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NCT ID: NCT01069289 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Efficacy and Safety Study of Symbicort® Turbuhaler® Versus Oxis® Turbuhaler® in Chronic Obstructive Pulmonary Disease (COPD) Patients

SUMIRE
Start date: January 2010
Phase: Phase 3
Study type: Interventional

The primary purpose of the study is to investigate if Symbicort is more effective than Oxis in increasing forced expiratory volume in one second (FEV1), measured at the clinics, in patients with COPD.

NCT ID: NCT01064349 Completed - Cancer Clinical Trials

Breast Cancer With Over-expression of erbB2-BRAINSTORM

Start date: May 6, 2009
Phase:
Study type: Observational

This retrospective cohort study aims to improve our understanding of the current paradigm for treatment of brain metastases in erbB2+ breast cancer patients in the Asia Pacific region. We aim to identify approximately 300 erbB2+ breast cancer patients with brain metastases diagnosed between 2006-2008 in 6 countries. Medical records will be analyzed to determine the treatment pattern for brain metastases, including anti-erbB2 therapy. Additional objectives are to understand the impact of anti-erbB2 therapy on survival after brain metastases and to investigate the relationship between anti-erbB2 therapy for brain metastases and: 1) the time interval between diagnosis of erb2+ breast cancer and brain metastasis, and 2) the occurrence of brain metastasis as the first site of disease progression.

NCT ID: NCT01064141 Completed - Dengue Fever Clinical Trials

A Study of Dengue Vaccine in Healthy Toddlers Aged 12 to 15 Months in the Philippines

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

The purpose of this study is to investigate the potential for co-administration of the first dose of CYD Dengue vaccine with childhood vaccination. Primary Objectives: - To describe the safety of CYD Dengue vaccine after each dose; first dose given alone or coadministered with childhood vaccines. Secondary Objectives: - To describe the immunogenicity of CYD Dengue vaccine after each dose; first dose given alone or co-administered with childhood vaccines.

NCT ID: NCT01063907 Completed - Multiple Myeloma Clinical Trials

A Study of KW-2478 in Combination With Bortezomib in Subjects With Relapsed and/or Refractory Multiple Myeloma

Start date: March 2010
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and benefits of the investigational study drug, KW-2478, when given with bortezomib (Velcade®), a drug approved for the treatment of Multiple Myeloma (MM). The primary objectives: - To establish the safety, tolerability, and recommended Phase II dose (RP2D) of KW-2478 in combination with bortezomib (Phase I); - To assess the overall response rate (ORR) when subjects with advanced MM are treated (Phase II). The secondary objectives: - To characterize the Pharmacokinetic (PK) and Pharmacodynamic (PD) of KW-2478 with bortezomib (Phase I only); - To evaluate for preliminary evidence of efficacy (Phase I); - To determine progression free survival (PFS) and duration of response of KW-2478 with bortezomib (Phase II).

NCT ID: NCT01061736 Completed - Clinical trials for Rheumatoid Arthritis

Evaluation of Sarilumab (SAR153191/REGN88) on Top of Methotrexate in Rheumatoid Arthritis Patients

RA-MOBILITY
Start date: March 2010
Phase: Phase 2/Phase 3
Study type: Interventional

Primary Objectives: Part A (dose ranging study): To demonstrate that sarilumab (SAR153191/REGN88) on top of MTX was effective on reduction of signs and symptoms of rheumatoid arthritis at 12 weeks. Part B (pivotal study): To demonstrate that sarilumab added to MTX was effective in: - reduction of signs and symptoms of rheumatoid arthritis at 24 weeks - inhibition of progression of structural damage at 52 weeks - improvement in physical function at 16 weeks Secondary Objectives: Part B: To demonstrate that sarilumab added to MTX was effective in induction of a major clinical response at 52 weeks To assess the safety of sarilumab added to MTX To document the pharmacokinetic profile of sarilumab added to MTX in participants with active rheumatoid arthritis who were inadequate responders to MTX therapy.

NCT ID: NCT01061541 Completed - Clinical trials for Haemophilus Influenzae Type b

Immunogenicity, Safety & Reactogenicity of GSK Vaccine Tritanrix™-HepB/Hib2.5 Compared to GSK Vaccine Tritanrix™-HepB/Hiberix™

Start date: August 2003
Phase: Phase 2
Study type: Interventional

In order to reduce the amount of thiomersal in its vaccines, GSK Biologicals has developed a DTPw-HBV vaccine with low thiomersal content (Tritanrix™- HepB low thio). This vaccine is to be used in combination with a Hib low dose vaccine containing 2.5µg of PRP antigen (Hib 2.5). The purpose of this study is to generate clinical data with Tritanrix™-HepB low thio vaccine when extemporaneously mixed with Hib 2.5 vaccine. The control group will receive Tritanrix™-HepB/Hiberix™. Subjects received primary vaccination in study 208108/091 (double blind). Of these subjects 50% were randomised to participate in the PRP challenge study (208108/092) (open), and all subjects will be invited to participate in a booster study DTPWHBV=HIB2.5-093 (101477).

NCT ID: NCT01053988 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

A 6-month Study to Evaluate the Efficacy and Safety of Fluticasone Furoate (FF)/GW642444 Inhalation Powder in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Start date: October 5, 2009
Phase: Phase 3
Study type: Interventional

The Purpose of this study is to assess the efficacy and safety of two strengths of the FF/GW642444 Inhalation Powder in subjects with chronic obstructive pulmonary disease (COPD)

NCT ID: NCT01051661 Completed - Influenza Clinical Trials

Safety and Efficacy of H1N1 Vaccines in Children Aged 6 Months to Less Than 10 Years of Age

Start date: February 12, 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to characterize the safety and efficacy of GSK Biologicals' H1N1 flu candidate vaccines GSK2340274A and GSK2340273A in children 6 months to less than 10 years of age.

NCT ID: NCT01051531 Completed - Schizophrenia Clinical Trials

A Safety, Tolerability, and Treatment Response Study of Paliperidone Palmitate Administered to Patients With Schizophrenia

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

The purpose of the study is to evaluate the safety, tolerability and treatment response of paliperidone palmitate administered as once-monthly injections to patients with schizophrenia.

NCT ID: NCT01043809 Completed - Infectious Disease Clinical Trials

Evaluation of a Handwashing Promotion Program in Three Countries

Start date: January 2008
Phase: N/A
Study type: Interventional

The purpose of this study is to assess whether simple, school-based handwashing promotion impacts health and hygiene knowledge among students and their families.