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NCT ID: NCT00918957 Completed - Cystic Fibrosis Clinical Trials

A Study of Tobramycin Inhalation Powder From a Modified Manufacturing Process Versus Placebo

EDIT
Start date: June 2009
Phase: Phase 3
Study type: Interventional

This study is designed to show how well tobramycin inhalation powder works and how safe it is when produced by a modified manufacturing process

NCT ID: NCT00915018 Completed - Breast Cancer Clinical Trials

Study Evaluating Neratinib Plus Paclitaxel VS Trastuzumab Plus Paclitaxel In ErbB-2 Positive Advanced Breast Cancer

NEFERTT
Start date: August 21, 2009
Phase: Phase 2
Study type: Interventional

This study is investigating the effects of an experimental drug (neratinib) in combination with paclitaxel versus trastuzumab in combination with paclitaxel for the treatment of women who have not received previous treatment for erbB-2-positive locally recurrent or metastatic breast cancer. The study will compare the effectiveness of each regimen in shrinking tumors and extending the lives of women with erbB-2 (HER2) positive breast cancer. The study will also compare the safety of the two regimens and as well as the quality of life of subjects receiving either regimen.

NCT ID: NCT00911170 Completed - Cancer Clinical Trials

PAVES: Pegfilgrastim Anti-vascular Endothelial Growth Factor (VEGF) Evaluation Study

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

This is a phase 3, randomized, double-blind, placebo-controlled multi-center study evaluating the efficacy of pegfilgrastim to reduce the incidence of febrile neutropenia (FN) in patients with newly diagnosed, locally-advanced or metastatic colorectal cancer receiving first-line treatment with bevacizumab and either 5-fluorouracil, Oxaliplatin, Leucovorin (FOLFOX) or 5-fluorouracil, Irinotecan, Leucovorin (FOLFIRI). This study will also investigate the effect of adding pegfilgrastim to bevacizumab and either FOLFOX or FOLFIRI by evaluating overall survival, progression-free survival, and overall response rate in each arm at regular intervals over a maximum of 60 months follow-up.

NCT ID: NCT00910871 Completed - Tuberculosis Clinical Trials

To Evaluate the Safety, Tolerability, and Efficacy of TMC207 as Part of an Individualized Multi-drug Resistant Tuberculosis (MDR-TB) Treatment Regimen in Participants With Sputum Smear-positive Pulmonary MDR-TB.

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

The purpose of this study is to evaluate the safety, tolerability and effectiveness of TMC207 in combination with an individualized background regimen (BR) of antibacterial drugs as treatment for MDR-TB

NCT ID: NCT00910091 Completed - Endometrial Cancer Clinical Trials

The Study of Oral Steroid Sulphatase Inhibitor BN83495 Versus Megestrol Acetate (MA) in Women With Advanced or Recurrent Endometrial Cancer

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

This trial will explore the safety and efficacy of BN83485 compared to Megestrol Acetate (MA) on progression free survival (PFS) in post menopausal patients with endometrial cancer.

NCT ID: NCT00909025 Completed - Solid Tumors Clinical Trials

Safety and Tolerability Study of Claudiximab in Patients With Advanced Gastroesophageal Cancer

Start date: May 2009
Phase: Phase 1
Study type: Interventional

Claudiximab is a monoclonal antibody specific for gastric and gastroesophageal adenocarcinomas. Preclinically, claudiximab was shown to inhibit tumor growth and to kill cancer cells by indirect (complement-dependent cytoxicity, antibody-dependent cellular cytotoxicity) and direct mechanisms (antiproliferative and proapoptotic effects). The aim of this phase I study is to establish safety, toxicity and maximal tolerable dose of a single infusion of claudiximab in patients suffering from relapsing, advanced gastroesophageal and gastric adenocarcinoma

NCT ID: NCT00907296 Completed - Fracture Healing Clinical Trials

Study of Romosozumab (AMG 785) in Tibial Diaphyseal Fractures Status Post Intramedullary Nailing

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

The primary objective of this study is to investigate the effect of romosozumab compared with placebo on time to radiographic healing of fresh tibial diaphyseal fractures (fractures in the midsection of the shinbone).

NCT ID: NCT00906399 Completed - Clinical trials for Relapsing Multiple Sclerosis

Efficacy and Safety Study of Peginterferon Beta-1a in Participants With Relapsing Multiple Sclerosis

ADVANCE
Start date: June 2009
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to determine the efficacy of peginterferon beta-1a in reducing the annualized relapse rate (ARR) in participants with relapsing multiple sclerosis (RMS) at 1 year. The secondary objectives of this study are to determine whether peginterferon beta-1a, at 1 year when compared with placebo, is effective in reducing the total number of new or newly enlarging T2 hyperintense lesions on brain magnetic resonance imaging (MRI) scans, reducing the proportion of participants who relapse, and slowing the progression of disability.

NCT ID: NCT00902928 Completed - Clinical trials for Venous Thromboembolism

A Study Evaluating Efficacy and Safety of YM150 Compared to Enoxaparin in Subjects Undergoing Hip Replacement Surgery

ONYX-3
Start date: April 2009
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of various doses of YM150 (the experimental drug) compared to enoxaparin in the prevention of venous thromboembolism in patients that are undergoing elective hip replacement surgery.

NCT ID: NCT00894868 Completed - Clinical trials for Congestive Heart Failure

Effect of Vildagliptin on Left Ventricular Function in Patients With Type 2 Diabetes and Congestive Heart Failure

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

This study will assess the effect of vildagliptin on left ventricular function in patients with type 2 diabetes and congestive heart failure (NYHA Class I-III). Effect on HbA1c and overall safety and tolerability will also be assessed.