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NCT ID: NCT01234311 Completed - Prostate Cancer Clinical Trials

A Study of Tasquinimod in Men With Metastatic Castrate Resistant Prostate Cancer

Start date: March 2011
Phase: Phase 3
Study type: Interventional

This is a Phase 3 randomized, double blind, placebo controlled study of tasquinimod in asymptomatic to mildly symptomatic patients with metastatic CRPC to confirm the effect of tasquinimod on delaying disease progression compared with placebo. Approximately 1200 eligible patients with metastatic CRPC will be randomly assigned in a 2:1 ratio to 1 of 2 treatment groups: Treatment Group A (tasquinimod 0.25, 0.5, or 1 mg/day; n=800) or Treatment Group B (placebo; n=400).

NCT ID: NCT01232569 Completed - Clinical trials for Rheumatoid Arthritis

A Study of RoActemra/Actemra (Tocilizumab) Given Subcutaneously in Combination With Traditional DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis

Start date: March 2011
Phase: Phase 3
Study type: Interventional

This randomized, parallel-group, placebo-controlled, multicenter study will evaluate the reduction in disease activity and the safety of tocilizumab (RoActemra/Actemra) in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs) in patients with active, moderate to severe rheumatoid arthritis. In the double-blind part of the study, patients will be randomized to receive either 162 mg tocilizumab or placebo subcutaneously every 2 weeks for 24 weeks using a pre-filled syringe. In the open-label part of the study, patients will be randomized to receive 162 mg tocilizumab subcutaneously every 2 weeks from Week 24 to Week 96 using a pre-filled syringe or an auto-injector.

NCT ID: NCT01218308 Completed - Influenza Clinical Trials

A Study to Evaluate the Efficacy of GSK Biologicals' Influenza Vaccine in Children

Start date: December 9, 2010
Phase: Phase 3
Study type: Interventional

This study is designed to test the efficacy of an investigational influenza vaccine, in children compared to Havrix®, a licensed Hepatitis A virus vaccine. This study will also evaluate the immunogenicity and safety of the investigational vaccine.

NCT ID: NCT01210885 Completed - Clinical trials for Meningococcal Disease

Immunogenicity and Safety of Different rMenB Plus MenACWY Formulations in Adolescents

Start date: December 2010
Phase: Phase 2
Study type: Interventional

The purpose of this phase 2 study is to evaluate the safety, tolerability and immunogenicity of two doses of 4 different investigational MenABCWY combination vaccine when administered to healthy adolescents aged 11-18 years.

NCT ID: NCT01209780 Completed - Seasonal Influenza Clinical Trials

Safety and Immunogenicity of Trivalent Subunit Inactivated Flu Vaccine Administered to Healthy Children and Adolescents 3 to 17 Years of Age

Start date: September 2010
Phase: Phase 3
Study type: Interventional

This study will evaluate the safety and immunogenicity in healthy children and adolescents after one or two IM dose(s) of trivalent subunit inactivated flu vaccine.

NCT ID: NCT01201356 Completed - Clinical trials for Relapsing Forms of Multiple Sclerosis

Long-term Safety and Tolerability of 0.5 mg Fingolimod in Patients With Relapsing Forms of Multiple Sclerosis

Start date: September 13, 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study was to collect long-term safety and tolerability, long-term efficacy, and health outcome data in all patients currently ongoing in the fingolimod multiple sclerosis clinical development program. This study combined all currently ongoing Phase II and III fingolimod extension studies as well as ongoing and newly planned studies into one single long-term extension protocol that provided patients with continuous treatment until fingolimod was registered, commercially available, and reimbursed in the respective countries.

NCT ID: NCT01171144 Completed - Gastroenteritis Clinical Trials

Trends Over Time (1990-2010) of Diarrhoea-related Incidence, Hospitalizations and Deaths in Children of Panama

Start date: January 2009
Phase: N/A
Study type: Observational

This study aims at collecting data from secondary sources to obtain baseline incidence and monitor trends over time (1990 - 2010) of reported gastroenteritis cases, gastroenteritis related hospital discharges and gastroenteritis related deaths in children < 5 years of age in Panama before and after implementation of Rotarix™ universal mass vaccination.

NCT ID: NCT01168791 Completed - Soft Tissue Sarcoma Clinical Trials

Study of Palifosfamide-tris in Combination With Doxorubicin in Patients With Front-line Metastatic Soft Tissue Sarcoma

PICASSO III
Start date: July 2010
Phase: Phase 3
Study type: Interventional

This is an international, randomized, double-blind, placebo-controlled trial to evaluate the clinical efficacy of palifosfamide-tris administered with doxorubicin in combination, compared with doxorubicin administered with placebo in front-line patients diagnosed with metastatic soft tissue sarcoma (STS).

NCT ID: NCT01164852 Completed - Preeclampsia Clinical Trials

Aggressive Versus Expectant Management of Severe Preeclampsia Remote From Term

MEXPRE-Latin
Start date: August 2010
Phase: N/A
Study type: Interventional

How best to manage preeclampsia remote from term is controversial because of conflicting maternal and neonatal risks. Gestational age is the most important determinant of neonatal outcome. There are two basic approaches when delivery is not clear indicated by assessment of maternal and fetal well-being. The interventionist care when the delivery is planned within 48 hours and the expectant care which refers to pregnancy prolongation during which time women and fetuses are carefully monitored for indications for delivery. The purpose of this study is to evaluate maternal and perinatal outcomes with expectant vs interventionist or aggressive management of severe preeclampsia at 28 to 33 weeks of gestation.

NCT ID: NCT01162122 Completed - Influenza Clinical Trials

Safety and Immunogenicity of MF59C.1 Adjuvanted Trivalent Subunit Influenza Vaccine in Elderly Subjects

Start date: August 2010
Phase: Phase 3
Study type: Interventional

The present phase III study aims to evaluate the safety and immunogenicity of MF59-adjuvanted subunit seasonal influenza vaccine and to evaluate the consistency in the manufacturing process of three consecutive lots of MF59-adjuvanted subunit seasonal influenza vaccine with respect to immunogenicity in subjects aged 65 years and older. The active comparator non-adjuvanted seasonal influenza vaccine is approved for use in this age group in the United States and will be used to provide a comparative assessment for immunogenicity and safety.