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NCT ID: NCT02008357 Completed - Cognition Disorders Clinical Trials

Clinical Trial of Solanezumab for Older Individuals Who May be at Risk for Memory Loss

A4
Start date: February 28, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to test whether an investigational drug called solanezumab can slow the progression of memory problems associated with brain amyloid (protein that forms plaques in the brains of people with Alzheimer Disease [AD]).

NCT ID: NCT02008227 Completed - Clinical trials for Non-Squamous Non-Small Cell Lung Cancer

A Study of Atezolizumab Compared With Docetaxel in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum-Containing Therapy

OAK
Start date: March 11, 2014
Phase: Phase 3
Study type: Interventional

This global, multicenter, open-label, randomized, controlled study evaluated the efficacy and safety of atezolizumab (an anti-programmed death−ligand 1 [anti-PD-L1] antibody)compared with docetaxel in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure with platinum-containing chemotherapy. Participants were randomized 1:1 to receive either docetaxel or atezolizumab. Treatment may continue as long as participants experienced clinical benefit as assessed by the investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.

NCT ID: NCT02007720 Terminated - Acute Heart Failure Clinical Trials

Efficacy, Safety and Tolerability of Sexelaxin When Added to Standard Therapy in AHF

RELAX-AHF-ASIA
Start date: March 12, 2014
Phase: Phase 3
Study type: Interventional

The purpose of the study was to evaluate the efficacy, safety and tolerability of intravenous infusion of serelaxin, when added to standard therapy, in acute heart failure (AHF) patients.

NCT ID: NCT02007655 Completed - Clinical trials for NonValvular Atrial Fibrillation

Eliquis Safety Surveillance in Japanese Patients With NonValvular Atrial Fibrillation

Start date: September 1, 2013
Phase:
Study type: Observational

The primary objectives of this study are: - To estimate the incidence rate of unexpected adverse events - To characterize the bleeding events and assess risk factors of bleeding - To identify ancillary baseline variables that may also be associated with adverse outcomes

NCT ID: NCT02005536 Completed - Poliomyelitis Clinical Trials

Study of IMOVAX POLIO® Subcutaneous as a Booster Vaccine in Pre-school Age Children in Japan

Start date: December 2013
Phase: Phase 4
Study type: Interventional

The aim of the study is to assess the immunogenicity of SP059 (IMOVAX POLIO®: Inactive Poliovirus Vaccine) vaccine against poliovirus and safety after fifth dose. Primary Objective: - To investigate the booster vaccine response rate against poliovirus types 1, 2 and 3 one month following the vaccination dose with SP059 as 2nd booster Secondary Objectives: - To investigate seroprotection rates (percentage of subjects presenting poliovirus neutralizing antibody titers above 1:8 (1/dil.) at pre- and post-booster time points, Geometric mean titers (GMT) at pre- and post-booster time points and geometric mean of individual titer ratio (GMTR). - To investigate the safety after dosing of SP059 as 2nd booster.

NCT ID: NCT02005211 Completed - Clinical trials for Healthy Japanese Young and Elderly Male and Non-fertile Female Volunteers

A Two-part Single and Multiple Dose Study to Assess the Safety , Pharmacokinetics and Effects of AZD3293 in Healthy Japanese Young and Elderly Volunteers

Start date: December 2013
Phase: Phase 1
Study type: Interventional

This study consists of two parts, ie, single dose part with young healthy subjects (Part 1) and single and multiple dose part with elderly healthy subjects (Part 2), to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD3293 following single and multiple ascending dose administration to healthy subjects.

NCT ID: NCT02004873 Completed - Clinical trials for Class I or II Indication for Implantation of a Single Chamber Ventricular Pacemaker According to ACC/AHA/HRS 2001 Guidelines and Any National Guidelines

Micra Transcatheter Pacing Study

Start date: November 2013
Phase: N/A
Study type: Interventional

The purpose of this clinical study is to evaluate the safety and efficacy of the Micra Transcatheter Pacing System and to assess long term performance.

NCT ID: NCT02004717 Completed - Solid Tumors Clinical Trials

Phase 1 Study of DS-8895a in Subjects With Advanced Solid Tumors

Start date: October 2013
Phase: Phase 1
Study type: Interventional

This is an open-label, sequential dose escalation and expansion study to evaluate the safety, tolerability, and pharmacokinetics of DS-8895a in Japanese subjects with advanced solid tumors.

NCT ID: NCT02004691 Completed - Clinical trials for Sphingomyelin Lipidosis

Efficacy, Safety, Pharmacodynamic, and Pharmacokinetics Study of Olipudase Alfa in Patients With Acid Sphingomyelinase Deficiency

ASCEND
Start date: December 18, 2015
Phase: Phase 2/Phase 3
Study type: Interventional

Primary Objective: The primary objective of this phase 2/3 study is to evaluate the efficacy of olipudase alfa (recombinant human acid sphingomyelinase) administered intravenously once every 2 weeks for 52 weeks in adult participants with acid sphingomyelinase deficiency (ASMD) by assessing changes in: 1) spleen volume as measured by abdominal magnetic resonance imaging (MRI) (and, for the United States [US] only, in association with participant perception related to spleen volume as measured by splenomegaly-related score [SRS]); and 2) infiltrative lung disease as measured by the pulmonary function test, diffusing capacity of the lung for carbon monoxide (DLCO). Secondary Objectives: - To confirm the safety of olipudase alfa administered intravenously once every 2 weeks for 52 weeks. - To characterize the effect of olipudase alfa on the participant perception related to spleen volume as measured by the SRS after 52 weeks of study drug administration. (For the US, the effect of olipudase alfa on the SRS is part of the primary objective). - To characterize the effect of olipudase alfa after 52 weeks of study drug administration on the following outcome measures assessed sequentially: - The effect of olipudase alfa on liver volume; - The effect of olipudase alfa on platelet count; - The effect of olipudase alfa on fatigue; - The effect of olipudase alfa on pain; - The effect of olipudase alfa on dyspnea.

NCT ID: NCT02004119 Completed - Atopic Dermatitis Clinical Trials

Phase 2 Study of KHK4577

Start date: November 2013
Phase: Phase 2
Study type: Interventional

This study is an randomized double-blind placebo-controlled study to evaluate the efficacy and the safety of oral KHK4577 for 6 weeks in patients with atopic dermatitis. Pharmacokinetics of KHK4577 will also be assessed.