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NCT ID: NCT01458119 Terminated - Fabry Disease Clinical Trials

Open-Label Phase 3 Long-Term Safety Study of Migalastat

AT1001-041
Start date: October 14, 2011
Phase: Phase 3
Study type: Interventional

This was a long-term, open-label study of migalastat (123 milligrams [mg] of migalastat [equivalent to 150 mg of migalastat hydrochloride]) (migalastat) in participants with Fabry disease who completed treatment in a previous monotherapy trial with migalastat.

NCT ID: NCT01456936 Completed - Smoking Cessation Clinical Trials

Study Evaluating The Safety And Efficacy Of Varenicline and Bupropion For Smoking Cessation In Subjects With And Without A History Of Psychiatric Disorders

EAGLES
Start date: November 2011
Phase: Phase 4
Study type: Interventional

This study is being conducted to assess varenicline and bupropion as aids to smoking cessation treatment in subjects with and without an established diagnosis of major psychiatric disorder and to characterize the neuropsychiatric safety profile (pre-specified adverse events (AEs) in both of these populations).

NCT ID: NCT01456806 Completed - Type 2 Diabetes Clinical Trials

Educative Intervention to Improve Type 2 Diabetes Mellitus Control in Corrientes

PRODIACOR
Start date: December 2006
Phase: N/A
Study type: Interventional

Objective: To evaluate the effect of system interventions (data recording procedures and complete coverage of medications and supplies) with or without physician and/or patient education, upon the psychological, clinical, metabolic and therapeutic indicators and the costs of care of people with type 2 diabetes. Design: Randomized 2x2 design; sample size was determined considering the change in haemoglobin A1c (primary outcome variable) using a two-sided test at the 5% level of significance, and 80% power using a paired t-test. Sample size was increased by 25% to account for non-independence and patient drop-out. Setting: Primary care level in the city of Corrientes, Argentina with involvement of all three Argentinean health subsectors (public health, social security and the private, prepaid system). Participants: 36 general practitioners and 468 adults (62-71% women, mean age 62 years) with type 2 diabetes. Patients of the participating physicians (nine in each group), were randomly selected and assigned to one of four groups (117 patients each): control, provider education, patient education, and provider/patient education. Intervention: Structured group education programmes were delivered to provider and/or people with type 2 diabetes by trained professionals; identical system interventions were applied to all four groups. Main outcome measures: Body mass index, blood pressure, fasting glucose, haemoglobin A1c levels, lipid profile, drug consumption, resource use, and patient well being (WHO-5 questionnaire and Lowe score), at baseline and up to 42 months at every 6 months intervals.

NCT ID: NCT01456325 Completed - Clinical trials for Non-Squamous Non-Small Cell Lung Cancer

A Study of Onartuzumab (MetMAb) in Combination With Tarceva (Erlotinib) in Participants With Met Diagnostic-Positive Non-Small Cell Lung Cancer Who Have Received Chemotherapy For Advanced or Metastatic Disease (MetLung)

Start date: January 2012
Phase: Phase 3
Study type: Interventional

This randomized, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of onartuzumab (MetMAb) in combination with Tarceva (erlotinib) in participants with incurable non-small cell lung cancer identified to be Met diagnostic-positive. Participants will be randomized to receive either onartuzumab (MetMAb) or placebo in combination with erlotinib. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

NCT ID: NCT01456195 Completed - Clinical trials for Diabetes Mellitus, Type 2

Comparison of TAK-875 With Placebo in Participants With Type 2 Diabetes

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

The purpose of this study is to determine the efficacy and safety of TAK-875, once daily (QD), in participants with type 2 diabetes mellitus (T2DM).

NCT ID: NCT01455701 Completed - Clinical trials for Juvenile Idiopathic Arthritis

A Study to Evaluate Pharmacokinetics and Safety of Tocilizumab (RoActemra/Actemra) in Participants Less Than 2 Years Old With Active Systemic Juvenile Idiopathic Arthritis (sJIA)

Start date: October 26, 2012
Phase: Phase 1
Study type: Interventional

This is a multi-center, open-label single-arm study to investigate the pharmacokinetics and safety of tocilizumab (RoActemra/Actemra) in participants less than 2 years old with active sJIA. Participants will receive tocilizumab infusions every 2 weeks. The anticipated time on study treatment is 12 weeks (Main evaluation period). Participants will have the option to continue tocilizumab treatment until participant reaches 2 years of age or up to one year from baseline, whichever is longer. An optional extension period will follow the main evaluation period.

NCT ID: NCT01455194 Completed - Bronchial Asthma Clinical Trials

Effect of High Dose Ciclesonide on Asthma Control

CONTRAST
Start date: November 2011
Phase: Phase 3
Study type: Interventional

The aim of the trial is to investigate asthma control with 160 to 640 μg ciclesonide/day. Asthma control will be assessed by the Asthma Control Questionnaire (ACQ).

NCT ID: NCT01450761 Completed - Clinical trials for Small Cell Lung Carcinoma

Trial in Extensive-Disease Small Cell Lung Cancer (ED-SCLC) Subjects Comparing Ipilimumab Plus Etoposide and Platinum Therapy to Etoposide and Platinum Therapy Alone

Start date: December 13, 2011
Phase: Phase 3
Study type: Interventional

The purpose of the study is to determine whether the addition of Ipilimumab to Etoposide and Platinum therapy will extend the lives of patients with Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) more than Etoposide and Platinum therapy alone.

NCT ID: NCT01450449 Completed - Clinical trials for Glioblastoma Multiforme

Short Course vs. Standard Course Radiotherapy in Elderly and/or Frail Patients With Glioblastoma Multiforme

Start date: February 2009
Phase: Phase 3
Study type: Interventional

This is a multi-centre prospective, non-inferiority trial. Patients will be randomized to two treatment groups in a 1:1 ratio and will be stratified by age, Karnofsky Performance Status and extent of the surgical resection. This study will assess the effect of a one-week radiotherapy regimen in comparison with a three-week radiotherapy regimen on the survival of elderly and/or frail patients with glioblastoma multiforme (Frail: ≥>50 years old and with a KPS of 50% or less50%-70%; Elderly and frail: ≥65 years and with a KPS of 50% - 70%; Elderly: ≥65 years and with a KPS of 80% - 100%).

NCT ID: NCT01445678 Completed - Clinical trials for Complicated Intra-abdominal Infection

Study Comparing the Safety and Efficacy of Intravenous CXA-201 and Intravenous Meropenem in Complicated Intraabdominal Infections

Start date: December 23, 2011
Phase: Phase 3
Study type: Interventional

This is a Phase 3, multicenter, prospective, randomized, double-blind, double dummy study of CXA-201 Intravenous (IV) infusions (1500mg q8h) and metronidazole (500mg q8h) versus meropenem (1000mg q8h)for the treatment of adults with Complicated Intraabdominal Infections (cIAI).