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NCT ID: NCT01318993 Terminated - Crohn's Disease Clinical Trials

Open-Label Extension Study of GSK1605786A

SHIELD-3
Start date: April 2011
Phase: Phase 3
Study type: Interventional

An open-label study to evaluate the safety and effectiveness of GSK1605786A 500 mg twice daily over 108 weeks in adult subjects with Crohn's disease. Subjects completing previous GSK-sponsored studies with GSK1605786A or subjects who withdraw early from Study CCX114157 (maintenance study of GSK1605786A) due to worsening of Crohn's disease requiring a treatment change may be eligible to participate. The primary objective is to evaluate the safety of GSK1605786A, as assessed by recording of adverse events, clinical laboratory parameters, vital signs and electrocardiogram. Secondary objectives will include assessments of effectiveness of long-term treatment with GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire (IBDQ), SF-36v2, EQ-5D, Work and Productivity Activity Impairment-Crohn's Disease (WPAI-CD) and receipt of disability.

NCT ID: NCT01316939 Terminated - Crohn's Disease Clinical Trials

GSK1605786A in the Maintenance of Remission in Subjects With Crohn's Disease

SHIELD-2
Start date: May 2011
Phase: Phase 3
Study type: Interventional

A randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of two doses (500 mg once daily and 500 mg twice daily) of GSK1605786A in maintaining remission over 52 weeks in adult subjects with Crohn's disease. Efficacy will be assessed by the Crohn's Disease Activity Index (CDAI) score. Eligible subjects will have achieved response (CDAI decrease of at least 100 points) and/or remission (CDAI less than 150) in a prior GSK sponsored induction study. The primary endpoint will be proportion of subjects in remission at both Weeks 28 and 52. Safety will be assessed by recording of adverse events, clinical laboratory parameters including liver function tests, vital signs and electrocardiogram. Population pharmacokinetics will evaluate the two doses of GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire (IBDQ), SF-36v2, EQ-5D, Work Productivity and Activity Impairment - Crohn's Disease (WPAI-CD) and disability.

NCT ID: NCT01290887 Terminated - Eosinophilic Asthma Clinical Trials

Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Reslizumab (3.0 mg/kg) as Treatment for Patients (12 Through 75 Years of Age) With Eosinophilic Asthma

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

The primary objective of the study is to evaluate the long-term safety of reslizumab at a dosage of 3.0 mg/kg every 4 weeks for approximately 24 months in pediatric and adult patients with eosinophilic asthma as assessed by adverse events, physical examination findings, vital sign measurements, and concomitant medication usage throughout the study (every 4 weeks), clinical laboratory test results, and measurement of antidrug antibodies.

NCT ID: NCT01259297 Terminated - Clinical trials for Cardiovascular Events

A Randomized Controlled Trial of Aliskiren in the Prevention of Major Cardiovascular Events in Elderly People

APOLLO
Start date: January 2011
Phase: Phase 3
Study type: Interventional

This study was planned to provide new information regarding the role of aliskiren (with or without additional therapy with a diuretic or a Calcium channel blockers (CCB)) in elderly individuals (≥ 65 years) with systolic blood pressure (SBP) 130 to 159 mmHg, in preventing major cardiovascular (CV) events and on global measures of physical, executive and cognitive function.

NCT ID: NCT01252355 Terminated - Clinical trials for Multiple Sclerosis Relapse

Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis and Treated With Interferon-beta

TERACLES
Start date: January 2011
Phase: Phase 3
Study type: Interventional

The primary objective was to demonstrate the effect of teriflunomide, in comparison to placebo, on frequency of Multiple Sclerosis (MS) relapses in patients with relapsing forms of MS who are treated with Interferon-beta (IFN-beta). The secondary objectives were: - Assess the effect of teriflunomide, in comparison to placebo, when added to IFN-beta on: - Disease activity as measured by brain Magnetic Resonance Imaging (MRI) - Disability progression - Burden of disease and disease progression as measured by brain MRI - Evaluate the safety and tolerability of teriflunomide when added to IFN-beta therapy - Assess the pharmacokinetics of teriflunomide in use in addition to baseline IFN-beta therapy - Assess associations between variations in genes and clinical outcomes (safety and efficacy) - Assess other measures of efficacy of teriflunomide such as fatigue and health-related quality of life - Assess measures of health economics (hospitalization due to relapse, including the length of stay and any admission to intensive care unit)

NCT ID: NCT01244191 Terminated - Clinical trials for Non Squamous, Non-small-cell Lung Cancer

Tivantinib Plus Erlotinib Versus Placebo Plus Erlotinib for the Treatment of Non-squamous, Non-small-cell Lung Cancer

Start date: January 11, 2011
Phase: Phase 3
Study type: Interventional

This study is to determine if the combination regimen of tivantinib with erlotinib will improve overall survival relative to erlotinib alone in subjects with locally advanced or metastatic non-squamous, non-small cell lung cancer who have received 1 or 2 prior systemic anti-cancer therapies.

NCT ID: NCT01242514 Terminated - Clinical trials for Rheumatoid Arthritis

Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA)

OSKIRA-X
Start date: January 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the long term safety and tolerability of fostamatinib in patients with rheumatoid arthritis (RA).

NCT ID: NCT01181791 Terminated - Clinical trials for Premature Infant Disease

Effects of Lactobacillus Reuteri in Premature Infants

Reuteri
Start date: July 2010
Phase: N/A
Study type: Interventional

This application a phase II clinical trial to address the possible active mechanisms of probiotics and to obtain preliminary efficacy and safety data after the administration of a probiotic, Lactobacillus reuteri a population of premature infants. The hypothesis is that the exogenous supplementation Lactobacillus reuteri to premature infants will lead to clinical beneficial effects by modifying their intestinal microbiota and enhancing their intestinal immunological response.

NCT ID: NCT01163253 Terminated - Psoriasis Clinical Trials

A Long Term Study To Evaluate The Safety And Tolerability Of CP-690,550 For Patients With Moderate To Severe Chronic Plaque Psoriasis

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

The main objective of this study is to evaluate the long-term safety of CP-690,550 in patients being treated for moderate to severe chronic plaque psoriasis. This is an open label extension study available to patients who participated in one of the qualifying studies with CP-690,550 providing entry criteria is met.

NCT ID: NCT01151137 Terminated - Atrial Fibrillation Clinical Trials

Permanent Atrial fibriLLAtion Outcome Study Using Dronedarone on Top of Standard Therapy

PALLAS
Start date: July 2010
Phase: Phase 3
Study type: Interventional

Primary Objective: - Demonstrate the efficacy of Dronedarone in preventing major cardiovascular events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death) or unplanned cardiovascular hospitalization or death from any cause in patients with permanent Atrial Fibrillation [AF] and additional risk factors Secondary Objective: - Demonstrate the efficacy of Dronedarone in preventing cardiovascular death This was an event-driven study where a common study end date [CSED] was to be determined by Steering Committee based on the number of events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death).