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NCT ID: NCT02094729 Completed - Alzheimer's Disease Clinical Trials

A Randomized, Double-blind, Placebo-controlled Study to Assess Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamic Response of Repeated Intravenous Infusions of BAN2401 in Subjects With Mild Cognitive Impairment Due to Alzheimer's Disease and Mild Alzheimer's Disease

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

The purpose of this study is to assess the safety, tolerability, pharmacokinetics, immunogenicity, and pharmacodynamic response of repeated intravenous infusions of BAN2401 in subjects with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild Alzheimer's disease.

NCT ID: NCT02094261 Completed - Clinical trials for Non Small Cell Lung Cancer

Phase II AZD9291 Open Label Study in NSCLC After Previous EGFR TKI Therapy in EGFR and T790M Mutation Positive Tumours

AURA2
Start date: May 20, 2014
Phase: Phase 2
Study type: Interventional

A Phase II, Open Label, Single-arm Study to Assess the Safety and Efficacy of AZD9291 in Patients with Locally Advanced/Metastatic Non Small Cell Lung Cancer whose Disease has Progressed with Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and whose Tumours are Epidermal Growth Factor Receptor Mutation and T790M Mutation Positive

NCT ID: NCT02094235 Completed - Atopic Dermatitis Clinical Trials

A Phase 1/2 Study of E6005 in Pediatric Subjects With Atopic Dermatitis

Start date: January 2014
Phase: Phase 1/Phase 2
Study type: Interventional

This is a multicenter, double-blind, vehicle-control study of 0.05% and 0.2% E6005 ointment. Pediatric subjects with atopic dermatitis (AD) will be grouped into two; an elder group (childhood - adolescent: 7 to 15 years of age) and a younger group (children: 2 to 6 years of age) according to the sequential cohorts by confirming the safety.

NCT ID: NCT02094053 Completed - Down Syndrome Clinical Trials

A Double-blind, Placebo-controlled Comparative Study and Open-label Extension Study to Confirm the Efficacy and Safety of E2020 in Subjects With Down Syndrome Having Regression Symptoms and Disabled Activities of Daily Living.

Start date: September 12, 2013
Phase: Phase 2
Study type: Interventional

The purpose of this double-blind, placebo-controlled, comparative study and open-label extension study is to confirm the efficacy and safety of E2020 in subjects with Down syndrome having regression symptoms and disabled activities of daily living.

NCT ID: NCT02092025 Completed - Hypertension Clinical Trials

Azilsartan Tablets Special Drug Use Surveillance: Long-term Use

Start date: June 20, 2012
Phase:
Study type: Observational

The purpose of this survey is to evaluate the safety and efficacy of long-term use of azilsartan tablets (Azilva Tablets) in patients with hypertension in a routine clinical setting.

NCT ID: NCT02091440 Completed - Heart Failure Clinical Trials

Clinical Evaluation of HW005 Ventricular Assist System for the Treatment of Advanced Heart Failure in Japan

HW005
Start date: March 2014
Phase: N/A
Study type: Interventional

The purpose of the study is to evaluate the safety and effectiveness of the HW005 System in patients listed for cardiac transplantation with refractory, advanced heart failure at risk of death.

NCT ID: NCT02091011 Completed - Clinical trials for Implantable Cardioverter Defibrillators

LONGEVITY Study. Evaluation of the Device and Battery Longevity of Boston Scientific Market-released ICD and CRT-D Devices

Start date: January 27, 2014
Phase:
Study type: Observational

The study is to determine the rate and cause of device replacements at 5 years post-implantation. It will assess the battery and device longevity of the Implantable Cardioverter Defibrillators (ICD) and CRT-D Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices. It will also validate the device survival information given in Boston Scientific's Product Performance Report by comparing the pulse generator (PG) survival probability in the study to that presented in the Product Performance Reports (PPR)

NCT ID: NCT02089997 Completed - Osteoporosis Clinical Trials

Special Drug Use Surveillance on Long-term Use of Sodium Risedronate Tablets (Benet 75 mg Tablets) (12-month Treatment Survey)

Start date: May 27, 2013
Phase:
Study type: Observational

The purpose of this study is to evaluate the safety and efficacy of sodium risedronate tablets (Benet 75 mg Tablets) in osteoporosis patients in daily medical practice, as well as to examine "the status of treatment compliance" - i.e., whether sodium risedronate tablets are taken properly in accordance with the prescribed once-monthly regimen

NCT ID: NCT02089711 Completed - Healthy Clinical Trials

Optical Coherence Tomography (OCT) Normative Data Collection Study (S-2013-2)

S-2013-2
Start date: January 2014
Phase: N/A
Study type: Observational

This study is being initiated to create a normal database including measures of optic nerve head (ONH), peripapillary retinal nerve fiber layer (RNFL), and macula using the Heidelberg Spectralis OCT device. The range will be determined for each structural parameter across normal eyes in Japanese subjects, and the measurements stratified according to age.

NCT ID: NCT02089347 Completed - Tetanus Clinical Trials

Study of SP306 Given Intramuscularly Compared to DT BIK® Given Subcutaneously in Japanese Adolescents 11 - 12 Years Old

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

The aim of the study is to generate additional safety and immunogenicity data to support the registration of the product in Japan. Primary objectives: - To demonstrate the non-inferiority of SP306 versus DT (DT BIK® 0.1mL) vaccine in terms of diphtheria and tetanus booster response rate (proportion of subjects with booster responses) and seroprotection rate (percentage of subjects with antitoxin concentrations ≥0.1 IU/mL) at 28 days (window 28-35 days) after one injection in Japanese adolescents 11-12 years of age. - To evaluate the immune response of SP306 against the pertussis antigens PT and FHA in terms of booster response rate (proportion of subjects with booster responses) at 28 days (window 28-35 days) after one injection in Japanese adolescents 11-12 years of age. Secondary objectives: - To further evaluate the immune response of the study vaccines against diphtheria, tetanus and pertussis antigens. - To assess the safety of the study vaccines after one injection in Japanese adolescents 11-12 years of age.