Clinical Trials Logo

Filter by:
NCT ID: NCT01666236 Withdrawn - Clinical trials for Choroidal Neovascularization

Triple Treatment for Detachment of Retinal Pigment Epithelium Secondary to Polypoidal Choroidal Vasculopathy

Start date: September 2012
Phase: Phase 4
Study type: Interventional

Study the effectiveness of the treatment detachment of retinal pigment epithelium secondary to polypoidal choroidal vasculopathy. Efficacy will be assessed by regression of polyp area after twelve months, compared to baseline. Treatment under study is a triple therapy with: 1) reduced-fluence photodynamic therapy (PDT), 2) intravitreal (IVT) triamcinolone and, 3) IVT ranibizumab, for the treatment of detachment of the retinal pigment epithelium (PED) secondary to Polypoidal Choroidal Vasculopathy (PCV).

NCT ID: NCT01665391 Completed - Clinical trials for Primary Focal Segmental Glomerulosclerosis

A Study of Fresolimumab in Patients With Steroid-Resistant Primary Focal Segmental Glomerulosclerosis (FSGS)

FSGS
Start date: August 2012
Phase: Phase 2
Study type: Interventional

The primary objectives of this trial are as follows: - to compare the achievement of a partial remission (PR) or complete remission (CR) in urinary protein: creatinine ratio (Up/c ratio) in patients treated with fresolimumab versus placebo - to compare the safety profile of patients treated with fresolimumab versus placebo The secondary objectives are as follows: - To compare the reduction in proteinuria in patients treated with fresolimumab versus placebo - To evaluate fresolimumab dose-dependent reduction in proteinuria - To compare the change in renal function (estimated glomerular filtration rate [eGFR]) in patients treated with fresolimumab versus placebo - To evaluate the multiple-dose pharmacokinetics of fresolimumab

NCT ID: NCT01664884 Recruiting - Stigma Clinical Trials

Internalized Stigma in Patients With Bipolar Disorder or Schizophrenia

ESTINT
Start date: June 2012
Phase: N/A
Study type: Observational

The aim of this study is to explore the levels of internalized stigma in a sample of young patients with bipolar disorder or schizophrenia.

NCT ID: NCT01664221 Not yet recruiting - Healthy Clinical Trials

PK and PD Parallel Study After Multiple Dose, Intravenous Administration of Two Epoetin Alfa, Eritromax and Eprex, in Healthy Subjects.

Start date: February 2013
Phase: Phase 1
Study type: Interventional

The hypothesis of this trial is that the test drug (Eritromax ®) pharmacokinetics and pharmacodynamics parameters are similar to the comparator drug (Eprex ®) in healthy subjects following administration of multiple intravenous dose. The objective of this randomized, parallel, clinical trial is to evaluate the pharmacokinetic and pharmacodynamic profile of the test drug Eritromax® marketed by Blau Farmacêutica, compared to the comparator drug Eprex®, produced by Janssen-Cilag, by assessing plasma concentration of the drug and the reticulocyte count following a multiple intravenous administration during 4 weeks of 100 IU/kg in healthy subjects.

NCT ID: NCT01664195 Not yet recruiting - Healthy Clinical Trials

PK and PD Study After Single Dose, Intravenous Administration of Two Epoetin Alfa, Eritromax and Eprex, in Healthy Subjects

Start date: February 2013
Phase: Phase 1
Study type: Interventional

The hypothesis of this trial is that the test drug (Eritromax ®) pharmacokinetics and pharmacodynamics parameters are similar to the comparator drug (Eprex ®) in healthy subjects following administration of single intravenous dose. The objective of this randomized, crossover, clinical trial is to evaluate the pharmacokinetic and pharmacodynamic profile of the drug Eritromax® marketed by Blau Farmacêutica, compared to the product Eprex ®, produced by Janssen-Cilag, by assessing plasma concentration of the drug and the reticulocyte count following a single-dose intravenous administration of 100 IU/kg in healthy subjects.

NCT ID: NCT01663805 Recruiting - Clinical trials for Delayed Function of Renal Transplant

Effects of the Use of "de Novo" Everolimus in Renal Tranplant Population

Start date: January 2012
Phase: Phase 4
Study type: Interventional

This is an open, randomized, single-center study. The selected patients will be first divided into two major groups according to the type of organ to be transplanted: standard criteria donor (SCD) or extended criteria (ECD) kidney. Then, each group will be randomly allocated to one of the treatments: tacrolimus (TAC) or everolimus (EVL). All patients received induction therapy with basiliximab (BXB) and maintenance with Mycophenolate Sodium (MYF) and prednisone (P). This study will evaluate as Primary objectives: To characterize the molecular profile of cytokines in kidneys obtained from deceased donors such as "standard" (SCD) and extended criteria (ECD) in biopsies taken before and after transplantation and to evaluate the effect of treatment with everolimus (EVL) in the expression of these molecules. And as Secondaries objectives: To correlate the pattern of cytokines with delayed graft function (DGF), cold ischemia time, episodes of acute rejection and patient and graft survival.

NCT ID: NCT01663727 Completed - Clinical trials for Metastatic Breast Cancer

Study To Evaluate the Efficacy and Safety Of Bevacizumab, and Associated Biomarkers, In Combination With Paclitaxel Compared With Paclitaxel Plus Placebo as First-line Treatment Of Patients With Her2-Negative Metastatic Breast Cancer

Start date: August 27, 2012
Phase: Phase 3
Study type: Interventional

This is a Phase III, randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of bevacizumab administered in combination with paclitaxel in patients with previously untreated, locally recurrent, or metastatic HER2-negative breast cancer. Patients will be randomized to one of two treatment arms: bevacizumab or placebo. All patients will be given an intravenous (IV) infusion of of paclitaxel (90 mg/m2) for 3 weeks during each 28-day cycle. bevacizumab or placebo (10 mg/kg) will be administered by IV infusion on Days 1 and 15 of each 28-day cycle. Patients will be treated until disease progression, unacceptable toxicity or death from any cause occurs.

NCT ID: NCT01663402 Completed - Clinical trials for Atherosclerotic Cardiovascular Disease

ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab

Start date: October 2012
Phase: Phase 3
Study type: Interventional

Primary Objective: To compare the effect of alirocumab with placebo on the occurrence of cardiovascular (CV) events (composite endpoint of coronary heart disease (CHD) death, non-fatal myocardial infarction (MI), fatal and non-fatal ischemic stroke, unstable angina (UA) requiring hospitalization) in participants who experienced an acute coronary syndrome (ACS) event 4 to 52 weeks prior to randomization and were treated with evidence-based medical and dietary management of dyslipidemia. Secondary Objectives: - To evaluate the effect of alirocumab on secondary endpoints (any CHD event , major CHD event, any CV event, composite of all cause mortality/non-fatal MI/non-fatal ischemic stroke, CHD deaths, CV deaths, all cause mortality). - To evaluate the safety and tolerability of alirocumab. - To evaluate the effect of alirocumab on lipid parameters.

NCT ID: NCT01662518 Completed - Macular Edema Clinical Trials

DDS-25 Gauge in Patients With Macular Edema Secondary to Retinal Vein Occlusion (RVO)

DDS-25
Start date: July 2011
Phase: Phase 1/Phase 2
Study type: Interventional

This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone (DDS-25) for the treatment of macular edema associated with retinal vein occlusion.

NCT ID: NCT01661634 Completed - Clinical trials for Acute Decompensated Heart Failure

Efficacy and Safety of Ularitide for the Treatment of Acute Decompensated Heart Failure

TRUE-AHF
Start date: July 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of a continuous intravenous (IV) ularitide infusion on the clinical status and outcome of patients with acute decompensated heart failure (ADHF).