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NCT ID: NCT02637206 Completed - Dermatitis, Atopic Clinical Trials

Skin Irritation Study of GSK2894512 Cream

Start date: October 27, 2015
Phase: Phase 1
Study type: Interventional

GSK2894512 is a novel anti-inflammatory agent that is currently under development for the topical treatment of atopic dermatitis and chronic plaque psoriasis. This study will be a Phase I, single-center, randomized, partial-blinded (evaluator blinded) study which consists of two parts (Part 1 and 2). Part 1 of this study will assess skin irritation following a single application of GSK2894512 cream at 2 concentrations (e.g. 0.5% and 1%) and placebo by simple-patch test and photo-patch test under semi-occlusive conditions in 20 healthy Japanese volunteers. Part 2 of this study will assess skin irritation following repeat application at 0.5% and 1% of GSK2894512 cream and placebo for 7 days under non-occlusive condition in 6 healthy Japanese volunteers. The study will have Screening visit which will occur within 30 days from the Day 1 visit of each part. Eligible subjects will be able to participate either of Part 1 or Part 2. Subjects will visit the site on Day -1, and hospitalized until the end of all assessments on Day 4 (Part 1) or Day 7 (Part 2). Subjects will re-visit the site on Day 8 (Part 1) or Day 15 (Part 2) for follow-up assessments. This study will be the first to evaluate the safety, tolerability and pharmacokinetics of GSK2894512 cream after single and repeat application in Japanese subjects. Results from this study will enable further clinical investigation in the Japanese population.

NCT ID: NCT02636686 No longer available - Clinical trials for Duchenne Muscular Dystrophy

Extension Study of Drisapersen in DMD Subjects

Start date: n/a
Phase: N/A
Study type: Expanded Access

This is a phase IIIb, multi-centre, open-label extension study in male subjects with DMD who previously have been treated with drisapersen, aiming at assessing the safety and efficacy of drisapersen.

NCT ID: NCT02635789 Completed - Plaque Clinical Trials

Phase III Trial of Topical Formulation of Sirolimus to Skin Lesions in Patients With Tuberous Sclerosis Complex (TSC)

Start date: December 2015
Phase: Phase 3
Study type: Interventional

The purpose of this trial is to evaluate the efficacy and safety of NPC-12G gel (topical formulation of sirolimus) versus placebo gel to facial angiofibroma and other skin lesions in patients with tuberous sclerosis complex (TSC)

NCT ID: NCT02634931 Completed - Plaque Clinical Trials

Long-term Trial of Topical Sirolimus to Angiofibroma in Patient With Tuberous Sclerosis Complex

Start date: December 2015
Phase: Phase 3
Study type: Interventional

The purpose of this trial is to evaluate the safety and efficacy of long-term treatment with NPC-12G gel (0.2% sirolimus gel) to angiofibroma and other skin lesions in patients with tuberous sclerosis complex in the open-label trial.

NCT ID: NCT02634580 Completed - Clinical trials for Hypercholesterolemia

Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-4

GAUSS-4
Start date: February 27, 2016
Phase: Phase 3
Study type: Interventional

The primary objective of the study was to evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in hypercholesterolemic adults unable to tolerate an effective dose of a statin.

NCT ID: NCT02633982 Recruiting - Atrial Fibrillation Clinical Trials

GENERAL;GENeral Practitioners and Embolism pRevention in NVAF Patients Treated With RivAroxaban:reaL-life Evidence

GENeRAL
Start date: September 2015
Phase: N/A
Study type: Observational [Patient Registry]

In atrial fibrillation patients,anticoagulant therapy with warfarin has an excellent stroke preventive. Meantime,Warfarin may also increase the risk of hemorrhagic events. Considering this,warfarin is a drug which puts a great burden on patients and medical providers. With the population aging, the number of non-valvular atrial fibrillation patients is increasing, and a necessity that not only specialist but also general practitioners. Anticoagulant therapy with warfarin is not easy for general practitioners and is not commonly used among general practioners. In such circumstances, Rivaroxaban,a new oral direct factor Xa inhibitor,has become available. Rivaroxaban is administrated once a day and exert an anti- coagulant effect soon after administration. It hardly reacts with foods or other drugs and therefore does not require regular monitoring. GENERAL study is to investigate the effectiveness of stroke and systemic embolism in non-valvular atrial fibrillation patients when it is prescribed by general practioners in real life settings.

NCT ID: NCT02632409 Active, not recruiting - Clinical trials for Various Advanced Cancer

An Investigational Immuno-therapy Study of Nivolumab, Compared to Placebo, in Patients With Bladder or Upper Urinary Tract Cancer, Following Surgery to Remove the Cancer

CheckMate 274
Start date: March 22, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the effectiveness and safety of Nivolumab compared to placebo in participants who have undergone radical surgery for invasive urothelial cancer.

NCT ID: NCT02632331 Completed - Healthy Volunteers Clinical Trials

ASP8825 - A Study to Investigate the Food Effect on the Pharmacokinetics of ASP8825

Start date: January 2009
Phase: Phase 1
Study type: Interventional

The objective of this study is to evaluate the effect of food on the pharmacokinetics and safety after administration of ASP8825 in healthy non-elderly adult male subjects.

NCT ID: NCT02632175 Active, not recruiting - Ulcerative Colitis Clinical Trials

Long-term Safety and Efficacy Study of Adalimumab in Pediatric Subjects With Ulcerative Colitis

Start date: November 26, 2015
Phase: Phase 3
Study type: Interventional

This study assesses the long-term safety and efficacy of adalimumab in pediatric subjects with ulcerative colitis.

NCT ID: NCT02631057 Completed - Atrial Fibrillation Clinical Trials

Length of Stay in NVAF Patients Hospitalized and Initiated With Dabigatran or Warfarin in Japan

Start date: September 1, 2016
Phase:
Study type: Observational

The primary objective of this study is to compare the Length of Stay from treatment of oral anticoagulant initiation to hospital discharge of patients hospitalized and subsequently treated with dabigatran or warfarin for non-valvular atrial fibrillation in a real-world Japanese clinical practice. The secondary objective of the study is to compare LoS of patients hospitalized with 1) acute ischemic stroke, and 2) due to non-valvular atrial fibrillation. Other objectives are (1) to compare the in-hospital direct and indirect-related costs between dabigatran and warfarin, and (2) to compare the rates of patients directly discharged at home after the index hospitalization between dabigatran and warfarin.