Up to 196 patients will be enrolled, and the primary endpoints are reduction in prostate-specific antigen levels and safety...The primary endpoint of the study is immune-related progression-free survival at six months

Results showed that dalbavancin achieved its primary endpoint of noninferiority at 48 hours to 72 hours after initiation of therapy, as determined by the cessation of spread of the lesion, as well as the resolution of fever...Durata said the key secondary endpoints were supportive of the primary endpoint

The study, which will enroll up to 80 subjects and will determine safety as the primary endpoint, is expected to complete in the first half of 2013...The primary endpoint is the change in mean spontaneous pain intensity score between baseline and the last week of 28 days of dosing using the Numeric Pain Rating Scale

Iroko Pharmaceuticals LLC, of Philadelphia, reported that a Phase III study of submicron indomethacin for postsurgical pain met its primary endpoint of significant pain relief compared to placebo

As reported previously, Study 202 met its primary endpoint of increased novel dystrophin as assessed in muscle biopsies at week 48 and is now in the long-term extension phase in which patients continue to be followed for safety and clinical outcomes

The study enrolled 2,051 subjects at 127 sites in 13 countries, and was designed to evaluate safety and efficacy, with a primary endpoint of mortality or death over two years, and a secondary endpoint of treatment emergent adverse events

The primary endpoint of the study is overall survival, and the objective is to demonstrate superiority of elacytarabine over current therapies...The primary endpoints of the study are safety and the change in peak walking time at six months compared to baseline

The primary endpoint is improvement in pain, while secondary or exploratory endpoints will assess improvement in other established fibromyalgia measures and the drug's effect on co-morbidities such as fatigue

The primary endpoint of the double-blind study was safety and tolerability of the vaccine four weeks after the third injection

The primary endpoint is change in the mean target to background ratio of a radioactive tracer assessed by PET/CT scan after three months of treatment

Top-line data from the PEARL-SC trial, presented in June, showed the drug missed its primary endpoint, defined as clinical improvement at 24 weeks in the SLE responder index, but further data showed that the BAFF inhibitor produced sustained and greater treatment effects vs

The study will evaluate the effects of once-daily dosing of AC-1204 for 26 weeks on cognition, pharmacokinetic measures, activities of daily living, resource utilization and quality of life among subjects with mild-to-moderate AD with a primary endpoint tagged to the effects of AC-1204 on memory and cognition as measured by the Alzheimer's Disease Assessment Scale-cognitive subscale after 26 weeks among both carriers and noncarriers of the epsilon 4 variant of the gene apolipoprotein E...It is

The primary endpoint of the randomized, double-blind, vehicle-controlled study enrolling 1,655 subjects was complete cure rate at week 52

The study is expected to enroll 270 patients with histological diagnoses of NASH, and the primary endpoint is to demonstrate the drug's efficacy at one year of treatment vs

Data, however, showed the co-primary endpoint of overall survival (OS) failed to reach statistical significance (p = 0.2135

Pfizer Inc., of New York, said top-line data from a Phase III study testing pregabalin controlled-release (CR) formulation in patients with fibromyalgia indicated that the product had a statistically significant positive effect compared to placebo in the primary endpoint, defined as time to loss of therapeutic response...The first study in partial onset seizures did not meet its primary endpoint

Pfizer Inc., of New York, said top-line results from a Phase III study testing the 165-mg dose and the 330-mg dose of pregabalin controlled-release (CR) formulation in adults with partial onset seizures showed that the trial did not meet its primary endpoint comparing the change in seizure frequency to placebo, although both doses were well tolerated

The primary endpoint of the study was controlling growth or recurrence of the cancer six months after treatment, equivalent to surgery as compared to historical controls

The primary endpoint is the Newcastle Paediatric Mitonchondrial Disease Scale, while secondary endpoints will measure effects using neurologic, muscular, imaging and biomarker indices...The study is measuring the feasibility of the injection of NBTXR3 and its activation by radiotherapy in small and big tumors and evaluating the product's safety profile as the primary endpoints