastatin, Ezetimibe
- Where
- 64 sites in United States, Puerto Rico
- Volunteers
- 366 people
- Sponsor
- Eli Lilly and Company
Healthy
Characterization Of The Effect Of Food On Palbociclib (PD-0332991) Absorption
This study is intended to quantify the effect of food on the extent of absorption of palbociclib. The caloric content of the food and the time of the meals with respect to palbociclib administration may influence the capacity of…
- Trial name
- NCT01904747
- Testing
- Palbociclib administered Fasted, Palbociclib administered Fed high calorie, Palbociclib administered Fed low calorie
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Pfizer
Hypercholesterolemia
Safety and Tolerability Study of Ezetimibe (SCH 058235/MK-0653) Plus Atorvastatin or Simvastatin in Homozygous Familial Hypercholesterolemia (P01417/MK-0653-019)
The primary purpose of this study is to evaluate the long-term safety and tolerability of ezetimibe (SCH 058235/MK-0653) 10 mg dosed daily and co-administered with either atorvastatin or simvastatin for up to 24 months in…
- Trial name
- NCT03885921
- Testing
- Ezetimibe, Atorvastatin, Simvastatin
- Volunteers
- 44 people
- Sponsor
- Organon and Co
Hypertriglyceridemia, Mixed Hyperlipidemia
A Pilot Study to Evaluate the Lipid Effects of TRIA-662
The purpose of this pilot study is to learn what study factors are important in designing a large, full-scale study of the effects of TRIA-662 on serum triglycerides (TG) and high-density lipoprotein cholesterol (HDL-C) levels.
- Trial name
- NCT02008084
- Testing
- TRIA-662
- Where
- 17 sites in Canada
- Volunteers
- 71 people
- Sponsor
- Cortria Corporation
Hypercholesterolemia
Effect of the Molecular Weight of Oat β-glucan on Its Ability to Lower Serum Cholesterol
The purposes of this study were: 1. To determine if a breakfast cereal containing 3g of high molecular weight oat beta-glucan fiber would lower low-density lipoprotein (LDL) - cholesterol (the "bad" cholesterol) compared to a…
- Trial name
- Bluebird (NCT00981981)
- Testing
- Wheat bran, 3g high MW, 4g medium MW
- Where
- 5 sites in Australia, Canada and 1 more
- Volunteers
- 367 people, healthy volunteers welcome
- Sponsor
- Glycemic Index Laboratories, Inc
Gaucher Disease, Splenomegaly
A National Study in Patients With Unexplained Splenomegaly
Primary Objective: To estimate the prevalence of Gaucher disease and of other etiologies, in patients of 15 years old or more presenting with unexplained splenomegaly after exclusion of first intention-diagnoses (e.g.
- Trial name
- SMS (NCT04430881)
- Where
- France
- Volunteers
- 506 people
- Sponsor
- Sanofi
Dyslipidemia, Hypertension
To Evaluate the Efficacy and Safety in Patients With Dyslipidemia and Hypertension
A Multi-center, Randomized, Double-blind, Parallel, phase III Clinical Trial to Evaluate the Efficacy and Safety of Co-administration of JW0101+C2101 in Patients with Dyslipidemia and Hypertension.
- Trial name
- NCT05331014
- Testing
- LivaloVA, LivaloV, VA
- Where
- South Korea
- Volunteers
- 155 people
- Sponsor
- JW Pharmaceutical
Hyperlipidemia
Efficacy and Safety Study of Lipid-Lowering Effects of XueZhiKang (XZK) in Patients With Hyperlipidemia
The purpose of this study is to demonstrate the efficacy of XueZhiKang to improve plasma lipid profile, as compared to placebo, in outpatients with hyperlipidemia.
- Trial name
- NCT01327014
- Testing
- XueZhiKang (XZK), a botanic product with multiple components
- Where
- 13 sites in United States, China
- Volunteers
- 116 people
- Sponsor
- Beijing Peking University WBL Biotech Co., Ltd.
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
Homozygous Familial Hypercholesterolemia
Evaluate the Long-term Efficacy and Safety of SHR-1918 in Patients With Homozygous Familial Hypercholesterolemia
A multicenter, single arm, open label phase II clinical study evaluating the long-term efficacy and safety of SHR-1918 in homozygous familial hypercholesterolemia patients
- Trial name
- NCT07133815
- Testing
- SHR-1918
- Where
- China
- Volunteers
- 55 people
- Sponsor
- Beijing Suncadia Pharmaceuticals Co., Ltd
Hypertriglyceridemia
Study of MAR001 in Adults With Elevated Triglycerides and Remnant Cholesterol
The primary objective of the study is to evaluate the effect of MAR001 compared to placebo on levels of TG in adults with elevated TG and RC.
- Trial name
- TYDAL-TIMI 78 (NCT07028749)
- Testing
- MAR001
- Where
- 55 sites in United States, Australia and 2 more
- Volunteers
- 316 people
- Sponsor
- Marea Therapeutics
Hypertension, Dyslipidemia
A Randomized, Open-label, Two-arm, Two-period, Multiple-dose, Study to Evaluate Pharmacokinetic Drug-drug Interaction, Safety and Tolerability of UIC202601 and UIC202602 in Healthy Volunteers
A Randomized, Open-label, Two-arm, Two-period, Multiple-dose, Study to Evaluate Pharmacokinetic Drug-drug Interaction, Safety and Tolerability of UIC202601 and UIC202602 in Healthy Volunteers
- Trial name
- NCT07682948
- Testing
- Investigational Product 1, Investigational Product 2, Investigational Product 1 + Investigational Product 2
- Where
- South Korea
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Korea United Pharm. Inc.
Dyslipidemia
A 12-week Study to Compare the Efficacy and Safety of Fixed Combinations of Fenofibrate/Simvastatin 145/20mg and Fenofibrate/Simvastatin 145/40mg Tablets Versus Fenofibrate or Simvastatin Monotherapies in Subjects With Abnormal Blood Levels of Fats (Lipids) and at High Risk of Cardiovascular Disease
This is a double-blind, randomized study designed to compare the efficacy and safety of two fixed combinations of fenofibrate / simvastatin 145/20 mg and fenofibrate / simvastatin 145/40 mg tablets vs.
- Trial name
- NCT01674712
- Testing
- Fixed Combination of Fenofibrate/simvastatin 145/20 mg, Simvastatin 20 mg, Fenofibrate 145 mg
- Where
- 69 sites in Argentina, Czechia and 5 more
- Volunteers
- 575 people
- Sponsor
- Abbott
Healthy Volunteers, Fasting
Comparative Bioavailability Study of TAH3311 5 mg Oral Dissolving Film vs ELIQUIS® 5 mg Tablet in Healthy Volunteers
The goal of this clinical trial is to evaluate the pharmacokinetic profiles and bioequivalence, and to determine the safety and tolerability of the TAH3311 Oral Dissolving Film (ODF) 5mg compared with ELIQUIS® (Apixaban) 5mg Oral…
- Conditions
- Healthy Volunteers, Fasting, Fed
- Trial name
- NCT05995119
- Testing
- Apixaban 5 mg Oral Dissolving Film (TAH3311) and Tablet (Eliquis®)
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- TAHO Pharmaceuticals Ltd.
Fabry Disease
Fabry Outcome Survey (FOS)
The purpose of this study is to collect data that will increase understanding of Fabry disease history and progression, in treated and untreated patients with Fabry disease.
- Trial name
- FOS (NCT03289065)
- Where
- United States
- Volunteers
- 4,000 people
- Sponsor
- Shire
Niemann-Pick Disease, Type C
A Prospective Non-therapeutic Study in Patients Diagnosed With Niemann-Pick Disease Type C
This is a prospective non-therapeutic observational study in NP-C patients. The aim is to characterize the individual patient disease progression profile through the historical and 6 months prospective evaluation of clinical…
- Trial name
- NCT02435030
- Where
- 16 sites in Denmark, France and 6 more
- Volunteers
- 35 people
- Sponsor
- ZevraDenmark
Hypertriglyceridemia
Implitapide in Patients With Hypertriglyceridemia (HTG) on Maximal, Concurrent Triglyceride-Lowering Therapy
The purpose of this study is to determine if implitapide is effective in lowering triglyceride (TG) levels in patients with Fredrickson Type I or V hypertriglyceridemia where the maximum tolerable medication and diet were not…
- Trial name
- NCT00080132
- Testing
- implitapide
- Where
- 9 sites in United States, Netherlands and 1 more
- Volunteers
- 50 people
- Sponsor
- Medical Research Laboratories International
Multiple Sclerosis
Prevalence of Fabry Disease in a Defined Population at Risk - Patients Formerly Diagnosed With Multiple Sclerosis
The association of Multiple Sclerosis (MS) and Fabry disease is known from own clinical experiences as well as from case reports in the literature, where symptoms and suspicious results in the brain MRI led to the misdiagnosis of…
- Trial name
- NCT01271699
- Volunteers
- 250 people
- Sponsor
- CENTOGENE GmbH Rostock
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