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NCT ID: NCT00409617 Completed - Crohn's Disease Clinical Trials

Study of Adalimumab Treatment for Induction and Maintenance of Clinical Remission in Subjects With Crohn's Disease

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

The purpose of this study is to evaluate the safety of adalimumab for treatment of patients with moderate to severe Crohn's Disease (CD) and to measure the effects of treatment on patient general well-being, health-related quality of life (QoL), fistula healing, CD-related extra-intestinal manifestations, work performance, and overall activity.

NCT ID: NCT00409188 Completed - Clinical trials for Non-small Cell Lung Cancer

Cancer Vaccine Study for Unresectable Stage III Non-small Cell Lung Cancer (START)

START
Start date: January 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether the cancer vaccine tecemotide (L-BLP25) in addition to best supportive care is effective in prolonging the lives of subjects with unresectable stage III non-small cell lung cancer, compared to best supportive care alone. A local ancillary (sub) study in European centers will evaluate the immune response in peripheral blood after tecemotide (L-BLP25) or placebo vaccination.

NCT ID: NCT00405808 Terminated - Obesity Clinical Trials

Rimonabant in Abdominally Obese Patients With Impaired Fasting Blood Glucose

PRADO
Start date: December 2006
Phase: Phase 3
Study type: Interventional

Primary objective: To determine the effect of Rimonabant 20mg on the co-primary endpoint including Fasting Plasma Glucose (FPG), HDL-Cholesterol (HDL-C) and triglyceride (TG) levels over a period of 12 months when prescribed with a mild hypocaloric diet in abdominally obese patients with impaired fasting blood glucose and with or without associated comorbidities. Main Secondary objectives: To determine the effect of 12 months Rimonabant treatment versus placebo on changes in waist circumference (WC), body weight, glycemic parameters and lipid parameters. To assess the safety of 12 months Rimonabant treatment versus placebo in these patients.

NCT ID: NCT00405756 Active, not recruiting - Clinical trials for Newly Diagnosed Multiple Myeloma

A Study to Compare MPR With MP in Newly Diagnosed Multiple Myeloma Subjects 65 Years Old or Older.

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

The purpose of this study is to determine whether lenalidomide is safe and effective in the treatment of patients with newly diagnosed Multiple Myeloma who are 65 years of age or older.

NCT ID: NCT00405418 Completed - Clinical trials for Diabetes Mellitus, Type 2

Lantus Versus Levemir Treat-To-Target

L2T3
Start date: November 2006
Phase: Phase 4
Study type: Interventional

Primary objective: To demonstrate the non-inferiority of insulin glargine in comparison to insulin detemir in term of percentage of patients who reach the target of HbA1c < 7% at the end of the treatment period and do not experience symptomatic hypoglycemia, confirmed by plasma glucose (PG) ≤ 56 mg/dL (3.1 mmol/L) Secondary objectives: - To compare between the 2 treatment groups, the percentage of patients who reach the target of HbA1c < 7% and < 6.5% at the end of the treatment period - To compare the changes in HbA1c and fasting plasma glucose (FPG) - To compare the evolution of blood glucose profiles - To compare the day to day FPG variability, the insulin doses - To determine in each treatment group the biochemical and patient-related determinants of failure to reach HbA1c targets - To compare the overall incidence and rate of symptomatic hypoglycemia and nocturnal symptomatic hypoglycemia confirmed by PG ≤ 56 mg/dL (3.1 mmol/L) - To compare over the treatment period, the overall incidence and rate of symptomatic hypoglycemia and symptomatic nocturnal hypoglycemia (with PG ≤ 70 mg/dL [3.9 mmol/L]), of symptomatic day-time hypoglycemia (with PG ≤ 70 mg/dL and with PG ≤ 56 mg/dL), of severe hypoglycemia, of asymptomatic hypoglycemia with PG ≤ 56 mg/dL - To compare the overall safety: incidence of adverse events (including serious hypoglycemia and local tolerance at injection site), change in body weight, in waist circumference and in waist / hip ratio - To assess the quality of life and treatment satisfaction

NCT ID: NCT00402727 Completed - Diabetic Foot Clinical Trials

Comparison of Sequential IV/PO Moxifloxacin With IV Piperacillin/Tazobactam Followed by PO Amoxicillin/Clavulanic Acid in Patients With a Complicated Skin and Skin Structure Infection

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

Patients, who are considered suitable by their physicians to take part in this research, will have a physical examination (including an Electrocardiogram (ECG)), blood and urine samples taken, as well as a sample of the secretions or tissue around their infection site. In addition, the site of the infection will be photographed. The patients will be randomly assigned one of the treatments: intravenous (IV)/per oral (PO) moxifloxacin (drug under evaluation) or IV piperacillin/tazobactam followed by PO amoxicillin/clavulanic acid (i.e., one of the reference treatments for this kind of infection). The maximum treatment duration will be 21 days, and the minimum will be 7 days. During the hospitalization, the patients will have a physical examination every day. On Day 3-5 during therapy as well as at the end of treatment, the patients will have repeated examinations. These tests and evaluations will be repeated 14 to 28 days after the end of treatment. During this visit, blood and urine samples will be taken only if judged necessary by the physicians.

NCT ID: NCT00402272 Completed - Clinical trials for Coronary Artery Disease

SPIRIT V: Post-marketing Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in Europe

SPIRIT V
Start date: November 2006
Phase: Phase 4
Study type: Interventional

The purpose of this Clinical Evaluation is a continuation in the assessment of the performance of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in the treatment of patients with de novo coronary artery lesions.

NCT ID: NCT00393939 Completed - Breast Neoplasms Clinical Trials

Study Of Sunitinib In Combination With Docetaxel Vs Docetaxel In Patients With Advanced Breast Cancer

SUN 1064
Start date: February 2007
Phase: Phase 3
Study type: Interventional

This is a phase 3 randomized trial evaluating the anti-tumor activity and safety of sunitinib combined with docetaxel versus docetaxel, administered as first-line treatment, in patients with unresectable locally recurrent or metastatic breast cancer.

NCT ID: NCT00393198 Completed - Contraception Clinical Trials

Bleeding Pattern and User Satisfaction During Second Consecutive MIRENA® in Contraception and Treatment of Menorrhagia

Start date: October 2006
Phase: Phase 4
Study type: Interventional

The purpose of this study is to assess the bleeding pattern during the last 3 months of the first MIRENA® and the first year of the second MIRENA® use.

NCT ID: NCT00391612 Active, not recruiting - Emphysema Clinical Trials

EASE Trial: Exhale Airway Stents for Emphysema

EASE
Start date: May 2006
Phase: Phase 3
Study type: Interventional

This is an international clinical research study evaluating the safety and effectiveness of a new procedure called airway bypass. The goal of this research is to see if airway bypass can relieve hyperinflation (overfilling) of the lungs, thereby improving lung function and reducing shortness of breath in patients with severe homogeneous (diffuse) emphysema. "EASE" stands for Exhale Airway Stents for Emphysema.