Pivotal Clinical Trial

ENDEAVOR II Pivotal Clinical Trial - Medtronic
ENDEAVOR II Pivotal Clinical Trial Fact Sheet & Clinical Data Summary Caution: The Endeavor™ Drug Eluting Coronary Stent is an investigational device with ... Document Retrieval

Pivotal Phase 2b Clinical Trial Results - Flexion Therapeutics
Baseline-observation carried forward (BOCF): patients discontinuing due to AE or reasons other than lack of efficacy; Last -observation carried forward (LOCF): patients discontinuing due to lack of ... Retrieve Document

Neuros Medical Enrolls First Patients In Pivotal Study For ...
Neuros Medical Enrolls First Patients in Pivotal Study for Post-Amputation Pain . Cleveland, OH, January 28, 2015– Neuros Medical, Inc., a medical device company , announced it has enrolled the first patients in its pivotal clinical trial to evaluate the Company’s ... Return Document

Exelixis Announces European Medicines Agency Acceptance Of Marketing Authorization Application For Cabozantinib As A ...
Exelixis, Inc. today announced the European Medicines Agency has accepted for review the Marketing Authorization Application for cabozantinib as a treatment for patients with advanced renal cell carcinoma who have received one prior therapy. ... Read News

FDA Approves Eisai's Halaven® (eribulin Mesylate) Injection For The Treatment Of Patients With Advanced Liposarcoma
WOODCLIFF LAKE, N.J., Jan. 29, 2016 /PRNewswire/ -- Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) approved Halaven ® (eribulin mesylate) Injection (0.5 mg per mL) for the ... Read News

The Phase 3 VALOR Trial: Adaptive Sample Size Re-estimation ...
The Phase 3 VALOR Trial: Adaptive Sample Size Re-estimation CytelVideos. Subscribe Subscribed The Cytel-designed Phase 3 study also played a pivotal role in the continued funding of the biological and device developmental at the clinical trial, program and portfolio levels ... View Video

Availability And Affordability Of New Medicines In Latin ...
Availability and affordability of new medicines in Latin American . countries where pivotal clinical trials were conducted. Núria Homedes. a & Antonio Ugalde. b. assessment of the clinical trial protocols. ... Doc Retrieval

RESULTS OF PIVOTAL PHASE III CLINICAL TRIAL
Details for the Clinical Trial are as follows 1. The study was a Pivotal Phase III trial. 2. Primary Endpoint: To evaluate the short-term efficacy of methoxyflurane for the ... Read Full Source

Neuros Medical Receives Regulatory Approval To Conduct ...
Neuros Medical Receives Regulatory Approval to Conduct Pivotal Study Cleveland, OH, (FDA) allowing it to commence a pivotal clinical trial to evaluate the Company’s patented Altius™ System High Frequency Nerve Block technology for the management of intractable limb pain of ... Read More

Understanding Cancer Clinical Trial Data
– Two pivotal trials are routinely required outside of oncology! Understanding Clinical Trial Data! Understanding Cancer Clinical Trial Data • April 2013! Confidential & Proprietary! Isn’t it Time You Had an Epiphany?! ... Retrieve Content

Cabozantinib - Wikipedia, The Free Encyclopedia
In October 2011, cabozantinib met its primary endpoint in a phase 3 clinical trial the phase 3 pivotal trial of cabozantinib in men with metastatic castration-resistant prostate cancer whose disease progressed after treatment with docetaxel as well as abiraterone and/or enzalutamide, ... Read Article

THE PIVOTAL TRIAL: REFLECTIONS FROM A ... - British Renal Society
THE PIVOTAL TRIAL: REFLECTIONS FROM A RESEARCH NURSE 1 YEAR ON. Emmanuel Mangahis1, Claire White1, Iain C Macdougall1. 1Renal Unit, King’s College Hospital, London ... Return Doc

CEL-SCI Expands Its Pivotal Phase III Immunotherapy Trial ...
VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE MKT: CVM) today announced that during November it has added seven new clinical sites to its global pivotal Phase III head and neck cancer trial for its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection). ... View Video

Intercept Pharmaceuticals Announces Pivotal Phase 3 Clinical ...
May 19, 2015 Intercept Pharmaceuticals Announces Pivotal Phase 3 Clinical Trial of Obeticholic Acid in NASH-Key features of the REGENERATE Phase 3 trial in non-cirrhotic NASH with liver fibrosis finalized pursuant to ... Document Retrieval

FDA Special Protocol Assessment - Wikipedia, The Free ...
A Special Protocol Assessment (SPA) is a declaration from the Food and Drug Administration that an uncompleted Phase III trial's design, clinical endpoints, and statistical analyses are acceptable for FDA approval. ... Read Article

Medtronic CoreValve U.S. Pivotal Trial - Iowa Heart
Medtronic CoreValve® U.S. Pivotal Trial CLINICAL STUDY PLAN SYNOPSIS For more information refer to www.clinicaltrials.gov and www.AorticStenosisTrial.com ... Doc Viewer

Agilis Biotherapeutics And National Taiwan University Enter Into Worldwide, Exclusive License Agreement For The Gene ...
Agilis Biotherapeutics, LLC , a biotechnology company advancing innovative gene therapies for rare genetic diseases that affect the central nervous system , announced today that the Company has entered into an exclusive worldwide license agreement with National Taiwan University for the treatment of Aromatic L-Amino Acid Deficiency using gene therapy developed by Dr. ... Read News

Pivotal Clinical Trial Investigates Flow Diversion Device For ...
UCLA’s Division of Interventional Neuroradiology is participating in a multi- center U.S. clinical trial to evaluate the safety and efficacy of the MicroVention, Inc. ... Retrieve Content

Talent LPS AAA Stent Graft: Results Of A pivotal Clinical Trial
CLINICAL RESEARCH STUDIES Talent LPS AAA stent graft: Results of a pivotal clinical trial Frank J. Criado, MD, Ronald M. Fairman, MD, and Gary J. Becker, MD, for investigators of Talent LPS ... Fetch Content

The CoreValve US Pivotal Trial - Home | Clinical Trials ...
1 The CoreValve US Pivotal Trial Ted Lystig, Ph.D. Distinguished Statistician Medtronic, Inc. January 29, 2014 ... Access This Document

Medical Device Clinical Trials: What We Should Know
4 | Medical Device Clinical Trials: What We Should Know • Handling Missing Data. One of the main challenges in clinical trial analysis is addressing how to handle missing data. ... Return Doc

Vismodegib (Erivedge®) Treatment For Basal Cell Carcinoma
(Erivedge®) Treatment for Basal Cell Carcinoma. A targeted therapy. Recent clinical trials have also shown that vismodegib A.e. Oro, A. Hauschild, K. Lewis, A.b. Mueller, R. Yauch, J.c. Reddy, and A. Sekulic. "A Pivotal Multicenter Trial Evaluating Efficacy and ... Read Article

Clinical trials Of Herceptin (trastuzumab) - Columbia University
Clinical trials of Herceptin1 (trastuzumab) J. Baselga* pivotal phase III trial of trastuzumab in combination with chemotherapy are discussed. 2. Early trials with trastuzumab clinical outcomes was still longer with trastuzumab plus ... View This Document

AUGMENT North American Pivotal Trial Data Summary
Clinical Trial Design » Prospective » Randomized » Controlled » Multi-center » Statistically-powered Principal Investigator Christopher DiGiovanni, MD North American Pivotal Trial Data Summary Conclusion For the first time, the published results ... Access Doc

Tryton Pivotal IDE Study Complete FINAL[3][1]
Tryton Medical Announces Completion of Patient Enrollment in Landmark Pivotal Study of Side Branch Stent Study Is the First and Largest Randomized Multi-Center Bifurcation Trial ... View This Document

Results From The Rheos Pivotal Trial - My American Heart
Results from the Rheos Pivotal Trial. Baroreflex Activation Therapy Sustainably Lowers Blood Pressure in Patients with Resistant Hypertension. John Bisognano , Domenic Sica, Mitra Nadim, Luis Sanchez, George Bakris, ... Fetch Document