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NCT ID: NCT01709903 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

A 26-week Treatment Randomized, Double-blind, Double Dummy Study to Assess the Efficacy and Safety of QVA149

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

To demonstrate the non-inferiority of QVA149 110/50 µg o.d. to fluticasone/salmeterol 500/50 µg b.i.d. in terms of trough Forced Expiratory Volume in one second (FEV1) (mean of 23 hours 15 min and 23 hours 45 min post QVA149 dose) following 26 weeks of treatment in patients with moderate to severe COPD

NCT ID: NCT01709578 Completed - Clinical trials for Rheumatoid Arthritis

To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)

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

Primary Objective: To demonstrate that sarilumab added to disease modifying anti-rheumatic drugs (DMARDs) is effective for: - reduction of signs and symptoms at Week 24 and - improvement of physical function at Week 12 in patients with active rheumatoid arthritis (RA) who are inadequate responders or intolerant to tumor necrosis factor alpha (TNF-α) antagonists. Secondary Objectives: The secondary objectives are to investigate the effects of SAR153191 (REGN88) when added to DMARD therapy, in patients with active RA who are inadequate responders or intolerant to TNF-α antagonists, for: - Reduction of signs and symptoms at 12 weeks. - Improvement in physical function at Week 24. - Improvement in disease activity score as measured by other American College of Rheumatology derived components at Weeks 12 and 24. - Improvement in quality of life as measured by patient reported outcomes (PROs) at intermediate visits and Week 24. To assess the safety of sarilumab in this population. To assess the exposure of sarilumab added to DMARD therapy in this population.

NCT ID: NCT01706926 Completed - Clinical trials for Rheumatoid Arthritis

A Study of Mavrilimumab in Subjects With Moderate-to-Severe Rheumatoid Arthritis

Start date: August 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to see if mavrilimumab can provide benefit to subjects with rheumatoid arthritis.

NCT ID: NCT01706094 Completed - Ischemic Stroke Clinical Trials

Head Position in Stroke Trial

HeadPoST-Pilot
Start date: January 2013
Phase: N/A
Study type: Interventional

A simplest manner to augment cerebral blood flow to irrigate the ischemic penumbra in acute ischemic stroke could be to place the patient in a 'lying flat' rather than upright head position. Given uncertainty over the balance of potential modest benefits and risks, and variability regarding the ideal head position policy for patients with acute ischemic stroke around the world, reliable randomized evidence is required to standardize clinical practice. The main objectives of this pilot phase clinical trial are to determine the feasibility, safety and potential efficacy of a large-scale cluster randomized clinical trial to assess whether a simple nursing care policy - 'lying flat head position' - provides beneficial effects as compared to the standard upright head position in patients with acute ischemic stroke. The main efficacy outcome of the pilot phase is demonstration of increased mean cerebral blood flow velocity in the flat down compared to the upright head position, as assessed by transcranial Doppler to the medial cerebral arteries of patients with anterior circulation infarction. Secondary efficacy objectives are to demonstrate that the flat down head position improves neurological status at 7 days and disability at 90 days.

NCT ID: NCT01705977 Completed - Clinical trials for Systemic Lupus Erythematosus

Belimumab Assessment of Safety in SLE

BASE
Start date: November 27, 2012
Phase: Phase 4
Study type: Interventional

The purpose of this study is to further enhance the existing knowledge regarding the side effects of belimumab when given with other lupus medicines to adults with active systemic lupus erythematosus (SLE). This study mainly focuses on collecting information on serious events that are not that common or may only be seen with long-term treatment. These events include death, serious infections and other infections of interest, cancers, serious mental health problems, including depression and suicide, and serious infusion and hypersensitivity reactions. This study is being done to help understand if treatment with belimumab increases the risk for these types of events. This study will also see if patients receiving belimumab with other lupus medicines can reduce their use of steroids, such as prednisone, over 1 year.

NCT ID: NCT01696279 Completed - Clinical trials for Chronic Kidney Disease

A Study to Assess the Pharmacokinetics of Lanthanum Carbonate, Investigate and Compare the Efficacy, Safety and Tolerability of Lanthanum Carbonate With Calcium Carbonate in Hyperphosphataemic Children and Adolescents With Chronic Kidney Disease on Dialysis

Start date: February 15, 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to summarize the percentage of participants achieving age-specific Kidney Disease Outcomes Quality Initiative (KDOQI) targets for serum phosphorus in hyperphosphatemic children and adolescents with chronic kidney disease (CKD) who are on dialysis, following 8 weeks of treatment with lanthanum carbonate.

NCT ID: NCT01694927 Enrolling by invitation - Spinal Cord Injury Clinical Trials

Autologous Mesenchymal Stem Cells in Spinal Cord Injury (SCI) Patients

MSC-SCI
Start date: January 2012
Phase: Phase 2
Study type: Interventional

The aim of this study is to evaluate the use of autologous expanded mesenchymal stem cells intralesional transplantation as a safe and potentially beneficial treatment for patients with spinal cord injury.

NCT ID: NCT01691859 Completed - Asthma Clinical Trials

MEA112997 Open-label Long Term Extension Safety Study of Mepolizumab in Asthmatic Subjects

Start date: September 28, 2012
Phase: Phase 3
Study type: Interventional

This is a multi-centre, open-label long term safety study of 100 milligrams (mg) mepolizumab administered subcutaneously (SC) in addition to standard of care in subjects who participated in the MEA112997 study. At each clinic visit, adverse events will be assessed and exacerbations will also be reviewed.

NCT ID: NCT01691794 Completed - HIV, Pediatric Clinical Trials

Safety Sudy of Atazanavir Boosted With Ritonavir in the Treatment of HIV Infection in Pediatric Patients

Start date: November 30, 2012
Phase: Phase 4
Study type: Interventional

The purpose of this study is to collect safety clinical data in HIV-infected pediatric patients aged 6 and older to younger than18 years and weighing 15 kg or more, who are receiving atazanavir capsule boosted with ritonavir and an optimized nucleoside reverse transcriptase inhibitor backbone therapy as part of their antiretroviral regimen.

NCT ID: NCT01691521 Completed - Asthma Clinical Trials

Efficacy and Safety Study of Mepolizumab Adjunctive Therapy in Subjects With Severe Uncontrolled Refractory Asthma

Start date: October 8, 2012
Phase: Phase 3
Study type: Interventional

This study will evaluate two dose regimens of mepolizumab [75mg intravenous (i.v.) or 100mg subcutaneous (SC) every 4 weeks] compared with placebo over a 32 week treatment period in subjects with severe refractory asthma with elevated blood eosinophils. Efficacy will be measured by a reduction in the frequency of asthma exacerbations. Additional efficacy assessments will include measurements of lung function, symptom scores, and quality of life. Safety will be assessed by clinical laboratory samples, ECGs, immunogenicity and adverse events. This study is intended to replicate the Phase IIb/III study MEA112997. Subjects in MEA115588, who meet all eligibility criteria at screening visit, will enter the run-in period. Those subjects that are not able/eligible to be randomised at the end of the 6 week run-in period will be deemed run-in failures. Subjects will remain on their current maintenance therapy throughout the run-in, double-blind treatment administration and follow-up periods. Subjects who meet the randomisation eligibility criteria will be randomised in a 1:1:1 ratio to receive one of the following treatments every 4 weeks for a total of 8 doses: Mepolizumab 75 miligram (mg) i.v. and placebo SC, or Mepolizumab 100 mg SC and placebo i.v. or Placebo i.v. and placebo SC. Subjects that receive all 8 doses of double-blind treatment, and meet the eligibility criteria for the Open-Label Extension (OLE) Study, will be offered the opportunity to participate in the OLE trial.