Clinical trials: Metabolic Evaluation
Phenylketonuria
A Phase 3 Substudy to Evaluate Executive Function in Adults With PKU Who Are Participating in the Phase 3 Study, 165-302
A Phase 3 substudy to evaluate executive function in adults with phenylketonuria who are participating in the phase 3 Study, 165-302. Approximately 100 subjects, aged ≥ 18 to ≤ 70 years old, with PKU will be enrolled.
- Trial name
- PRISM303 (NCT02468570)
- Testing
- Administration of CANTAB and Subject Global Assessment
- Where
- 4 sites in United States
- Volunteers
- 9 people
- Sponsor
- BioMarin Pharmaceutical
Diabetes
User Performance Evaluation of an Investigational Blood Glucose Monitoring System
The purpose of this study is to demonstrate that untrained subjects with diabetes can use an investigational Blood Glucose Monitoring System (BGMS) with capillary blood obtained from fingerstick and from Alternative Site (AST)…
- Trial name
- NCT01410773
- Testing
- Ninja 2 Investigational Blood Glucose Monitoring System
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- Ascensia Diabetes Care
Hypercholesterolemia
Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With High Cardiovascular Risk and Hypercholesterolemia (ODYSSEY COMBO I)
Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds proprotein convertase subtilisin/kexin type 9 (PCSK9).
- Trial name
- NCT01644175
- Testing
- Alirocumab, Lipid-Modifying Therapy (LMT)
- Where
- 76 sites in United States
- Volunteers
- 316 people
- Sponsor
- Sanofi
Overweight and Obesity
Safety and Feasibility Assessment of the Bio-electrical One Day Capsule System in Overweight and Class I Obese Participants
The study represents the first effort to prospectively investigate the Melcap's bio-electrical ingestible ODC system in human. The study goal is to evaluate the safety and feasibility of GES treatment in stomach and in the small…
- Trial name
- NCT03734081
- Testing
- ODC system (type 1 capsule), ODC system (type 2 capsule)
- Where
- Israel
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Melcap Systems Ltd.
Pressure Injury, Fall Prevention
Clinical Investigation Evaluating the Use of NETSmart Solution , Incorporated to NETSoins Software, in the Care and Support of Elderly People Living in Nursing Homes
NETSmart software is designed to help doctors, nurses and care assistants adapt the care of elderly people living in nursing homes to the following risks: pressure injuries undernutrition interactions between different drugs…
- Conditions
- Pressure Injury, Fall Prevention, Undernutrition, Drug Interaction
- Trial name
- NETSMART DM (NCT07027358)
- Testing
- NETSmart software
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Teranga Software
Phenylketonuria
GenSci144 Tablets Phase I Clinical Trial
This study is a Phase I single ascending dose clinical trial in which healthy adult volunteers were administered single oral doses of GenSci144 tablets at different levels.
- Trial name
- NCT07685210
- Testing
- GenSci144 tablets
- Where
- China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Friedreich's Ataxia
Long-Term Efficacy Study of Vatiquinone for the Treatment of Friedreich's Ataxia (FA)
The purpose of this study is to confirm the treatment effects of vatiquinone on the key measures of FA disease progression.
- Trial name
- PROVE-FA (NCT07681713)
- Testing
- Vatiquinone
- Where
- 9 sites in United States, Belgium and 4 more
- Volunteers
- 120 people
- Sponsor
- PTC Therapeutics
Hypertension, Hypercholesterolemia
A Randomized Study To Evaluate Efficacy And Safety Of A Fixed Combination Therapy Of Amlodipine And Atorvastatin
To assess the changes in the trough Systolic Blood Pressure (SBP) and the percent changes in Low Density Lipoprotein-Cholesterol (LDL-C) from baseline at Week 8 in the treatment period
- Trial name
- NCT00530946
- Testing
- Amlodipine 2.5mg/Atorvastatin 5mg, Amlodipine 2.5mg/Atorvastatin 10mg, Amlodipine 5mg/Atorvastatin 5mg
- Where
- 17 sites in Japan
- Volunteers
- 165 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Hypercholesterolemia, Coronary Disease
Co-administration Study in Patients With Elevated Cholesterol and Coronary Heart Disease (0653-803)
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
- NCT00092625
- Testing
- MK0653, ezetimibe
- Volunteers
- 442 people
- Sponsor
- Organon and Co
Hyperkalemia
An Open-Label, Multiple Dose Study to Evaluate the Pharmacology, Safety, and Tolerability of Patiromer in Participants on Hemodialysis
This study assessed the pharmacodynamic effects of patiromer on serum potassium in participants on hemodialysis.
- Trial name
- NCT02033317
- Testing
- patiromer
- Where
- 2 sites in United States
- Volunteers
- 6 people
- Sponsor
- Relypsa, Inc.
Metabolic X Syndrome Dyslipidemia
MK0767 in Metabolic Syndrome-Dyslipidemia (0767-016)
This is a clinical trial in patients with Metabolic Syndrome and Dyslipidemia to study the effects of MK0767 on triglycerides.
- Trial name
- NCT00703690
- Testing
- MK0767, Comparator: fenofibrate
- Volunteers
- 436 people
- Sponsor
- Merck Sharp & Dohme LLC
Type 2 Diabetes Mellitus
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-06882961 in Japanese Adults With Type 2 Diabetes Mellitus
This is a Phase 1, randomized, double blind (sponsor open), parallel, placebo controlled, twice daily oral dosing study of PF 06882961 in adult Japanese participants with T2DM inadequately controlled on diet and exercise alone.
- Trial name
- NCT04552470
- Testing
- PF-06882961
- Where
- Japan
- Volunteers
- 37 people
- Sponsor
- Pfizer
Diabetes Mellitus
FreeStyle Libre Glucose Monitoring System Paediatric Study
The study is designed to determine glycaemic control achieved using the FreeStyle Libre Flash Glucose Monitoring System (FreeStyle Libre) versus Self-Monitoring Blood Glucose (SMBG) for the self-management of diabetes.
- Trial name
- SELFY (NCT02821117)
- Testing
- FreeStyle Libre Flash Glucose Monitoring System
- Where
- 10 sites in Germany, Ireland and 1 more
- Volunteers
- 76 people
- Sponsor
- Abbott Diabetes Care
Type 2 Diabetes Mellitus
Clinical Evaluation of Fenfuro (Fenugreek Seed Extract) in Type-2 Diabetic Subjects: an add-on Study
This study is an open label, two armed trial evaluating the safety and efficacy of Fenfuro capsule twice daily for 90 days in 100 patients with type 2 diabetes that will be conducted in single center in India.
- Trial name
- NCT03066089
- Testing
- Fenfuro
- Where
- India
- Volunteers
- 104 people
- Sponsor
- Chemical Resources
Type 2 Diabetes Mellitus, Secondary Hypogonadism
Study to Evaluate the Efficacy of Androxal in Controlling Blood Glucose in Men With Type-2 Diabetes Mellitus
The purpose of this study is to determine the effect the investigative drug has on glycemic control in men with type 2 diabetes mellitus (T2DM) and secondary hypogonadism
- Trial name
- NCT01191320
- Testing
- Androxal
- Where
- 18 sites in United States
- Volunteers
- 102 people
- Sponsor
- Repros Therapeutics Inc.
Type 2 Diabetes Mellitus
Dose Comparisons of Leucine-Metformin Combinations on Blood Glucose Levels In Type 2 Diabetic Patients
The goal of this study is to demonstrate that leucine in combination with a low does of metformin can serve as an adjunct to diet and exercise to improve blood glucose levels in type 2 diabetic subjects.
- Trial name
- NCT02151461
- Testing
- Low Metformin, Metformin, Mid Metformin
- Where
- 9 sites in United States
- Volunteers
- 96 people
- Sponsor
- NuSirt Biopharma
Type 1 Diabetes Mellitus
Protege Extension Trial - Long Term Follow Up Trial for Subjects Who Completed the Protege Study (CP-MGA031-01)
The purpose of this study is to assess the long term safety and efficacy in subjects with Type 1 Diabetes Mellitus who completed the Protege Study (CP-MGA031-01).
- Trial name
- NCT00870818
- Testing
- Blood samples for safety, Patient reported outcome questionnaires, Analysis of T-cell subsets
- Where
- United States
- Volunteers
- 219 people
- Sponsor
- MacroGenics
Healthy
Investigation of the Metabolism and Pharmacokinetics of 10 mg [14C] BI 1356 Administered Orally Compared to 5 mg [14C] BI 1356 Administered Intravenously in Healthy Male Volunteers
To determine the basic pharmacokinetics of BI 1356 BS, its metabolite CD 1750 XX and radioactivity including excretion mass balance, excretion pathways and metabolism following the intravenous and oral administration of [14C] BI…
- Trial name
- NCT02183610
- Testing
- [14C] BI 1356 as oral (p.o.) solution, [14C] BI 1356 solution for i.v. infusion
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Fabry Disease
Study to Evaluate the Safety and EffIcacy of PRX-102 on Gastrointestinal Symptoms in Naïve Fabry Disease
The study will be a randomized, double blind, placebo-controlled study of the safety and efficacy of PRX-102 in ERT naïve male patients randomized 1:1. Patient age will be 14 to 45 years.
- Trial name
- NCT02921620
- Testing
- PRX-102
- Sponsor
- Protalix
Type 2 Diabetes Mellitus
A Study to Evaluate the Effect of Ranolazine on Postprandial Glucagon in Subjects With Type 2 Diabetes.
To explore the mechanism of action of ranolazine as a potential treatment for type 2 diabetes mellitus (T2DM).
- Trial name
- NCT01843127
- Testing
- Ranolazine, Exenatide
- Where
- 3 sites in United States
- Volunteers
- 24 people
- Sponsor
- Gilead Sciences
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