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NCT ID: NCT01711125 Completed - Alcohol Dependence Clinical Trials

Baclofen in the Treatment of Alcohol Dependence With or Without Alcoholic Liver Disease

BacALD
Start date: March 2013
Phase: Phase 3
Study type: Interventional

To explore the effectiveness and biobehavioural basis of baclofen in improving treatment outcomes for alcohol dependence in people with or without alcoholic cirrhosis in a double-blind randomised placebo-controlled trial.

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: NCT01708629 Terminated - Plaque Psoriasis Clinical Trials

Efficacy and Safety of Brodalumab Compared With Placebo and Ustekinumab in Moderate to Severe Plaque Psoriasis Subjects

AMAGINE-3
Start date: September 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of brodalumab at two different doses compared with placebo in participants with moderate to severe plaque psoriasis. A second purpose of this study is to assess the safety and efficacy brodalumab at two different doses compared with ustekinumab in participants with moderate to severe plaque psoriasis. A third purpose of this study is to assess the safety and efficacy of 4 maintenance regimens of brodalumab.

NCT ID: NCT01708603 Terminated - Clinical trials for Moderate to Severe Plaque Psoriasis

P3 Study Brodalumab in Treatment of Moderate to Severe Plaque Psoriasis

AMAGINE-2
Start date: August 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of brodalumab at two different doses

NCT ID: NCT01708174 Completed - Medulloblastoma Clinical Trials

A Phase II Study of Oral LDE225 in Patients With Hedge-Hog (Hh)-Pathway Activated Relapsed Medulloblastoma (MB)

Start date: May 6, 2013
Phase: Phase 2
Study type: Interventional

This Phase II study evaluated the safety and efficacy of LDE225 in adult and pediatric patients with Hh-pathway activated, relapsed MB.

NCT ID: NCT01707394 Completed - Thromboembolism Clinical Trials

Study to Evaluate a Single Dose of Apixaban in Pediatric Participants at Risk for a Thrombotic Disorder

Start date: January 10, 2013
Phase: Phase 1
Study type: Interventional

CV185118 is a single dose Apixaban PK/PD study in pediatric participants. The objective of this study is primarily to study the PK/PD of Apixaban in pediatric participants at risk for thrombosis

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: NCT01705704 Completed - Clinical trials for Hepatitis B, Chronic

A Retrospective Biomarker Study of Stored Samples Obtained From Patients With Chronic Hepatitis B

Start date: June 2012
Phase: N/A
Study type: Observational

This retrospective study will evaluate the association of biomarkers and the treatment response of patients with chronic hepatitis B, who have completed therapy with Pegasys (peginterferon alfa-2a) ± lamivudine. For the analysis stored serum samples obtained from patients will be used; no actual patients are involved.

NCT ID: NCT01705080 Terminated - Hypertension Clinical Trials

IntErnational Long-term Follow-up Study of Patients With Uncontrolled HyperTensioN

EnligHTN-II
Start date: January 17, 2013
Phase:
Study type: Observational

The purpose of this post market clinical investigation is to further evaluate the safety and performance of the EnligHTN™ Renal Denervation System in the treatment of patients with uncontrolled hypertension.