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NCT ID: NCT00719394 Completed - Healthy Clinical Trials

Study Evaluating Safety of GSI 136 in Young and Elderly Japanese Males

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

This is a first-in-human study of GSI-136, a gamma-secretase inhibitor being developed for the treatment of Alzheimer disease. This study will take place in Japan only and will provide an initial assessment of the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of GSI-136 after administration of ascending single oral doses to healthy Japanese male subjects and healthy Japanese elderly male subjects.

NCT ID: NCT00718926 Not yet recruiting - Dry Eye Disease Clinical Trials

The Evaluation of Thiol Redox Status in Conjunctiva of Dry Eye Patients

Start date: August 2008
Phase: N/A
Study type: Observational

Dry eye disease is related with oxidative stress at the ocular surface. GSH is one of the key factor of protect from oxidative stress. To evaluate thiol status of ocular surface cells by monitoring GSH concentration, we can evaluate the severity of dry eye.

NCT ID: NCT00718718 Completed - Clinical trials for Arthritis, Rheumatoid

A Study of Effectiveness and Safety of CNTO 136 in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy

Start date: August 11, 2008
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the effectiveness and safety of subcutaneous (under the skin) administration of anti-interleukin-6 monoclonal antibody (CNTO 136) in reducing signs and symptoms of participants with active rheumatoid arthritis (RA) with methotrexate (MTX) therapy.

NCT ID: NCT00718562 Completed - Clinical trials for Gastrointestinal Stromal Tumors

Efficacy and Safety of AMN107 in Patients With GastroIntestinal Stromal Tumors (GIST) Who Have Failed Both Imatinib and Sunitinib

Start date: September 2008
Phase: Phase 2
Study type: Interventional

This study will evaluate the efficacy and safety of nilotinib in gastrointestinal stromal tumors patients who failed imatinib and sunitinib therapy.

NCT ID: NCT00718263 Active, not recruiting - Clinical trials for Myelogenous Leukemia, Chronic

Efficacy and Safety of Nilotinib Patients With Newly Diagnosed CML - CP (Chronic Myelogenous Leukemia - Chronic Phase)

PHCHBS-WD4070
Start date: April 2008
Phase: Phase 3
Study type: Interventional

This study will evaluate the safety and tolerability of nilotinib after failure of imatinib therapy or imatinib therapy after nilotinib failure.

NCT ID: NCT00716846 Completed - Healthy Volunteers Clinical Trials

Effects of Statins on the Pharmacokinetics for Midazolam in Healthy Volunteers

H-17-21
Start date: June 2006
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate whether statins have any influence on cytochrome P450 (CYP) 3A4 enzyme activity using a probe drug midazolam.

NCT ID: NCT00716248 Active, not recruiting - Clinical trials for Rheumatoid Arthritis

Bucillamine Study of Holding Remission After Infliximab Dose-off

Start date: January 2007
Phase: Phase 4
Study type: Interventional

Patients with rheumatoid arthritis who have been well controlled with methotrexate plus infliximab may remain in remission or low disease activity without infliximab. And the chance of sustained remission increase by the addition of another DMARD, bucillamine, at the time of discontinuing infliximab. The BuSHIDO trial is the prospective, randomized, controlled study comparing MTX monotherapy and MTX plus bucillamine combination therapy as to the rate of disease flare after discontinuing infliximab.

NCT ID: NCT00713830 Completed - Clinical trials for Diabetes Mellitus, Type 2

GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Sulfonylurea

GETGOAL-S
Start date: July 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to sulfonylurea without or with metformin, over a period of 24 weeks of treatment, followed by an extension. The primary objective is to assess the effects of lixisenatide when added to sulfonylurea with or without metformin on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24. The secondary objectives are to assess the effects of lixisenatide on percentage of patients reaching HbA1c less than (<) 7 percent (%); percentage of patients reaching HbA1c less than or equal to (<=) 6.5%; body weight; fasting plasma glucose (FPG); beta-cell function assessed by homeostasis model assessment (HOMA) beta; 2-hour postprandial plasma glucose (PPG), glucagon, insulin, proinsulin, and C-peptide after a standardized meal challenge test in a sub-study in all patients in selected centers; to evaluate safety, tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody development.

NCT ID: NCT00711919 Active, not recruiting - Hyperlipidemia Clinical Trials

Pitavastatin on Carotid Intima-media Thickness

PEACE
Start date: July 2007
Phase: N/A
Study type: Interventional

This study is aimed to analyze the effects of aggressive and conventional lipid lowering therapy with Pravastatin on carotid intima-media thickness (IMT) in patients with hyperlipidemia and abnormal thickening of IMT.

NCT ID: NCT00711776 Completed - Herpes Labialis Clinical Trials

Bioequivalence Study of Aciclovir 5% Cream in Japanese Healthy Volunteers

Start date: April 10, 2008
Phase: Phase 1
Study type: Interventional

This study is designed to show bioequivalence between Current and New formulation of Aciclovir cream 5% in keratin layer of the epidermis in Japanese Subjects