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NCT ID: NCT00545571 Completed - Anemia Clinical Trials

MIRACLE Study: A Study Of Once-Monthly Intravenous Mircera in Hemodialysis Patients With Chronic Renal Anemia.

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

This single arm study will assess the long-term maintenance of hemoglobin levels, safety and tolerability of once-monthly intravenous administration of Mircera in hemodialysis patients with chronic renal anemia. Patients currently receiving darbepoetin alfa, epoetin alfa or epoetin beta maintenance treatment will receive intravenous Mircera at a starting dose of 120 or 200 micrograms/month (based on the ESA dose administered on week -1). Subsequent doses will be adjusted to maintain hemoglobin levels within the country-specific target range (11-13g/dL for Switzerland and 10-12g/dL for Austria). The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.

NCT ID: NCT00545129 Completed - Neoplasm Metastasis Clinical Trials

A Study Of Tanezumab as Add-On Therapy to Opioid Medication In Patients With Pain Due To Cancer That Has Spread To Bone

Start date: April 29, 2009
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate the safety and efficacy of tanezumab in combination with opioids in treating pain due to cancer that has spread to bone.

NCT ID: NCT00544895 Completed - Clinical trials for Brain Damage, Chronic

Neonatal Estimation Of Brain Damage Risk And Identification of Neuroprotectants

NEOBRAIN
Start date: October 2007
Phase: N/A
Study type: Observational

NEOBRAIN brings together small and medium sized enterprises (SMEs), industry and academic groups devoted to the diagnosis, management, and neuroprotection in newborns with perinatal brain damage. The focus of NEOBRAIN is to identify strategies prevention of brain damage mainly observed in preterm newborns. (Copy from www.neobrain.eu)

NCT ID: NCT00544037 Completed - Multiple Sclerosis Clinical Trials

BENEFIT Extension Study

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

To assess the long-term effects of early therapeutic intervention, i.e. within two years following a first clinical demyelinating event suggestive of MS.

NCT ID: NCT00543439 Completed - Hemophilia A Clinical Trials

Study Evaluating Prophylaxis Treatment & Characterizing Efficacy, Safety, & PK Of B-Domain Deleted Recombinant FVIII

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

The purpose of this research study is to determine the effectiveness, safety, and pharmacokinetics (PK) of moroctocog alfa (AF-CC) in previously treated subjects, who are younger than 6 years of age, with severe or moderately severe hemophilia A.

NCT ID: NCT00542815 Completed - Clinical trials for Chronic Kidney Disease

A Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia

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

This is a PIII multi-center, open-label, flexible dose, long-term safety study, that in conjunction with the E07(NCT00416520), E08(NCT00542386) and E09(NCT00451295) studies will allow exposure to MCI-196 for up to 52 weeks

NCT ID: NCT00542308 Completed - Clinical trials for Head and Neck Cancer

Zalutumumab in Non-curable Patients With SCCHN

Start date: January 2008
Phase: Phase 2
Study type: Interventional

Treatment, In combination with BSC, Open-label, Single arm, Efficacy Study.

NCT ID: NCT00540449 Completed - HIV Infections Clinical Trials

TMC278-TiDP6-C209: A Clinical Trial in Treatment Naive HIV-1 Patients Comparing TMC278 to Efavirenz in Combination With Tenofovir + Emtricitabine.

Start date: May 2008
Phase: Phase 3
Study type: Interventional

The purpose of this trial is to compare the effectiveness, safety and tolerability of TMC278 given at a dose of 25 mg once daily versus efavirenz (EFV) at a dose of 600 mg once daily, when combined with a fixed background regimen consisting of emtricitabine (FTC) + tenofovir disoproxil fumarate (TDF), in HIV-1 infected patients who have not yet taken any anti-HIV drugs. The following evaluations will be done: antiviral activity, immunologic changes, and viral geno-/phenotype evolution, relationship of Pharmacokinetics (PK) and PK/Pharmacodynamics, medical resource utilization and treatment adherence.

NCT ID: NCT00538785 Completed - Clinical trials for Congenital Heart Disease

A Study to Evaluate MEDI-524 In Children With Hemodynamically Significant Congenital Heart Disease

Start date: October 2005
Phase: Phase 2
Study type: Interventional

The primary goal was to describe the safety of the investigational product when given monthly to prevent serious respiratory infection among children with significant heart disease.

NCT ID: NCT00538356 Completed - Clinical trials for Congestive Heart Failure

Influence of Home Monitoring on the Clinical Status of Heart Failure Patients With an Impaired Left Ventricular Function

IN-TIME
Start date: July 2007
Phase: Phase 4
Study type: Interventional

Re-hospitalizations or deaths by worsening heart failure are often preceded by distinct trends of clinical parameters such as atrial or ventricular arrhythmia, activity, heart rate variability, or ventricular ectopy. The Home Monitoring™ capability offered by BIOTRONIK active implants has the potential to detect some of these trends early and thus to offer the possibility to intervene in time for prevention of fatal worsening of heart failure. To investigate the predictive value of Home Monitoring parameters, patients with symptomatic heart failure and reduced ejection fraction receiving an implantable cardioverter-defibrillator (ICD) or an ICD in combination with cardiac resynchronization therapy (CRT-D) will be randomized between prospective patient management by Home Monitoring analysis or standard care. The influence of Home Monitoring on the clinical status of heart failure patients will be assessed.