Clinical trials: Lipid Disorders
Hypercholesterolemia
A Study Evaluating the Safety and Efficacy of AVE5530 (4 Weeks) in Patients With Mild to Moderate Hypercholesterolemia
The primary objective of this study is to assess the effect of AVE5530 on LDL-C levels over a period of 4 weeks. The secondary objectives are to assess the effects of AVE5530 on other lipid plasma levels and the safety and…
- Trial name
- NCT00440154
- Testing
- AVE5530, ezetimibe
- Where
- 6 sites in Chile, Hungary and 4 more
- Volunteers
- 206 people
- Sponsor
- Sanofi
Erectile Dysfunction
Assessing Efficacy and Safety of Flexible Dosing With Vardenafil in Subjects With Erectile Dysfunction and Hyperlipidemia
This study is being conducted in US to obtain information on the efficacy, safety, and duration of erection of flexible-dose regime of vardenafil compared to placebo (dummy medication with no pharmacological activity), in…
- Trial name
- NCT00663845
- Testing
- Levitra (Vardenafil, BAY38-9456)
- Volunteers
- 395 people
- Sponsor
- Bayer
Acid Sphingomyelinase Deficiency, Niemann-Pick Disease
Safety Study of rhASM Enzyme Replacement Therapy in Adults With Acid Sphingomyelinase Deficiency (Niemann-Pick Disease)
The purpose of this study is to determine the safe range of single doses of rhASM administered to adults with ASM deficiency.
- Trial name
- NCT00410566
- Testing
- rhASM
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Genzyme, a Sanofi Company
Healthy
Bioequivalence Study of Terbinafine Hydrochloride Tablets, 250 mg of Dr. Reddy's Under Fed Conditions
The purpose of this study is to compare the rate and extent of absorption of terbinafine hydrochloride 250 mg tablets versus Lamisil® 250 mg tablets administered as 1 x 250 mg tablet under fed conditions.
- Trial name
- NCT01286701
- Testing
- Terbinafine Hydrochloride Tablets, 250 mg
- Where
- Canada
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Fabry Disease
A 12-Week Safety and Pharmacodynamic Study of AT1001 (Migalastat Hydrochloride) in Female Participants With Fabry Disease
Study to evaluate the safety, tolerability, and pharmacodynamics of migalastat hydrochloride (HCl) (migalastat) in participants with Fabry disease.
- Trial name
- NCT00304512
- Testing
- migalastat HCl
- Where
- 6 sites in United States, Australia and 4 more
- Volunteers
- 9 people
- Sponsor
- Amicus Therapeutics
Cancer, Solid Tumor
Intravenously Administered Pegylated Liposomal Mitomycin-C Lipid-based Prodrug (PROMITIL) in Cancer Patients With Solid Tumors.
This is a Phase I, multi-center, Dose-Escalating, Safety Study of an Intravenously Administered Pegylated Liposomal Mitomycin-C Lipid-based Prodrug (PL-MLP, PROMITIL) in Cancer Patients with Solid Tumors.
- Conditions
- Cancer, Solid Tumor, Metastatic Colorectal Cancer (mCRC)
- Trial name
- NCT01705002
- Testing
- Promitil, Capecitabine, Bevacizumab
- Where
- 4 sites in Israel
- Volunteers
- 88 people
- Sponsor
- Lipomedix Pharmaceuticals Inc.
Hypertriglyceridemia
Study to Assess the Safety and Tolerability of Single Doses of REGN1500
Phase 1, first-in-human, randomized, ascending single-dose, placebo-controlled, double-blind study of the safety, tolerability, and bioeffect of REGN1500
- Trial name
- NCT01749878
- Testing
- REGN1500
- Where
- 2 sites in United States
- Volunteers
- 99 people, healthy volunteers welcome
- Sponsor
- Regeneron Pharmaceuticals
Hypercholesterolemia
Combination of AB-LIFE Probiotic Plus Monacolin K to Reduce Blood Cholesterol
This randomized study evaluates the effectiveness of a nutraceutical combining billion colony forming units (cfu) of three L. plantarum strains (CECT7527, CECT7528 and CECT7529) and 10 mg of monacolin K in reducing blood…
- Trial name
- NCT04677335
- Testing
- AB-LIFE with Monacolin K
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- AB Biotics, SA
Parkinson Disease
Phase 1/2a Clinical Trial of PR001 (LY3884961) in Patients With Parkinson's Disease With at Least One GBA1 Mutation (PROPEL)
Study J3Z-MC-OJAA is a Phase 1/2a, multicenter, open-label, ascending dose, first in-human study that will evaluate the safety of intracisternal LY3884961 administration in patients with moderate to severe Parkinson's disease…
- Trial name
- NCT04127578
- Testing
- LY3884961, Methylprednisolone, Sirolimus
- Where
- 15 sites in United States, Israel
- Volunteers
- 32 people
- Sponsor
- Prevail Therapeutics
Erectile Dysfunction
Assessment of Efficacy of Vardenafil in Subjects With Erectile Dysfunction and Diabetes, Hypertension or Hyperlipidemia
Assessment of efficacy of vardenafil in subjects with erectile dysfunction and diabetes, hypertension or hyperlipidemia
- Trial name
- LUTECIA (NCT00668109)
- Testing
- Levitra (Vardenafil, BAY38-9456), Tadalafil
- Where
- 74 sites in Belgium, Colombia and 11 more
- Volunteers
- 614 people
- Sponsor
- Bayer
Cholesterol; Lipidosis, Arterial Hypertension
Assessment of Lifestyle, Blood Pressure, Cholesterol and Glycated Hemoglobin in a Specific Population
The project Shall we get to know your health better? Lifestyle assessment, blood pressure and cholesterol in the population of Libbs Farmacêutica employeesLTDA.; consists of a study that will bring knowledge and enable…
- Conditions
- Cholesterol; Lipidosis, Arterial Hypertension, Blood Glucose, High
- Trial name
- LB1901 (NCT04373863)
- Where
- Brazil
- Volunteers
- 2,472 people, healthy volunteers welcome
- Sponsor
- Libbs Farmacêutica LTDA
Leukemia
Use of Lipid Emulsion or Nanoemulsion of Propofol on Children Undergoing Ambulatory Invasive Procedures.
The purpose of this study is to compare the safety and efficacy of the of propofol nanoemulsion and lipid emulsion for sedation in non-invasive ambulatory procedures.
- Trial name
- NCT01326078
- Testing
- propofol
- Sponsor
- Cristália Produtos Químicos Farmacêuticos Ltda.
Type 2 Diabetes Mellitus, Hypercholesterolemia
A Multicenter Study to Evaluate the Cholesterol Lowering Effects of Two Marketed Products in Patients With Type 2 Diabetes Mellitus and Hypercholesterolemia (MK-0653A-077)
The purpose of this 10-week study is to compare the reduction in cholesterol following treatment with two different marketed drugs, in patients with type 2 diabetes mellitus and hypercholesterolemia.
- Trial name
- NCT00110435
- Testing
- MK0653A, ezetimibe (+) simvastatin, Comparator: atorvastatin
- Volunteers
- 1,229 people
- Sponsor
- Organon and Co
Dyslipidemia
Safety Study of JTT-302 in Subjects With Low HDL-C Levels
The purpose of this study is to evaluate the safety of JTT-302 when administered for eight or 12 weeks in subjects with low HDL-C levels and to determine the effect of JTT-302 on lipid parameters and CETP activity and mass.
- Trial name
- NCT00748852
- Testing
- JTT-302
- Where
- United States
- Volunteers
- 103 people
- Sponsor
- Shionogi Inc.
Dyslipidaemias
The Efficacy of a Food Supplement Consisting of the Combination of an Olive Extract and a Myrtle Extract for the Improvement of Lipid Metabolism in Subjects With Slightly Altered Cholesterolemia Values
Study Objective The aim of the study is to evaluate the efficacy of a dietary supplement based on a mixture of olive (Olea europaea L., fruit) and myrtle (Myrtus communis L., leaves) extracts in maintaining normal plasma…
- Trial name
- COLTECH25 (NCT07668791)
- Testing
- Food supplement (T1675)
- Where
- Italy
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- Labomar SPA
Hypercholesterolemia, Familial, Lipid Metabolism, Inborn Errors
Investigational Drug in Patients With Hypercholesterolemia or in Patients With Sitosterolemia (0653-026)(COMPLETED)
The purpose of this study is to provide an investigational drug to patients with a specific type of hypercholesterolemia (high cholesterol) or sitosterolemia (unusually high absorption of non-cholesterol sterols) in a treatment…
- Trial name
- NCT00092833
- Testing
- Comparator: ezetimibe
- Volunteers
- 49 people
- Sponsor
- Organon and Co
Generalized Lipodystrophy
Immunogenicity of Metreleptin in Patients With Generalized Lipodystrophy
MYALEPT™ (metreleptin) has been approved as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy (MYALEPT Prescribing…
- Trial name
- NCT04026178
- Testing
- Metreleptin
- Where
- 8 sites in United States
- Volunteers
- 11 people
- Sponsor
- Aegerion Pharmaceuticals, Inc.
Fabry Disease
A Phase I, Randomized, Single-Blind, Four-Period Cross-Over, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of Single Oral Doses of GR181413A/AT1001 in Healthy Japanese Subjects
GR181413A/AT1001 (migalastat hydrochloride) is a low molecular weight iminosugar, an analog of the terminal galactose group that is cleaved from the substrate GL-3.
- Trial name
- NCT01853852
- Testing
- GR181413A/AT1001 solution, GR181413A/AT1001 capsule, Potable water
- Where
- Australia
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Amicus Therapeutics
Healthy Subjects, Dyslipidaemias
Study To Evaluate The Effects Of GW856553 On Endothelial Function/Vascular Compliance In Subjects With Dyslipidaemia.
The rationale for this study is to determine whether GW856553 (7.5mg BD for 28 days) has an effect on endothelial function in dyslipidaemic subjects as assessed by venous occlusion plethysmography using brachial artery…
- Conditions
- Healthy Subjects, Dyslipidaemias, Dyslipidaemia
- Trial name
- NCT00474864
- Testing
- GW856553
- Where
- 3 sites in United Kingdom
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hypertriglyceridemia
A Mechanistic Study of MAR001 in Adults With Elevated Triglycerides and Remnant Cholesterol
The primary objective of the study is to determine the effect of MAR001 as compared to placebo on levels of the triglycerides (TG) in the postprandial state in adults with elevated TG.
- Trial name
- NCT07199309
- Testing
- MAR001
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Marea Therapeutics
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