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NCT ID: NCT03409731 Completed - Clinical trials for Coronary Artery Disease

Absorb GT1 Japan PMS

Start date: December 13, 2016
Phase: N/A
Study type: Interventional

The purpose of the Surveillance is to know the frequency and status of adverse device effects and adverse events in order to assure the safety of the new medical device, and to collect efficacy and safety information for evaluating clinical use results.

NCT ID: NCT03408795 Completed - Clinical trials for Surgical Procedure, Unspecified

Assessing the Surgical Skills of Trainees in Learning the LDG

Start date: February 1, 2016
Phase: N/A
Study type: Interventional

Laparoscopic distal gastrectomy (LDG) is a common surgery in the surgical trainees. However, there is no assessment system to measuring the surgical skill of surgical trainees. The novel surgical assessment system, which called Japanese Operative Rating Scale for Laparoscopic Distal Gastrectomy (JORS-LDG) by the task analysis and the Delphi method have been developed. This study describes assessing the development of surgical skill by JORS-LDG in the initial experience of LDG.

NCT ID: NCT03407118 Completed - Clinical trials for Diabetes Mellitus, Type 1

A Study of LY900014 in Japanese Participants With Type 1 Diabetes Mellitus

Start date: February 17, 2018
Phase: Phase 1
Study type: Interventional

This study will compare LY900014, a drug that lowers blood sugar, with insulin lispro (Humalog). Both drugs will be given by injection under the skin of the abdomen. This study will be conducted in participants with type 1 diabetes to investigate how quickly and how much LY900014 is absorbed and the effect of LY900014 on blood sugar levels in comparison with insulin lispro. The study will last about 3 to 6 weeks for each participant, not including screening.

NCT ID: NCT03406871 Completed - Clinical trials for Advanced and Metastatic Solid Tumor

Regorafenib and Nivolumab Simultaneous Combination Therapy

REGONIVO
Start date: January 25, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

the efficacy and safety ofhe use of regorafenib in combination with nivolumab

NCT ID: NCT03403790 Completed - Depression Clinical Trials

A Survey on Quetiapine Extended-release Tablets in Patients With Depression in Bipolar Disorder

Start date: January 15, 2018
Phase:
Study type: Observational

The purpose of this study is to evaluate the safety and effectiveness of quetiapine in actual clinical settings.

NCT ID: NCT03402386 Completed - Clinical trials for Anemia; Peritoneal Dialysis Dependent Chronic Kidney Disease

Efficacy and Safety Study to Evaluate MT-6548 in Peritoneal Dialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan

Start date: January 3, 2018
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy and safety of MT-6548 in peritoneal dialysis subjects with anemia associated with chronic kidney disease

NCT ID: NCT03399786 Completed - Clinical trials for Homozygous Familial Hypercholesterolemia

Efficacy and Safety of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia

Start date: January 18, 2018
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by evinacumab intravenously (IV) in comparison to placebo after 24 weeks in patients with homozygous familial hypercholesterolemia (HoFH). The secondary objectives of the study are to evaluate the effect of evinacumab IV on other lipid parameters, evaluate the effect of evinacumab on LDL-C goal attainment, assess the effect of evinacumab on eligibility for apheresis (using German and US apheresis criteria), evaluate the safety and tolerability of evinacumab in patients with HoFH, assess the pharmacokinetics (PK) of evinacumab in patients with HoFH and evaluate the potential development of anti-evinacumab antibodies.

NCT ID: NCT03399734 Completed - Clinical trials for Healthy Participants

Bioequivalence Study Between a 4-mg Dose of Fine Granules of Perampanel and a 4-mg Tablet of Perampanel in Healthy Japanese Subjects

Start date: December 18, 2017
Phase: Phase 1
Study type: Interventional

This study will be conducted to demonstrate the bioequivalence between a single 4 milligram (mg) dose of fine granules of perampanel and a single 4 mg tablet of perampanel.

NCT ID: NCT03398876 Completed - Healthy Clinical Trials

A Study to Assess the Nicotine Pharmacokinetics, Tolerability and Safety With a New Oral Nicotine Replacement Product in Healthy Japanese Smokers

Start date: December 22, 2017
Phase: Phase 1
Study type: Interventional

In Part 1, the purpose of this study is to elucidate the single-dose pharmacokinetic profiles of 1 spray and 2 consecutive sprays of oromucosal nicotine spray (ONS) in comparison with those of nicotine gum and cigarette smoking in healthy Japanese smokers. In Part 2, the purpose is to evaluate the multiple-dose nicotine pharmacokinetics of ONS administered repeated-dose administration in healthy Japanese smokers.

NCT ID: NCT03398655 Completed - Clinical trials for Recurrent Platinum Resistant Ovarian Cancer

A Study of VB-111 With Paclitaxel vs Paclitaxel for Treatment of Recurrent Platinum-Resistant Ovarian Cancer (OVAL)

OVAL
Start date: December 19, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this phase 3, randomized, multicenter study is to compare VB-111 and paclitaxel to placebo and paclitaxel in adult patients with Recurrent Platinum-Resistant Ovarian Cancer.