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Thoratec Says Interim Data Analysis Demonstrates Statistical Superiority for the HeartMate II(R) in Destination Therapy Trial

PLEASANTON, Calif., Dec. 4 /PRNewswire-FirstCall/ -- Thoratec Corporation (Nasdaq: THOR ), a world leader in device-based mechanical circulatory support therapies to save, support and restore failing hearts, said today that a pre-specified interim analysis of data from its HeartMate II Destinati...

Phase III Clinical Studies of Aclidinium Bromide Show Statistical Significance vs. Placebo in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NEW YORK, Sept. 3 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. (NYSE: FRX ) and Laboratorios Almirall, S.A. today announced results from two global Phase III studies of aclidinium bromide, a novel long-acting inhaled anticholinergic for the treatment of patients with chronic obstructiv...

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

XIAFLEX also Meets Primary Endpoint (p III Study Pharmacokinetic Study Demonstrates Lack of Systemic Exposure of XIAFLEX Serious Adverse Events Occurring at a 0.33% Rate per XIAFLEX injection Conference call scheduled for today, June 3, at 8:45 a.m. Eastern T...

Positive Statistical Analysis from Synthetic Blood's Oxycyte Traumatic Brain Injury Trial Indicates Achievement of Primary Endpoint

COSTA MESA, Calif.--(BUSINESS WIRE)--May 15, 2007 - Synthetic Blood International, Inc. (OTCBB:SYBD) today announced positive data from a statistical analysis of its Phase IIa study with Oxycyte(TM) in patients with traumatic brain injury. In line with preliminary study results announced in Decembe...

Further Statistical Analysis of the Recent Phase III trial on Lead Product M6G Shows Additional Benefits

* Statistically significant reduction in sedation during the early post-operative period compared to morphine * Statistically significant reduction in nausea in the female patient population compared to morphine Cambridge, UK, 8th June 2007 - CeNeS Pharmaceuticals plc (AIM: CEN), the Cambridge...

Labopharm files New Drug Submission with Health Canada for novel antidepressant

...ne to the end of the study in the trazodone group versus the placebo group. statistical significance was achieved for the primary endpoint (p value of 0.012). The ...pression Rating Scale (MADRS) total score and a Responder's Analysis showed statistical significance in favor of the group administered Labopharm's trazodone. In a...

FDA Issues Complete Response Letter for INTUNIV(TM) (guanfacine) Extended Release for the Treatment of ADHD in Children and Adolescents

... and social resources, utilizing diagnostic criteria such as Diagnostic and statistical Manual of Mental Disorders-IV (DSM-IV(R)) or International Classification o...asrh/NC-EST2005-sa.html . Accessed July 13, 2009. 17. Diagnostic and statistical Manual of Mental Disorders. 4th ed., Text Revision (DSM-IV-TR(R)). Arlingto...

Takeda Provides Update on the Investigational Fixed-Dose Combination of alogliptin and ACTOS(R) (pioglitazone HCl)

...rapies to Treat Type 2 Diabetes," the amount of existing alogliptin clinical data in the alogliptin monotherapy NDA was not sufficient to meet certain statistical requirements outlined in that Guidance. On June 26, the FDA asked Takeda to conduct an additional cardiovascular safety trial that satisfies the Decem...

Human Genome Sciences and GlaxoSmithKline Announce Positive Phase 3 Study Results for BENLYSTA(TM) in Systemic Lupus Erythematosus

...ard of care, while the safety profile was comparable overall to placebo. BENLYSTA met the primary endpoint in this Phase 3 study at a robust level of statistical significance. BENLYSTA also significantly reduced SLE disease activity versus placebo based on a number of other measures, including SELENA SLEDAI an...

Why Do African-Americans Fare Worse With Cancer? Access and Economics Are Only Part of the Story

...ays Joseph Unger of the Southwest Oncology Group's statistical Center, who was statistician and co-author on the ...hn Crowley, Ph.D., of the Southwest Oncology Group statistical Center and Charles A. Coltman, M.D., of the Unive...s an operations office in San Antonio, Texas and a statistical center in Seattle, Wash. ...

Takeda Receives FDA Complete Response Letter for Alogliptin, an Investigational Treatment for Type 2 Diabetes

...betic Therapies to Treat Type 2 Diabetes," the FDA did not believe that the amount of existing alogliptin clinical data was sufficient to meet certain statistical requirements outlined in that Guidance. The FDA has asked Takeda to conduct an additional cardiovascular safety trial that satisfies the December 2008...

Cytel Signs Cooperative Research And Development Agreement With FDA Center for Devices and Radiological Health (CDRH)

... About Cytel Cytel Inc. is a leading provider of specialized statistical software and clinical trial services for the biopharmaceutical, medic... device, academic and government research markets. Cytel pioneered the statistical and computational science of adaptive clinical trials and has designed mo...

DIA Annual Meeting Attendees Invited to Participate in Electronic Data Capture (EDC) Clinical Trial Survey

...rom the University of Ghent, Department of Management, Innovation and Entrepreneurship is supervising the survey and will validate its methodology and statistical relevance. TechTeam is scheduled to announce the survey's findings in a webinar on October 12, 2009. About TechTeam Global, Inc. TechTeam Glo...

Alfacell Provides Shareholder Update

...int of overall survival in our Phase IIIb clinical trial in patients suffering from unresectable malignant mesothelioma (UMM). We did however; achieve statistical significance with a subgroup of patients who failed a prior chemo therapy. Overall survival was 10.5 months for this group. As we reported in January ...

VIA Pharmaceuticals Meets With FDA to Discuss Next Steps For VIA-2291 and Phase 3 Outcome Trial in Cardiovascular Disease

...- our failure to obtain sufficient data from enrolled patients that can be used to evaluate VIA- 2291, thereby impairing the validity or statistical significance of our clinical trials; -- our ability to successfully complete our clinical trials of VIA-2291 on expected timetables and the...

FDA Advisory Committee Votes in Favor of Zyprexa for Two Adolescent Indications

...l. (2007). Olanzapine versus Placebo in the Treatment of Adolescents with Bipolar Mania. Am J Psychiatry 2007, 164: 1547-1556 (9) Diagnostic and statistical Manual of Mental Disorders, Fourth Edition, pg. 385. Available at: http://www.dsmivtr.org/ . Accessed 6.3.2009 (10) Korn, M. (2002). Buildin...

Published Study Shows VNUS ClosureFAST(TM) System Significantly Superior to Laser for Varicose Vein Treatment

...ction of symptoms than laser as soon as two days after treatment, and remaining considerably better for at least two weeks or longer. In addition, all statistical differences in postprocedural and quality-of-life parameters were superior in the ClosureFAST group, and minor complications were five times less prev...

Study Results Present Efficacy and Safety Findings from the PHIRST-1 Study of Patients with Pulmonary Arterial Hypertension Taking Tadalafil Tablets Once Daily

...ed again at weeks eight and sixteen(3). Tadalafil increased 6MWD in a dose-dependent manner, only the 40 mg dose met the pre-specified level of statistical significance of less than 0.01 (p<0.01). Overall, the placebo-corrected treatment effect was 33m (95 percent confidence-interval, 15m to 50m). In t...

DOR BioPharma Receives EMEA Agreement on the Design of its Confirmatory Phase 3 Clinical Trial of orBec(R) in GI GVHD

...n (e.g., endpoints, sample size, control group and statistical analyses) is acceptable to support a regulatory su...lure rate at Study Day 80,' we expect to replicate statistical significance in this clinically meaningful endpoin...e US and France. Although orBec(R) did not achieve statistical significance in the primary endpoint of its pivota...

ISTA Pharmaceuticals Announces Positive Results for Phase 2 Study of Low-Dose Bromfenac in Dry Eye Disease

...ac ophthalmic solution) 0.09%. The study achieved statistical significance in the primary endpoint of the object... as compared to baseline. The study also achieved statistical significance on the objective sign of corneal stai...Lissamine Green test in the Phase 2 study revealed statistical significance for low-dose bromfenac versus the pat...

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

...the development of cardiac valvular insufficiency. Previously announced BLOOM data demonstrated that lorcaserin was highly efficacious, achieving statistical significance on all three co-primary efficacy endpoints, and was very well tolerated. The BLOOM results also satisfy the efficacy requirement in the m...

Pixantrone Produces High Rates of Complete and Partial Remissions Even Among Aggressive NHL Patients With Extensive Prior Doxorubicin Treatment or Prior Rituximab Treatment

... months, p=0.03, HR=0.279; a hazard ratio of less than one indicates a decreased risk of disease progression and a p-value of less than 0.05 indicates statistical significance). An analysis was also reported that evaluated the effect of prior rituximab therapy on response rates. In the 38 patients who rece...

Horizon Therapeutics' HZT-501 Significantly Reduces Incidence of NSAID-Induced Upper Gastrointestinal Ulcers in Patients With Mild-to-Moderate Pain

...nosed gastric and/or duodenal ulcers during a 24-week treatment period. The results for each study were analyzed using both life-table and crude-rate statistical methods. Results are listed in the table below: REDUCE 1 (n=812) REDUCE 2 (n=570) HZT-501 Ibup...

Neurobiological Technologies' Partner, Celtic Pharma, Announces Results of XERECEPT(R) Phase 3 Clinical Program

... primary endpoint (during weeks two through five of treatment), the study demonstrated a strong trend in favor of XERECEPT(R), though it did not reach statistical significance (p=0.1). Placebo patients tolerated a 50 percent reduction in dexamethasone dosing much better than anticipated over this time frame. ...

Results and Additional Analyses From Study Show That Corthera's Relaxin for Acute Heart Failure is the Strongest Predictor of Improved Longer-Term Outcomes Following Hospital Discharge When Compared to Other Variables

...sing Safety and Efficacy Results for Relaxin SAN MATEO¿ Calif.¿ June 1 /PRNewswire/ -- Corthera Inc. today announced that the results and additional statistical analyses conducted from Pre-RELAX-AHF, the Phase II portion of a Phase II/III multicenter, randomized, double-blind, international study, showed that ...

Three Independent Studies Include the ImmuKnow(R) Assay to Manage and Optimize Immunosuppression Therapy in Transplant Patients

...muKnow assay levels. In 32 other patients, changes in immunosuppression therapy were based on immunosuppressive drug levels. Although it did not reach statistical significance, the use of the ImmuKnow assay resulted in substantially lower mean serum creatinine levels at 5 months. In a study to determine whe...

Video: Phase III Study Data With Vandetanib (Zactima(TM)) in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Presented at American Society of Clinical Oncology

...ogram, are supportive of ZODIAC although the primary endpoint did not reach statistical significance in the ZEAL study (hazard ratio [HR] 0.86, 97.58% CI 0.69-1.06...rvival in both studies showed a positive trend, although they did not reach statistical significance (ZODIAC Study: HR 0.91, 97.52% CI 0.78-1.07: P=0.196; ZEAL Stu...

Scientists at The Karmanos Cancer Institute in Detroit Identify Potential New Target for Breast Cancer Therapy

...ancer Institute and Wayne State University School of Medicine; Adnan Munkarah, M.D., of the Henry Ford Health System in Detroit; and Michael Kruger, statistical analyst with Wayne State University School of Medicine's Department of Obstetrics and Gynecology. Dr. Nahleh noted that the discovery of a po...

Catalyst Pharmaceutical Partners Announces Top-Line Results of CPP-109 Phase II Trial for Cocaine Addiction

...ed top-line results from its U.S. Phase II clinical trial to treat cocaine addiction. The data from the trial showed that CPP-109 did not demonstrate statistical significance in the primary endpoint -- that a significantly larger proportion of CPP-109-treated subjects than placebo-treated subjects were cocaine-...

Mayo Researchers Help Discover Genetic Cause for Primary Biliary Cirrhosis

...rica for primary biliary cirrhosis. The University of Texas MD Anderson Cancer Center in Houston provided historical controls and conducted the statistical analysis of the study. The genetic link to primary biliary cirrhosis has been well-established by previous studies. "Indeed, mothers, sisters and...

New Study Evaluating the ADHD Medication VYVANSE(R) (lisdexamfetamine dimesylate) CII Demonstrated No Change in the Pharmacokinetic Profile of VYVANSE When Coadministered with Prilosec OTC(R) 40 mg (20 mg X 2), a Commonly Used Proton Pump Inhibitor (PPI)

...agnosis requires the use of medical and special psychological, educational and social resources, utilizing diagnostic criteria such as Diagnostic and statistical Manual of Mental Disorders-IV (DSM-IV) or International Classification of Diseases 10 (ICD-10). Although there is no "cure" for ADHD, there ar...

Getting More From Whole-Transcript Microarrays

...ering the gene and the nature of the splicing event. They constructed a new statistical method, called FIRMAGene, that uses information about adjacent poorly fitti... Dr Robinson added that, "To the best of our knowledge, this is the first statistical method that interrogates differential splicing using the Gene 1.0 ST platfo...

Dainippon Sumitomo Pharma Announces Lurasidone Phase III Data in Patients With Schizophrenia

...t doses ranging between 40 mg and 120 mg/day. A third study, which examined three fixed doses of lurasidone (20 mg, 40 mg, and 80 mg/day) did not show statistical differences vs. placebo. This trial is regarded as "failed," or inconclusive, as haloperidol (10 mg/day), which was included for purposes of assay sen...

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

...orced Vital Capacity (FVC) at Week 72 was met with statistical significance in CAPACITY 2 (p=0.001). The seconda...) and categorical change in FVC were also met with statistical significance. The primary endpoint was not met in...t predicted FVC. While CAPACITY 1 did not achieve statistical significance on the primary endpoint, the results ...

Mutant Genes in High-Risk Childhood Leukemias Identified

...al Sciences Pharmacogenetics Research Network and Database; National Institutes of Health Cancer Center Core Grants; the Children's Oncology Group and statistical Center; the Leukemia and Lymphoma Society Specialized Center of Research grant supporting University of New Mexico Cancer Center; CureSearch; St. Ba...

Shire Announces Study Results of the Effects of INTUNIV(TM) (Guanfacine) Extended Release on Secondary Measures in Children with ADHD and Oppositional Symptoms

...agnosis requires the use of medical and special psychological, educational and social resources, utilizing diagnostic criteria such as Diagnostic and statistical Manual of Mental Disorders(TM)-IV (DSM-IV) or International Classification of Diseases 10 (ICD-10). Although there is no "cure" for ADHD, the...

ADVENTRX Announces Results From ANX-514 Bioequivalence Study

...ata to support an NDA. Pharmacokinetic equivalence was assessed by a statistical comparison of both the areas under the curve (AUC) and maximum plasma conce... to have equivalent pharmacokinetics. Pursuant to the study's protocol and statistical analysis plan, data from 31 patients who received both study drugs, had no ...

ISTA Pharmaceuticals Highlights Bepreve(TM) Clinical Data at the Association for Research in Vision and Ophthalmology (ARVO) 2009 Annual Meeting

... allergic conjunctivitis. The studies demonstrated Bepreve 1.5% was effective at reducing ocular itching for at least 8 hours after dosing, with high statistical significance for improvement in ocular itching compared to placebo for up to 16 hours after dosing. In addition, there was evidence that Bepreve 1.5%...

Cardium Announces Completion of Patient Recruitment in Phase 2b Clinical Trial of Excellarate(TM) for the Potential Treatment of Diabetic Foot Ulcers

...between patients treated with the Excellarate drug candidate (one or two doses as a single group) compared to placebo treated patients based on an 80% statistical powering and a 95% confidence interval. The ability to achieve closure of chronically non-healing wounds following application of a simple topica...

Perceptive Informatics Survey Results Reveal Top Barriers to Implementing Adaptive Trial Designs

...y Perceptive Informatics with partner Cytel Inc., a provider of specialized statistical applications, was attended by over 500 professionals from the biopharmaceut...t were cited by respondents included understanding and implementing complex statistical methodologies as well as difficulties in medication supplies estimation and...
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