Clinical Trials Logo

Filter by:
NCT ID: NCT01649765 Active, not recruiting - Clinical trials for Systemic Lupus Erythematosus

Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy

PLUTO
Start date: September 7, 2012
Phase: Phase 2
Study type: Interventional

This is a multi-center study to evaluate the safety, pharmacokinetics, and efficacy of belimumab intravenous (IV) in pediatric patients 5 to 17 years of age with active systemic lupus erythematosus

NCT ID: NCT01649570 Completed - Clinical trials for Diabetes Mellitus, Type 2

Safety and Efficacy of Insulin Aspart in Type 2 Diabetes

Start date: March 2002
Phase: Phase 4
Study type: Interventional

This trial is conducted in Japan. The aim of this trial is to investigate the safety and efficacy of NovoRapid® (insulin aspart) as meal time insulin in subjects with type 2 diabetes treated on a basal-bolus regimen with Neutral Protamine Hagedorn (NPH) human insulin.

NCT ID: NCT01646671 Completed - Severe Hypertension Clinical Trials

Safety and Tolerability and Efficacy of LCZ696 in Japanese Severe Hypertensive Patients

Start date: July 2012
Phase: Phase 3
Study type: Interventional

This study assessed the safety, tolerability, and efficacy of LCZ696 in severe hypertensive Japanese patients

NCT ID: NCT01646398 Completed - Clinical trials for Pneumococcal Vaccines

A Phase 3 Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Japanese Elderly Adults Aged 65 Years Old and Older

Start date: June 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability and immunogenicity of a single dose of 13-valent pneumococcal conjugate vaccine compared to a single dose of 23-valent pneumococcal polysaccharide vaccine in Japanese adults aged 65 years old and older.

NCT ID: NCT01646125 Terminated - Clinical trials for Advanced Non Small Cell Lung Cancer (NSCLC)

An Open-label, Randomized Phase II Study to Evaluate the Efficacy of AUY922 vs Pemetrexed or Docetaxel in NSCLC Patients With EGFR Mutations

Start date: November 23, 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study was to determine if AUY922 had superior efficacy when compared to chemotherapy agents docetaxel or pemetrexed in patients whose tumor had EGFR mutations. The primary purpose of this study was to compare the efficacy of AUY922, when administered i.v. on a once-weekly schedule at 70 mg/m2, versus docetaxel or pemetrexed in adult patients with advanced NSCLC, whose tumors harbored EGFR activating mutations, and had developed resistance to EGFR TKI.

NCT ID: NCT01645800 Completed - COPD Clinical Trials

Effects of Lysozyme on Acute Exacerbation of Chronic Obstructive Pulmonary Disease : A Randomised Placebo-Controlled Study

Start date: August 2012
Phase: Phase 4
Study type: Interventional

The aim of this study is to assess the effectiveness in preventing exacerbation of 52 weeks lysozyme administration in patients with COPD.

NCT ID: NCT01644890 Completed - Clinical trials for Breast Cancer Nos Metastatic Recurrent

A Phase III Study of NK105 in Patients With Breast Cancer

Start date: July 2012
Phase: Phase 3
Study type: Interventional

To verify the non-inferiority of NK105, a paclitaxel-incorporating micellar nanoparticle, to paclitaxel in terms of the progression-free survival in patients with metastatic or recurrent breast cancer.

NCT ID: NCT01644604 Completed - Clinical trials for Uncontrolled Hypertension

Renal Denervation by MDT-2211 System in Patients With Uncontrolled Hypertension

HTN-J
Start date: July 2012
Phase: N/A
Study type: Interventional

The objective of this study is to demonstrate that the MDT-2211 renal denervation system is a safe and effective treatment for uncontrolled hypertension subjects despite treatment with 3 or more anti-hypertensive medications of different classes, of which one must be a diuretic, as best available antihypertensive therapy

NCT ID: NCT01642407 Completed - Clinical trials for Pulmonary Arterial Hypertension

Safety And Efficacy Of Sildenafil In Children With Pulmonary Arterial Hypertension

Start date: August 24, 2012
Phase: Phase 4
Study type: Interventional

Pulmonary arterial hypertension (PAH) is a rare, progressive, and life-threatening disease. In many patients, the course of PAH is a steady deterioration and reduced life expectancy. Sildenafil was approved by the European Commission for the treatment of PAH in pediatric patients in May 2011, making it the first agent to be approved for the treatment of children with PAH. The approval was based on the largest placebo-controlled study to be conducted in this population. The recommended dose in pediatric patients aged 1 year to 17 years old is 10 mg TID in patients ≤ 20 kg and 20 mg TID for patients > 20 kg. Higher doses are not recommended in pediatrics patients. This study is an open-label, multi-center study to investigate safety, efficacy and pharmacokinetics of sildenafil citrate in Japanese pediatric patients with PAH.

NCT ID: NCT01642108 Recruiting - Type 2 Diabetes Clinical Trials

Treatment With Sitagliptin in Non-obese Japanese Patients With Type 2 Diabetes Mellitus

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

Type 2 diabetes mellitus (T2DM) results from early phase insulin secretory defect and insulin resistance. Studies have shown that most of the populations in which insulin resistance is considered to be the primary pathogenetic cause of diabetes, have a higher degree of obesity than those of primary insulin defect. Meanwhile, defective early insulin secretion plays a predominant role in the non-obese subtype of T2DM which includes majority of Japanese patients. Sitagliptin is a dipeptidyl peptidase-4 (DPP-IV) inhibitor as indicated for the treatment of T2DM. Sitagliptin increases plasma concentrations of active glucagon-like peptide-1 (GLP-1) and active glucose-dependent insulinotropic peptide (GIP) two- to three-fold in patients with T2DM. The effect of sitagliptin on GLP-1 results in lower fasting and postprandial glucose concentrations through increases in glucose dependent insulin release and suppression of inappropriate glucagon secretion. Namely, several mechanistic studies using standardized meal showed that sitagliptin improved glucose control with decreased glucagon levels and increased insulin concentration in obese or overweight T2DM patients with BMI > 25 kg/m2. However, how sitagliptin affects islet function, including glucagon secretion in non-obese patients with low insulin secretion are not known. Therefore, the investigators will examine the effect of sitagliptin on glycemic control and the mechanism involved using a standardized test meal in non-obese Japanese patients with T2DM whose BMI levels are < 25 kg/m2.