Clinical Trials Logo

Filter by:
NCT ID: NCT00707239 Terminated - Clinical trials for Pneumonia, Bacterial

Study Evaluating Safety and Efficacy of Tigecycline Versus Imipenem/Cilastatin Subjects With Hospital-Acquired Pneumonia

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

This study will compare the safety and efficacy of a tigecycline regimen versus an imipenem/cilastatin regimen for the treatment of subjects who are hospitalized with hospital-acquired pneumonia (HAP). At least 70% of enrolled subjects will have ventilator-associated pneumonia (VAP). Two dose levels of tigecycline will be assessed and compared to imipenem/cilastatin in parallel. Subjects will receive intravenous therapy from a minimum of 7 & up to 14 consecutive days, the exact duration will be at the decision of the investigator based on the subject's condition. Additional protocol specified antibiotics may be given to ensure appropriate coverage. A final assessment at test-of-cure (TOC) visit will be done 10 to 21 days after the last day of therapy. The total duration of subject participation will be between 17 and 44 days, including a follow up period of 30 days after the last day of therapy for SAEs. Subjects will be followed for safety and efficacy. The safety assessment will include: physical examinations, vital signs, assessment of the clinical signs and symptoms of pneumonia, collection of adverse events, 12-lead ECG, collection of samples for hematology, serum chemistries, and coagulation parameters, & a serum or urine pregnancy test before study entry for women of childbearing potential. The clinical and microbiological efficacy will both be evaluated.

NCT ID: NCT00706082 Terminated - Clinical trials for Pulmonary Hypertension

Early, Simple and Reliable Detection of Pulmonary Arterial Hypertension (PAH) in Systemic Sclerosis (SSc)

DETECT
Start date: October 2008
Phase: N/A
Study type: Observational

A two-stage prospective observational cohort study in scleroderma patients to evaluate screening tests and the incidence of pulmonary arterial hypertension and pulmonary hypertension

NCT ID: NCT00703950 Terminated - Clinical trials for Infant, Very Low Birth Weight

Sucking Pattern of Preterm Infants Using Cup or Bottle Before Breastfeeding

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

The aim of this study is evaluates the effect of the use of bottle and cup in breast sucking patterns in preterm infants. It will be a randomized blind study. One group will be randomized to use bottle to feed and another one to use a cup to feed. As secondary endpoints, weight gain, days of life to begin full oral feeding, length of hospital stay and breast feeding rates will be observed.

NCT ID: NCT00700622 Terminated - Diabetes, Type 1 Clinical Trials

Safety and Efficacy of Technosphere® Insulin Inhalation Powder and Lantus® Compared to Humalog® and Lantus® Over 16-Weeks

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

The objective of this study is to demonstrate that TI® Inhalation Powder combined with Lantus® is as effective as Humalog® combined with Lantus® on HbA1c.

NCT ID: NCT00682656 Terminated - Clinical trials for Cutaneous Leishmaniasis

Safety and Efficacy of Azithromycin to Treat Cutaneous Leishmaniasis

PCL01
Start date: June 2008
Phase: Phase 2/Phase 3
Study type: Interventional

The adequate treatment of the American tegumentary leishmaniasis is crucial since the disease, differently from the caused by the Old World species, is painful and not self-healing and may lead to the disfiguring mucosal involvement. So far, pentavalent antimony compounds have been considered the treatment of choice for cutaneous leishmaniasis (CL), however, these drugs present high frequency of side effects and important disadvantages as parenteral administration and need for careful renal and cardiac monitoring. Azithromycin is a macrolide antibiotic, non-expensive, largely commercially available that has shown in-vitro and in vivo activity against different species of Leishmania. The main objective of this study is to evaluate the efficacy and safety of oral azithromycin for the treatment of CL. The efficacy of oral treatment of azithromycin 500 mg/day for 20 days is going to be compared with the standard treatment of intramuscular injections of 20 mg/Kg/day of pentavalent antimonials (Glucantime®) for 20 days in patients with CL from two endemic regions of Brazil: the metropolitan region of Belo Horizonte and Montes Claros (MG)in the southeast Brazil and in Corte de Pedras (Bahia), Northeastern Brazil. The patients follow up lasts for 12 months.

NCT ID: NCT00680563 Terminated - Anemia Clinical Trials

A Study of Once-Monthly Subcutaneous Mircera for the Treatment of Chronic Renal Anemia in Pre-Dialysis Patients Not Currently Treated With ESA.

Start date: April 2009
Phase: Phase 3
Study type: Interventional

This single arm study will assess the efficacy and safety of subcutaneous Mircera for the correction and maintenance of hemoglobin levels in predialysis patients with renal anemia who are not currently treated with ESA. Eligible patients will receive monthly subcutaneous injections at an initial recommended dose of 1.2 micrograms/kg. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

NCT ID: NCT00676650 Terminated - Prostatic Neoplasms Clinical Trials

Sunitinib Plus Prednisone In Patients With Metastatic Castration-Resistant Prostate Cancer After Failure Of Docetaxel Chemotherapy

SUN 1120
Start date: July 2008
Phase: Phase 3
Study type: Interventional

This study will compare the safety and efficacy of sunitinib in combination with prednisone versus placebo and prednisone in patients that have metastatic castration-resistant prostate cancer that has progressed after treatment with a docetaxel-containing chemotherapy regimen. This is a second-line study.

NCT ID: NCT00673049 Terminated - Clinical trials for Carcinoma, Non-Small-Cell Lung

Trial Of CP-751, 871 And Erlotinib In Refractory Lung Cancer

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

The objective of this study is to test a clinical benefit of the addition of CP 751,871 to erlotinib therapy in patients with advanced NSCLC of non adenocarcinoma histology. The primary endpoint is Overall Survival (OS).

NCT ID: NCT00670228 Terminated - AMI Clinical Trials

Effect of Lantus and Apidra in Patients With Acute ST Elevation Myocardial Infarction

INTENSIVE
Start date: April 2008
Phase: Phase 3
Study type: Interventional

Primary objective: To demonstrate that in hyperglycemic subjects with anterior STEMI (ST Elevation Myocardial Infarction) undergoing Percutaneous Coronary Intervention (PCI), tight glycemic control using insulin glulisine and insulin glargine, i.e. Intensive Insulin Therapy (IIT), results in reducing infarct size at day 60 versus (vs) Standard Glycemic Care (SGC). Secondary objectives: To demonstrate that tight glycemic control using insulin glulisine and insulin glargine reduces markers of inflammation and improves Left Ventricular (LV) function and Cardio-Vascular (CV) outcomes from baseline values, in hyperglycemic subjects with STEMI undergoing Percutaneous Coronary Intervention (PCI).

NCT ID: NCT00664573 Terminated - Clinical trials for Rheumatoid Arthritis

104RA204 Assessment of the Safety and Efficacy of BG9924 in Rheumatoid Arthritis (RA) Participants

RESPOND-EXT
Start date: November 2007
Phase: Phase 2
Study type: Interventional

To observe the long-term treatment with BG9924 when administered to participants with RA who previously participated in a Biogen Idec Study.