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INTERVENTIONAL MANAGEMENT OF STROKE TRIAL CLINICAL PROTOCOL - IMS III
A phase III, randomized, multi-center, open label, 900 subject clinical trial that will examine whether a combined intravenous (IV) and intra-arterial (IA) approach to recanalization is superior to standard IV rt-PA (Activase®/Actilyse®) alone when initiated within three hours of acute ischemic stroke onset.

The primary objective of the trial is to determine if ischemic stroke subjects with a baseline NIH Stroke Scale Score (NIHSSS] >= 10 (8-9 with positive CTA) treated with recombinant tissue plasminogen activator (rt-PA; [Alteplase recombinant…

Evaluation of the effectiveness, safety, and tolerability of tapentadol PR versus a combination of tapentadol PR and pregabalin in subjects with severe chronic low back pain with a neuropathic pain component

Primary objectiveThe primary objective is to evaluate the effectiveness, safety, and tolerability of increasing doses of tapentadol PR (300 mg per day after run in, up titration to 500 mg per day) versus a combination of tapentadol PR (300 mg per…

A Randomized, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of JNJ 28431754 on Cardiovascular Outcomes in Adult Subjects With Type 2 Diabetes Mellitus

In subjects with T2DM, with inadequate glycemic control, who have a history or high risk of CV disease:Primary Objectives*to assess the effect of canagliflozin plus standard of care relative to placebo plus standard of care on CV risk as measured by…

A Phase IIIb Double-Blind, Randomised, Placebo-Controlled Study of Patient Reported Outcomes in Friedreichâ¤*s Ataxia Patients after withdrawal from Treatment with Idebenone (PROTI Study)

The primary objective of the PROTI study is to establish whether patients can correctly determine which treatment assignment they received during the randomised phase of the trial.The key secondary objective is to compare the rate of withdrawal from…

MEA115575: A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of Mepolizumab Adjunctive Therapy to Reduce Steroid Use in Subjects with Severe Refractory Asthma (MEA115575)

Primary: To compare the effects of mepolizumab adjunctive therapy with placebo on reducing the use of maintenance oral corticosteroids (OCS).Secondary: Safety, tolerability, other efficacy parameters, quality of life.

A randomised, double-blind, placebo-controlled,
multicentre prospective dose-finding Phase II/III study
with atacicept given subcutaneously to subjects having
recently experienced a flare of systemic lupus
erythematosus (SLE)

PRIMAIRYThe primary objective of this trial is to evaluate the efficacy of atacicept compared to placeboin preventing new flares in subjects with SLE.SECONDARYSecondary objectives of the trial are:• To evaluate the safety and tolerability profile of…

An open-label, randomized, Phase IIIb trial evaluating the efficacy and safety of standard of care +/- continuous bevacizumab treatment beyond progression of disease (PD) in patients with advanced non-squamous non-small cell lung cancer (NSCLC) after first (1st)-line treatment with bevacizumab plus a platinum doublet-containing chemotherapy

The main aim of this study is to find out if the continuation of bevacizumab, in addition to standard 2nd & 3rd -line treatment, can help patients with NSCLC that has progressed to live longer. The study also aims to find out if continued…

A Phase 3, Randomized, Two-Arm, Open-Label, Multicenter, International Trial of Alisertib (MLN8237) or Investigator*s Choice (Selected Single Agent) in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma

Primary:* To determine if alisertib improves overall response rate (ORR; complete response [CR] plus partial response [PR]) versus a selection of single agents in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL)* To determine…

A randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate cardiovascular outcomes during treatment with lixisenatide in type 2 diabetic patients after an Acute Coronary Syndrome event

The primary objective of this phase III study is to demonstrate that lixisenatide can reduce cardiovascularmorbidity and mortality (composite endpoint of cardiovascular (CV) death, non-fatal myocardialinfarction (MI), non-fatal stroke,…

Protocol I1V-MC-EIAN Assessment of Clinical Effects of Cholesteryl Ester Transfer Protein Inhibition with Evacetrapib in Patients at a High-Risk for Vascular Outcomes - the ACCELERATE Study

The primary objective of this study is to test the hypothesis that evacetrapib 130 mg daily, in comparison to placebo, reduces the incidence of the composite endpoint of cardiovascular (CV) death, myocardial infarction (MI), stroke, coronary…

A Phase 3, Randomized, Controlled Study of Cabozantinib (XL184) vs Everolimus in Subjects with Metastatic Renal Cell Carcinoma that has Progressed after Prior VEGFR Tyrosine Kinase Inhibitor Therapy

The objective of this study is to evaluate the effect of cabozantinib compared with everolimus on progression-free survival (PFS) and overall survival (OS) in subjects with advanced renal cell cancer that has progressed after prior VEGFR tyrosine…

A Multicenter, Phase III, Randomized, Placebo-Controlled Trial to Assess the Safety and Efficacy of MK-3102 Monotherapy in Subjects with Type 2 Diabetes Mellitus and Inadequate Glycemic Control

The purpose of this study is: * To test the safety of the research study drug MK-3102.* To assess how well the research study drug MK-3102 lowers blood sugar levels (fasting plasma glucose [FPG], post meal glucose [PMG], and glycosylated hemoglobin…

Double-blind, double-dummy, randomised, placebo-controlled, multi-centre phase III study on the efficacy and tolerability of a 8-week treatment with 9 mg budesonide vs. 3 g mesalazine vs. placebo in patients with lymphocytic colitis

To evaluate the efficacy of 9mg budesonide/day and 3g mesalazine/day compared to placebo for the induction of remission in lymphocitic colitis.

Randomised controlled study comparing AEZS-108 with doxorubicin as second line therapy for locally advanced, recurrent or metastatic endometrial cancer

1. Overall survival (primary efficacy endpoint)2a. Efficacy: progression-free survival (PFS), overall response rate (ORR = CR + PR), and a clincal benefit rate (CBR) will be evaluated as CR + PR + SD for at least 3 months.2b. Safety: adverse events…

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Tadalafil for Duchenne Muscular Dystrophy

The primary objective is to test the hypothesis that once daily tadalafil administered orally for 48 weeks lessens the decline in ambulatory ability as measured by the 6MWD compared to placebo in boys with Duchenne muscular dystrophy (DMD). Two…

A Phase 3, Open Label Study to Evaluate Switching from a TDF-Containing Combination Regimen to a TAF-Containing Combination Single Tablet Regimen (STR) in Virologically Suppressed, HIV 1 Positive Subjects

The primary objective of this study is:• To evaluate the non-inferiority of switching to a TAF Containing STR relative to maintaining TDF Containing Regimens in Virologically Suppressed HIV-1 positive subjects as determined by having HIV 1 RNA * 50…

Off taRget Effects of Linagliptin monothErapy on Arterial Stiffness in Early diabetes

1. To assess whether linagliptin compared with placebo improves arterial stiffness in treatment naïve subjects with type 2 diabetes.2. To assess whether linagliptin compared with placebo improves blood pressure parameters, inflammatory and…

A randomized, double-blind, placebo-controlled, multi-center study to evaluate the safety and efficacy of eculizumab in subjects with refractory generalized myasthenia gravis (gMG)

Main Objective:Assess the efficacy of eculizumab as compared with placebo in the treatment of refractory gMG based on the improvement in the MG specific Activities of Daily Living profile (MG-ADL).Secondary Objectives: - Safety and tolerability of…

A randomized, 30-week, active-controlled, open label, 2-treatment arm, parallel-group, multicenter study comparing the efficacy and safety of the insulin glargine/lixisenatide fixed ratio combination to insulin glargine with or without metformin in patients with T2DM

Primary: To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination to insulinglargine in HbA1c change from baseline to week 30.Secondary: To compare the overall efficacy and safety of insulin glargine/lixisenatide…

A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T)

Primary Objective is to evaluate the long-term safety of sirukumab in subjects with RA who are refractory to DMARDs or anti-TNF* agents.The secondary objectives are to observe the following long-term effects of sirukumab in subjects with RA who are…