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NCT ID: NCT00993473 Completed - Clinical trials for Type 1 Diabetes Mellitus

6-month Comparison of Morning Lantus Versus Neutral Protamine Hagedorn Insulin in Young Children With Type 1 Diabetes

PRESCHOOL
Start date: October 2009
Phase: Phase 3
Study type: Interventional

The primary study objective was to compare the rate of "all hypoglycemia" (composite outcome of the following hypoglycemia events: symptomatic hypoglycemia episodes, low continuous glucose monitoring system (CGMS) excursions confirmed by fingerstick blood glucose (FSBG), low FSBG readings performed at other times) between children treated with Lantus (insulin glargine) and Neutral Protamine Hagedorn (NPH) insulin. Secondary objectives were to compare insulin glargine and NPH in terms of: - rates of specific types of hypoglycemia: symptomatic, severe, nocturnal, nocturnal symptomatic, and severe nocturnal symptomatic hypoglycemia - HbA1c change from baseline to end-of-treatment, and HbA1c at end-of-treatment - percentage of patients reaching HbA1c less than 7.5% (target value) at end of treatment - average blood glucose over whole trial and at end of trial, as estimated by continuous glucose monitoring (CGM), and blood glucose variability

NCT ID: NCT00993382 Completed - Clinical trials for Ventricular Arrhythmia

Dose Ranging Study of Celivarone With Amiodarone as Calibrator for the Prevention of Implantable Cardioverter Defibrillator (ICD) Interventions or Death

ALPHEE
Start date: September 2009
Phase: Phase 2
Study type: Interventional

The Primary Objective was to assess the efficacy of celivarone for the prevention of Implantable Cardioverter Defibrillator (ICD) interventions or death. Secondary Objectives were: - To assess the tolerability and safety of the different dose regimens of celivarone in the selected population. - To document SSR149744 plasma levels during the study.

NCT ID: NCT00992186 Completed - Prostate Cancer Clinical Trials

A Study of the Safety and Efficacy of Single-agent Carlumab (an Anti-Chemokine Ligand 2 [CCL2]) in Participants With Metastatic Castrate-Resistant Prostate Cancer

Start date: September 2009
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the safety and effectiveness of the study drug carlumab in participants with metastatic castrate-resistant prostate cancer (cancer of the gland that makes fluid that aids movement of sperm).

NCT ID: NCT00989131 Completed - Clinical trials for Fallopian Tube Cancer

Study of Paclitaxel in Patients With Ovarian Cancer

Start date: February 2009
Phase: Phase 3
Study type: Interventional

RATIONALE: Paclitaxel is one of the most widely used human anticancer agents. Paclitaxel has a low degree of solubility and Cremophor EL is typically used as the solubiliser. Cremophor EL is known to cause hypersensitivity reactions that can be life-threatening. As Paclical® does not contain Cremophor EL, hypersensitivity reactions can be expected to be less. PURPOSE: To study the efficay and safety of two different formulations of paclitaxel, Paclical® and Taxol®.

NCT ID: NCT00988221 Completed - Clinical trials for Juvenile Idiopathic Arthritis

A Study of Tocilizumab in Patients With Active Polyarticular Juvenile Idiopathic Arthritis

Start date: November 2009
Phase: Phase 3
Study type: Interventional

This 3-part study evaluated the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis who have an inadequate response to, or were intolerant of methotrexate. In Part I of the study, all patients received intravenous (iv) infusions of tocilizumab (8 mg/kg for patients ≥ 30kg, 8 mg/kg or 10 mg/kg for patients < 30kg) every 4 weeks for 16 weeks. In Part II of the study, patients with an adequate response in Part I were randomized to receive either tocilizumab at the same dose as in Part I or placebo every 4 weeks for up to 24 weeks. In Part III of the study, patients received tocilizumab at the same dose as in Part I every 4 weeks for up to another 64 weeks. Standard of care therapy with or without non-steroidal anti-inflammatory drugs (NSAID), corticosteroids, or methotrexate was continued throughout the study.

NCT ID: NCT00988208 Completed - Prostate Cancer Clinical Trials

Study to Evaluate Safety and Effectiveness of Lenalidomide in Combination With Docetaxel and Prednisone for Patients With Castrate-Resistant Prostate Cancer

Mainsail
Start date: November 11, 2009
Phase: Phase 3
Study type: Interventional

The purpose of the study is to determine whether lenalidomide is safe and effective for use in combination with docetaxel and prednisone for the treatment of subjects with metastatic Castrate-Resistant Prostate Cancer. The addition of lenalidomide to docetaxel and prednisone is proposed to increase the life expectancy of these subjects.

NCT ID: NCT00988156 Completed - Clinical trials for Partial Epilepsy in Children and Adolescents

Eslicarbazepine Acetate (BIA 2 093) as Therapy for Refractory Partial Seizures in Children

Start date: December 7, 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study is to examine the efficacy and safety of Eslicarbazepine acetate (BIA 2-093) when given with other anti-epileptic drugs to treat children with partial seizures whose condition has not been controlled by other drug treatments.

NCT ID: NCT00987792 Completed - Pneumonia Clinical Trials

CAPRIVI: Community Acquired Pneumonia: Treatment With Avelox® in Hospitalized Patients

Start date: September 2009
Phase: N/A
Study type: Observational

The aim of this study is to obtain data from hospitalized Community Acquired Pneumonia (CAP) patients on the disease including disease severity, clinical signs and symptoms and measures used for diagnosis in daily routine practice as well as data on Avelox® including information on the use, effectiveness, treatment outcome, safety and tolerability. As this is a non-interventional observational study, routine clinical practice is observed. The application of medications follows the normal routines and is decided by the treating physician under recognition of the package insert.

NCT ID: NCT00986154 Completed - Clinical trials for Venous Thromboembolism

Comparative Investigation of Low Molecular Weight (LMW) Heparin/Edoxaban Tosylate (DU176b) Versus (LMW) Heparin/Warfarin in the Treatment of Symptomatic Deep-Vein Blood Clots and/or Lung Blood Clots. (The Edoxaban Hokusai-VTE Study).

Start date: October 2009
Phase: Phase 3
Study type: Interventional

Evaluation of heparin/edoxaban tosylate (DU176b) versus heparin/warfarin in preventing recurrence of blood clots in patients with acute symptomatic deep-vein blood clots in the legs and/or blood clots in the lungs.

NCT ID: NCT00985504 Completed - Clinical trials for Major Depressive Disorder

A Study of Patients With Major Depressive Disorder and Residual Apathy

Start date: September 2009
Phase: Phase 4
Study type: Interventional

The purpose of this study is to provide a comparison of the apathy, depression, and functional outcomes associated with switching to duloxetine or escitalopram in patients who have previously responded to treatment with a selective serotonin reuptake inhibitor (SSRI) for major depressive disorder and who have residual apathy in the absence of depressed mood.