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Last update 08 May 2025

Ortho-Mcneil Janssen Scientific Affairs LLC

Private Company|United States

Last update 08 May 2025

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Translational Medicine

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Clinical Trials associated with Ortho-Mcneil Janssen Scientific Affairs LLC

NCT01193166

/ WithdrawnPhase 4

A Twelve-Month, Prospective, Randomized, Active-Controlled, Open-Label, Flexible-Dose Study of Paliperidone Palmitate Compared With Oral Antipsychotic Treatment in Adults With Schizophrenia Who Have Been Recently Discharged From an Inpatient Psychiatric Hospital

The study will assess the use of paliperidone palmitate compared with oral antipsychotic treatment in delaying time to a protocol-defined treatment failure over 12 months, in patients diagnosed with schizophrenia who were recently released from an inpatient psychiatric hospital.

Start Date01 Aug 2010

Sponsor / Collaborator

Ortho-Mcneil Janssen Scientific Affairs LLC

NCT01134731

/ CompletedPhase 4IIT

Paliperidone and Lithium in the Treatment of Suicidality - Treatment Indication and Epigenetic Regulation

The study aims to use a combined clinical and translational approach to identify an efficient pharmacotherapy for the acute management of suicidality and the epigenetic regulation associated with the treatment.The primary objective is a clinical trial to compare the efficacy of paliperidone versus lithium and placebo as adjunctive therapy to the standard of care antidepressants in the acute management of suicidality in depressed subjects.
Specific Aims 1 and 2 are described in detail below. Analysis for Specific Aim 2 is still underway.

Start Date01 May 2010

Sponsor / Collaborator

The University of Alabama at Birmingham

[+2]

NCT00931398

/ WithdrawnPhase 4IIT

Treatment of College Students With ADHD Using OROS Methylphenidate

The purpose of the proposed study is to determine the effectiveness of methylphenidate HCl (Concerta) in college students with ADHD. This study will consist of 110 college students between the ages of 18 and 25 who are enrolled full-time in a local or junior college. The study consists of an 8-week double-blind, placebo-controlled trial of placebo versus methylphenidate HCl (Concerta®) followed by a 10-week extension of open label methylphenidate HCl (Concerta®).

Start Date01 Apr 2010

Sponsor / Collaborator

University of Pittsburgh

[+1]

100 Clinical Results associated with Ortho-Mcneil Janssen Scientific Affairs LLC

0 Patents (Medical) associated with Ortho-Mcneil Janssen Scientific Affairs LLC

Literatures (Medical) associated with Ortho-Mcneil Janssen Scientific Affairs LLC

22 Aug 2013·Journal of the American Heart AssociationQ2 · MEDICINE

Provider Specialty and Atrial Fibrillation Treatment Strategies in United States Community Practice: Findings From the ORBIT‐AF Registry

Q2 · MEDICINE

ArticleOA

Author: Mills, Roger M. ; Gersh, Bernard J. ; Thomas, Laine ; Fosbol, Emil L. ; Piccini, Jonathan P. ; Reiffel, James A. ; Mahaffey, Kenneth ; Holmes, DaJuanicia N. ; Peterson, Eric D. ; Kowey, Peter

Background The prevalence of atrial fibrillation ( AF ) continues to increase; however, there are limited data describing the division of care among practitioners in the community and whether care differs depending on provider specialty. Methods and Results Using the Outcomes Registry for Better Informed Treatment of AF ( ORBIT ‐ AF ) Registry, we described patient characteristics and AF management strategies in ambulatory clinic practice settings, including electrophysiology ( EP ), general cardiology, and primary care. A total of 10 097 patients were included; of these, 1544 (15.3%) were cared for by an EP provider, 6584 (65.2%) by a cardiology provider, and 1969 (19.5%) by an internal medicine/primary care provider. Compared with those patients who were cared for by cardiologists or internal medicine/primary care providers, patients cared for by EP providers were younger (median age, 73 years [interquartile range, IQR , 64, 80 years, Q1, Q3] versus 75 years [ IQR , 67, 82 years] for cardiology and versus 76 years [ IQR , 68, 82 years] for primary care). Compared with cardiology and internal medicine/primary care providers, EP providers used rhythm control (versus rate control) management more often (44.2% versus 29.7% and 28.8%, respectively, P <0.0001; adjusted odds ratio [ OR ] EP versus cardiology, 1.66 [95% confidence interval, CI , 1.05 to 2.61]; adjusted OR for internal medicine/primary care versus cardiology, 0.91 [95% CI , 0.65 to 1.26]). Use of oral anticoagulant therapy was high across all providers, although it was higher for cardiology and EP providers (overall, 76.1%; P =0.02 for difference between groups). Conclusions Our data demonstrate important differences between provider specialties, the demographics of the AF patient population treated, and treatment strategies—particularly for rhythm control and anticoagulation therapy.

01 May 2013·Circulation: Cardiovascular Quality and Outcomes

Abstract 250: Economic Burden of Mortality and Cardiovascular Events among Patients with Acute Coronary Syndromes in a Commercial Health Plan

Author: Crivera, Concetta ; Veerman, Mark ; Quock, Tiffany P ; Mody, Samir H ; Ogden, Kristine ; Patel, Aarti A

Introduction: Despite current advances in treatment, acute coronary syndromes (ACS), continues to result in high morbidity and mortality. Annually, an estimated 1.5 million hospital discharges involve patients with ACS. As such, ACS is associated with a substantial economic burden to the US healthcare system, with current estimates ranging from $75-$150 billion annually in aggregate direct medical costs. Adding anticoagulant to standard of care (SOC) may reduce the number of cardiovascular (CV) events in ACS patients. This study estimates the economic burden of mortality and CV events among ACS patients within a commercial health plan. Methods: We developed an Excel-based decision-analytic model to estimate the annual economic burden of mortality and CV events (myocardial infarction (MI), ischemic stroke (IS), stent thrombosis (ST), intracranial hemorrhage (ICH), and major bleeds) in a hypothetical commercial plan with a population of ACS patients who were candidates for rivaroxaban anticoagulation therapy. The baseline ACS population of 6,650 patients was calculated from literature estimates and included 100% on standard of care, and 0% on dual SOC and rivaroxaban anticoagulation therapy. ACS prevalence was adjusted for age and anticoagulation status. Estimates for the two-year rates for mortality and CV events were obtained from the two-year randomized double-blind, placebo-controlled rivaroxaban ATLAS clinical trial. Healthcare costs were drawn from the published literature and adjusted to 2011 USD. Results: The baseline model projected a total of 299 deaths from any cause, resulting in an estimated $9.52 million in two-year mortality-related healthcare costs to a commercial health plan. In addition, the baseline model estimated 439 MI, 67 IS, 193 ST, 13 ICH, and 27 major bleeding events that were not associated with CABG, resulting in a total of $41.3 million in two-year healthcare costs to a commercial health plan. All other factors being equal, a 10% increase in the dual SOC and rivaroxaban anticoagulation therapy from the SOC population would reduce the number of mortalities by 11, ST events by 5, and MI events by 3, while the number of ischemic stroke events would remain the same. Conversely, there would be an increase of 1 ICH event and 7 major bleeding events not associated with CABG. Two-year ACS-related mortality and CV event costs to the commercial health plan would be reduced by $48,437 for every 1,000 patients with ACS. Conclusion: Our findings suggest that a modest 10% increase in anticoagulant use among patients with ACS would reduce mortality, MI, ST and related healthcare costs by 4%, 0.7%, and 3%, respectively. Addition of anticoagulation therapy potentially reduces the incidence of ACS-related mortality, MI, ST and associated healthcare costs to a commercial health plan, and benefits from anticoagulation use should be balanced against the risk of bleeding.

01 Feb 2012·Journal of Clinical MicrobiologyQ2 · MEDICINE

Epidemiology and Outcomes of Complicated Skin and Soft Tissue Infections in Hospitalized Patients

Q2 · MEDICINE

Article

Author: Kim, Myoung ; Zervos, Marcus J. ; Vo, Lien ; Pokharna, Hiren ; Haque, Nadia ; Raut, Monika ; Freeman, Katherine

ABSTRACTComplicated skin and soft tissue infections (cSSTIs) are among the most rapidly increasing reasons for hospitalization. To describe inpatients with regard to patient characteristics, cSSTI origin, appropriateness of initial antibiotics, and outcomes, we performed a retrospective cohort study in patients hospitalized for cSSTI. To identify independent predictors of outcomes, we performed multivariate analyses. Of 1,096 eligible patients, 48.7% had health care-associated (HCA) cSSTI and 51.3% had community-acquired (CA) cSSTI. After adjustment for baseline variables, hospital length of stay (LOS) was longer for HCA than for CA cSSTI (difference, 2.1 days; 95% confidence interval [CI], 0.8 to 3.5;P< 0.05). Other covariates associated with a longer LOS were need for dialysis (regression coefficient ± standard error, 4.5 ± 1.1) and diabetic wound diagnosis (2.6 ± 1.0) (allP< 0.05). In the subset with culture-positive cSSTI within 24 h of admission, the most common pathogen wasStaphylococcus aureus(298/449 [66.4%]), of which 74.8% (223/298) were methicillin-resistantS. aureus(MRSA). Eighty-three patients (18.5%) received inappropriate initial antibiotics. After adjustment for other variables, the following were associated with inappropriate initial therapy: direct admission to hospital (not via emergency department), cSSTI caused by MRSA or mixed pathogens, and cSSTI caused by pathogens other thanS. aureusor streptococci (allP< 0.05). We did not find an association between inappropriate therapy and outcomes, except in the subset with ulcers (adjusted odds ratio, 11.8; 95% CI, 1.3 to 111.1;P= 0.03). More studies are needed to examine the impact of HCA cSSTI and inappropriate initial therapy on outcomes.

100 Deals associated with Ortho-Mcneil Janssen Scientific Affairs LLC

100 Translational Medicine associated with Ortho-Mcneil Janssen Scientific Affairs LLC

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Ortho-Mcneil Janssen Scientific Affairs LLC

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