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NCT ID: NCT00387764 Completed - Clinical trials for Carcinoma, Renal Cell

Extension Study to VEG105192 to Assess Pazopanib in Patients With Advanced/Metastatic Renal Cell Cancer

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

This is an open-label, international, multi-center study designed to provide access to pazopanib for subjects who have been enrolled in the Phase III renal cell carcinoma study (VEG105192) and have progressed on placebo. Subjects will receive 800 mg pazopanib once daily. The study treatment will continue until subjects experience disease progression, unacceptable toxicity, withdrawal of consent, or death. The primary objective of the study is to evaluate the safety and tolerability of pazopanib for the treatment of renal cell carcinoma. The secondary objectives of the study are to assess response rate (defined as complete response or partial response), progression-free survival, and overall survival. Response rates will be collected per investigator assessment (no central review). Subjects will have a CT/MRI scan every 6 weeks until week 24 and every 12 weeks thereafter.

NCT ID: NCT00385697 Completed - Clinical trials for Type 1 Diabetes Mellitus

The Protégé Study - Clinical Trial of MGA031 in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus

Start date: October 2006
Phase: Phase 2/Phase 3
Study type: Interventional

The primary purpose of this protocol is to assess the efficacy, tolerability, and safety of MGA031 when administered according to 3 different MGA031 dosing regimens in children and adults with recent-onset (diagnosis within past 12 weeks) type 1 diabetes mellitus. All regimens will be administered as an addition to insulin and other standard of care treatments. Efficacy will be defined primarily by the capacity of MGA031 to markedly reduce typical insulin requirements while maintaining relatively normal blood sugar levels. Other studies involving the study drug use the name hOKT3γ1 (Ala-Ala). MGA031, a humanized monoclonal antibody, is the name used for hOKT3γ1 (Ala-Ala) that is produced by MacroGenics, Inc. The United States Adopted Name (USAN) for MGA031 is teplizumab.

NCT ID: NCT00384176 Completed - Colorectal Cancer Clinical Trials

First Line Metastatic Colorectal Cancer Therapy in Combination With FOLFOX

HORIZON III
Start date: August 30, 2006
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to see if Cediranib in combination with FOLFOX is effective in treating metastatic colorectal cancer and to see how it compares with Avastin (Bevacizumab) in combination with FOLFOX.

NCT ID: NCT00379769 Completed - Clinical trials for Diabetes Mellitus, Type 2

RECORD: Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes

RECORD
Start date: April 2001
Phase: Phase 3
Study type: Interventional

This study is a phase 3b, multicentre, randomised, open label, parallel group study. A 4-week run-in period will be followed by a median of 6 years of treatment with study medication in addition to continuation of background glucose lowering therapy. Patients inadequately controlled on background metformin will be randomised to receive, in addition to metformin, either rosiglitazone or a sulfonylurea(glibenclamide, gliclazide or glimepiride) in a ratio of 1:1. Patients inadequately controlled on background SU will be randomised to receive, in addition to SU, either rosiglitazone or metformin in a ratio of 1:1. Equal numbers of patients receiving background metformin and SU at entry will be entered into the study.

NCT ID: NCT00376116 Completed - Clinical trials for Heart Failure, Congestive

Home Monitoring in Cardiac Resynchronisation Therapy

HomeCARE
Start date: March 2005
Phase: N/A
Study type: Observational

In spite of success in the management of heart failure, repetitive rehospitalisation and high mortality rate remain a serious problem. Recent studies, especially the COMPANION trial, have demonstrated that cardiac resynchronisation therapy (CRT) reduces mortality and rehospitalisation in heart failure patients. There is also evidence that telemonitoring of heart failure patients potentially reduces both mortality and morbidity. Recently, a Home Monitoring (HM) function has been integrated into BIOTRONIK CRT-defibrillators and CRT-pacemakers with a view of harnessing the powerful combination of CRT with close remote monitoring of heart failure patients. It is possible now to transmit predefined parameters on a daily basis from the implanted devices to a web-based platform accessible by patients' physicians. Our study evaluates clinical usefulness of Biotronik HM function in CRT-defibrillators and CRT-pacemakers.

NCT ID: NCT00374322 Completed - Neoplasms, Breast Clinical Trials

Tykerb Evaluation After Chemotherapy (TEACH): Lapatinib Versus Placebo In Women With Early-Stage Breast Cancer

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

This study was designed to evaluate and compare the safety and efficacy of an oral dual tyrosine kinase inhibitor, lapatinib, versus placebo in women with early-stage ErbB2-overexpressing breast cancer who have completed their primary neoadjuvant or adjuvant chemotherapy and have no clinical or radiographic evidence of disease.

NCT ID: NCT00368472 Completed - Epilepsy Clinical Trials

4-Year Open-Label Extension Phase of the Parallel-Group Study of E2007 in Patients With Refractory Partial Seizures

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

The purpose of this study is to determine the safety of perampanel given as adjunctive, long-term treatment in patients with refractory partial onset seizures.

NCT ID: NCT00366834 Completed - Nausea Clinical Trials

Intravenous And Oral Casopitant (GW679769) For The Prevention Of Chemotherapy Induced Nausea And Vomiting

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

This is a Phase III trial designed to demonstrate that casopitant (GW679769) plus dexamethasone and ondansetron is more effective in the prevention of vomiting than dexamethasone and ondansetron alone following the administration of moderately emetogenic chemotherapy.

NCT ID: NCT00366379 Completed - Clinical trials for Diabetes Mellitus Type 2

A Dose-Titration Study of GK Activator (2) in Patients With Type 2 Diabetes.

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

This study will assess the efficacy, safety and tolerability of increasing doses of GK Activator (2) in patients with type 2 diabetes whose condition has not been optimally controlled with one previous oral antihyperglycemic agent. After a 2 week washout from their previous antidiabetic therapy, patients will receive GK Activator (2) orally, twice a day for 12 weeks, at increasing doses of 25mg bid to 200mg bid; doses will be titrated to achieve a target fasting glucose level (FPG) of <100mg/dL. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.

NCT ID: NCT00366249 Completed - Diabetic Foot Clinical Trials

Study Evaluating the Safety and Efficacy of a Once-daily Dose of Tigecycline vs Ertapenem in Diabetic Foot Infections (DFI) With a Substudy in Patients With Diabetic Foot Infections Complicated by Osteomyelitis.

Start date: January 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study was to look at the safety and effectiveness of a once-daily dose of tigecycline compared to ertapenem for the treatment of diabetic foot infections. The co-primary efficacy endpoints were not met.