The company said the other co-primary endpoint, defined as FEV1 from baseline to two hours post-dosing on day 28, still met protocol-defined success criteria, and reanalysis of the post-dose measure actually revealed an incrementally stronger signal of drug effect than the initial analysis
Bayer HealthCare Pharmaceuticals Inc., of Wayne, N.J., a subsidiary of Bayer AG, said its Phase III GRID (GIST – Regorafenib in Progressive Disease) trial evaluating investigational compound regorafenib (BAY 73-4506) in patients with progressive metastatic and/or unresectable gastrointestinal stromal tumors (GIST) met its primary endpoint of statistically significant improvement in progression-free survival
Primary endpoint data on efficacy and safety of albiglutide across seven Phase III studies supported progression to regulatory submissions for the drug as a possible once-weekly treatment for Type II diabetes
Novartis AG, of Basel, Switzerland, said the first three Phase III studies of QVA149 (indacaterol/glycopyrronium bromide) to treat chronic obstructive pulmonary disease (COPD) met their primary endpoints
Inc., of Indianapolis, published new Phase II data in The New England Journal of Medicine showing that ixekizumab (LY2439821), an anti-IL-17 monoclonal antibody, met its primary endpoint of achieving at least a 75 percent improvement in psoriasis area and severity index (PASI) scores from baseline
The study will be randomized and double-blind, comparing once-daily LCP-Tacro to twice-daily Prograf with a composite primary endpoint including biopsy-proven acute rejection, graft failure, loss to follow-up or death
Allergan Inc., of Irvine, Calif., said two Phase III trials of Botox (onabotulinumtoxinA) met their primary endpoints in overactive bladder, with data from both studies showing that Botox significantly reduced urinary incontinence episodes compared to placebo in patients not adequately managed by an anticholinergic treatment
The randomized, double-blind trial will compare farletuzumab at two doses in combination with second-line standard of care against standard of care and placebo with a primary endpoint of progression-free survival...With data from that site included, the study did not meet its primary endpoint, as measured using the Abnormal Involuntary Movement Scale
Among patients treated with Dificid, 87.7 percent achieved the primary endpoint of clinical cure, compared to 86.8 percent of patients treated with vancomycin
Addex Therapeutics SA, of Geneva, reported top-line data showing that a Phase IIa trial testing dipraglurant, a small-molecule allosteric modulator, in Parkinson's disease patients suffering from debilitating levodopa-induced dyskinesia (LID) met its primary endpoint, with the drug exhibiting a good safety and tolerability profile
Data from the trials, dubbed RENAISSANCE 4 and RENAISSANCE 5, showed that TC-5214 failed to meet the primary endpoint of change on the Montgomery-Asberg Depression Rating Scale compared to placebo when added to antidepressant therapy in patients who did not respond adequately to initial antidepressant treatment
The amended protocol calls for both groups to receive the same chemotherapy regimen, and it will revise underlying timing assumptions, which could move the primary endpoint forward, as early as 2014...The trial met its primary endpoint of exercise tolerance, with an average improvement of 21 percent compared to placebo
The study is targeted to enroll 744 patients, and the primary endpoint is sustained virological response at 12 weeks (SVR12...The primary endpoint of that study is SVR12
In the intravenous Zemplar group, 57.7 percent of patients achieved the primary endpoint of a mean intact parathyroid hormone level of 150 pg/mL to 300 pg/mL during weeks 21 and 28 vs. 32.7 percent in the cinacalcet group (p = 0.016
The primary endpoint of the trial will be change in pulmonary function after three treatment cycles, or about six months