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NCT ID: NCT00403767 Completed - Stroke Clinical Trials

An Efficacy and Safety Study of Rivaroxaban With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Patients With Non-Valvular Atrial Fibrillation

Start date: December 2006
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy and safety of rivaroxaban with warfarin for the prevention of blood clots in the brain (referred to as stroke) and blood clots in other parts of the body referred to as non-central nervous system systemic embolism) in patients with non-valvular atrial fibrillation (a heart rhythm disorder).

NCT ID: NCT00402727 Completed - Diabetic Foot Clinical Trials

Comparison of Sequential IV/PO Moxifloxacin With IV Piperacillin/Tazobactam Followed by PO Amoxicillin/Clavulanic Acid in Patients With a Complicated Skin and Skin Structure Infection

Start date: September 2006
Phase: Phase 3
Study type: Interventional

Patients, who are considered suitable by their physicians to take part in this research, will have a physical examination (including an Electrocardiogram (ECG)), blood and urine samples taken, as well as a sample of the secretions or tissue around their infection site. In addition, the site of the infection will be photographed. The patients will be randomly assigned one of the treatments: intravenous (IV)/per oral (PO) moxifloxacin (drug under evaluation) or IV piperacillin/tazobactam followed by PO amoxicillin/clavulanic acid (i.e., one of the reference treatments for this kind of infection). The maximum treatment duration will be 21 days, and the minimum will be 7 days. During the hospitalization, the patients will have a physical examination every day. On Day 3-5 during therapy as well as at the end of treatment, the patients will have repeated examinations. These tests and evaluations will be repeated 14 to 28 days after the end of treatment. During this visit, blood and urine samples will be taken only if judged necessary by the physicians.

NCT ID: NCT00401973 Completed - Schizophrenia Clinical Trials

Assessment of Safety and Efficacy of Therapy for the Prevention of Weight Gain Associated With Olanzapine

Start date: November 2006
Phase: Phase 3
Study type: Interventional

The goal of this study is to answer the following questions: - Whether treatment with amantadine, metformin or zonisamide can prevent or reverse the weight gain that is associated with olanzapine - Whether taking amantadine, metformin or zonisamide can help patients decrease or eliminate some of the changes in body that occur with weight gain - How weight gain associated with olanzapine can affect people - Whether treatment with amantadine, metformin or zonisamide can help eliminate weight gain associated with olanzapine and not interfere with the positive effects of olanzapine on functioning of people with schizophrenia and other diseases

NCT ID: NCT00401843 Completed - Multiple Myeloma Clinical Trials

A Study of the Safety and Efficacy of CNTO 328 and Bortezomib to Bortezomib Alone in Patients With Relapsed or Refractory Multiple Myeloma

Start date: November 28, 2006
Phase: Phase 2
Study type: Interventional

The purpose of Part 1 of the study is to determine the safety of the combination of Siltuximab (CNTO 328) and bortezomib (Velcade). The purpose of Part 2 of the study is to compare the length of progression free survival for those patients given CNTO 328 and bortezomib to those patients given bortezomib alone.

NCT ID: NCT00401323 Completed - Neoplasm Metastasis Clinical Trials

Taxotere (Docetaxel) in 1st Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Start date: January 1998
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of the study is to compare time to progression and overall survival after treatment with Taxotere plus cisplatin versus cisplatin plus 5-FU (PF treatment group) in the first line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck.

NCT ID: NCT00400478 Completed - Clinical trials for Diffuse Large B-Cell Lymphoma (DLBCL)

A Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment Versus Observation in Patients With Aggressive B-cell Lymphoma: NHL-13

Start date: January 2006
Phase: Phase 3
Study type: Interventional

This is a randomized, open label, phase III study to evaluate the ability of rituximab maintenance therapy to prolong event-free survival in aggressive NHL. Patients will be screened after successful standard induction therapy (CR or Cru following standard R-CHOP-like therapy with 8 infusions of rituximab plus CHOP-like chemotherapy (4-8 cycles). Patients will be followed until an event occurs as defined in the protocol. To evaluate the clinical efficacy of rituximab maintenance therapy as compared to observation in patients with aggressive B-cell Non-Hodgkins lymphoma or follicular lymphoma grade 3b who have achieved a complete remission after appropriate first-line therapy, measured by event-free survival (EFS), 440 patients with DLCBL or follicular NHL grade 3 (220 per arm) will be recruited.

NCT ID: NCT00400153 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Respimat® Combivent Trial in Chronic Obstructive Pulmonary Disease (COPD)

Start date: November 2006
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to compare the effect of ipratropium bromide/salbutamol inhalation spray combination administered by the Respimat® inhaler (20 mcg/100 mcg), ipratropium bromide inhalation spray administered by the Respimat® inhaler (20 mcg), and COMBIVENT® MDI administered q.i.d on FEV1 at intervals over a treatment period of 12 weeks in patients with COPD. Specifically, non-inferiority of Combivent Respimat® to COMBIVENT® MDI in FEV1 AUC from 0 to 6 hours , superiority of Combivent Respimat® to Atrovent Respimat® monotherapy in FEV1 AUC from 0 to 4 hours, and non-inferiority of Combivent Respimat® to Atrovent Respimat® monotherapy in FEV1 AUC from 4 to 6 hours will be analyzed. In addition, steady state pharmacokinetics over one dosing interval following 4 weeks of therapy will be characterized in a subgroup of patients.

NCT ID: NCT00398645 Completed - Asthma Clinical Trials

A Randomized Study To Evaluate The Efficacy And Safety Of An Investigational Drug In Adolescent And Adult Subjects With Persistent Asthma.

Start date: November 15, 2006
Phase: Phase 2
Study type: Interventional

This study is designed to determine if the investigational drug is effective and safe in individuals with asthma.

NCT ID: NCT00398216 Completed - Thrombosis Clinical Trials

A Study of DU-176b in Preventing Blood Clots After Hip Replacement Surgery

Start date: May 2006
Phase: Phase 2
Study type: Interventional

This study is to assess if DU176b is effective in prevention of blood clots following hip replacement surgery. The duration is 7-10 days of treatment and 30 and 60 day follow-up visits.

NCT ID: NCT00397553 Completed - Clinical trials for Diabetes Mellitus, Type 1

Insulin Glulisine, Diabetes Mellitus Type 1

Start date: January 2005
Phase: Phase 3
Study type: Interventional

To provide local data on efficacy and safety of insulin glulisine in patients with Type 1 Diabetes Mellitus receiving insulin glargine as basic insulin therapy