12 results
Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects with Moderate to Severe Crohn*s Disease.
1.1 Safety To evaluate the safety of long-term exposure with AMG 827 in subjects with Crohn*s disease 1.2 Efficacy * To evaluate the efficacy of AMG 827 as measured by the Harvey-Bradshaw Index (HBI) and the Crohn*s Disease Activity Index (CDAI)* To…
Objectives:The following objectives are designed to address the effects of SCH 530348 when administered orally in addition to the standard of care for a minimum of 1 year in subjects with documented atherosclerotic disease.Primary Objective: The…
The purpose of this study is to evaluate the single dose pharmacokinetics and pivotal bioequivalence of Darunavir (DRV) 800 milligram (mg), Emtricitabine (FTC) 200 mg, and tenofovir alafenamide (TAF) 10 mg when administered as a fixed dose…
Primary objective: * To assess the treatment effect on progression-free survival in patients who receive AUY922 on a once-weekly schedule versus patients who receive docetaxel or irinotecanSecondary Objectives* To estimate the overall survival…
Primary Objective: The primary objective is to determine if AMG 827 is effective compared to placebo as measured by change in Asthma Control Questionnaire (ACQ) composite scores from baseline to week 12. Secondary Objectives: Evaluate the efficacy…
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
Efficacy Objectives:- Primary objective of this study is to demonstrate non inferior efficacy of PGL4001 versus GnRH-agonist to reduce, prior to surgery, excessive uterine bleeding caused by uterine myomas.- Secondary objectives are to demonstrate…
Objectives:Primary Objective:* To compare the overall survival (OS) distributions of RP101 and gemcitabine to placebo and gemcitabine in subjects with unresectable, locally advanced or metastatic pancreatic adenocarcinomaSecondary Objectives:* To…
The primary objective of this study is to assess the efficacy and safety of Genz-112638 compared with Cerezyme after 52 weeks of treatment in patients with Gaucher disease type 1 who have been stabilized with Cerezyme. The secondary objective of…
The objectives of STIMO-2 are to demonstrate the safety and feasibility and to obtain preliminary evidence on the effectiveness of mobility rehabilitation facilitated by TESS to improve neurological recovery when this intervention is delivered in…
The primary objective of this study is to investigate if the use of Heli-FX EndoAnchors in conjunction with placement of aortic stent grafts under instructions for use (IFU) conditions in aneurysms with a wide neck is superior to treatment with…