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A multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety, preliminary clinical activity and immunogenicity of multiple doses of MOR103 administered intravenously to patients with active rheumatoid arthritis.

Primary objective:To determine the safety and tolerability of multiple doses of MOR103 in patients with active rheumatoid arthritis, at ascending dose levels.Secondary objectives:- to evaluate signs of efficacy of MOR103 in patients with active…

A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Determine
the Efficacy, Safety, and Tolerability of AMG 785 in Adults with Fresh Unilateral
Hip Fracture, Status Post Surgical Fixation

To investigate the effect of AMG 785 compared to placebo on functionalhealing as measured by the timed-up-and-go test (TUG) over Weeks 6 through 20 in subjectswith fresh unilateral low energetic hip (intertrochanteric or femoral neck) fracture

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 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…

The effects of ARA290 on the cognitive and neural processing of emotions in healthy volunteers

To study the effects of ARA290 on the cognitive and neural processing of emotions in healthy volunteers 7 days post-administration.

The effect of Local Infiltration Analgesia on postoperative pain in Total Knee Arthroplastia

Reduction of the postoperative pain in Total Knee Arthroplatia through the use of a peri- and intracticular injection of Local Infiltration Analgesia.

A randomized, double-blind, cross-over trial of two speech coding strategies in cochlear implantation

Hypothesis: PLS will improve speech understanding in noise in comparison to HiRes, an exisiting state-of-the-art speech coding strategy. The objective is to test this hypothesis. A secondary hypothesis is that PLS improves pitch perception. A…

A pivotal trial of safety and efficacy of ADRCs delivered via the intracoronary route in the treatment of patients with ST-elevation acute myocardial infarction â¤* The ADVANCE Trial

The objective of this study is to determine the Safety and Efficacy of ADRCs delivered via the intracoronary route in the treatment of patients with ST-elevation acute myocardial infarction (STEMI).Investigation of stem and regenerative cell therapy…

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 DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIAL
EVALUATING THE SAFETY AND EFFICACY OF EARLY TREATMENT WITH
EPLERENONE IN PATIENTS WITH ACUTE MYOCARDIAL INFARCTION

To assess the impact of eplerenone on cardiovascularmortality and morbidity in patients with acutemyocardial infarction (STEMI) when initiated withinthe first 24 hours of onset of symptoms (preferablyduring the first 12 hours)To investigate the…

A Phase 2 Study of LY2157299 Monohydrate Monotherapy or LY2157299 Monohydrate plus Lomustine Therapy compared to Lomustine Monotherapy in Patients with Recurrent Glioblastoma

The primary objective of this study is to compare the overall survival (OS) distributions between LY2157299 monohydrate plus lomustine therapy with lomustine plus placebo therapy (control arm), in patients who have relapsed or have progressive GB…

A multicenter, double blind, randomized, parallel group, placebo-controlled study to evaluate the hemodynamic responses to intravenous RLX030 infusion in subjects with acute heart failure.

Primary objective(s)• To assess the effects of RLX030 compared to placebo on hemodynamic variables (PCWP, CI) during the first 8 hours administered as i.v. infusion over 20 hours in subjects with Acute Hart FailureSecondary objective(s)• To assess…

Effect of cholecalciferol on the systolic blood pressure in hypertensive, vitamine D insufficient patients.

To evaluate the effect of cholecalciferol supplection on the systolic blood pressure in hypertensive patients with a 25-hydroxycholecalciferol insufficiency. Secondly, the effects on PRA, aldosteron, 25-hydroxycholecalciferol, alkaline phosphatase,…

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…

A randomised, multicentre, double-blind, placebo-controlled, crossover trial determining the efficacy of dry powder mannitol in improving lung function in subject with Cystic Fibrosis aged six to seventeen years.

The purpose of this trial is primarily to assess the efficacy of inhaled mannitol compared with a true placebo in subjects with cystic fibrosis aged 6 to 17 years.We hypothesize that inhaled mannitol will improve the overall health and hygiene of…

A multicenter, randomized, double blind, placebo controlled, phase II trial evaluating the safety and efficacy of TKI258 combined with fulvestrant, in postmenopausal patients with HER2- and HR+ breast cancer that have evidence of disease progression on or after prior endocrine therapy

Primary: treatment effect of TKI258 in combination with fulvestrant vs. fulvestrant plus placebo on Progression-Free Survival (voor for each of the 2 groups, namely FGF pathway amplified and regardless of FGF pathway amplification status).Secondary…

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 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE SAFETY AND EFFICACY OF 3-MONTH SUBCUTANEOUS REGN1033 TREATMENT IN PATIENTS WITH SARCOPENIA

Please refer to protocol, section 1.2 "Rationale"

A Double-blind, Placebo-Controlled, Randomized, 4-Week, Multiple-Dose, Proof-of-Mechanism Study in Subjects with Early Alzheimer*s Disease Investigating the Effects of JNJ-54861911 on Aß Processing in CSF and Plasma

This proof-of-mechanism (POM) study in subjects with early AD, being subjects asymptomatic at risk for AD and subjects with pAD, is performed to confirm a drug interaction with the intended enzyme (BACE) at the intended target location (brain) by…