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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: 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: 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: 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.

NCT ID: NCT02630459 Completed - Migraine Clinical Trials

A Safety and Efficacy Study to Evaluate AMG 334 in Migraine Prevention

Start date: January 6, 2016
Phase: Phase 2
Study type: Interventional

Randomized, double-blind, placebo-controlled, parallel-group, multicenter study followed by an open-label treatment phase (OLTP). To evaluate the effect of erenumab (AMG 334) compared to placebo on the change from baseline in monthly migraine days.

NCT ID: NCT02629965 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Comparing the Efficacy of Tiotropium + Olodaterol Fixed Dose Combination (FDC) Over Tiotropium in Improvement of Lung Hyperinflation, Exercise Capacity and Physical Activity in Japanese COPD Patients

Start date: February 12, 2016
Phase: Phase 3
Study type: Interventional

This is a multi-centre, randomised, double-blinded, active-controlled, 2-way cross over trial to assess the effects of once daily administration of orally inhaled tiotropium + olodaterol FDC or tiotropium (both delivered by the RESPIMAT Inhaler) on pulmonary function (lung hyperinflation), exercise capacity (6-minute walk distance) and physical activities after 6 weeks of treatment in Japanese patients with Chronic Obstructive Pulmonary Disease.

NCT ID: NCT02629861 Completed - Migraine Clinical Trials

Efficacy and Safety of 2 Dose Regimens of TEV-48125 Versus Placebo for the Preventive Treatment of Episodic Migraine

Start date: March 23, 2016
Phase: Phase 3
Study type: Interventional

The study is being conducted to evaluate two doses of TEV-48125 in adult patients with episodic migraine

NCT ID: NCT02629224 Completed - Clinical trials for Patients With Impaired Renal Function and Haemodialysis

ASP8825 - Pharmacokinetics Study in Patients With Impaired Renal Function and Haemodialysis

Start date: February 2008
Phase: Phase 1
Study type: Interventional

The objective of this study is to evaluate the pharmacokinetics and safety of ASP8825 in patients with impaired renal function and haemodialysis.