Clinical trials: Cholesterol; Metabolic Disorder
Hypercholesterolemia
(H.E.L.P.)Apheresis Therapy to Compare the Reduction of LDL (Low Density Lipoprotein) Cholesterol
The primary objective of the study is to demonstrate that the performance of the modified Plasmat® Futura H.E.L.P. Apheresis System is non-inferior to the current FDA approved Plasmat® Secura H.E.L.P Apheresis System for use…
- Trial name
- FUTURA (NCT00526058)
- Testing
- Secura then Futura, Futura then Secura
- Where
- 2 sites in United States
- Volunteers
- 18 people
- Sponsor
- B. Braun Medical Inc.
Dyslipidemias, Hypercholesterolemia
Serum Cholesterol Reduction Efficacy of Biscuit With Plant Stanol Ester
Efficacy of plant stanols as esters on LDL-cholesterol reduction is well documented. LDL-cholesterol lowering efficacy of the ingredient in a biscuit (providing 2 g plant stanols as esters per day) is less well known.
- Conditions
- Dyslipidemias, Hypercholesterolemia, Hyperlipidemias
- Trial name
- NCT02331043
- Testing
- Plant stanol ester
- Where
- Thailand
- Volunteers
- 119 people, healthy volunteers welcome
- Sponsor
- Raisio Group
Hypercholesterolemia, Atherosclerosis
Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) as Add-on to Ezetimibe Therapy in Patients With Elevated LDL-C (CLEAR Tranquility)
The purpose of this study is to determine if bempedoic acid (ETC-1002) added-on to ezetimibe therapy is effective and safe versus placebo in patients with elevated LDL cholesterol.
- Conditions
- Hypercholesterolemia, Atherosclerosis, Statin Adverse Reaction
- Trial name
- NCT03001076
- Testing
- Bempedoic acid, Ezetimibe
- Where
- United States
- Volunteers
- 269 people
- Sponsor
- Esperion Therapeutics, Inc.
Hypercholesterolaemia
A Phase III Study to Assess the Effect of FDC Laroprovstat/Rosuvastatin Compared With Rosuvastatin on LDL-C in Patients With Hypercholesterolaemia
The purpose of this study is to evaluate the effect on low-density lipoprotein-cholesterol (LDL-C) and the safety and tolerability of a fixed dose combination (FDC) of laroprovstat/rosuvastatin versus rosuvastatin alone in…
- Trial name
- NCT07619118
- Testing
- laroprovstat/rosuvastatin 1, laroprovstat/rosuvastatin 2, laroprovstat/rosuvastatin 3
- Where
- 45 sites in United States, Australia and 2 more
- Volunteers
- 200 people
- Sponsor
- AstraZeneca
Healthy Volunteers, Hypercholesterolemia
A Study of LY3015014 in Healthy Participants With High Cholesterol
This is a study in healthy participants with high levels of "bad" cholesterol who are already taking a popular type of cholesterol-lowering medication called statins.
- Trial name
- NCT01671085
- Testing
- LY3015014
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Hypercholesterolemia
Efficacy and Safety of Pitavastatin/Ezetimibe After Switching From Statin Monotherapy to Pitavastatin/Ezetimibe in Patients With Hypercholesterolemia
A Multi-center, Open-label, Observational Study to evaluate the Efficacy and Safety of Pitavastatin/Ezetimibe after switching from Statin Monotherapy to Pitavastatin/Ezetimibe in patients with Hypercholesterolemia
- Trial name
- NCT07445542
- Where
- South Korea
- Volunteers
- 6,927 people
- Sponsor
- JW Pharmaceutical
Fed
Bioequivalence Study of Quetiapine Fumarate Tablets 25 mg Under Fed Condition
This is a randomized, open Label, two-treatment, two-period, two-sequence, crossover, single dose pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference…
- Trial name
- NCT01603186
- Testing
- Quetiapine Fumarate Tablets 25 mg, Quetiapine Fumarate
- Where
- India
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- IPCA Laboratories Ltd.
Lysosomal Acid Lipase Deficiency
Screening for Lysosomal Acid Lipase Deficiency
The primary outcome of this study is the development of a clinical profile of pediatric patients with LAL-D, which will enable the Sponsor to provide more focused guidance to the medical community as to which pediatric patients…
- Trial name
- NCT02926872
- Testing
- There is no intervention in the study
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Fed
Bioequivalence Study of Olanzapine Tablets, 5 mg Under Fed Study
The purpose of this study is to compare the bioequivalence and characterize the profile of the olanzapine tablets, 5 mg with zyprexa tablets, 5 mg in healthy, adult, human subjects under fed conditions and to monitor the adverse…
- Trial name
- NCT01503424
- Testing
- Olanzapine
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Hypercholesterolaemia
OLE Study to Evaluate Safety / Efficacy of ZD4522
The purpose of this study is to assess the long term safety of Crestor.
- Trial name
- NCT00654303
- Testing
- Rosuvastatin
- Volunteers
- 3,500 people
- Sponsor
- AstraZeneca
Primary Hypercholesterolemia, Dyslipidemia
A Study to Evaluate Efficacy and Safety of Extended-Release Niacin + Laropiprant + Simvastatin in Participants With Primary Hypercholesterolemia or Mixed Dyslipidemia (MK-0524B-118)
This study is being done to find out if tablets containing extended release (ER) niacin, laropiprant, and simvastatin (ERN/LRPT/SIM) are as effective as tablets containing ER niacin and laropiprant taken with simvastatin tablets…
- Trial name
- NCT01294683
- Testing
- Simvastatin, Extended Release (ER) niacin/laropiprant/simvastatin (N/LRPT/SIM), Extended Release (ER) niacin/laropiprant (N/LRPT)
- Volunteers
- 977 people
- Sponsor
- Merck Sharp & Dohme LLC
Lysosomal Acid Lipase Deficiency, Wolman Disease
Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Sebelipase Alfa in Children With Growth Failure Due to Lysosomal Acid Lipase Deficiency
This was an open-label, repeat-dose, intra-participant dose-escalation study of SBC-102 (sebelipase alfa) in children with growth failure due to lysosomal acid lipase (LAL) Deficiency.
- Trial name
- NCT01371825
- Testing
- Sebelipase alfa (SBC-102)
- Where
- 7 sites in United States, Egypt and 3 more
- Volunteers
- 9 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Hyperlipidemia and Mixed Dyslipidemia
Open-label Extension Study of Evolocumab (AMG 145) in Adults With Hyperlipidemia and Mixed Dyslipidemia
This study will contribute to the evaluation of long-term safety, tolerability and efficacy of evolocumab (AMG 145) in adults with hyperlipidemia and adults with mixed dyslipidemia.
- Trial name
- OSLER-2 (NCT01854918)
- Testing
- Evolocumab, Standard of Care
- Where
- 363 sites in United States, Australia and 23 more
- Volunteers
- 3,681 people
- Sponsor
- Amgen
Dyslipidemia, Atherosclerosis
Safety, Pharmacokinetic Study of RVX000222 in Healthy Subjects and Subjects With Low HDL Cholesterol
The purpose of this study is to investigate an oral formulation of RVX000222 for safety, pharmacokinetic and efficacy in healthy subjects.
- Conditions
- Dyslipidemia, Atherosclerosis, Acute Coronary Syndrome, Cardiovascular Disease
- Trial name
- NCT00768274
- Testing
- RVX000222
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Resverlogix Corp
Diabetic Patients, Low HDL-cholesterol (< 35 mg/dL)
DLBS1449 in Diabetic Patients With Low HDL
This is a parallel, 3-arm, randomized, prospective, placebo-controlled, and double-blind clinical study for eight weeks of therapy to investigate the clinical efficacy of DLBS1449 in elevating high density lipoprotein (HDL)…
- Conditions
- Diabetic Patients, Low HDL-cholesterol (< 35 mg/dL), Lifestyle Intervention for at Least 1 Month
- Trial name
- NCT01972477
- Testing
- DLBS1449
- Where
- Indonesia
- Sponsor
- Dexa Medica Group
Coronary Artery Disease, Atherosclerosis
Effect of ACP-501 on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Subjects With Coronary Artery Disease
This study is a phase 1, intravenous, open-label, single-dose escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ACP-501 (recombinant human Lecithin Cholesterol Acyl Transferase…
- Trial name
- NCT01554800
- Testing
- ACP-501
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- MedImmune LLC
Hypercholesterolemia, Coronary Disease
An Investigational Drug Study in Patients With Elevated Cholesterol and Coronary Heart Disease (0653-804)(COMPLETED)
The purpose of this study is to investigate additional cholesterol lowering effects in patients with coronary heart disease by giving an investigational drug with a patient's current approved cholesterol lowering medication.
- Trial name
- NCT00092638
- Testing
- MK0653, ezetimibe
- Volunteers
- 450 people
- Sponsor
- Organon and Co
Hypercholesterolemia
A Study to Determine the Number of Patients Who Reach Optimal Cholesterol Levels on Each of Three Different Treatments (0653A-121)
To evaluate the percentage of patients with either established cardiovascular disease (CVD), at "high risk" of developing CVD or with diabetes who are on simvastatin 40mg, with fasting LDL-C > 2mmol/l, who are able to attain the…
- Trial name
- NCT00462748
- Testing
- ezetimibe (+) simvastatin, Comparator: atorvastatin, Comparator: rosuvastatin
- Volunteers
- 786 people
- Sponsor
- Organon and Co
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.
Healthy
A Comparative Bioavailability/Food Effect Study of Immediate-Release and Extended-Release Tramadol HCl/Acetaminophen Combination Products Following Single-Dose and Multiple-Dose Administration in Healthy Adult Volunteers
The objectives of this two-part study were to compare the single-dose and multiple-dose pharmacokinetics of extended release and immediate-release fixed combination formulations containing tramadol-HCl/acetaminophen and to…
- Trial name
- NCT00973232
- Testing
- DDS-06C (650 mg acetaminophen and 75 mg tramadol HCl), DDS-06C (650 mg acetaminophen and 75 mg tramadol), Zaldiar®
- Where
- United Kingdom
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Labopharm Inc.