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NCT ID: NCT01670435 Completed - Infection Clinical Trials

Assessment of the Safety and Efficacy of Ciproxan-I.V. in Daily Clinical Practice - Analysis Results From a Post-marketing Surveillance

Start date: May 2007
Phase: N/A
Study type: Observational

This study is a post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Ciproxan intravenously as a first-line treatment for sepsis, secondary skin infections followed by superficial burn, post-surgical or post-traumatic, pneumonia, peritonitis, cholecystitis, cholangitis, anthrax. The objective of this study is to assess safety and efficacy of Ciproxan in daily clinical practice. A total of 3,000 patients are to be enrolled and assessed during the period of treatment with Ciproxan.

NCT ID: NCT01669811 Completed - Clinical trials for Refractory Reflux Esophagitis

Compare D961H 20 mg Bid and 20 mg qd in Patients With Refractory Reflux Esophagitis (Inflammation of Lower Esophagus)

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

This is a phase 3 multicentre, randomised, double-blind, parallel-group, comparative study to evaluate the efficacy of esomeprazole (D961H) 20 mg twice daily and esomeprazole (D961H) 20 mg once daily in patients (in the form of esomeprazole magnesium salt) with refractory reflux esophagitis after 8 weeks of standard Proton-pump inhibitor (PPI) therapy by assessment of presence/absence of inflammation (esophagitis) at Week 8 according to the Los Angeles (LA) classification

NCT ID: NCT01668784 Completed - Clinical trials for Advanced or Metastatic (Medically or Surgically Unresectable) Clear-cell Renal Cell Carcinoma

Study of Nivolumab (BMS-936558) vs. Everolimus in Pre-Treated Advanced or Metastatic Clear-cell Renal Cell Carcinoma (CheckMate 025)

Start date: October 9, 2012
Phase: Phase 3
Study type: Interventional

The purpose of the study is to compare the clinical benefit, as measured by duration of overall survival, of Nivolumab vs. Everolimus in subjects with advanced or metastatic clear-cell renal cell carcinoma who have received prior anti-angiogenic therapy

NCT ID: NCT01667133 Completed - Clinical trials for Chronic Myeloid Leukemia (CML)

A Study of Ponatinib in Japanese Participants With Chronic Myeloid Leukemia (CML) and Ph+ Acute Lymphoblastic Leukemia (ALL)

Start date: August 31, 2012
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of ponatinib in Japanese patients with chronic myeloid leukemia (CML) who have experienced failure of dasatinib or nilotinib or with Ph+ acute lymphoblastic leukemia (ALL) following failure of prior tyrosine kinase inhibitors (TKIs).

NCT ID: NCT01665144 Completed - Clinical trials for Secondary Progressive Multiple Sclerosis

Exploring the Efficacy and Safety of Siponimod in Patients With Secondary Progressive Multiple Sclerosis (EXPAND)

Start date: December 20, 2012
Phase: Phase 3
Study type: Interventional

Evaluate the safety and efficacy of Siponimod (BAF312) versus placebo in a variable treatment duration in patients with secondary progressive multiple sclerosis (Core Part) followed by extended treatment with open-label BAF312 to obtain data on long-term safety, tolerability and efficacy (Extension Part).

NCT ID: NCT01665053 Completed - Clinical trials for Coronary Artery Disease

The EVOLVE II Clinical Trial To Assess the SYNERGY Stent System for the Treatment of Atherosclerotic Lesion(s)

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

The purpose of this study is to assess the safety and effectiveness of the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System for the treatment of subjects with atherosclerotic lesion(s) ≤ 34 mm in length (by visual estimate) in native coronary arteries ≥2.25 mm to ≤4.0 mm in diameter (by visual estimate).

NCT ID: NCT01664078 Completed - Clinical trials for Abdominal Aortic Aneurysm

A Multicenter, Open Label, Prospective, Non-randomized Study of the InCraft® Stent Graft System in Subjects With Abdominal Aortic Aneurysms (INSPIRATION)

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

The purpose of this study is to evaluate the safety and effectiveness of InCraft® in subjects with abdominal aortic aneurysms requiring endovascular repair.

NCT ID: NCT01663896 Completed - Clinical trials for Coronary Artery Disease

Observational Study of OCT in a Patients Undergoing FFR

ILUMIEN I
Start date: December 11, 2012
Phase:
Study type: Observational

The purpose of this study is to define and evaluate optical coherence tomography (OCT) stent guidance parameters through prospective data collection in percutaneous coronary intervention (PCI) procedures of de novo lesions.

NCT ID: NCT01663727 Completed - Clinical trials for Metastatic Breast Cancer

Study To Evaluate the Efficacy and Safety Of Bevacizumab, and Associated Biomarkers, In Combination With Paclitaxel Compared With Paclitaxel Plus Placebo as First-line Treatment Of Patients With Her2-Negative Metastatic Breast Cancer

Start date: August 27, 2012
Phase: Phase 3
Study type: Interventional

This is a Phase III, randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of bevacizumab administered in combination with paclitaxel in patients with previously untreated, locally recurrent, or metastatic HER2-negative breast cancer. Patients will be randomized to one of two treatment arms: bevacizumab or placebo. All patients will be given an intravenous (IV) infusion of of paclitaxel (90 mg/m2) for 3 weeks during each 28-day cycle. bevacizumab or placebo (10 mg/kg) will be administered by IV infusion on Days 1 and 15 of each 28-day cycle. Patients will be treated until disease progression, unacceptable toxicity or death from any cause occurs.

NCT ID: NCT01663402 Completed - Clinical trials for Atherosclerotic Cardiovascular Disease

ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab

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

Primary Objective: To compare the effect of alirocumab with placebo on the occurrence of cardiovascular (CV) events (composite endpoint of coronary heart disease (CHD) death, non-fatal myocardial infarction (MI), fatal and non-fatal ischemic stroke, unstable angina (UA) requiring hospitalization) in participants who experienced an acute coronary syndrome (ACS) event 4 to 52 weeks prior to randomization and were treated with evidence-based medical and dietary management of dyslipidemia. Secondary Objectives: - To evaluate the effect of alirocumab on secondary endpoints (any CHD event , major CHD event, any CV event, composite of all cause mortality/non-fatal MI/non-fatal ischemic stroke, CHD deaths, CV deaths, all cause mortality). - To evaluate the safety and tolerability of alirocumab. - To evaluate the effect of alirocumab on lipid parameters.