composite

Phase 3 Results for Dabigatran Etexilate, an Investigational Oral Anticoagulant, Presented Today at the XXIst Congress of the International Society on Thrombosis and Haemostasis

...of 33 days. The incidences for theprimary efficacy composite endpoint of total VTE and all-causemortality were ...y subcutaneousinjection. The primary endpoint of a composite of total VTE, andall-cause mortality was not achieved (33.7% and 31.1% for 150 mgand 220 mg dabigatr...

Phase III Trial Results Show Superiority of Rivaroxaban over Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Knee Replacement Surgery

... relative risk reduction(RRR) (p<0.001) of the composite primary endpoint of deep veinthrombosis (DVT), non...ction of risk (p=0.01) of developing major VTE(the composite of proximal DVT, non-fatal PE and VTE-relateddeath), the secondary endpoint of the trial, was observ...

Phase III Trial Results Show Superiority of Rivaroxaban over Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Knee Replacement Surgery

...ive risk reduction (RRR) (p less than0.001) in the composite primary endpoint of deep vein thrombosis(DVT), non...tion of risk(p=0.01) for developing major VTE (the composite of proximal DVT,non-fatal PE and VTE-related death) - the secondary endpoint of thetrial - was obser...

ENDEAVOR IV Clinical Trial Meets Primary Endpoint

... primary endpoint of TargetVessel Failure (TVF - a composite of cardiac death, myocardialinfarction and target vessel revascularization) at nine months.Medtronic will submit these data to the U.S. Food and DrugAdministration (FDA) in support of the Endeavor Pre-Market Approval(PMA) application and intends to p...

An Investigational Study Released at ADA Showed that Initial Combination Therapy with Januvia (sitagliptin) and Metformin Led to Improvement in Markers of Beta Cell Function in Patients with Type 2 Diabetes

...t on the pharmacokinetics ofsitagliptin based on a composite analysis of Phase I pharmacokineticdata and on a p...t on the pharmacokinetics of sitagliptinbased on a composite analysis of Phase I pharmacokinetic data and on apopulation pharmacokinetic analysis of Phase I and ...

Sangamo BioSciences Announces Presentation of Phase 1 ZFP Therapeutic Data at American Diabetes Association Meeting

...endfor improvement in SB-509 treated patients in a composite measureof nerve health, the Total Neuropathy Score or TNS. The TNS is acomprehensive approach to evaluating changes in nerve health andincludes assessment of several factors, including neurologic exam,QST, electrophysiologic studies and neurologic sy...

Phase IIIb Clinical Data Validate the Overall and Cardiovascular Safety Profile of Cycloset (A Quick Release Formulation of Bromocriptine Mesylate) in Patients with Type 2 Diabetes

...n the cardiovascular endpoint,pre-specified as the composite of myocardial infarction, stroke,and hospitalization for either angina, congestive heart failure, orcoronary revascularization surgery events (hazard ratio 0.57 and95% confidence interval of 0.34 - 0.93; P = 0.025). The mostfrequently observed non-se...

Late Breaking Data Released at ADA Showed that the Investigational Use of Januvia and Metformin as Initial Combination Therapy Provided Significant Glucose Lowering Efficacy over 54 Weeks in Patients with Type 2 Diabetes

...t on the pharmacokinetics ofsitagliptin based on a composite analysis of Phase I pharmacokineticdata and on a p...t on the pharmacokinetics of sitagliptinbased on a composite analysis of Phase I pharmacokinetic data and on apopulation pharmacokinetic analysis of Phase I and ...

Landmark Study Published in the New England Journal of Medicine Shows Important Benefits of Eprodisate (KIACTA) Treatment for Patients with Amyloid A (AA) Amyloidosis

...decreased the risk of the primary endpoint, a composite of worsening of renal function or death, by 42% ... disease, one of the clinical measures of the composite primary endpoint that was not statistically significant at the two-year time point. - There ...

Newly Published Data from Large Study Support Cardiovascular Safety of Avandia (Rosiglitazone Maleate)

... • there was no difference in the risk ofthe composite outcome with Avandia monotherapy compared tometformin monotherapy (hazard ratio 1.07, 95% CI: 0.85 –1.34), and similarly with Avandia monotherapy compared tosulfonylurea monotherapy (hazard ratio 0.82, 95% CI: 0.67 –1.02); • there w...

Topline Results of Phase III Study in Acute Ischemic Stroke (Dias-2) Do Not Demonstrate Difference Between Desmoteplase and Placebo

...tween active treatment and placeboin percentage of composite responders as defined below) was notmet. The blinded, randomized, placebo-controlled, dose-rangingtrial was jointly conducted by PAION and Forest Laboratories, Inc.,and enrolled a total of 186 patients in Europe, USA, Canada,Australia, Hong Kong and ...

Top Line Results of Phase III Study in Acute Ischemic Stroke (DIAS-2) Do Not Demonstrate Difference Between Desmoteplase and Placebo

...tween active treatment and placeboin percentage of composite responders as defined below) was notmet. The blinded, randomized, placebo-controlled, dose-rangingtrial was jointly conducted by PAION and Forest Laboratories, Inc.,and enrolled a total of 186 patients in Europe, USA, Canada,Australia, Hong Kong and ...

Medicure's MEND-CABG Trial Results Published in Peer Reviewed Journal

...roke versus placebo (p@028). The reduction in the composite endpoint was driven by asignificant 46.9% decrease in the incidence of non-fatal myocardialinfarction (peak CK-MB ?100ng/ml) with the 250 mg dose of MC-1versus placebo (p@008). The clinical results reported at POD 30 were maintainedthroughout the 90...

New Study Suggests no Significant Impairment in Middle-of-the-Night Balance, Mobility or Memory in Older Adults Using Ramelteon

...esystem having to do with the auditory organ). The composite scoreof each individual sensory test characterizes... compared to placebo, a significant decreasein SOT composite score was observed with zolpidem (P<0.001), butnot with ramelteon (P=0.837). Additional results ...

Forest Laboratories, Inc. and Cypress Bioscience, Inc. Announce Positive Results of Phase III Study for Milnacipran as a Treatment for Fibromyalgia Syndrome

...he primary pre-defined endpoints ofthis trial were composite responder assessments to evaluate eitherthe treatment of the pain associated with fibromyalgia syndrome orthe overall treatment of fibromyalgia syndrome. This compositeresponder analysis approach, which requires a clinically meaningfulimprovement in ...

Investigators Report COSTAR II Pivotal Drug-Eluting Stent Trial Results at EuroPCR 2007

...essel disease. In this trial, MACE wasdefined as a composite of clinically driven target vesselrevascularization (re-treatment), new myocardial infarction (heartattack or MI) related to the target vessel and cardiac deathrelated to an intervened vessel. At eight-month follow-up, the CoStar(R) stent had sign...

Medtronic Updates Long-Term ENDEAVOR I-II Clinical Data Showing Sustained Safety and Significant Reductions in Repeat Procedures

... bare metal stent has a rate of 1.5%.Additionally, composite analysis of myocardial infarction andcardiac mortality showed three-year freedom from death or MI of96.0% for Endeavor and 93.4% for the Driver bare metal stent. "The body of data now available on Endeavor is significant andthe results are impressiv...

New Analysis of Data Shows Treatment With Abbott's Humira (Adalimumab) Significantly Reduced Disease-Related Hospitalization for Patients with Crohn's Disease

...I is theCrohn's Disease Activity Index, a weighted composite score of eightclinical factors that evaluate patient wellness, including dailynumber of liquid or very soft stools, severity of abdominal pain,level of general well-being, and other measures. CHARM enrolled 854 adult patients with moderately to seve...

Data Published in The Lancet Show Gardasil was 100 Percent Effective in Preventing High-Grade Vulvar and Vaginal Lesions Caused by HPV Types 16 and 18

...ay 1.Note 1: The 16- and 18-related CIN 2/3 or AIS composite endpoint included data from studies 005, 007, 013, and 015. All other endpoints only included data from studies 007, 013, and 015.Note 2: Positive status at Day 1 denotes PCR positive and/or seropositive for the respective type at Day 1.Note 3: Perce...

New England Journal of Medicine Publishes New Data on Gardasil, Merck's Cervical Cancer Vaccine

...ay 1.Note 1: The 16- and 18-related CIN 2/3 or AIS composite endpoint included data from studies 005, 007, 013, and 015. All other endpoints only included data from studies 007, 013, and 015.Note 2: Positive status at Day 1 denotes PCR positive and/or seropositive for the respective type at Day 1.Note 3: Perce...

Alba Therapeutics Corporation Reports Preliminary Phase IIa Clinical Trial Results for AT-1001 for the Treatment of Celiac Disease

...f AT-1001utilizing multiple endpoints, including a composite index ofdisease activity. The first patient is expected to be enrolled intothis study in the third quarter of 2007, and the study shouldconclude in early 2008. About Celiac Disease Celiac Disease is a T-cell mediated autoimmune disease thatoccurs i...

Conor Medsystems, LLC Reports COSTAR II Pivotal Drug-Eluting Stent Trial Conclusions

...essel disease. In this trial, MACE wasdefined as a composite of clinically driven target vesselrevascularization, heart attack (new myocardial infarction) relatedto the target vessel and cardiac death related to an intervenedvessel. "While we are disappointed in these results, we remainoptimistic about the ab...

First Controlled Large-Scale Intervention Angiotensin Receptor Blocker (ARB) Trial in a Japanese Population, JIKEI HEART Study Demonstrates Significant Reduction in Blood Pressure and Protection of Organs with Valsartan

...e valsartan group also showed asignificant drop in composite cardiovascular events: the primaryendpoint cardiovascular events were compared between the groupswith the valsartan- added group exhibiting significant relativereductions, including a 65% reduction in angina pectoris, 46% inheart failure and 81% in a...

The Lancet Publishes PREVAIL Study Results Showing Lovenox Superiority Over Unfractionated Heparin for Reducing the Risk of Venous ThromboEmbolism in Patients With Acute Ischemic Stroke

...x(R) vs. UFH forthe primary efficacy endpoint, the composite of symptomatic orasymptomatic DVT, symptomatic and...48 hours after stroke onset. The incidence of the composite of symptomatic intracranial andmajor extracranial haemorrhage was small with no difference betweengr...

CombinatoRx Provides Topline Results from Phase 2 RA Study with CRx-139 and Very Low Dose Prednisolone

...e ActivityScore using 28 joint counts (DAS28) is a composite score used tomonitor disease activity in RA patients. Conference Call Information CombinatoRx management will host a conference call to discussthese results at 5:30 p.m. ET on Monday, March 26, 2007. To accessthe call, please dial 800-706-7745 (dom...

Cypher Sirolimus-eluting Coronary Stent Had Similar Results to Bypass Surgery in Long-Term Study of Patients With Multi-Vessel Coronary Artery Disease

...atisticalsignificance (p The severe event rate (a composite for death, stroke and heartattack) for the CYPHER(R) Stent was compared with both the bypasssurgery and BMS. The three-year follow-up data showed that 92.0percent of the patients who received the CYPHER(R) Stent hadsurvived and had not experienced a ...

Two-Year Results from the Medtronic ENDEAVOR III Trial Confirm Stent's Positive Clinical Profile

...years, the rate of MajorAdverse Cardiac Events - a composite safety measure of death,repeat procedures and myocardial infarction (MI) - was reported tobe 9.3% for Endeavor and 11.6% for the Cypher stent also studied inthe ENDEAVOR III trial (p = 0.47). There was no statisticallysignificant difference in the ne...

Everest Data on Short- and Long-Term Use of Otsuka's Investigational Novel Treatment, Tolvaptan, Published in Journal of the American Medical Association and Featured in ACC's Late Breaking Clinical Trials

....001 and studyB: p less than 0.001), which was the composite score of changes inpatient-assessed global clinica...econdary Endpoints The secondary endpoints of the composite of cardiovascular deathor cardiovascular hospitalization, the incidence of cardiovascularmortality, ...

Scios Announces Results From Exploratory Nesiritide Study Providing Important New Renal and Mortality Safety Data with a Neutral Effect on the Primary Endpoint

... showed aneutral effect on the primary endpoint, a composite of death andcardiorenal hospitalization at 12 week...ents with advanced CDHF. The primaryendpoint was a composite of all-cause mortality and/or cardiorenalhospitalization at 12 weeks. The study also measured numero...

AtheroGenics Reports ARISE Trial Results for AGI-1067

...points. These endpoints included areduction in the composite of "hard" atherosclerotic clinicalendpoints, compo... CDT. While the company isdisappointed that the composite primary endpoint was not met, it isencouraged by the positive results demonstrated in a number ofdis...