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NCT ID: NCT02834390 Completed - Clinical trials for Acute Myeloid Leukemia

Study of Quizartinib in Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

Start date: August 12, 2016
Phase: Phase 1
Study type: Interventional

This is a phase 1b, dose escalation, study of quizartinib to evaluate the safety profile, the pharmacokinetics, and the recommended dose of quizartinib for subsequent clinical studies of the combination of quizartinib and induction and consolidation chemotherapy.

NCT ID: NCT02834221 Completed - Atrial Fibrillation Clinical Trials

Ultrasound-guided Femoral Vein Accessibility, Safety and Time for Atrial Fibrillation Treatment

ULTRA-FAST
Start date: June 2016
Phase: N/A
Study type: Interventional

This study is designed to evaluate the use of real-time ultrasound-guided femoral venipuncture during pulmonary vein isolation for treating atrial fibrillation .

NCT ID: NCT02832622 Completed - Heart Failure Clinical Trials

MultiPoint Pacing™ Post Market Study

MPP-PMS
Start date: July 2016
Phase:
Study type: Observational

This is a prospective, multicenter, non-randomized registry/observational study. The study will enroll up to 2,000 patients with successful St. Jude Medical (SJM) Cardiac Resynchronization Therapy (CRT) MP device implant from up to 140 centers undergoing CRT implantation.

NCT ID: NCT02832037 Completed - Schizophrenia Clinical Trials

Clinical Trial of BI 425809 Effect on Cognition and Functional Capacity in Schizophrenia

Start date: July 25, 2016
Phase: Phase 2
Study type: Interventional

The objective of the study is to investigate the efficacy, safety and pharmacokinetics of four different doses of BI 425809 once daily compared to placebo given for 12 weeks in patients with schizophrenia on stable antipsychotic treatment.

NCT ID: NCT02831660 Completed - Hemorrhage Clinical Trials

CU Programme of Idarucizumab for Japanese Patients

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

The objective is to collect the safety data of idarucizumab for patients treated with dabigatran who require rapid reversal of the anticoagulant effects of dabigatran in cases of uncontrolled or life-threatening bleeding or when emergency surgery or urgent procedures are required.

NCT ID: NCT02831569 Completed - Pain Clinical Trials

Japanese IP-TN Trial

Start date: July 27, 2016
Phase: Phase 3
Study type: Interventional

This is an open-label, single-group, multi-centre trial to confirm the safety and efficacy of loxoprofen sodium/methocarbamol ( IP-TN) when administered orally for 2 weeks to patients with low back pain, scapulohumeral periarthritis, or cervico-omo-brachial syndrome associated with muscle strain. More than 90 patients will be screened to enroll approximately 80 patients in the trial. After giving written informed consent, patients will be enrolled in the trial. Patients who are considered eligible for the trial by the Investigator after consent and complete the trial procedures and assessments at Visit 1 will receive the trial medication and enter the open-label treatment period of 2 weeks. Patients who complete the open-label treatment period will enter the follow-up period of 1 week and complete the trial after confirmation at the last visit (or phone interview).

NCT ID: NCT02829320 Completed - Anaemia Clinical Trials

Efficacy and Safety Study of GSK1278863 in Japanese Hemodialysis Subjects With Anemia Associated With Chronic Kidney Disease Who Are Not Taking Erythropoiesis Stimulating Agents

Start date: August 8, 2016
Phase: Phase 3
Study type: Interventional

This 24-week, Phase 3, open-label, non-comparative, multicentre study aims to evaluate the efficacy and safety of GSK1278863 in Japanese hemodialysis (HD) patients with renal anemia not using erythropoiesis-stimulating agents (ESAs). The primary objective is to evaluate the initial response to GSK1278863 measured by hemoglobin (Hgb) levels in HD patients not using ESAs enrolled in this study. The study is designed to evaluate the appropriateness of the starting dose of GSK1278863 and of the GSK1278863 dose adjustment regimen to achieve or maintain the target Hgb levels. This study will consist of a 4-week screening period, a 24-week treatment period (4-week fixed-dose period and a 20-week dose adjustment period), and a 2- to 4-week follow-up period.

NCT ID: NCT02828917 Completed - Clinical trials for de Novo or Restenosis Lesions

MedJ-01 Ridaforolimus Eluting Coronary Stent System Trial (JNIR)

JNIR
Start date: January 16, 2017
Phase: N/A
Study type: Interventional

MedJ-01 Ridaforolimus Eluting Coronary Stent System is a single use device/drug combination product comprising: - A mounted Cobalt Chromium (CoCr) alloy based stent - A Rapid Exchange (RX) Coronary System Delivery System - A Poly n-butyl methacrylate (PBMA) and CarboSil®Polymer matrix coating - Ridaforolimus drug - CAS Registry Number: 572924-54-0 MedJ-01 is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to lesions in vessels with reference diameters of 2.5 mm to 4.25 mm, including complex lesions. JNIR01 is aimed at assessing TLF at one year with the MedJ-01 stent in a Japanese patient population to show equivalence to the results of the BIONICS Trial.

NCT ID: NCT02828319 Completed - Clinical trials for Iron Deficiency Anemia

Clinical Study of Z-213 in Subjects With Iron-deficiency Anemia

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

To confirm the safety and efficacy of Z-213 until 12 weeks after start of Z-213 administration in patients with iron deficiency Anemia

NCT ID: NCT02828254 Completed - Clinical trials for Hepatitis C Virus-infected Cirrhosis

A Follow-up Evaluation Study of PRI-724-1101

Start date: December 18, 2014
Phase:
Study type: Observational [Patient Registry]

The purpose of this study To evaluate the safety and efficacy of PRI-724 administration in patients with cirrhosis due to hepatitis C by 12-month follow-up.