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Amgen Announces Positive Top-Line Results for Denosumab in Trial for Delay of Skeletal Related Events in Bone Metastases Patients Compared to Zometa(R)

... the tumor are reduced or delayed. The primary and secondary endpoints of the denosumab bone metastases ... cancer) or multiple myeloma and bone metastases. secondary endpoints were to evaluate if denosumab is ... number of patients developing metastatic disease secondary to a primary cancer is increasing. Bone ...

Dirucotide Does Not Meet Primary Endpoint in Phase III MAESTRO-01 Trial in Secondary Progressive Multiple Sclerosis

... MAESTRO-01 Phase III trial in patients with secondary progressive multiple sclerosis (SPMS). In ... differences between dirucotide and placebo on the secondary endpoints of the study. The data also ... 30-40 percent of all MS patients have the secondary progressive form of the disease(vi), in which ...

Denosumab Demonstrates Superiority Over Zometa(R) in Pivotal Phase 3 Head-to-Head Trial in Breast Cancer Patients With Bone Metastases

... with advanced breast cancer met its primary and secondary endpoints and demonstrated superior efficacy ... tumor are reduced or delayed. The primary and secondary endpoints of the denosumab bone metastases ... with advanced breast cancer and bone metastases. secondary endpoints were to evaluate if denosumab was ...

Arena Pharmaceuticals Announces Lorcaserin Data Demonstrating Highly Significant Categorical and Absolute Weight Loss and Improvements in Secondary Endpoints Associated with Cardiovascular Risk

... improvements as compared to placebo in multiple secondary endpoints associated with cardiovascular risk. ... Center. "Lorcaserin's positive impact on multiple secondary measures has important implications for improving ... the ITT-LOCF and per protocol populations. secondary Endpoint Analysis New data demonstrate that ...

Study Demonstrating Lurasidone Is Effective in Patients With Schizophrenia Published in The Journal of Clinical Psychiatry

... improvement versus placebo in both primary and secondary efficacy assessments at all study visits starting ... BPRSd (-8.9 vs. -4.2; p=0.012), as well as on all secondary efficacy measures, including the PANSS (Positive ... was the BPRSd extracted from the PANSS. The secondary efficacy measures included the PANSS total and ...

Video: UCB Launches Vimpat(R) in the U.S. for Add-On Treatment of Epilepsy in Adults

... of partial onset seizures with or without secondary generalization in patients with epilepsy age 16 ... uncontrolled seizures or significant side effects secondary to medication. This highlights the ongoing need ... of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 16 ...

Results of Two Phase 3 CAPACITY Studies of Pirfenidone in IPF Presented at American Thoracic Society (ATS)

... significance in CAPACITY 2 (p=0.001). The secondary endpoints of progression-free survival (PFS) and ... endpoint of change in percent predicted FVC and secondary endpoints of progression-free survival and ... 2, p=0.004 and CAPACITY 1, p=0.001). secondary Efficacy Endpoint Results In CAPACITY 2, ...

Ongoing Landmark ROADMAP Study Demonstrates Significant Improvement in Blood Pressure Control at One Year, According to Blinded Results

... factor of cardiovascular disease (CVD).(1) The secondary objective of the ROADMAP trial includes incidence ... and mortality. A qualitative parameter in the secondary objective was to measure cuff blood pressure ... excludes agents that directly block the RAS. The secondary objective is to test the hypothesis that ...

Anthera's Varespladib Meets Primary Endpoint in Phase 2 FRANCIS Trial for the Treatment of Acute Coronary Syndrome

... - Favorable results for secondary endpoints support outcomes benefit HAYWARD, ... positive results for all clinically important secondary endpoints. The initial data review demonstrated: ... "In addition to meeting the primary and several secondary endpoints, clinical data from the FRANCIS study ...

Two-Year Phase III Data Presented at AAN 61st Annual Meeting Show Positive Outcome of Cladribine Tablets in Patients With Multiple Sclerosis

... a Significant Reduction in Relapse Rate - secondary Endpoints met Including MRI Measures, Proportion ... (AAN) in Seattle, WA. "All primary and secondary endpoints of the CLARITY study were statistically ... of patients who remained relapse-free (one secondary endpoint of the trial) was significantly higher ...

Schering-Plough Highlights Hepatitis C Clinical Data Presentations at the European Association for the Study of the Liver (EASL) Annual Meeting

... of experts blinded to the study arm. The secondary efficacy analyses included time to disease ... significant difference. However, in the secondary efficacy analysis there were 87 clinical events ... The main events causing the difference on secondary analysis were emergence or enlargement of varices ...

Schering-Plough Announces Results of the Early ACS Trial

... failed to achieve either the primary or secondary endpoints of the trial. Significantly higher ... or thrombotic bailout through 96 hours. The secondary endpoint was death or (re)MI at 30 days. Safety ... between the groups in either the primary or secondary endpoints. The primary endpoint occurred in 9.3 ...

Schering-Plough's Investigational Oral Thrombin Receptor Antagonist Meets Primary Endpoint in a Newly Published Study

... (TRAP)-induced platelet aggregation inhibition, a secondary endpoint. Thrombin is the most potent platelet ... of TRA in patients undergoing PCI. A secondary objective was to assess whether patients treated ... The Phase III Thrombin Receptor Antagonist in secondary Prevention of Atherothrombotic Ischemic Events ...

Video: Zometa(R) Reduces Risk of Breast Cancer Recurrence in Premenopausal Women, Study in The New England Journal of Medicine Reports

... overall survival and bone-mineral density were secondary endpoints. Disease-free survival was defined as ... contralateral breast cancer, distant metastasis, secondary carcinoma and/or death from any cause. ... breast cancer, distant metastasis and/or secondary carcinoma. Exploratory endpoints included bone ...

Merck Serono's Safinamide Significantly Improved Motor Function in Patients With Advanced Parkinson's Disease in a Phase III Pivotal Trial

... mid- to Late-Stage Parkinson's Disease -- secondary Efficacy Endpoints of the Study Analyzed to Date ... effect on dyskinesias as primary endpoint. secondary efficacy endpoints of this study were also met, ... in the dopaminergic neurons of the brain. secondary symptoms may include high-level cognitive ...

Alexza's AZ-004 (Staccato(R) Loxapine) Meets Primary Endpoint of Treating Acute Agitation in Patients with Bipolar Disorder in Phase 3 Trial

... positive top-line results for the primary and secondary endpoints," said James V. Cassella, PhD, Alexza ... 12.9 - Key secondary Efficacy Endpoint A Clinical Global ... completed for each patient. CGI-I was the key secondary endpoint of the study. Both the 10 mg and the 5 ...

Research Highlights New Approaches to Prevent Blood Clots in Several High-Risk Patient Populations Including Largest Study Ever to Examine Use of Blood-Thinning Medication in Patients With Cancer

... manner to idraparinux (i.e., bioequipotency). The secondary objective of the study was occurrence of ... which might be indicative of hepatic toxicity. secondary endpoints included major adverse cardiovascular ... were no significant differences in the rates of secondary endpoints. Once-Daily Oral Rivaroxaban ...

ISTA Pharmaceuticals Announces Phase III Results for Once-Daily Topical Xibrom(TM) 0.09%

... surgery. In addition, Xibrom 0.09% QD met the secondary efficacy endpoint of elimination of ocular pain ... statistical significance in both the primary and secondary efficacy endpoints. The ER exhibited strong ... eye ("cells") and cellular debris ("flare"). The secondary efficacy endpoint was evaluated via a pain score ...

NicOx Announces Second Naproxcinod Pivotal Phase 3 Study (302) Meets Efficacy Primary Endpoints and Supports Non-Detrimental Blood Pressure Effect

... The study also comfortably met the main secondary endpoint, demonstrating that naproxcinod 750 mg ... signs and symptoms of osteoarthritis. The main secondary endpoint of the trial assessed the efficacy ... 750 mg bid comfortably met the secondary endpoint of being statistically non-inferior to ...

n-3 PUFAs Reduce Mortality and Hospital Admissions in Patients With Symptomatic Heart Failure

... * hospital for cardiovascular reasons secondary endpoint n-3 PUFAs vs ... Accordingly, current indications of n-3 PUFAs are secondary prevention in post-myocardial infarction patients ... in Europe and some Middle East countries for secondary prevention of myocardial infarction (MI) ...

Bioimpedance Spectroscopy is More Accurate and Reliable Than Other Methods of Subclinical Assessment of Lymphedema in Breast Cancer Patients, According to Paper Published in Journal of Clinical Oncology

... clinical assessment by health care providers of secondary lymphedema of the arm in women. About ... assess patients early for the potential onset of secondary lymphedema. Pre-operative clinical assessment in ... clinical assessment, by health care providers, of secondary lymphedema of the arm in women. For ...

Eisai Provides Preliminary Efficacy Update On EORTC Phase III Trial of Dacogen(R) Versus Supportive Care in Patients With Myelodysplastic Syndromes

... results of the study, including secondary efficacy endpoints and safety data, will be ... Patients included in the trial had primary or secondary MDS with or without previous therapy with growth ... study of Dacogen in 99 patients with de novo or secondary MDS. Dacogen was administered daily for five days ...

SuperGen Comments on Preliminary Efficacy Update on EORTC Phase 3 Trial of Dacogen(R) Versus Supportive Care in Patients With Myelodysplastic Syndromes

... results of the study, including secondary efficacy endpoints and safety data, will be ... Patients included in the trial had primary or secondary MDS, with or without previous therapy with growth ... treated and untreated, de novo and secondary MDS of all French-American-British (FAB) subtypes ...

Auxilium Pharmaceuticals, Inc. Announces XIAFLEX(TM) Meets Primary Endpoint With Statistical Significance (p<0.001) in CORD I Pivotal Phase III Study for Dupuytren's Contracture

... addition to the primary endpoint, there were 26 secondary endpoints that were measured, each of which was ... significance. The Company believes two important secondary endpoints are the difference between the pre- and ... the filing of the BLA; the importance of certain secondary endpoints in the CORD I trial, including the ...

QRxPharma Releases Additional Phase 3 Data for Q8003IR 'Dual Opioid' Pain Therapy

... Efficacy and Tolerability; Study Goals and secondary Endpoints Met SYDNEY, Australia and BEDMINSTER, ... and establish the preferred dose parameters. secondary endpoints included: (1) efficacy relating to the ... completed a Phase 3 study and met primary and secondary endpoints. The Company's preclinical and ...

Tioga Pharmaceuticals' Asimadoline Demonstrates Positive Results in a Phase 2b Clinical Trial for the Treatment of Irritable Bowel Syndrome

... the primary endpoint of pain, as well as secondary endpoints of urgency, frequency and bloating in ... of asimadoline in all of the following secondary endpoints: urgency, adequate relief of IBS ... significant benefit was also seen in the secondary endpoint of adequate relief of IBS ...

Study in JAMA Shows Patients Treated With Abbott's XIENCE(TM) V Drug Eluting Stent Experience Better Outcomes Than Patients Treated With Market-Leading Drug Eluting Stent

... Statistical non-inferiority to TAXUS in the major secondary (co-primary) endpoint of target vessel ... 43 percent reduction in the pre-specified secondary endpoint of major adverse cardiac events ... late loss at eight months and the major secondary (co-primary) endpoint was TVF at nine months. An ...

Study Results of GAMMAGARD S/D and GAMMAGARD LIQUID in Patients with Mild-to-Moderate Alzheimer's Disease Announced

... month data will be available later this year. secondary endpoint results suggest that levels of ... building blocks of Alzheimer's. The primary and secondary endpoint data were reported by the ... of Change (ADCS-CGIC) change rating). The secondary endpoints measured changes in beta-amyloid ...

FDA Approves MiddleBrook's Amoxicillin PULSYS for Pharyngitis/Tonsillitis in Adolescents and Adults

... and older with pharyngitis and/or tonsillitis secondary to Streptococcus pyogenes (commonly referred to ... to the comparator therapy in all primary and secondary endpoints. Important Safety Information ... the treatment of tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes in adults and ...

Indevus Reports Additional Positive Phase III Trial Data for NEBIDO(R)

... were males with a diagnosis of either primary or secondary hypogonadism, a body weight >65 kg, and at least ... a concentration of 1500 ng/dL. In addition, secondary outcomes included measurements evaluating ... improvements from baseline in the key secondary clinical outcome variables. NEBIDO was ...

NicOx Announces TOPIGEN Initiates Phase 2 Proof of Concept Study in COPD for TPI 1020

... of inhaled TPI 1020 in COPD patients. A secondary outcome will also measure the change in ... of neutrophils in the lungs. Additional secondary outcome measures will follow the effect of ... neutrophil counts between baseline and day 42. A secondary endpoint will also measure the change in sputum ...

SCH 530348 (TRA), a Novel Investigational Antiplatelet Agent, Shown to Inhibit Platelet Aggregation in PCI Patients

... an additional 60 days post-treatment. A secondary endpoint in a sub-study within the primary ... The Phase III Thrombin Receptor Antagonist in secondary Prevention of Atherothrombotic Ischemic Events ... coronary revascularization or stroke. The key secondary endpoint is the composite of cardiovascular ...

CuraGen and TopoTarget Announce Presentation of Belinostat Clinical Trial Results at AACR-NCI-EORTC International Conference

... endpoints of the study were objective response. secondary endpoints included stable disease rate, survival, ... and pharmacokinetics of oral belinostat. secondary objectives include assessment of the ... or for which no standard treatment exists. secondary endpoints included pharmacokinetics (PK), ...

R7128 Receives Fast Track Designation from the FDA for the Treatment of Chronic Hepatitis C Infection

... doses under fasting conditions. The secondary objective of Part 1 is to explore the effect of ... or twice- daily (BID) dosing for 14 days. The secondary objective is to assess antiviral activity by ... in combination with Pegasys plus Copegus. The secondary objective of Part 3 is to evaluate the short-term ...

Tezampanel Meets Primary Endpoint in Phase IIb Clinical Trial in Acute Migraine Headache

... statistical significance, improvement in key secondary measures at 40 mg, nevertheless, were either ... for the primary endpoint of the study. These key secondary measures included nausea or ... headache pain response at two hours post-dose. secondary efficacy endpoints included the traditional ...

New Analyses of Long-Term LIALDA(TM) (mesalamine) Data Presented at ACG

... -- Post-hoc and other analyses of secondary endpoints of a long-term safety and ... active, mild to moderate UC. Post-hoc analysis of secondary endpoints provided evidence that LIALDA ... Exhibit Hall B, #950 A post-hoc analysis of secondary endpoints from the long-term 303 study was ...

Pharmasset Commences Dosing in 28-Day Combination Study of R7128 with Pegasys(R) plus Copegus(R) for Hepatitis C

... doses under fasting conditions. The secondary objective of Part 1 is to explore the effect of ... or twice- daily (BID) dosing for 14 days. The secondary objective is to assess antiviral activity by ... in combination with Pegasys plus Copegus. The secondary objective of Part 3 is to evaluate the short-term ...

Pharmasset Presents R7128 Phase 1 Single Ascending Dose Study in Healthy Volunteers

... doses under fasting conditions. The secondary objective of this study was to explore the effect ... ascending doses under fasting conditions. The secondary objective of Part 1 is to explore the effect ... once-daily or twice-daily dosing for 14 days. The secondary objective is to assess antiviral activity by ...

NeurogesX Announces Positive Results from Second Phase 3 Clinical Trial in Postherpetic Neuralgia

... Trial Meets Primary and All secondary Endpoints San Carlos, Calif., Sept. 4 ... were achieved for study weeks 2-12 (p<0.02), a secondary endpoint. All other secondary endpoints, including 30% and 50% responder ...

Genzyme Announces Second Pivotal Mozobil Trial Meets Primary Endpoint

... has successfully met its primary and secondary endpoints, demonstrating positive results in ... the G-CSF/placebo group to reach this threshold. secondary outcomes were consistent with the primary ... two million cells collected in four days. Other secondary outcomes were also supportive, including the ...
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