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NCT ID: NCT01633112 Terminated - Clinical trials for Relapsing-remitting Multiple Sclerosis (RRMS)

MS Study Evaluating Safety and Efficacy of Two Doses of Fingolimod Versus Copaxone

ASSESS
Start date: August 9, 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study was to demonstrate that at least one dose (0.5 mg followed by 0.25 mg) of fingolimod is superior to glatiramer acetate 20 mg SC in reducing the ARR up to 12 months in patients with relapsing-remitting MS

NCT ID: NCT01536418 Terminated - Crohn's Disease Clinical Trials

An Active Treatment Study to Induce Clinical Response and/or Remission With GSK1605786A in Subjects With Crohn's Disease

SHIELD-4
Start date: November 11, 2011
Phase: Phase 3
Study type: Interventional

This is a multi-centre, randomised, double-blind, active treatment, parallel group induction study in subjects with moderately-to-severely active Crohn's disease. Subjects will receive one of two doses (500 milligrams once daily, 500 milligrams twice daily) of GSK1605786A for 12 weeks. The primary objective of the study is to induce clinical response (Crohn's Disease Activity Index [CDAI] decrease from baseline of at least 100 points) and/or remission (CDAI score less than 150) with GSK1605786A at Week 12 in subjects with active Crohn's disease to qualify subjects for enrolment into a 52 week maintenance study (CCX114157). Secondary objectives will include assessment of the safety and evaluation of the efficacy in induction of clinical response or remission. Safety will be assessed by recording of adverse events and assessment of changes in clinical laboratory parameters, vital signs and electrocardiogram. Population pharmacokinetics will evaluate the two doses of GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire, SF-36, EQ-5D, and Work Productivity and Activity Impairment-Crohn's Disease.

NCT ID: NCT01512199 Terminated - Clinical trials for Metastatic Breast Cancer

Phase 1b/2 Study of U3-1287 in Combination With Trastuzumab Plus Paclitaxel in Newly Diagnosed Metastatic Breast Cancer (MBC)

Start date: November 2011
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 1b/2 study. In Phase 1b portion, subjects will know the treatment they are receiving . Subjects will receive U3-1287 with trastuzumab plus paclitaxel . The phase 1b portion will determine if adding U3-1287 to trastuzumab plus paclitaxel will be safe in subjects with metastatic breast cancer. In phase 2 portion, subjects will be blinded to the treatments they are receiving . Subjects will receive either trastuzumab plus paclitaxel with U3-1287 or trastuzumab plus paclitaxel and placebo.The phase 2 portion will determine if adding U3-1287 to trastuzumab plus paclitaxel will be safe and improve survival in subjects with metastatic breast cancer.

NCT ID: NCT01506401 Terminated - Clinical trials for Acute Respiratory Distress Syndrome (ARDS)

The Oscillation for Acute Respiratory Distress Syndrome (ARDS) Treated Early (OSCILLATE) Trial

OSCILLATE
Start date: June 2009
Phase: Phase 3
Study type: Interventional

What is the effect of early high frequency oscillation (HFO) versus a lung-protective conventional ventilation (CV) strategy (using HFO only as rescue therapy), on all-cause hospital mortality among patients with severe early acute respiratory distress syndrome (ARDS)?

NCT ID: NCT01489046 Terminated - HIV-1 Infection Clinical Trials

Safety, Efficacy and Dose-response Study of BMS-986001 in Subjects With HIV-1 Infection Who Are Treatment-naive

Start date: February 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to identify at least one dose of BMS-986001 which is safe, well tolerated, and efficacious when combined with Efavirenz (EFV) + Lamivudine (3TC) for treatment-naive Human Immunodeficiency Virus 1 (HIV-1) infected subjects

NCT ID: NCT01480245 Terminated - Clinical trials for Muscular Dystrophies

Open Label Study of GSK2402968 in Subjects With Duchenne Muscular Dystrophy

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

The purpose of this study is to explore long-term safety, tolerability and efficacy of GSK2402968 in DMD subjects who previously participated in either DMD114117 or DMD114044.

NCT ID: NCT01467713 Terminated - Bipolar Disorder Clinical Trials

Efficacy and Safety of Ramelteon Sublingual as Adjunctive Therapy for Maintenance Treatment of Bipolar I Disorder in Adult Patients

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

The purpose of this study is to determine the efficacy and safety of ramelteon, once nightly before bedtime (QHS), sublingual (SL), in the maintenance treatment of Bipolar I Disorder in adult patients.

NCT ID: NCT01467700 Terminated - Clinical trials for Acute Depressive Episode

Efficacy and Safety of Ramelteon Sublingual in Adult Patients With Acute Depressive Episodes Associated With Bipolar I Disorder

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

The purpose of this study is to determine the efficacy and safety of Ramelteon, once daily (QD), sublingual (SL), in adult patients with acute depressive episodes associated with Bipolar I disorder.

NCT ID: NCT01436175 Terminated - Clinical trials for Major Depressive Disorder

SPD489 Adult Major Depressive Disorder (MDD) Open-label Safety and Tolerability Rollover Extension Study

Start date: February 27, 2012
Phase: Phase 3
Study type: Interventional

This study is an optional continuation of previous short-term adult major depressive disorder (MDD) augmentation studies. Patients may only take part in this long-term, open-label research study if they completed a previous double-blind MDD augmentation study using SPD489.

NCT ID: NCT01345669 Terminated - Clinical trials for Head and Neck Neoplasms

LUX-Head&Neck 2: A Phase III Trial of Afatinib (BIBW 2992) Versus Placebo for the Treatment of Head and Neck Squamous Cell Cancer After Treatment With Chemo-radiotherapy

Start date: October 17, 2011
Phase: Phase 3
Study type: Interventional

This randomised, double-blind phase III trial will be performed in patients with head and neck squamous cell carcinoma (HNSCC). The objectives of the trial are to compare the efficacy and safety of afatinib (BIBW 2992) with placebo as adjuvant therapy to patients who have received definitive chemo-radiotherapy.