Clinical trials: Lipid Disorders
Acid Sphingomyelinase Deficiency
A Study to Evaluate Safety and Tolerability of Olipudase Alfa in Pediatric and Adult Participants With Acid Sphingomyelinase Deficiency (ASMD) Who Completed the DFI12712 or the LTS13632 Study in France
This was an open-label study to evaluate safety and tolerability and provide enzyme replacement therapy (ERT) with olipudase alfa to patients with acid sphingomyelinase deficiency (ASMD) who completed the DFI12712 or the LTS13632…
- Trial name
- NCT06949358
- Testing
- Olipudase alfa
- Where
- 2 sites in France
- Volunteers
- 3 people
- Sponsor
- Sanofi
Diabetes Mellitus Type 2, Non Alcoholic Fatty Liver Disease
Amlexanox for Type 2 Diabetes and Obesity
This study involves the use of a research drug, Amlexanox, for the treatment of type 2 diabetes, insulin resistance, obesity and non-alcoholic fatty liver disease (NAFLD). Amlexanox is taken orally in a pill three times a day.
- Conditions
- Diabetes Mellitus Type 2, Non Alcoholic Fatty Liver Disease, Obesity
- Trial name
- NCT01842282
- Testing
- Amlexanox
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- University of Michigan
Niemann-Pick Disease, Type C
Study of IV VTS-270 for Infantile Liver Disease Associated With Niemann-Pick Disease, Type C
Niemann-Pick disease, type C (NPC) is a lethal, autosomal recessive, lysosomal storage disorder characterized by neurodegeneration in early childhood and death in adolescence.
- Trial name
- NCT03471143
- Testing
- VTS-270
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Washington University School of Medicine
Hypercholesterolemia, Heterozygous Familial
A Study of the Safety and Efficacy of Two Different Regimens of Mipomersen in Patients With Familial Hypercholesterolemia and Inadequately Controlled Low-Density Lipoprotein Cholesterol
Primary objective: Determine whether mipomersen (ISIS 301012) significantly reduces atherogenic lipid levels in patients with severe heterozygous familial hypercholesterolemia (severe HeFH), defined as low-density lipoprotein…
- Trial name
- FOCUS FH (NCT01475825)
- Testing
- mipomersen sodium 200 mg, mipomersen sodium 70 mg
- Where
- 113 sites in United States, Argentina and 28 more
- Volunteers
- 309 people
- Sponsor
- Kastle Therapeutics, LLC
Hypercholesterolemia
Efficacy and Safety of Colesevelam in Pediatric Patients With Genetic High Cholesterol
This study will evaluate the lipid-lowering effect and safety of colesevelam therapy administered to heterozygous familial pediatric patients 10 through 17 years of age who are on a stable dose of a pediatric-approved statin…
- Trial name
- NCT00145574
- Testing
- colesevelam HCl
- Where
- 25 sites in United States, Australia and 6 more
- Volunteers
- 194 people
- Sponsor
- Daiichi Sankyo
Dry Eye
Clinical Outcomes Following Treatment With Systane® Balance in Dry Eye Subjects
The purpose of this study is to demonstrate the superior efficacy of Systane® Balance over Preservative-Free 0.9% Saline following 35 days of QID (4 times a day) dosing in treating dry eye subjects with lipid deficiency.
- Trial name
- NCT01967147
- Testing
- Propylene Glycol, 0.6% eye drops, Preservative-free 0.9% Saline solution
- Volunteers
- 279 people
- Sponsor
- Alcon Research
Gaucher Disease
Plant Cell Expressed Recombinant Human Glucocerebrosidase Extension Trial
Gaucher disease, the most prevalent lysosomal storage disorder, is caused by mutations in the human glucocerebrosidase gene (GCD) leading to reduced activity of the lysosomal enzyme glucocerebrosidase and thereby to the…
- Trial name
- NCT00705939
- Testing
- Taliglucerase alfa
- Where
- 11 sites in United States, Australia and 6 more
- Volunteers
- 45 people
- Sponsor
- Pfizer
Hypercholesterolemia
A Study to Assess the Cholesterol Lowering Effect of Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Elderly Patients With High Cholesterol at High or Moderately High Risk for Coronary Heart Disease (0653A-128)
A multicenter study to evaluate the safety and efficacy of ezetimibe/simvastatin versus atorvastatin in elderly patients with high cholesterol at high or moderately high risk for coronary heart disease.
- Trial name
- NCT00535405
- Testing
- Atorvastatin 10 mg, Ezetimibe 10 mg/simvastatin 20 mg, Atorvastatin 20 mg
- Volunteers
- 1,289 people
- Sponsor
- Organon and Co
Type 1 Hyperlipoproteinemia
Phase 2 Study of Orlistat and SLx-4090 for the Treatment of Type 1 Hyperlipoproteinemia
Funding Source - FDA OOPD This study is being done to find out whether an investigational (not approved by FDA ) drug called SLx-4090 or Orlistat (FDA approved medication for weight loss) when given alone or in combination can…
- Trial name
- NCT01675154
- Testing
- Orlistat, Slx-4090
- Where
- 2 sites in United States
- Volunteers
- 5 people
- Sponsor
- University of Texas Southwestern Medical Center
Mucopolysaccharidosis, Hurler Syndrome
Allogeneic Bone Marrow Transplant for Inherited Metabolic Disorders
Rationale: Chemotherapy administration before a donor stem cell transplant is necessary to stop the patient's immune system from rejecting the donor's stem cells.
- Conditions
- Mucopolysaccharidosis, Hurler Syndrome, Hunter Syndrome, Maroteaux-Lamy Syndrome
- Trial name
- NCT01043640
- Testing
- Campath-1H, Cyclophosphamide, Busulfan
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- Masonic Cancer Center, University of Minnesota
Atherosclerotic Cardiovascular Disease, Familial Hypercholesterolemia
Trial to Evaluate the Effect of ALN-PCSSC Treatment on Low Density Lipoprotein Cholesterol (LDL-C)
This study is a Phase II, placebo-controlled, double-blind, randomized trial in 480 participants with atherosclerotic cardiovascular disease (ASCVD) or ASCVD-risk equivalents (for example, diabetes and familial…
- Conditions
- Atherosclerotic Cardiovascular Disease, Familial Hypercholesterolemia, Diabetes
- Trial name
- ORION-1 (NCT02597127)
- Testing
- ALN-PCSSC, Normal Saline
- Where
- 54 sites in United States, Canada and 3 more
- Volunteers
- 501 people
- Sponsor
- The Medicines Company
Peripheral Artery Disease, Amputation
Digital Ankle Brachial Index (ABI) as a Screening Tool in Detecting Peripheral Arterial Disease
Peripheral artery disease (PAD) affects 8-18 million in the US and is an economic burden, currently estimated to be greater than cancer and heart disease.
- Conditions
- Peripheral Artery Disease, Amputation, Smoking, Diabetes
- Trial name
- NCT03161327
- Testing
- ABI using QuantaFlo™
- Where
- United States
- Volunteers
- 238 people, healthy volunteers welcome
- Sponsor
- St. Louis University
Lipodystrophy, HIV Infections
TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy
Assessing the Efficacy and Long-Term Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation
- Trial name
- NCT00608023
- Testing
- Tesamorelin
- Where
- 47 sites in United States, Belgium and 4 more
- Volunteers
- 263 people
- Sponsor
- Theratechnologies
Fabry Disease
A Study Evaluating Glycosphingolipid Clearance in Patients Treated With Agalsidase Alfa Who Switch to Agalsidase Beta
This is an exploratory study to evaluate changes in glycosphingolipid levels and other (exploratory) Fabry disease parameters in male Fabry disease participants who were previously treated with agalsidase alfa (Replagal®) 0.2…
- Trial name
- NCT01650779
- Testing
- Agalsidase beta
- Where
- 6 sites in United States
- Volunteers
- 15 people
- Sponsor
- Genzyme, a Sanofi Company
Gaucher Disease
Survey Study for Velaglucerase Alfa (VPRIV) in Japan
The objective of this post-marketing survey study is to collect data to determine the safety and efficacy of velaglucerase alfa (VPRIV) in participants with Gaucher disease who are new to therapy or have been switched from…
- Trial name
- NCT03625882
- Where
- 35 sites in Japan
- Volunteers
- 63 people
- Sponsor
- Takeda
Hypercholesterolemia
A Clinical Trial to Assess the Efficacy and Safety of MK-0653C in Japanese Participants With Hypercholesterolemia (MK-0653C-383)
This study will evaluate the efficacy and safety of MK-0653C (Ezetimibe [EZ] 10 mg/Atorvastatin [Atora] 10mg or 20 mg) compared to EZ 10 mg, Atora 10 mg, or Atora 20 mg alone when administered to Japanese participants with…
- Trial name
- NCT02550288
- Testing
- Ezetimibe 10 mg, Atorvastatin 10 mg, Diet control/Daily Exercise
- Volunteers
- 309 people
- Sponsor
- Organon and Co
Chronic Kidney Disease, Dialysis
A Study of MCI-196 in Chronic Kidney Disease Subjects on Dialysis With Hyperphosphatemia and Dyslipidaemia
This is a phase III multi-centre study in two periods: the first period is a phosphate binder and lipid lowering drugs washout for 8 weeks, the second period is a double-blind, randomised, parallel group, fixed dose, for 12 weeks.
- Conditions
- Chronic Kidney Disease, Dialysis, Hyperphosphatemia, Dyslipidemia
- Trial name
- NCT00542386
- Testing
- MCI-196
- Where
- 73 sites in Hungary, Italy and 6 more
- Volunteers
- 642 people
- Sponsor
- Tanabe Pharma Corporation
Type 2 Diabetes Mellitus
Impact of Structured Physical Activity Education Delivery in Patients With Type 2 Diabetes Mellitus
The objective of this study is to assess whether a structured exercise program compared to routine recommendation for exercise has any positive impact on disease outcome in patients with type 2 diabetes.
- Trial name
- NCT02093702
- Testing
- Physical activity and exercise education and behaviour counseling from a Registered Kinesiologist and a YMCA Wellness Coach, Unstructured Physical Activity and Exercise Education
- Where
- Canada
- Volunteers
- 5 people
- Sponsor
- Royal Victoria Hospital, Canada
Hyperlipidemias
Compare the Efficacy and Safety of Beta-Glucan as Add-On to Statin in Subjects With Hyperlipidemia.
The objective of this study is to evaluate the effects of adding beta-glucan (1.5 g, 3 g or 6 g daily) administered three times a day (TID) in divided doses, to atorvastatin (10 mg - 20 mg) once a day or an equivalent dose of…
- Trial name
- BetAvena (NCT03857256)
- Testing
- CP105F
- Where
- Canada
- Volunteers
- 263 people
- Sponsor
- Montreal Heart Institute
Inflammation, Atherosclerosis
Anti-inflammatory Effects of Simvastatin
The purpose of this research study is to determine which of the two ingredients of Vytorin (Simvastatin or Ezetimibe) is responsible for the anti-inflammatory effects of Vytorin
- Conditions
- Inflammation, Atherosclerosis, Hypercholesterolemia
- Trial name
- NCT04638400
- Testing
- Simvastatin 40mg, Ezetimibe 10mg
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- paresh Dandona