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NCT ID: NCT02908685 Completed - Clinical trials for Muscular Atrophy, Spinal

A Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Risdiplam (RO7034067) in Type 2 and 3 Spinal Muscular Atrophy (SMA) Participants

SUNFISH
Start date: October 19, 2016
Phase: Phase 2
Study type: Interventional

Multi-center, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of Risdiplam in adult and pediatric participants with Type 2 and Type 3 SMA. The study consists of two parts, an exploratory dose finding part (Part 1) of Risdiplam for 12 weeks and a confirmatory part (Part 2) of Risdiplam for 24 months.

NCT ID: NCT02906930 Completed - Clinical trials for Diabetes Mellitus, Type 2

Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes Mellitus Treated With Diet and Exercise Only

PIONEER 1
Start date: September 20, 2016
Phase: Phase 3
Study type: Interventional

This trial is conducted globally. The aim of this trial is to investigate efficacy and safety of oral semaglutide versus placebo in subjects with type 2 diabetes mellitus treated with diet and exercise only.

NCT ID: NCT02906917 Completed - Clinical trials for Diabetes Mellitus, Type 2

A 38 Week Trial Comparing Effect and Safety of Insulin Degludec/Insulin Aspart vs. Insulin Glargine Plus Insulin Aspart in Subjects With Type 2 Diabetes Treated With Basal Insulin With or Without Oral Antidiabetic Treatment in Need of Treatment Intensification

Start date: September 20, 2016
Phase: Phase 3
Study type: Interventional

Trial comparing effect and safety of insulin degludec/insulin aspart vs. insulin glargine plus insulin aspart in subjects with type 2 diabetes treated with basal insulin with or without oral antidiabetic treatment in need of treatment intensification.

NCT ID: NCT02903966 Completed - Colitis, Ulcerative Clinical Trials

GSK2982772 Study in Subjects With Ulcerative Colitis

Start date: November 15, 2016
Phase: Phase 2
Study type: Interventional

This study is the first experience with GSK2982772, a receptor-interacting protein-1 (RIP1) kinase inhibitor, in subjects with active ulcerative colitis (UC). The primary objective will be to investigate the safety and tolerability of repeat oral doses of GSK2982772 60 mg or placebo three times daily for 42 days (Part A) followed by open label with GSK298772 60 mg three times daily for 42 days (Part B). In addition to pharmacokinetics (PK), a number of experimental and clinical endpoints will be employed to obtain information on the pharmacodynamics (PD), and preliminary efficacy in subjects with active UC. Although no formal hypothesis will be tested, these endpoints will enable a broader understanding of the mechanism of action and potential for clinical efficacy of GSK2982772 in UC. Within 30 Days of screening visit, subjects will be randomized to receive either GSK2982772 60 mg or placebo orally three times daily for 42 Days (6 weeks) in a 2:1 ratio in Part A study. Subjects who complete the Part A study will move to open label Part B study to receive GSK2982772 60 mg three times daily for an additional 42 Days (6 weeks). After the open label (Part B) treatment period, subjects will enter the Follow-up period which lasts for 28 Days (+/- 3 Days) post the last administration of study medication. The total duration of participation in the study will be approximately 20 Weeks from screening to the last study visit.

NCT ID: NCT02902939 Completed - Clinical trials for Systemic Inflammatory Response Syndrome

Myeloid-Derived Supressor Cells in Cardiac Surgery Patients

MyDeCCS
Start date: September 2016
Phase: N/A
Study type: Interventional

Pro- and anti-inflammatory response during the formation of the critical state develops at the same time. Because of its balanced or unbalanced systemic inflammation can be either aborted or able to lead to multiple organ failure. With regard to sepsis, systemic inflammatory response characteristics are well understood, is not achieved in respect of the "sterile" inflammation. Extracorporeal circulation is a clinical model of systemic inflammatory response due to non-physiological activation of tissue factor in the extracorporeal perfusion, the use of non-pulsatile circulation mode, intentional / unintentional hypothermia, bacterial translocation from the gastrointestinal tract and perfusion deficit. We have proved that the monocytes demonstrate suppressor function, which can be a predictor of complications from cardiac surgery patients. The most important component of the formation of multiple organ failure (MOF) in critically ill patients is immunosuppression. During the study of experimental and clinical tumor growth process scientists has provided a new population of immature myeloid cells (myeloid suppressor cells or suppressor cells of myeloid origin, MDSC). Most of the works have been devoted to the role of MDSC in the development of tumors, where it has been clearly shown that this cell population has an undoubted effect of immune suppression. However, recent studies show that the role of MDSC is not limited to cancer process, but extends to chronic or acute inflammation. The aim of this study is to determine the role of MDSC in the development of immune suppression and complications after heart surgery carried out under cardiopulmonary bypass.

NCT ID: NCT02899299 Completed - Mesothelioma Clinical Trials

Study of Nivolumab Combined With Ipilimumab Versus Pemetrexed and Cisplatin or Carboplatin as First Line Therapy in Unresectable Pleural Mesothelioma Patients

CheckMate743
Start date: November 29, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to test the effectiveness and tolerability of the combination of Nivolumab and Ipilimumab compared to Pemetrexed and Cisplatin or Carboplatin in patients with unresectable pleural mesothelioma.

NCT ID: NCT02898454 Completed - Clinical trials for Chronic Rhinosinusitis Phenotype With Nasal Polyps (CRSwNP)

Controlled Clinical Study of Dupilumab in Patients With Nasal Polyps

SINUS-52
Start date: November 28, 2016
Phase: Phase 3
Study type: Interventional

Primary Objective: To evaluate the efficacy of dupilumab 300 mg every 2 weeks (q2w) compared to placebo on a background of mometasone furoate nasal spray (MFNS) in reducing nasal congestion (NC)/obstruction severity and endoscopic nasal polyp score (NPS) in participants with bilateral nasal polyps (NP). In addition for Japanese participants, reduction in computed tomography (CT) scan opacification of the sinuses was a co-primary objective. Secondary Objectives: - To evaluate the efficacy of dupilumab in improving total symptoms score. - To evaluate the efficacy of dupilumab in improving sense of smell. - To evaluate the efficacy of dupilumab in reducing CT scan opacification of the sinuses (primary objective for Japanese participants). - To evaluate ability of dupilumab in reducing proportion of participants who required treatment with systemic corticosteroids (SCS) or surgery for NP. - To evaluate the effect of dupilumab on participant reported outcomes and health related quality of life. - To evaluate the efficacy of dupilumab 300 mg q2w up to Week 52. - To evaluate the efficacy of dupilumab 300 mg q2w up to Week 24 followed by 300 mg every 4 weeks (q4w) up to Week 52. - To evaluate the effect of dupilumab in the subgroups of participants with prior surgery and comorbid asthma including non-steroid anti-inflammatory drug exacerbated respiratory disease. - To evaluate the safety of dupilumab in participants with bilateral NP. - To evaluate functional dupilumab concentrations (systemic exposure) and incidence of treatment emergent anti-drug antibodies.

NCT ID: NCT02892422 Completed - Schizophrenia Clinical Trials

Flexible-dose, Long-term Safety Study of Lu AF35700 in Adult Patients With Schizophrenia

Debut
Start date: August 2016
Phase: Phase 3
Study type: Interventional

To evaluate the safety and tolerability of the long-term treatment with Lu AF35700.

NCT ID: NCT02892344 Completed - Mild Asthma Clinical Trials

Study of QMF149 (150/80 µg) Compared With MF Twisthaler® (200 µg) in Patients With Asthma

Start date: January 16, 2017
Phase: Phase 3
Study type: Interventional

The purpose of the trial was to evaluate efficacy and safety of QMF149 150/80 microgram o.d. delivered via Concept1 compared to MF 200 microgram o.d., delivered via Twisthaler® in terms of lung function and symptom control in poorly (ie inadequately) controlled asthma patients. This study was to assess contribution of LABA as an add-on therapy to low dose ICS monotherapy.

NCT ID: NCT02892149 Completed - Anemia Clinical Trials

Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Participants With Dialysis-dependent Chronic Kidney Disease (DD-CKD)

Start date: August 2016
Phase: Phase 3
Study type: Interventional

A multicenter, randomized, open-label, active-controlled Phase 3 study for the maintenance treatment of anemia in participants with dialysis-dependent chronic kidney disease (DD-CKD)