Sanofi-Aventis

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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

Background information
Other unique IDs: 
CYD10

Safety Dermatological Evaluation: Acceptability With Odontological Follow up - Cepacol Teen.

Trial phase: 
Phase III
Recruitment status: 
Completed

To prove the safety, in normal conditions, of the Cepacol Teen, a formulation to odontological usage.

Background information
Trial ID: 
NCT00729599
Other unique IDs: 
CPYRY_L_04020
Official title: 

Single Site Study, Phase III, for Safety Dermatological Evaluation: Basic Acceptability With Odontological Follow up - Cepacol Teen.

Detailed description: 

 

Number to be enrolled: 
31 patients
Acronym: 
Cepacol Teen

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.

Background information
Other unique IDs: 
EFC6910
EudraCT: 2008-001550

36-Month Post Marketing Surveillance and Analysis of Menactra in 2-10 Year Olds

Recruitment status: 
Recruiting

To describe and characterize safety-related events occurring after vaccination with the Menactra vaccine.

Background information
Trial ID: 
NCT00728260
Other unique IDs: 
MTA38
Official title: 

 

Detailed description: 

 

Number to be enrolled: 
20000 patients

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.

Background information
Other unique IDs: 
EFC10102
EudraCT:2007-007941-10

Phase II Study Of Neoadjuvant Chemotherapy In Borderline Resectable Pancreatic Adenocarcinoma

Trial phase: 
Phase II
Recruitment status: 
Withdrawn

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.

Background information
Trial ID: 
NCT00728000
Other unique IDs: 
OX-06-030
Official title: 

Phase II Study Of Neoadjuvant Chemotherapy With Gemcitabine, Oxaliplatin And Erlotinib (Gemoxt) In Borderline Resectable Pancreatic Adenocarcinoma

Detailed description: 

Although surgery is the only curative modality for pancreatic adenocarcinoma, the majority of patients (~80%)are unresectable at presentation. The use of a multimodality approach may be a crucial method to improve the dismal survival rate of patients with pancreatic cancer. A logical tactic is to use neoadjuvant cytotoxic agents and targeted drugs to facilitate resectability.

Number to be enrolled: 
20 patients

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.

Background information
Other unique IDs: 
LANTU_L_04137

Japanese Efficacy and Safety Study of Enoxaparin in Patients With Curative Abdominal Cancer Surgery

Trial phase: 
Phase III
Recruitment status: 
Completed

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.

Background information
Trial ID: 
NCT00723216
Other unique IDs: 
EFC10094
Official title: 

Multicenter, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Enoxaparin Sodium (RP54563) 20mg Bid for 14 Days for Prevention of Venous Thromboembolism in Patients With Curative Abdominal Cancer Surgery. Physical Prophylaxis Only Arm [I

Detailed description: 

 

Number to be enrolled: 
125 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.

Background information
Other unique IDs: 
ARD6563
XRP6976J/2102

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.

Background information
Other unique IDs: 
EFC10343
EudraCT: 2007-007945-11
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