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
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 Phase III study met its primary endpoint and demonstrated statistically significant protection against clinical and severe malaria in infants...The primary endpoint, the results for which were previously released, showed significantly greater (p < 0.001) improvement in nasal symptoms compared with placebo for both QNASL 160 mcg and 80 mcg over the two-week treatment period
Janssen Research & Development LLC, of Spring House, Pa., a unit of Johnson & Johnson, said a Phase IIb study testing Stelara (ustekinumab) in moderate to severe Crohn's disease showed that, among patients who had previously failed or were intolerant to at least one tumor necrosis factor antagonist, a significantly greater proportion receiving intravenous Stelara achieved the primary endpoint of clinical response at week six, defined as a 100-point reduction in Crohn's Disease Activity Index
Pfizer Inc., of New York, said a Phase III study of Inlyta (axitinib) did not meet its primary endpoint of demonstrating statistically significantly longer progression-free survival (PFS) vs. Nexavar (sorafenib, Onyx Pharmaceuticals Inc. and Bayer AG) in treatment-naïve patients with advanced renal cell carcinoma
Eli Lilly and Co., of Indianapolis, said the Phase III REGARD trial testing ramucirumab in patients with metastatic gastric cancer met its primary endpoint of improved overall survival and also showed prolonged progression-free survival
Started in March, the Eslicarbazepine acetate in Partial-Onset Seizures study is intended to enroll about 800 patients, with a primary endpoint of six-month retention rate and other assessments, including seizure frequency, adverse events and quality of life
The primary endpoint is the annual rate of decline in forced vital capacity, while secondary endpoints include health-related quality of life, exacerbations, respiratory mortality, overall survival and on-treatment survival
Approximately 1,000 patients are enrolled in the pivotal INPULSIS Phase III trials at sites in 23 countries, with a primary endpoint of the annual rate of decline in forced vital capacity over 52 weeks
Eli Lilly and Co., of Indianapolis, said the Phase III POINTBREAK trial did not meet its primary endpoint of improved overall survival for patients with nonsquamous non-small-cell lung cancer who were randomized to receive a combination of Alimta (pemetrexed) with Avastin (bevacizumab, Roche AG) and carboplatin induction followed by Alimta plus Avastin maintenance, compared to the combination of paclitaxel with Avastin and carboplatin followed by Avastin maintenance
Sosei Group Corp., of Tokyo, said QVA149 (indacaterol maleate/glycopyrronium bromide) met the primary endpoint in its fifth Phase III trial, which enrolled more than 2,000 subjects
Additionally, the firm reported, a recently completed Phase II study testing the drug as an adjunctive treatment with atypical antipsychotics did not meet its primary endpoint
At 30 months, 13.9 percent of prasugrel patients vs. 16 percent of clopidogrel patients experienced the combined primary endpoint of heart attack, stroke or cardiovascular death in patients under 75 years of age, the primary analysis population
Pfizer Inc., of New York, reported that a Phase IV study assessing the efficacy and safety of Toviaz (fesoterodine fumarate) in patients with overactive bladder met its primary endpoint of reducing urge urinary incontinence (UUI
Teva Pharmaceutical Industries Ltd., of Jerusalem, presented Phase III results showing that lipegfilgrastim and balugrastim, long-acting granulocyte colony-stimulating factors, achieved the primary endpoint in breast cancer studies, demonstrating reduction in the duration of severe neutropenia in cycle 1, comparable to Neulasta (pegfilgrastim, Amgen Inc.) in both efficacy and safety measures
Pfizer Inc., of New York, said its ALK inhibitor Xalkori (crizotinib) met its primary endpoint in the PROFILE 1007 study, demonstrating significantly improved progression-free survival (PFS) when compared with pemetrexed or docetaxel, in previously treated patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small-cell lung cancer (NSCLC
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