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A Phase 3 Multicenter, Multi-dose, Open-label Maintenance Study to Investigate the Long-term Safety and Efficacy of ZS (Sodium Zirconium Cyclosilicate), an Oral Sorbent, in Subjects with Hyperkalemia

Primary objective of this trial is to generate open-label, long-term (up to 12 months) safety and tolerability data for ZS in subjects with hyperkalaemia (S-K * 5.1 mmol/L)Secondary objectives:* To evaluate the portion of ZS-treated subjects in whom…

An open label, long term, safety and tolerability extension to a randomized, double-blind, placebo controlled study of LCQ908 in subjects with Familial Chylomicronemia Syndrome

The purpose of this study is to determine long-term safety and tolerability, and continued efficacy in lowering triglycerides of LCQ908 in subjects FCS.

Open-Label Extension Study of EFC12492, R727-CL-1112, EFC12732 and LTS11717 Studies to Assess the Long-Term Safety and Efficacy of Alirocumab in Patients with Heterozygous Familial Hypercholesterolemia

Primary objective* To assess the long-term safety of alirocumab when added to currently available lipid-modifying drug therapy in patients with heterozygous familial hypercholesterolemia (heFH) who have completed one of the following studies:…

A Long-Term, Open-Label, Safety and Efficacy Study of Cysteamine Bitartrate Delayed-release Capsules (RP103) in Patients with Cystinosis.

The objective of this pivotal study is to assess the long-term safety, tolerability, pharmacokinetics and pharmacodynamics of RP103 in pediatric and adult patients with nephropathic cystinosis. Results of this Phase 3 study will be used to support…

Using D-Galactose as a food supplement in Congenital Disorders of Glycosylation (CDG)

The goal of this study is to better characterize the metabolic alterations and sugar structure alterations (glycosylation abnormalities) in patients diagnosed with Congenital Disorders of Glycosylation.

A randomized, 30-week, active-controlled, open label, 2-treatment arm, parallel-group, multicenter study comparing the efficacy and safety of the insulin glargine/lixisenatide fixed ratio combination to insulin glargine with or without metformin in patients with T2DM

Primary: To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination to insulinglargine in HbA1c change from baseline to week 30.Secondary: To compare the overall efficacy and safety of insulin glargine/lixisenatide…

A Randomized, Controlled, Long-term Safety Study Evaluating the Effect of Repeated Applications of QUTENZA plus Standard of Care versus Standard of Care alone in Subjects with Painful Diabetic Peripheral Neuropathy

Primary objective:To assess the safety of repeat applications of QUTENZA administered over a period of 12 months in subjects with PDPN.Secondary objectives:To assess the efficacy of repeat applications of QUTENZA administered over a period of 12…

Efficacy and safety of semaglutide once-weekly versus exenatide ER 2.0 mg once-weekly as add-on to 1-2 oral antidiabetic drugs (OADs) in subjects with type 2 diabetes.

To compare the effect of semaglutide 1.0 mg once-weekly versus exenatide extended release (ER) 2.0 mg once-weekly on glycaemic control after 56 weeks of treatment.

Efficacy and safety of semaglutide once weekly versus insulin glargine once daily as add on to metformin with or without sulphonylurea in insulin-naïve subjects with type 2 diabetes

To compare the effect of once-weekly dosing of two dose levels of semaglutide versus insulin glargine once-daily on glycaemic control after 30 weeks of treatment in insulin-naïve subjects with type 2 diabetes.

An Efficacy and 2-Year Safety Study of Open-label Rosuvastatin in Children and Adolescents (aged from 6 to less than 18 years) with Familial Hypercholesterolaemia

Primary Objectives * To assess the efficacy of rosuvastatin in paediatric patients with familial hypercholesterolaemia. * To establish long-term safety, tolerability and efficacy of rosuvastatin in paediatric patients with familial…

A Randomized, Multicenter, Multinational, Phase 3B, Open-Label, Parallel-Group Study of Fabrazyme (agalsidase beta) in Treatment-Naive Male Pediatric Patients with Fabry Disease Without Severe Symptoms

The objectives of this open-label study are to evaluate the efficacy (GL-3 clearance), pharmacokinetics (PK), and safety parameters (including immunogenicity) for 2 alternative dose regimens of Fabrazyme (0.5 mg/kg every 2 weeks [q2w] and 1.0 mg/kg…

A Multicenter, Multinational, Extension Study to Evaluate the Long-Term Efficacy and Safety of BMN 110 in Patients with Mucopolysaccharidosis IVA (Morquio A Syndrome)

To evaluate the long-term safety and efficacy of BMN 110 administration at 2.0 mg/kg/qw and 2.0 mg/kg/qow in patients with MPS IVA.

An Open-label, Multicentre, Randomised, 3-arm Study to Investigate the Comparative Efficacy and Safety of Intravenous Ferric Carboxymaltose (Ferinject® High- and Low-dosage Regimens) versus Oral Iron for the Treatment of Iron Deficiency Anaemia in Subjects with Non-dialysis-dependent Chronic Kidney Disease

* To evaluate the long-term efficacy of FCM (using targeted ferritin levels to determine dosing) or oral iron to delay and/or reduce erythropoiesis stimulating agent (ESA) use and/or other anaemia management options in NDD-CKD subjects with iron…

Effects of glutamine and epigallocatechin-3-gallate on glucose tolerance, markers of inflammation, oxidative stress and procoagulant status in Type 2 diabetes mellitus

In this pilot study, the objective is to show an improvement in glucose tolerance,a decrease in parameters for inflammation, oxidative stress and a procoagulant state after 4 weeks of daily supplementation of L -glutamine and Epigallocatechin-3-…

Evaluation of Insuman Implantable 400 IU/ml in patients with Type 1 diabetes treated with the Medtronic MiniMed Implantable Pump System using Insuplant 400 IU/mL

(1) To generate new clinical efficacy and safety data to support the registration of Insuman Implantable 400 IU/ml,(2) To ensure the continuation of the treatment of the patients already implanted and avoid pump explantation, up to the approval of…

BEGIN: YOUNG 1, trial id: NN1250-3561. A clinical trial investigating the efficacy and safety of insulin degludec in children and adolescents with type 1 diabetes mellitus.

Primary objective: to confirm the efficacy of insulin degludec administered once daily plus mealtime insulin aspart in controlling glycaemia with respect to change from baseline in HbA1c after 26 weeks of treatment. Secundary objective: to compare…

6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Both plus Mealtime Insulin in Patients with Type 2 Diabetes Mellitus with a 6-month Safety Extension Period

The purpose of the multicenter, randomized, open-label, parallel-group study EFC11628 is to compare the efficacy and safety of HOE901-U300 with that of Lantus®, both given once-daily s.c. as part of a basal-bolus insulin regimen in patients with…

Risk communication for patients with type 2 diabetes

The aim of this study is to investigate the effects of an intervention focussed on the communication of the absolute 10-year risk to develop cardiovascular disease on risk perception, attitude towards a specific behaviour and the intention to change…

postoperative intravenous iron injections (Venofer) vs. control in total hip and knee arthroplasty

Evaluate iron metabolism, erythropoiesis and hemoblobin level periooperative in patients treated with postoperative intravenous iron injections compared to controls.

A Randomized, Crossover, Pharmacokinetic and Pharmacodynamic Study to Determine the Safety and Efficacy of Cysteamine Bitartrate Delayed-release Capsules (RP103), Compared to Cystagon® in Patients with Nephropathic Cystinosis

The objective of this pivotal study is to assess the PK and PD as well as safety and tolerability of RP103 compared to Cystagon® in patients with nephropathic cystinosis. Results of this Phase 3 study will be used to support the registration…