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NCT ID: NCT02281201 Completed - Clinical trials for Acute Major Bleeding

Study of a Prothrombin Complex Concentrate for Rapid Reversal of Coagulopathy Induced by Vitamin K Antagonists in Japanese Subjects

Start date: October 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate efficacy and safety of a Prothrombin Complex Concentrate (PCC), BE1116. BE1116 will be used for the rapid reversal of coagulopathy induced by vitamin K antagonists in Japanese subjects who require immediate correction of international normalized ratio (INR) due to a major bleed or emergency surgery.

NCT ID: NCT02281019 Completed - Biliary Stricture Clinical Trials

SpyGlass AMEA Registry

Start date: November 15, 2014
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to document indications for cholangioscopy and clinical utility of the SpyGlass Direct Visualization System (DVS) throughout the AMEA (Asia, Middle-East, Africa) region when used per standard of practice.

NCT ID: NCT02280837 Completed - Clinical trials for Coronary Artery Disease

Is Glucagon-like Peptide-1 Insufficiency a Residual Risk in Coronary Artery Disease?

Start date: February 27, 2015
Phase:
Study type: Observational

In this study, the investigators hypothesized that significant proportion of patients with coronary artery disease (CAD) has reduced capacity of glucagon-like peptide-1 (GLP-1) secretion, which is detectable as blunted response of plasma active GLP-1 level to oral glucose loading and that reduced GLP-1 secretory function is associated with increased severity of coronary artery stenosis but not with classic risk factors for CAD. To test this hypothesis, the investigators will analyze correlation between GLP-1 secretory capacity and severity of coronary artery stenosis determined by Gensini Score (GS), an established score system for coronary artery stenoses. Additionally, the investigators will analyze relationship between level of "total" GLP-1 and severity of coronary artery stenosis to determine how it is different from the active GLP-1 - coronary stenosis relationship.

NCT ID: NCT02278393 Completed - Healthy Volunteers Clinical Trials

A Clinical Study for Evaluating the Safety of a Plant Sterol-enriched Fermented Dairy Product in Japanese Healthy Adults

Start date: February 2014
Phase: N/A
Study type: Interventional

Investigate the safety of excessive consumption of plant sterol-enriched fermented dairy product over a 4-week period in Japanese healthy adults

NCT ID: NCT02277743 Completed - Dermatitis, Atopic Clinical Trials

Study of Dupilumab Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis

SOLO 1
Start date: October 2014
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, parallel group study to confirm the efficacy and safety of Dupilumab monotherapy in adults with moderate-to-severe atopic dermatitis (AD).

NCT ID: NCT02277691 Completed - Clinical trials for Essential Hypertension

A Phase III Long-term Study of TAK-536TCH in Patients With Essential Hypertension

Start date: November 2014
Phase: Phase 3
Study type: Interventional

Primary objective of this study is to evaluate the safety of long-term administration of TAK-536, amlodipine (AML), and hydrochlorothiazide (HCTZ) in patients with essential hypertension.

NCT ID: NCT02276274 Completed - Clinical trials for Clinical Pharmacology

Effect of Food on the Pharmacokinetics of Single Oral Dose Administration of a Fixed-Dose Combination of SYR-322 and Metformin Hydrochloride in Healthy Adult Male Subjects

Start date: June 2014
Phase: Phase 3
Study type: Interventional

This is a randomized, open-label, crossover study to determine the effect of food when a combination tablet of SYR-322 and metformin hydrochloride ( hereinafter referred to as SYR-322-MET tablet) is orally administered under fasting conditions in the morning or after breakfast in Japanese healthy adult male subjects.

NCT ID: NCT02275910 Completed - Tumors Clinical Trials

Phase 1 Study of E7090 in Subjects With Solid Tumor

Start date: October 28, 2014
Phase: Phase 1
Study type: Interventional

This is a Phase 1 study of E7090 in subjects with advanced solid tumors. This study will be conducted in 2 parts: 1. Part 1 will be the dose escalation portion of this study to determine the maximum tolerated dose in subjects with solid tumors, and 2. Part 2 will comprise cohort expansions to further characterize the safety and tolerability of E7090 and to assess preliminary efficacy of E7090 in subjects with solid tumors characterized by genetic abnormalities in FGF/FGFR pathway.

NCT ID: NCT02274285 Completed - Tetanus Clinical Trials

DTaP-IPV/Hib Vaccine Primary & Booster Vaccinations Versus Co-administration of DTaP-IPV and Hib Vaccine in Japanese Infants

Start date: October 2014
Phase: Phase 3
Study type: Interventional

Primary objective: - To demonstrate the non-inferiority in terms of seroprotection rates (Hib antigen (PRP), Diphtheria, Tetanus, and Pertussis antigens (PT and FHA), and polio types 1, 2 and 3 antigens) of investigational arm (Group A: DTaP-IPV/Hib) versus control arm (Group B: DTaP-IPV and Hib vaccines administered at separate sites), one month after the primary vaccination (all antigens). Secondary objectives: - To describe immune responses against all vaccine antigens with no pre-specified hypothesis, and at all time points (pre-dose 1, post-dose 3, pre-dose 4 and post-dose 4) in the two study groups (Group A and Group B). - To describe the safety after each dose of each vaccine in the two study groups (Group A and Group B). - To describe immune responses against all vaccine antigens with no pre-specified hypothesis, and at all time points (pre-dose 1, post-dose 3, pre-dose 4 and post-dose 4 (Group C)

NCT ID: NCT02273908 Completed - Low-Back Pain Clinical Trials

PROs in Chronic Low Back Pain Patients With Accompanying Lower Limb Pain (Neuropathic Component) Treated With Pregabalin

PRO
Start date: July 2014
Phase:
Study type: Observational

The purpose of this study is to evaluate the effect of pregabalin comparing with the conventional analgesic care in chronic low back pain patients with accompanying lower limb pain (neuropathic component) treated in primary care settings under routine clinical practice.