Sanofi-Aventis
Study of ChimeriVaxâ„¢ Dengue Tetravalent Vaccine in Adult Subjects
To evaluate effect of previous flavivirus exposure on the safety and immunogenicity of the ChimeriVax™ dengue tetravalent vaccine Primary Objectives:
- To describe the safety of one injection of ChimeriVax™ dengue tetravalent vaccine.
- To describe the immune response against dengue before and after one injection of ChimeriVax™ dengue tetravalent vaccine
Safety Dermatological Evaluation: Acceptability With Odontological Follow up - Cepacol Teen.
To prove the safety, in normal conditions, of the Cepacol Teen, a formulation to odontological usage.
Evaluation of Safety and Efficacy of AVE5530 as Add-on to Ongoing Statins in Patients With Primary Hypercholesterolemia
The present study is assessing the efficacy and safety of AVE5530 (25 mg and 50 mg) in add-on to ongoing statin treatment in a double-blind manner in comparison with placebo, in the management of patients with primary hypercholesterolemia considered as inadequately controlled despite their ongoing statin treatment. The main objective is to evaluate the effects of the association AVE5530+statin on LDL-C level reduction after 12 weeks of treatment. The effects of AVE5530 on other lipid parameters will be assessed as secondary objectives.
36-Month Post Marketing Surveillance and Analysis of Menactra in 2-10 Year Olds
To describe and characterize safety-related events occurring after vaccination with the Menactra vaccine.
A Phase III Study Evaluating the Efficacy and Safety of Satavaptan Versus Placebo in Patients With Dilutional Hyponatremia
The primary objective of this study is to assess the efficacy of satavaptan versus placebo in patients with dilutional hyponatremia due to SIADH. Secondary objectives are to assess the safety of satavaptan, the maintenance of effect, and the clinical benefit in these patients.
Phase II Study Of Neoadjuvant Chemotherapy In Borderline Resectable Pancreatic Adenocarcinoma
The goal of this study is to determine the effect of chemotherapy on decreasing the size of unresectable pancreas cancer thereby allowing it to be surgically removed. In addition, this study may provide information on how tumors behave when exposed to certain types of chemotherapy.
Basal Insulin for Type 2 Diabetes Patients Treated in Outpatient Clalit Clinics
Treatment of diabetes mellitus type II with basal insulin, for patients treated in Clalit outpatient clinics that are not adequately controlled with current treatment.
Japanese Efficacy and Safety Study of Enoxaparin in Patients With Curative Abdominal Cancer Surgery
The primary objective of this study is to evaluate the effects of enoxaparin on venous thromboembolism incidence and bleeding rate (major and minor bleeding) in patients undergoing curative abdominal cancer surgery. The secondary objective is evaluate the incidence of adverse events of enoxaparin in these patients.
Japanese Study of the Combined Administration of Docetaxel With Prednisolone for Metastatic Hormone Refractory Prostate Cancer
The purpose of this study is to evaluate the safety of docetaxel administered every 3 weeks repeatedly for 11 and more cycles and in combination with daily prednisolone for metastatic hormone refractory prostate cancer.
Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Thromboembolism in Patients Undergoing Hip Fracture Surgery
The primary objective of the study is to compare the efficacy of AVE5026 with enoxaparin for the prevention of venous thromboembolic events (VTE) in patients undergoing hip fracture surgery. The secondary objectives of this study are to evaluate the safety of AVE5026 in patients undergoing hip fracture surgery, and to document AVE5026 exposures in this population.
