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NCT ID: NCT02796430 Completed - Critical Illness Clinical Trials

The ICALIC International Multicentric Study

ICALIC
Start date: September 10, 2017
Phase:
Study type: Observational

This study will evaluate the ease of use of the new calorimeter (Q-NRG (COSMED, Italy)) in intensive care unit (ICU) patients compared to currently used calorimeters (i.e. Quark RMR 1.0(COSMED, Italy) or Deltatrac Metabolic Monitor (Datex, Finland)), as well as the stability and the feasibility of the measurements in various clinically relevant situations. Time needed to prepare and start indirect calorimetry (IC) measurement will be compared as the measure of the ease of use of the calorimeter.

NCT ID: NCT02796118 Completed - Healthy Subjects Clinical Trials

Study to Evaluate the Safety and Pharmacokinetics of ASP2151 in Healthy Non-elderly and Elderly Subjects

Start date: July 2006
Phase: Phase 1
Study type: Interventional

The objective of this study is to evaluate the safety and the pharmacokinetics of ASP2151 after multiple oral dosing of ASP2151 in healthy non-elderly male and elderly male Japanese subjects, and to compare the pharmacokinetics of ASP2151 in healthy non-elderly male and elderly male Japanese subjects.

NCT ID: NCT02795767 Completed - Hemophilia A Clinical Trials

A Study of Emicizumab Administered Subcutaneously (SC) in Pediatric Participants With Hemophilia A and Factor VIII (FVIII) Inhibitors

HAVEN 2
Start date: July 22, 2016
Phase: Phase 3
Study type: Interventional

This non-randomized, multicenter, open-label, Phase III clinical study will evaluate the efficacy, safety, and pharmacokinetics of emicizumab administered subcutaneously initially once weekly (QW) in pediatric participants with hemophilia A with FVIII inhibitors. This study will open two additional non-randomized cohorts to investigate once every 2 weeks (Q2W) and once every 4 weeks (Q4W) regimens in pediatric participants.

NCT ID: NCT02794285 Completed - Clinical trials for Active Systemic Lupus Erythematosus

Long Term Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus

TULIP SLE LTE
Start date: June 30, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to characterise long-term safety and tolerability of intravenous anifrolumab.

NCT ID: NCT02792842 Completed - Clinical trials for Postoperative Stage II/III Colon Cancer

Exploratory Study of ART-123 for the Prevention of Cancer Treatment Related Symptoms in Patients With Postoperative Stage II / III Colon Cancer

Start date: July 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of ART-123 for the prevention of cancer treatment related symptoms in patients with postoperative stage II / III colon cancer.

NCT ID: NCT02792062 Completed - Clinical trials for Japanese Premenopausal Healthy Adult Women

A Food Effect Study of TAK-385 Final Formulation

Start date: July 4, 2016
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate food effects on the pharmacokinetics of a single oral dose of TAK-385 in Japanese premenopausal healthy adult women.

NCT ID: NCT02791763 Completed - Anaemia Clinical Trials

Phase III Study of GSK1278863 in Japanese Non-dialysis (ND) and Peritoneal Dialysis (PD) Subjects With Renal Anemia

Start date: June 6, 2016
Phase: Phase 3
Study type: Interventional

This is a Phase III, open-label, active-controlled, parallel-group, multi-center study to compare the efficacy and safety of GSK1278863 administered for 52 weeks versus epoetin beta pegol in approximately 286 Japanese ND and 50 PD subjects with renal anemia. The study will consist of three cohorts. Cohort 1 and Cohort 3 will consist of ND subjects (Erythropoiesis-Stimulating Agent [ESA] users and ESA non-users) randomized to receive GSK1278863 or epoetin beta pegol in a ratio of 1:1. PD subjects will be enrolled into Cohort 2 and will receive GSK1278863. This study consists of a 4-week screening phase, a 52-week treatment phase (including primary efficacy evaluation period [Weeks 40 to 52]), and a 4-week follow-up phase following the treatment phase. The primary objective of this study is to demonstrate non-inferiority of GSK1278863 to epoetin beta pegol based on mean hemoglobin (Hgb) during the primary efficacy evaluation period in ND subjects. ESA non-users from Cohort 1 will be excluded from the primary efficacy analysis. Study results will be used as pivotal study data for an NDA submitted for GSK1278863 for the treatment of renal anemia in Japan.

NCT ID: NCT02791438 Completed - Clinical trials for Pediatric Hypertension

A Phase 3 Long-term Study of TAK-536 in Pediatric Patients 6 to Less Than 16 Years With Hypertension

Start date: August 18, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety of administration of azilsartan in pediatric patients aged 6 to less than 16 years with hypertension.

NCT ID: NCT02791230 Completed - Clinical trials for Transthyretin (TTR) Amyloid Cardiomyopathy

Long-term Safety of Tafamidis in Subjects With Transthyretin Cardiomyopathy

Start date: June 13, 2016
Phase: Phase 3
Study type: Interventional

Open label study to evaluate tafamidis for the treatment of transthyretin cardiomyopathy

NCT ID: NCT02788513 Completed - Alzheimer Disease Clinical Trials

BI 425809 in Patients With Cognitive Impairment Due to Alzheimer's Disease.

Start date: August 11, 2016
Phase: Phase 2
Study type: Interventional

The study is designed to compare the effects of BI 425809 compared to placebo in patients with cognitive impairment due to Alzheimer's Disease.