In separate news, Pfizer reported data from a Phase IV study testing Pristiq (desvenlafaxine) extended-release tablets, showing that the trial met its primary endpoint and supports the efficacy of 50 mg/day and 100 mg/day doses of Pristiq vs
The primary endpoint of the studies will be the proportion of patients with viral load < 50 copies/mL at 48 weeks of treatment...The primary endpoint is progression-free survival per independent review facility assessment using the revised response criteria for malignant lymphoma
Results showed that patient groups in the evaluable per protocol population that added Cycloset to their treatment regimens achieved a 0.60 percent to 0.70 percent reduction in HbA1c (p < 0.0001) relative to placebo after 24 weeks, hitting the primary endpoint of the study
Teva Pharmaceutical Industries Ltd., of Jerusalem, said top-line results of its Phase III program testing narcolepsy drug Nuvigil (armodafinil) as adjunct therapy in adults with major depression associated with bipolar I disorder showed that the drug produced a numerical improvement but did not reach statistical significance in meeting its primary endpoint – determining whether armodafinil treatment, at a dosage of 150 mg per day, is more effective than placebo as adjunct therapy to mood
The primary endpoint will be improvement in visual acuity (VA), while secondary endpoints will include measurements of changes in VA and central macular thickness
Amgen Inc., of Thousand Oaks, Calif., reported top-line Phase III results for Aranesp (darbepoetin alfa) showing that the trial did not meet its primary endpoint of reducing the composite endpoint of time to death from any cause or first hospital admission for worsening heart failure
About 150 patients will be enrolled, and the primary endpoint is the change in the maximal walking distance from baseline during an exercise treadmill test
The 16-week study will enroll 180 patients to receive repeated doses of KB001-A, with the primary endpoint defined as the time to need for antibiotics to treat worsening of respiratory tract signs and symptoms
The trial will enroll about 200 patients, randomized to OCA or placebo, and will have a primary endpoint of histologic improvement...The primary endpoints of the study are mean change from baseline in inferior corneal staining score and mean eye dryness score at 12 weeks
Top-line data revealed that at the early clinical evaluation point, between 48 hours and 72 hours of treatment initiation, 90.9 percent of subjects were considered to be stable or improving in investigator assessments, meeting the primary endpoint of the study...The primary endpoint is visual function, with secondary endpoints including neurological and neuromuscular function and disease-relevant biomarkers
Boehringer Ingelheim GmbH, of Ingelheim, Germany, and Eli Lilly and Co., of Indianapolis, said top-line results showed that all four Phase III studies of empagliflozin, a sodium glucose co-transporter-2 inhibitor, in Type II diabetes met their primary endpoints, defined as significant changes in HbA1c from baseline compared to placebo, with the 10-mg and 25-mg doses
As initially reported in December, preliminary top-line data showed that dalbavancin achieved its primary endpoint of noninferiority at 48 to 72 hours following initiation of therapy, as determined by the cessation of spread of the lesion and resolution of fever...Durata said the secondary endpoint of clinical success at the end of treatment – the expected primary endpoint for regulatory review in Europe – also was met
placebo, with a primary endpoint of resolution of infection in the medical judgment of each treating physician in accordance with the standardized guidance set forth in the 2012 Infectious Disease Society of America Clinical Practice Guideline for the Diagnosis and Treatment of Diabetic Foot Infections...Last year, the drug failed to meet the primary endpoint of improving overall survival in a Phase III trial in non-small-cell lung cancer. (See BioWorld Today, May 23, 2012
The primary endpoint is disease control rate at 16 weeks, while secondary endpoints will include the incidence and severity of adverse events, global DNA methylation levels, methylation status of selected tumor suppressor genes in tumor tissue, progression-free survival and overall survival
Merck and Co Inc., of Whitehouse Station, N.J., reported that its large study of Tredaptive (extended-release niacin/laropiprant) missed its primary endpoint
The primary endpoint is the normalized number of angioedema attacks recorded during each treatment period, while secondary endpoints will assess attack severity, quality-of-life parameters and number of angioedema attacks requiring acute treatment
The study met its primary endpoint, with Neulasta significantly reducing the incidence of febrile neutropenia