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NCT ID: NCT00598442 Completed - Anemia Clinical Trials

Safety and Efficacy of Peginesatide for the Treatment of Anemia in Participants With Chronic Renal Failure Not on Dialysis

PEARL 2
Start date: November 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study was to evaluate the safety and efficacy of peginesatide for the treatment of anemia in participants with chronic kidney disease, who are not on dialysis and not on erythropoiesis stimulating agent (ESA) treatment.

NCT ID: NCT00598273 Completed - Anemia Clinical Trials

Safety & Efficacy of Peginesatide for the Treatment of Anemia in Participants With Chronic Renal Failure Not on Dialysis

PEARL 1
Start date: October 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study was to evaluate the safety and efficacy of peginesatide for the treatment of anemia in participants with chronic kidney disease, who are not on dialysis and not on erythropoiesis stimulating agent (ESA) treatment.

NCT ID: NCT00591253 Completed - Hypertension Clinical Trials

Efficacy and Safety of Azilsartan Medoxomil in African American Participants With Essential Hypertension

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

The purpose of this study is to evaluate the effectiveness and safety of azilsartan medoxomil compared to placebo, once daily (QD), in African-American participants with essential hypertension.

NCT ID: NCT00572559 Completed - Clinical trials for Pneumonia, Ventilator-Associated

Microbiologic Response With Linezolid And Vancomycin In Ventilator-Associated Pneumonia Due To Methicillin Resistant Staphylococcus Aureus

Start date: November 2002
Phase: Phase 4
Study type: Interventional

Ventilator-associated pneumonia (VAP) is a commonplace complication of intensive care patients ventilated for longer than 48 hours. Methicillin-resistant Staphylococcus aureus (MRSA) is the cause of late onset VAP in up to about 30% of cases in US hospitals. Ineffective treatment of MRSA VAP clearly leads to prolonged mechanical ventilation and is probably associated with higher mortality. The purpose of this protocol is to directly compare linezolid and vancomycin specifically for MRSA VAP.

NCT ID: NCT00567567 Completed - Clinical trials for Recurrent Neuroblastoma

Comparing Two Different Myeloablation Therapies in Treating Young Patients Who Are Undergoing a Stem Cell Transplant for High-Risk Neuroblastoma

Start date: November 5, 2007
Phase: Phase 3
Study type: Interventional

This randomized phase III trial compares two different high-dose chemotherapy regimens followed by a stem cell transplant in treating younger patients with high-risk neuroblastoma. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments before a peripheral blood stem cell transplant helps kill any tumor cells that are in the body and helps make room in the patient?s bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. High-dose chemotherapy and radiation therapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the high- chemotherapy. It is not yet known which regimen of high-dose chemotherapy is more effective for patients with high-risk neuroblastoma undergoing a peripheral blood stem cell transplant.

NCT ID: NCT00561925 Completed - HIV Infections Clinical Trials

VERxVE Study on Efficacy and Safety of Nevirapine XR in Comparison to Nevirapine IR With Truvada in Naive HIV+ Patients

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

The primary objective of this study is to evaluate the efficacy of 400 mg QD nevirapine extended release (NVP XR) formulation versus 200 mg BID nevirapine immediate release (NVP IR) in ARV therapy naïve HIV-1 infected patients after 48 weeks of treatment. Secondary objectives are to evaluate safety and pharmacokinetics of NVP XR and NVP IR.

NCT ID: NCT00561470 Completed - Clinical trials for Colorectal Neoplasms

Aflibercept Versus Placebo in Combination With Irinotecan and 5-FU in the Treatment of Patients With Metastatic Colorectal Cancer After Failure of an Oxaliplatin Based Regimen

VELOUR
Start date: November 2007
Phase: Phase 3
Study type: Interventional

The main objective of the study was to evaluate the effectiveness of aflibercept (versus placebo) in increasing the overall survival in participants with metastatic colorectal cancer treated with FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) and that have previously failed an oxaliplatin based treatment for metastatic disease. The secondary objectives were to compare progression-free survival, to evaluate overall response rate, to evaluate the safety profile, to assess immunogenicity of intravenous (IV) aflibercept, and to assess pharmacokinetics of IV aflibercept in both treatment arms.

NCT ID: NCT00560417 Completed - Clinical trials for Diabetes Mellitus, Type 2

Comparison of Two Basal Insulins for Patients With Type 2 Diabetes Taking Oral Diabetes Medicines and Exenatide

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

This study will compare insulin lispro protamine suspension (ILPS) and insulin glargine in combination with the patient's oral diabetes medications and exenatide, for their ability to control blood sugar in patients with type 2 diabetes.

NCT ID: NCT00547898 Completed - Clinical trials for HIV Associated Diarrhea

Safety and Effectiveness of 3 Doses of Crofelemer Compared to Placebo in the Treatment of HIV Associated Diarrhea

ADVENT
Start date: October 2007
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind, parallel-group, placebo-controlled, multi-center study. This study will compare an investigational new drug (crofelemer) to placebo for the control of HIV-associated diarrhea. The first stage of the study will determine the optimal dose of study drug based on safety and response to therapy and the second stage will evaluate further the effectiveness of the optimal dose.

NCT ID: NCT00545233 Completed - Clinical trials for Hepatitis C, Chronic

A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus COPEGUS (Ribavirin) With or Without Pioglitazone in Treatment-Naive Patients With Chronic Hepatitis C and Insulin Resistance.

Start date: January 2008
Phase: Phase 4
Study type: Interventional

This 2 arm study will assess the efficacy and safety of PEGASYS plus COPEGUS, with or without concomitant pioglitazone, on hepatitis C virus titers in treatment-naive patients with genotype 1 chronic hepatitis C, and insulin resistance. Patients will be randomized to receive either a)PEGASYS 180 micrograms/week + Copegus 1000-1600 mg/day (according to body weight) for 48 weeks or b)16 weeks of pioglitazone (30 mg daily for 8 weeks, then 45 mg daily for 8 weeks), followed by PEGASYS 180 micrograms/week + Copegus 1000-1600 mg/day + pioglitazone 45 mg daily for 48 weeks. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.