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NCT ID: NCT01064414 Completed - Clinical trials for Diabetes Mellitus, Type 2

An Efficacy, Safety, and Tolerability Study of Canagliflozin in Patients With Type 2 Diabetes Mellitus Who Have Moderate Renal Impairment

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

The purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in patients with type 2 diabetes mellitus who have reduced kidney function.

NCT ID: NCT01064401 Completed - Clinical trials for Relapsing-Remitting Multiple Sclerosis

Efficacy and Safety of BIIB019 (Daclizumab High Yield Process) Versus Interferon β 1a in Participants With Relapsing-Remitting Multiple Sclerosis

(DECIDE)
Start date: May 2010
Phase: Phase 3
Study type: Interventional

The primary study objective is to test the superiority of Daclizumab High Yield Process (DAC HYP) compared to interferon β 1a (IFN β-1a) in preventing multiple sclerosis (MS) relapse in participants with relapsing remitting multiple sclerosis. The secondary study objectives are to test the superiority of DAC HYP compared to IFN β-1a in slowing functional decline and disability progression and maintaining quality of life in this participant population.

NCT ID: NCT01064284 Completed - Hemophilia A Clinical Trials

Survey of Inhibitors in Plasma-Product Exposed Toddlers

SIPPET
Start date: January 2010
Phase: Phase 4
Study type: Interventional

The primary objective of the study is to assess the immunogenicity of VWF/FVIII and of rFVIII concentrates by determining the frequency of inhibitor development in previously untreated patients (PUPs) or minimally blood component-treated (MBCTPs) in the first 50 EDs or in the first 3 years from enrollment, whichever occurs first.

NCT ID: NCT01063231 Completed - Colonic Diseases Clinical Trials

Evaluation of PillCam™ Colon 2 in Visualization of the Colon

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

Evaluate accuracy of PCCE-2 in detecting patients with colonic polyps as compared to conventional colonoscopy.

NCT ID: NCT01063036 Completed - Chronic Hepatitis B Clinical Trials

Efficacy and Safety Study of Entecavir Plus Tenofovir in Patients With Chronic Hepatitis B Who Failed Previous Treatment

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

The purpose of this study is to show that the combination of entecavir and tenofovir, is effective and well tolerated in chronic hepatitis B patients who have failed previous treatment.

NCT ID: NCT01062295 Completed - Sleep Clinical Trials

Efficacy and Safety of the Device Siesta-SystemTM for Inducing Objective Sleep and re Rest

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

NTRODUCTION: The investigators have developed a new device to help passengers of vehicles to rest, sleep, and to avoid cervical injuries due to sleepiness postures while travelling. The device is attached to the headrest and is based in a new concept called "dynamic vertical holding of the head and neck". It could also provide some help in avoiding accidents by allowing a sleeping time for a secondary driver while the main one is driving. Several studies have shown that up to 30% of car crashes are related to sleepiness. AIM: To estimate the efficacy and safety of a new device in "patent pending" phase to facilitate the sleep and rest in the passenger. METODOLOGY: DESIGN: Prospective, cross-over and open clinical assay, comparing the results of 40 different passengers during a journey after using both systems, that is the new device and the standard headrest. MEASUREMENTS: A) Standard polysomnography for 3 and a half hours during the night; B) Anthropometric and clinical variables; C) Sleepiness scale and Epworth sleepiness; D) Questionnaires of sleep, health and quality of life. E) Evaluation of the neck posture in recorded images. ANALYSIS: To compare the results of questionnaires of sleep quality, comfort and safety as well as the images recorded and polysomnographic variables of objective sleep variables obtained by the device Siesta-SystemTM and the conventional headrest.

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: NCT01061723 Completed - Clinical trials for Ankylosing Spondylitis

Dose Ranging Study to Evaluate the Efficacy and Safety of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis

ALIGN
Start date: February 2010
Phase: Phase 2
Study type: Interventional

Primary objective: - to evaluate the efficacy of Sarilumab in patients with Ankylosing Spondylitis [AS] using the Assessment in AS working group criteria [ASAS] 20% response criteria [ASAS20] Secondary objectives: - to demonstrate that Sarilumab is effective on: - assessment of higher level of response (ASAS 40% response criteria [ASAS40]) - partial remission - disease activity - range of motion - Magnetic Resonance Imaging [MRI] of the spine - to assess the safety and tolerability of Sarilumab in patients with AS as well as the pharmacokinetic profile of Sarilumab in patients with AS

NCT ID: NCT01061177 Completed - Leukemia, Myeloid Clinical Trials

Nilotinib in Newly Diagnosed Adult Philadelphia Chromosome and /or BCR-ABL Positive Chronic Myeloid Leukaemia in Chronic Phase

`MACS1252
Start date: May 2010
Phase: Phase 4
Study type: Interventional

This study will assess the efficacy and safety of nilotinib in adult patients with newly diagnosed Philadelphia chromosome positive/BCR-ABL positive chronic myeloid leukaemia in chronic phase. The aim of the study is to confirm the rates of complete molecular remission (CMR) of nilotinib in newly diagnosed CML chronic phase patients in a pan-European population using the EUTOS standardized laboratories.

NCT ID: NCT01060813 Completed - Cirrhosis Clinical Trials

Study of the Benefit of Exercise and Aminoacid Supplements in Cirrhotic Patients

Start date: January 2010
Phase: N/A
Study type: Interventional

This is a pilot study including 20 cirrhotic patients that will be randomized to receive during 3 months leucine vs leucine plus a programme of physical exercise specially designed for cirrhotic patients. The hypothesis is that physical exercise in cirrhotic patients could increase muscle mass (and therefore glutamine synthetase activity leading to a higher blood ammonium clearance) and quality of life. Safety of physical exercise in cirrhotic patients will be strictly assessed.