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NCT ID: NCT00400478 Completed - Clinical trials for Diffuse Large B-Cell Lymphoma (DLBCL)

A Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment Versus Observation in Patients With Aggressive B-cell Lymphoma: NHL-13

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

This is a randomized, open label, phase III study to evaluate the ability of rituximab maintenance therapy to prolong event-free survival in aggressive NHL. Patients will be screened after successful standard induction therapy (CR or Cru following standard R-CHOP-like therapy with 8 infusions of rituximab plus CHOP-like chemotherapy (4-8 cycles). Patients will be followed until an event occurs as defined in the protocol. To evaluate the clinical efficacy of rituximab maintenance therapy as compared to observation in patients with aggressive B-cell Non-Hodgkins lymphoma or follicular lymphoma grade 3b who have achieved a complete remission after appropriate first-line therapy, measured by event-free survival (EFS), 440 patients with DLCBL or follicular NHL grade 3 (220 per arm) will be recruited.

NCT ID: NCT00397527 Completed - Hygiene Clinical Trials

Acceptability Dermacyd Wipes - Lactoserum - Hygiene

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

The purpose of this study is to demonstrate the safety of the gynecological formulation in normal and usual usage condition of Dermacyd Wipes

NCT ID: NCT00396877 Completed - Clinical trials for Heart Defects, Congenital

Efficacy And Safety Of Clopidogrel In Neonates /Infants With Systemic To Pulmonary Artery Shunt Palliation

CLARINET
Start date: November 2006
Phase: Phase 3
Study type: Interventional

Contemporary management of cyanotic congenital heart disease includes three stages of surgery. Incidence of shunt thrombosis and death between the two first stages of palliation remains important. The primary objective of the study is to evaluate the efficacy of Clopidogrel 0.2 mg/kg/day for the reduction of all cause mortality and shunt related morbidity in neonates or infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary artery shunt (e.g. modified Blalock Taussig Shunt [BTS]). The secondary objective was to assess the safety of Clopidogrel in the study population.

NCT ID: NCT00396084 Completed - Tuberculosis Clinical Trials

Early Bactericidal Activity of Linezolid, Gatifloxacin, Levofloxacin, Isoniazid (INH) and Moxifloxacin in HIV Negative Adults With Initial Episodes of Sputum Smear-Positive Pulmonary Tuberculosis

Start date: February 10, 2004
Phase: Phase 1/Phase 2
Study type: Interventional

This study will evaluate the ability of 4 antibiotics to kill the bacteria that cause tuberculosis (TB). The antibiotics to be studied are linezolid, gatifloxacin, levofloxacin, and moxifloxacin. All are approved by the Brazilian health authorities to treat infections caused by germs other than TB. Seventy human immunodeficiency virus (HIV)-negative adults, aged 18-65 years, who have been newly diagnosed with pulmonary (lung) TB, will participate in this study. Study volunteers will be given one of the 4 study drugs or a comparison antibiotic, Isoniazid, which has been used around the world as a standard of care treatment for TB. Volunteers will stay in the hospital for 10 days and be given a study antibiotic 7 of those days. Blood and saliva samples will be taken. Six weeks later, volunteers will return for a final health check. All volunteers will receive 6 months of standard tuberculosis treatment.

NCT ID: NCT00395772 Completed - Clinical trials for Venous Thromboembolism

Once-daily Oral Direct Factor Xa Inhibitor BAY59-7939 in Patients With Acute Symptomatic Deep-vein Thrombosis

Start date: December 2004
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the optimal dose of BAY 59-7939 and to compare the safety and effectiveness of this new drug with the standard way of treatment of deep vein thrombosis (heparin infusion plus one of the vitamin K antagonists), taking into account new events of thrombosis and pulmonary embolism and bleeding risk.

NCT ID: NCT00395512 Completed - Diabetes Mellitus Clinical Trials

Efficacy of Alogliptin With Pioglitazone (Actos®) in Subjects With Type 2 Diabetes Mellitus

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

The purpose of this study is to evaluate the combination of alogliptin, once daily (QD), and pioglitazone in patients with type 2 diabetes mellitus who are inadequately controlled with diet and exercise alone.

NCT ID: NCT00395070 Completed - Metastatic Melanoma Clinical Trials

A Phase 3 Pivotal Trial Comparing Allovectin-7® Alone vs Chemotherapy Alone in Patients With Stage 3 or Stage 4 Melanoma

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

To compare the safety and efficacy of Allovectin-7® versus Dacarbazine (DTIC)or Temozolomide (TMZ) in subjects with recurrent stage 3 or stage 4 melanoma.

NCT ID: NCT00395018 Completed - Clinical trials for Hepatitis B, Chronic

Antiviral Activity of Entecavir in Patients Receiving Liver Transplant Due to Chronic Hepatitis B Virus Infection

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

The purpose of this clinical research study is to learn if the study drug entecavir will prevent the recurrence of hepatitis B virus (HBV) in participants who receive an orthotopic liver transplant (OLT) due to HBV infection.

NCT ID: NCT00394394 Completed - Hypertension Clinical Trials

Antihypertensive Effectiveness of the Associations of Hydrochlorothiazide and Amiloride and Hydrochlorothiazide and Enalapril

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

The majority of hypertensive patients require antihypertensive associations to control their blood pressure. Most of clinical trials don’t compare different associations using Hydrochlorothiazide 25 mg as the standard initial therapy and compare the associations using doses that are not equivalent. This randomized trial where patients and investigators are blinded and compares the effectiveness two associations: Hydrochlorothiazide and Amiloride and Hydrochlorothiazide and Enalapril.

NCT ID: NCT00394277 Completed - Clinical trials for Hepatitis C, Chronic

A Study of Induction Dosing With PEGASYS (Peginterferon Alfa-2a [40KD]) Plus Copegus in Treatment-Naive Patients With Chronic Hepatitis C

Start date: February 2007
Phase: Phase 4
Study type: Interventional

This 4-arm study will compare the efficacy and safety of PEGASYS induction and maintenance dosing, versus standard fixed dosing in combination with Copegus, and the efficacy and safety of higher dose versus standard dose Copegus in combination with PEGASYS. Patients with chronic hepatitis C (CHC) genotype 1 infection of high viral titer, and baseline body weight ≥85 kg, will be randomized to one of 4 groups, to receive one of the following: a) PEGASYS 180 µg subcutaneously (sc) weekly plus Copegus 1200 mg orally (po) daily; b) PEGASYS 180 µg sc weekly plus Copegus 1400-1600 mg po daily; c)PEGASYS 360 µg sc weekly (induction) followed by 180 µg sc weekly (maintenance) plus Copegus 1200 mg po daily; or d) PEGASYS 360 µg sc weekly (induction) followed by 180 µg sc weekly (maintenance) plus Copegus 1400-1600 mg po daily. Following 48 weeks treatment, there will be a 24-week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.