[Translation] An open-label, multicenter, randomized, crossover, equivalence study to compare the efficacy and safety of two strengths of Creon in Chinese PEI subjects

主要目的：证明中国PEI受试者服用两种规格的胰酶肠溶胶囊（25000和10000脂肪酶单位）在脂肪吸收系数（CFA）方面具有等效性。

[Translation]

Primary objective: To demonstrate the equivalence of two strengths of pancreatic enteric-coated capsules (25,000 and 10,000 lipase units) in terms of the coefficient of fat absorption (CFA) in Chinese PEI subjects.

Start Date17 Aug 2017

Sponsor / Collaborator

AbbVie Pharmaceuticals GmbH

[+2]

CTR20170162

/ CompletedPhase 1

一项开放的评估ω-3 脂肪酸乙酯在中国健康受试者中单次和多次给药的药代动力学特征、安全性和耐受性研究

[Translation] An open-label study evaluating the pharmacokinetic characteristics, safety, and tolerability of single and multiple-dose ω-3 fatty acid ethyl esters in healthy Chinese subjects

主要目的：研究单次（2g）和多次口服（2 x 2g）欧米加-3-酸乙酯90软胶囊（Omacor）后，ω-3-脂肪酸乙酯在中国健康男性和女性受试者中的药代动力学次要目的：研究单次和多次口服欧米加-3-酸乙酯90软胶囊（Omacor）后的安全性和耐受性

[Translation]

Primary objective: To investigate the pharmacokinetics of omega-3 fatty acid ethyl esters in healthy Chinese male and female subjects after single (2 g) and multiple oral doses (2 x 2 g) of omega-3-acid ethyl ester 90 soft capsules (Omacor) Secondary objective: To investigate the safety and tolerability of omega-3-acid ethyl ester 90 soft capsules (Omacor) after single and multiple oral doses

Start Date30 Jun 2017

Sponsor / Collaborator

AbbVie Pharmaceuticals GmbH

[+3]

CTR20160569

/ CompletedPhase 3

多中心随机双盲平行组安慰剂对照研究评价ω-3脂肪酸乙酯治疗12周中国高甘油三酯血症受试者的疗效和安全性

[Translation] A multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of ω-3 fatty acid ethyl esters in the treatment of Chinese subjects with hypertriglyceridemia for 12 weeks

主要目的：研究为期12周的ω-3脂肪酸乙酯治疗对患有高甘油三酯血症的中国受试者的空腹血清甘油三酯（TG）的疗效次要目的：研究为期12周的ω-3脂肪酸乙酯治疗的安全性和耐受性及其对血脂参数的疗效

[Translation]

Primary objective: To investigate the efficacy of 12 weeks of ω-3 fatty acid ethyl ester treatment on fasting serum triglycerides (TG) in Chinese subjects with hypertriglyceridemia Secondary objective: To investigate the safety and tolerability of 12 weeks of ω-3 fatty acid ethyl ester treatment and its efficacy on lipid parameters

Start Date19 Sep 2016

Sponsor / Collaborator

AbbVie Pharmaceuticals GmbH

[+3]

100 Clinical Results associated with AbbVie Pharmaceuticals GmbH

0 Patents (Medical) associated with AbbVie Pharmaceuticals GmbH

Literatures (Medical) associated with AbbVie Pharmaceuticals GmbH

01 Jun 2014·Annals of the Rheumatic Diseases

AB0243 Data on the Impact of Anti-Cyclic-Citrulinnated Peptide Antibody Status (ANTI-CCP) on the Management of Patients with Early Rheumatoid Arthritis

Author: G. Poόr ; A. Baranauskaite ; T. Vlak ; R. Kuzminiene ; I. Iancuta ; K. Ratnik

Background Poor prognosis of RA is associated with early and destructive disease, and a better understanding of prognostic factors such as anti-CCP that are highly predictive of future development of RA would be beneficial to initiate an aggressive therapy early after diagnosis. Objectives To evaluate the impact of anti-CCP status on patient management and to assess associations between the anti-CCP status/levels and clinical outcome measures. Methods A multi-center, international, prospective, observational study. Adult patients recently diagnosed with RA were included in the study. Patients were followed up during 12 months (baseline, months 3, 6, 9, 12). Socio-demographic data, medical history, concomitant anti-rheumatic medication, CRP, ESR, anti-CCP and/or RF data were collected. TJC, SJC, DAS28, HAQ-DI were assessed quarterly. At each visit, the impact of patient9s serology and different outcome measures on treatment decisions were evaluated. Results 942 patients were enrolled and 685 patients completed all visits. Mean age was 56 years, 82.4% were females. Anti-CCP were positive in 71% with mean value of 538. Medical history indicated that 75.1% of the patients had at least one concomitant pathology, the most frequent of which within the cardiovascular system (32.2%). At baseline, 51.4% were treated with conventional synthetic DMARD as monotherapy (mainly methotrexate) combined with corticosteroids (46.1%); DMARD and corticosteroid usage decreased significantly by month 12 to 32.3% and 22.3%, respectively. Biologic DMARDs were used in 3.4% of patients at baseline and in 7.4% at final visit. Each of the clinical secondary parameters decreased by final visit. Mean TJC decreased from 14.8 to 4.5 and mean SJC decreased from 9.6 to 2.2. Mean duration of morning joint stiffness decreased from 75.2 min to 23.1 min. Mean DAS28 value decreased from 6.3 to 3.6, and VAS score decreased from 65.2 to 30.5. Mean HAQ-DI total score decreased from 1.5 to 0.8. For the majority (58%) of patients, clinicians believed that anti-CCP marker was significant or of ... highest possible importance, and the importance did not change for the majority (56.6%) by the end of the study. However, erosions, multiarticular expanding, and accelerated ESR were reported to be of more importance. Physician consideration of anti-CCP status as “important” impacted their decision-making with regards to increase in DMARD dose, use of combination therapy and application of aggressive treatment. Beyond the anti-CCP status, some other attributes also influenced physicians decision making: both duration of morning stiffness and presence of rheumatoid nodules induced biological DMARD adjustment, and presence of rheumatoid nodules induced use of DMARD combination. Conclusions Anti-CCP status is considered to be an important factor in treatment decision-making,but traditional inflammatory measures remain more influential factors. The use of anti-CCP status may allow to better predict the diagnosis and prognosis of patients with RA. Whether this or other serologic tests, will allow more rational therapeutic decision-making and influence the long-term RA outcome will be determined by further study. Acknowledgements The design, study conduct, and financial support for the clinical trial were provided by AbbVie. AbbVie participated in the interpretation of data, review, and approval of the abstract. Disclosure of Interest K. Ratnik: None declared, A. Baranauskaite Grant/research support: AbbVie, Pfizer, MSD, Roche, Speakers bureau: Abbvie, MSD, I. Iancuta Consultant for: Abbvie, MSD, Roche, Pfizer, UCB, BMS, Janssen, Speakers bureau: Abbvie, MSD, Roche Pfizer, T. Vlak Grant/research support: MSD, Roche, Abbott Laboratories, Speakers bureau: MSD, Roche, Lilly, Abbott Laboratories, G. Poόr Grant/research support: Abbott Laboratories, Abbvie, Consultant for: Abbott Laboratories, AbbVie, UCB, Pfizer, MSD, Amgen, Roche, Speakers bureau: Abbott Laboratories, R. Kuzminiene Employee of: Abbvie Pharmaceuticals DOI 10.1136/annrheumdis-2014-eular.3845

AbbVie polypharmacology explorer: A belief theory approach to constructing and querying chemical biology networks

Author: Muchmore, Steven W. ; Hajduk, Phillip J. ; Metz, James T.

The prediction of polypharmocol. effects from existing networks requires a method of establishing the relationship between mols. with unknown biol. properties and those which have well established pharmacol.Towards this end, several techniques have been developed to estimate the degree of similarity between the query mol. and the compounds in the polypharmacol. network.In our own work, we have developed a method that attempts to define the probability of iso-activity of a compound to others in the data set by calibrating the similarity coefficients against a large dataset of measured activities.We have used the resultant "Belief Theory" estimates of similarity in the generation and querying of the pharmacol. networks.This presentation will highlight the advantages of using this approach when defining networks, as well as efforts to extend the work from two-dimensional fingerprints to three-dimensional shape and electrostatic descriptors.

100 Deals associated with AbbVie Pharmaceuticals GmbH

100 Translational Medicine associated with AbbVie Pharmaceuticals GmbH

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Pancrelipase(AbbVie, Inc.)	Hypopituitarism More	Pending
Omega-3-acid ethyl esters(Trygg Pharma AS) ( Lipid x Triglyceride )	Hyperlipoproteinemia Type IV More	Pending

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