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NCT ID: NCT02695329 Completed - Clinical trials for Osteoarthritis, Knee

Vanguard TKA With KneeAlign 2 and Without KneeAlign 2

Start date: May 24, 2016
Phase: N/A
Study type: Interventional

Purpose of this study is to determine the effectiveness of the KneeAlign 2 system in terms of precise implant alignment by demonstrating that KneeAlign 2 provides better tibial alignment compared to conventional instruments

NCT ID: NCT02693613 Completed - Healthy Volunteers Clinical Trials

Pharmacokinetic Study of ASP1517 With Kremezin®

Start date: February 2016
Phase: Phase 1
Study type: Interventional

The objective of this study is to evaluate the effect of Kremezin® on the pharmacokinetics of single dose of ASP1517 in healthy non-elderly adult male subjects when administered concomitantly or in a time separated manner.

NCT ID: NCT02690337 Completed - Clinical trials for Advanced Solid Malignant Tumors

Study of DS-1123a in Advanced Solid Tumours

Start date: January 2016
Phase: Phase 1
Study type: Interventional

This is an open-label study to evaluate the safety, tolerability, and pharmacokinetics of DS-1123a in Japanese subjects with advanced solid tumors.

NCT ID: NCT02690207 Completed - Herpes Zoster Clinical Trials

Cross-vaccination Study of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine (GSK 1437173A) in Subjects Who Previously Received Placebo in ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) Studies.

Start date: March 16, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to cross-vaccinate and collect safety data in terms of unsolicited Adverse Events (AEs), Serious Adverse Events (SAEs) and potential Immune Mediated Disease (pIMD) from subjects >= 50 Years of age (YOA) who previously received placebo in ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229).

NCT ID: NCT02686814 Completed - Aortic Stenosis Clinical Trials

PERIGON Japan Trial

Start date: March 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the safety and effectiveness of the 17mm MDT-2215 aortic valve bioprosthesis.

NCT ID: NCT02685345 Completed - Clinical trials for Type 2 Diabetes Mellitus

A Study of DS-8500a in Japanese Subjects With Type 2 Diabetes Mellitus Receiving Sitagliptin

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

The objectives of the study is to evaluate the efficacy and safety of DS-8500a compared with placebo in patients with type 2 diabetes mellitus (T2DM) receiving sitagliptin.

NCT ID: NCT02684058 Completed - Glioblastoma Clinical Trials

Study of Efficacy and Safety of Dabrafenib in Combination With Trametinib in Pediatric Patients With BRAF V600 Mutation Positive LGG or Relapsed or Refractory HGG Tumors

Start date: December 28, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study was to investigate the activity of dabrafenib in combination with trametinib in children and adolescent patients with BRAF V600 mutation positive low grade glioma (LGG) or relapsed or refractory high grade glioma (HGG)

NCT ID: NCT02682927 Completed - Dravet Syndrome Clinical Trials

A Trial of Two Fixed Doses of ZX008 (Fenfluramine HCl) in Children and Young Adults With Dravet Syndrome

Start date: January 15, 2016
Phase: Phase 3
Study type: Interventional

Study 1 and Study 3 are the prospective, merged analyses of 2 identical double-blind, placebo-controlled studies, ZX008-1501 and ZX008-1502, to assess the efficacy, safety, and pharmacokinetics of ZX008 when used as adjunctive therapy in pediatric and young adult subjects with Dravet syndrome. Study 1501 and Study 1502 were conducted in parallel; Study 1501 was conducted at approximately 30 study sites in North America; Study 1502 was conducted at approximately 30 study sites in Europe, Asia and Australia. Upon completion of the Baseline Period after initial Screening and Baseline charting of seizure frequency, subjects who qualified for the studies were randomized (1:1:1) in a double-blind manner to receive either 1 of 2 doses of ZX008 (0.2 mg/kg/day or 0.8 mg/kg/day; maximum dose: 30 mg/day) or placebo. Randomization was stratified by age group (< 6 years, ≥6 to 18 years) to achieve balance across treatment arms, with the target of 25% of subjects in each age group. All subjects were titrated to their randomized dose over a 14-day Titration Period. Following titration, subjects continued treatment at their randomly assigned dose over a 12-week Maintenance Period. Subjects exiting the study underwent a 2-week taper, unless they enrolled in a follow-on study. Subjects were followed for post-study safety monitoring.

NCT ID: NCT02679508 Completed - Erosive Esophagitis Clinical Trials

Vonoprazan Study in Patients With Erosive Esophagitis to Evaluate Long-term Safety

Start date: March 20, 2016
Phase: Phase 4
Study type: Interventional

The purpose of this study is exploratorily evaluate the effect on gastric mucosal tissue and the safety of long-term administration (260 weeks: 5 years) of vonoprazan 10 mg or 20 mg in patients receiving maintenance treatment after healed erosive esophagitis (EE), and the curative effect of vonoprazan 20 mg versus lansoprazole in patients with EE.

NCT ID: NCT02679469 Completed - Alcohol Dependence Clinical Trials

A Single-center, Open-label, Single-dose Study Investigating the Safety, Tolerability, and Pharmacokinetic Properties of Nalmefene 10 mg Tablets in Healthy Japanese Male Subjects

Start date: February 2016
Phase: Phase 1
Study type: Interventional

The safety, tolerability, and pharmacokinetics of nalmefene at a single oral dose of 10 mg in healthy Japanese male subjects will be evaluated.