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NCT ID: NCT01844284 Completed - Clinical trials for Coronary Artery Disease

AVJ-301 Clinical Trial: A Clinical Evaluation of AVJ-301 (Absorbâ„¢ BVS) in Japanese Population

ABSORB JAPAN
Start date: April 2013
Phase: N/A
Study type: Interventional

Prospective, Randomized (2:1), active control, single-blind, non-inferiority, multicenter, Japanese Clinical Trial to evaluate the safety and effectiveness of Absorbâ„¢ BVS (AVJ-301) in the treatment of subjects with ischemic heart disease caused by de novo native coronary artery lesions in Japanese population by comparing to approved metallic drug eluting stent.

NCT ID: NCT01843556 Completed - Clinical trials for Healthy Elderly Male

A Phase 1 Study of E2022 Tape Formulation for Different Application Sites and Intervals in Japanese Healthy Elderly Males

Start date: December 2012
Phase: Phase 1
Study type: Interventional

A phase 1 study of E2022 tape formulation in healthy elderly males to evaluate the safety and pharmacokinetics.

NCT ID: NCT01843400 Completed - Clinical trials for Colorectal Neoplasms

Regorafenib Post-marketing Surveillance

Start date: April 22, 2013
Phase:
Study type: Observational

This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Regorafenib for colorectal cancer. The objective of this study is to assess safety and effectiveness of Regorafenib using in real clinical practice. A total of 1,250 patients are to be enrolled and assessed in 6 months standard observational period. At 12 months after the first administration of Regorafenib for confirmation of efficacy information including treatment duration and survival status of the patient.

NCT ID: NCT01842841 Completed - Gaucher Disease Clinical Trials

Multicenter Extension Study of Velaglucerase Alfa in Japanese Patients With Gaucher Disease

Start date: March 13, 2013
Phase: Phase 3
Study type: Interventional

Gaucher disease is an inherited deficiency of the lysosomal enzyme glucocerebrosidase (GCB) that leads to progressive accumulation of glucocerebroside within macrophages and subsequent tissue and organ damage; typically of the liver, spleen, bone marrow, and brain. Type 1 Gaucher disease affects an estimated 30,000 persons worldwide and is the most common. Type 1 Gaucher disease does not involve the central nervous system. Patients with Type 2 Gaucher disease present with acute neurological deterioration, which leads to early death. Those with Type 3 disease typically display a more sub-acute neurological course, with later onset and slower progression. The primary objective of this study is to evaluate the long-term safety of every other week (EOW) dosing of velaglucerase alfa in Japanese patients with Gaucher disease who completed study HGT-GCB-087 and elected to continue treatment with velaglucerase alfa. Velaglucerase alfa has been developed and approved as an enzyme replacement therapy for Type 1 Gaucher disease.

NCT ID: NCT01842607 Completed - Asthma Clinical Trials

A Study to Determine Long-term Safety of Mepolizumab in Asthmatic Subjects

Start date: May 27, 2013
Phase: Phase 3
Study type: Interventional

This is a multi-centre, open-label long-term safety study of 100 milligram (mg) mepolizumab administered subcutaneously (SC) every 4 weeks for 12 months in addition to standard of care in subjects who have severe, refractory asthma and a history of eosinophilic inflammation. Subjects who completed either MEA115588 or MEA115575 will be offered the opportunity to consent for this study.

NCT ID: NCT01840605 Completed - Dermatitis Clinical Trials

A Confirmatory Study of TAU-284 in Pediatric Patients With Atopic Dermatitis

Start date: March 2013
Phase: Phase 3
Study type: Interventional

The objective of this study is to verify the non-inferiority of TAU-284 to ketotifen fumarate dry syrup in the change in the severity of pruritus after the treatment period.

NCT ID: NCT01839825 Completed - Elderly People Clinical Trials

Comparative Study of QuietCare

Start date: December 2012
Phase: N/A
Study type: Interventional

The objective of the study is to examine the efficacy and safety of QuietCare in a randomized, open study in elderly subjects living in assisted/ independent living facilities for 6 months.

NCT ID: NCT01839604 Completed - Clinical trials for Advanced Adult Hepatocellular Carcinoma

A Phase I/Ib Study of AZD9150 (ISIS-STAT3Rx) in Patients With Advanced/Metastatic Hepatocellular Carcinoma

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

This is a phase I/Ib open-label, multicentre study to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumour activity of AZD9150 in patients with advanced/metastatic hepatocellular carcinoma.

NCT ID: NCT01838668 Completed - Multiple Sclerosis Clinical Trials

An Efficacy and Safety Study of BG00012 (Dimethyl Fumarate) in Asian Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)

Start date: March 28, 2013
Phase: Phase 3
Study type: Interventional

This is a multicenter study conducted in 2 parts: The primary objective in Part I of this study is to determine the efficacy of BG00012 (dimethyl fumarate, DMF) on inflammatory brain magnetic resonance imaging (MRI) lesion activity (Gadolinium-enhancing lesions) when compared with placebo from 4 scans performed at Weeks 12, 16, 20, and 24 in participants with Relapsing Remitting Multiple Sclerosis (RRMS) including participants from the Asia-Pacific region. The secondary objectives in Part I of this study in this study population are to determine whether BG00012, when compared with placebo over 24 weeks, is effective in reducing the cumulative number of new Gadolinium-enhancing lesions from Baseline to Week 24; reducing the number of new or newly enlarging T2 hyperintense lesions on brain MRI scans at Week 24 compared with Baseline. The primary objective in Part II (open label) of this study is to evaluate the long-term safety profile of BG00012 in eligible participants from Part I.

NCT ID: NCT01837641 Completed - Alzheimer Disease Clinical Trials

A Study of LY3002813 in Participants With Alzheimer's Disease

Start date: May 3, 2013
Phase: Phase 1
Study type: Interventional

The study will evaluate the safety of LY3002813 by looking at adverse events. The study will also look at the effect the body has on LY3002813. Study participants will be healthy or will have mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild to moderate AD. There will be seven groups of study participants. Five groups will receive a single dose of LY3002813 or placebo (no drug), followed by up to 4 multiple doses of LY3002813 or placebo given as an injection into a vein. Approximately 12 weeks will pass between the single dose and the first multiple dose. One group of participants will receive a single dose of LY3002813 given as an injection under the skin. One group of participants will receive a single dose of LY3002813 given as an injection into a vein.