type: Registry Identifier

title: A Phase 2/3, Placebo-Controlled, Efficacy and Safety Study of Once-Weekly, Subcutaneous LY2189265 Compared to Sitagliptin in Patients With Type 2 Diabetes Mellitus on Metformin

summary: This is an adaptive dose finding study and a Phase 3 efficacy study to evaluate the effects of once weekly injection of LY2189265 compared to Sitagliptin on glucose by measuring glycosylated hemoglobin (HbA1c) change from baseline after 52 weeks in participants with type 2 diabetes mellitus on Metformin.

ReferenceCitation: Sherman SI, Kloos RT, Tuttle RM, Pontecorvi A, Völzke H, Harper K, Vance C, Alston JT, Usborne AL, Sloop KW, Lakshmanan M. No calcitonin change in a person taking dulaglutide diagnosed with pre-existing medullary thyroid cancer. Diabet Med. 2018 Mar;35(3):381-385. doi: 10.1111/dme.13437.

name: Department of Endocrine Neoplasia and Hormonal Disorders; Division of Internal Medicine; University of Texas MD Anderson Cancer Center; Houston TX

family: Sherman

full_name: S. I. Sherman

given: S. I.

name: Department of Medical Affairs; Veracyte, Inc.; South San Francisco; CA

family: Kloos

full_name: R. T. Kloos

given: R. T.

name: Endocrinology Service; Memorial Sloan Kettering Cancer Center; New York NY

family: Tuttle

full_name: R. M. Tuttle

given: R. M.

name: Department of Internal Medicine; Catholic University; Rome Italy

family: Pontecorvi

full_name: A. Pontecorvi

given: A.

name: Institute for Community Medicine; University Medicine; Greifswald Germany

family: Völzke

full_name: H. Völzke

given: H.

family: Harper

full_name: K. Harper

given: K.

name: Rocky Mountain Diabetes and Osteoporosis Center, PA; Idaho Falls ID USA

family: Vance

full_name: C. Vance

given: C.

family: Alston

full_name: J. T. Alston

given: J. T.

family: Usborne

full_name: A. L. Usborne

given: A. L.

family: Sloop

full_name: K. W. Sloop

given: K. W.

family: Lakshmanan

full_name: M. Lakshmanan

given: M.

bso_classification: Biology (fond.)

journal_name: Diabetic Medicine

ReferenceCitation: Boustani MA, Pittman I 4th, Yu M, Thieu VT, Varnado OJ, Juneja R. Similar efficacy and safety of once-weekly dulaglutide in patients with type 2 diabetes aged ≥65 and <65 years. Diabetes Obes Metab. 2016 Aug;18(8):820-8. doi: 10.1111/dom.12687. Epub 2016 Jun 7.

family: Boustani

full_name: M. A. Boustani

given: M. A.

name: Providence Medical Group  Terre Haute IN USA

family: Pittman

full_name: I. Pittman

given: I.

suffix: IV

name: Eli Lilly and Company  Toronto ON Canada

family: Yu

full_name: M. Yu

family: Thieu

full_name: V. T. Thieu

given: V. T.

family: Varnado

title: Similar efficacy and safety of once‐weekly dulaglutide in patients with type 2 diabetes aged ≥65 and <65 years

ReferenceCitation: Yu M, Van Brunt K, Varnado OJ, Boye KS. Patient-reported outcome results in patients with type 2 diabetes treated with once-weekly dulaglutide: data from the AWARD phase III clinical trial programme. Diabetes Obes Metab. 2016 Apr;18(4):419-24. doi: 10.1111/dom.12624. Epub 2016 Feb 4.

name: Lilly Diabetes; Eli Lilly and Company; Indianapolis IN USA

ReferenceCitation: Weinstock RS, Guerci B, Umpierrez G, Nauck MA, Skrivanek Z, Milicevic Z. Safety and efficacy of once-weekly dulaglutide versus sitagliptin after 2 years in metformin-treated patients with type 2 diabetes (AWARD-5): a randomized, phase III study. Diabetes Obes Metab. 2015 Sep;17(9):849-58. doi: 10.1111/dom.12479. Epub 2015 May 20.

name: Endocrinology, Diabetes and Metabolism Upstate Medical University  Syracuse NY USA

name: Diabetology, Metabolic Disease and Nutrition University of Lorraine, CIC Inserm ILCV, CHU  Nancy France

name: Diabetes & Endocrinology Emory University  Atlanta GA USA

name: Diabeteszentrum Bad Lauterberg  Bad Lauterberg Germany

name: Lilly Research Laboratories  Indianapolis IN USA

name: Lilly Research Laboratories  Vienna Austria

title: Safety and efficacy of once‐weekly dulaglutide versus sitagliptin after 2 years in metformin‐treated patients with type 2 diabetes ( AWARD ‐5): a randomized, phase III study

ReferenceCitation: Skrivanek Z, Gaydos BL, Chien JY, Geiger MJ, Heathman MA, Berry S, Anderson JH, Forst T, Milicevic Z, Berry D. Dose-finding results in an adaptive, seamless, randomized trial of once-weekly dulaglutide combined with metformin in type 2 diabetes patients (AWARD-5). Diabetes Obes Metab. 2014 Aug;16(8):748-56. doi: 10.1111/dom.12305. Epub 2014 May 22.

name: Lilly Diabetes Eli Lilly and Company  Indianapolis IN USA

name: Cardiovascular & Metabolism Therapeutics, Regeneron Pharmaceuticals Inc  Tarrytown NY USA

name: Diabetes and Cardiometabolic Medicine  Carmel IN USA

name: Profil  Hellersbergstrasse Neuss Germany

title: Dose‐finding results in an adaptive, seamless, randomized trial of once‐weekly dulaglutide combined with metformin in type 2 diabetes patients ( AWARD ‐5)

ReferenceCitation: Spencer K, Colvin K, Braunecker B, Brackman M, Ripley J, Hines P, Skrivanek Z, Gaydos B, Geiger MJ. Operational challenges and solutions with implementation of an adaptive seamless phase 2/3 study. J Diabetes Sci Technol. 2012 Nov 1;6(6):1296-304.

location_country:
United States
India
Mexico
France
Korea, Republic of
Poland
Romania
Puerto Rico
Russian Federation
Spain
Germany
Canada
Taiwan

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.


title: Randomized, Open Label, Phase 3 Trial Of Erlotinib Alone Or In Combination With CP-751,871 In Patients With Advanced Non Small Cell Lung Cancer Of Non Adenocarcinoma Histology

acronym: NSCLC

summary: The objective of this study is to test a clinical benefit of the addition of CP 751,871 to erlotinib therapy in patients with advanced NSCLC of non adenocarcinoma histology. The primary endpoint is Overall Survival (OS).

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Scagliotti GV, Bondarenko I, Blackhall F, Barlesi F, Hsia TC, Jassem J, Milanowski J, Popat S, Sanchez-Torres JM, Novello S, Benner RJ, Green S, Molpus K, Soria JC, Shepherd FA. Randomized, phase III trial of figitumumab in combination with erlotinib versus erlotinib alone in patients with nonadenocarcinoma nonsmall-cell lung cancer. Ann Oncol. 2015 Mar;26(3):497-504. doi: 10.1093/annonc/mdu517. Epub 2014 Nov 13.

family: Scagliotti

full_name: G.V. Scagliotti

sequence: first

family: Bondarenko

full_name: I. Bondarenko

sequence: additional

family: Blackhall

full_name: F. Blackhall

given: F.

family: Barlesi

full_name: F. Barlesi

family: Hsia

full_name: T.-C. Hsia

family: Jassem

full_name: J. Jassem

given: J.

family: Milanowski

full_name: J. Milanowski

family: Popat

full_name: S. Popat

given: S.

family: Sanchez-Torres

full_name: J.M. Sanchez-Torres

family: Novello

full_name: S. Novello

family: Benner

full_name: R.J. Benner

family: Green

full_name: S. Green

family: Molpus

full_name: K. Molpus

family: Soria

full_name: J.-C. Soria

family: Shepherd

full_name: F.A. Shepherd

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Annals of Oncology

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

version: publishedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Pfizer

location_country:
Greece
Romania
Belgium
Russian Federation
Czech Republic
Taiwan
Ukraine
France
Poland
Indonesia
Canada
Slovenia
Korea, Republic of
South Africa
Chile
Switzerland
Bulgaria
Hungary
Ireland
Puerto Rico
United States
United Kingdom
Italy
Brazil
Serbia
Spain
Latvia

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Unknown


ReferenceCitation: Liu S, Chen B, Burugu S, Leung S, Gao D, Virk S, Kos Z, Parulekar WR, Shepherd L, Gelmon KA, Nielsen TO. Role of Cytotoxic Tumor-Infiltrating Lymphocytes in Predicting Outcomes in Metastatic HER2-Positive Breast Cancer: A Secondary Analysis of a Randomized Clinical Trial. JAMA Oncol. 2017 Nov 9;3(11):e172085. doi: 10.1001/jamaoncol.2017.2085. Epub 2017 Nov 9.

name: Department of Pathology and Laboratory Medicine, Genetic Pathology Evaluation Centre, University of British Columbia, Vancouver, Canada

family: Liu

full_name: Shuzhen Liu

given: Shuzhen

name: Canadian Cancer Trials Group, Queen’s University, Kingston, Ontario, Canada

family: Chen

full_name: Bingshu Chen

given: Bingshu

family: Burugu

full_name: Samantha Burugu

given: Samantha

family: Leung

full_name: Samuel Leung

given: Samuel

family: Gao

full_name: Dongxia Gao

given: Dongxia

family: Virk

full_name: Shakeel Virk

given: Shakeel

name: Department of Pathology and Laboratory Medicine, University of Ottawa, The Ottawa Hospital, Ottawa, Canada

family: Kos

full_name: Zuzana Kos

given: Zuzana

family: Parulekar

full_name: Wendy R. Parulekar

given: Wendy R.

full_name: Lois Shepherd

given: Lois

name: British Columbia Cancer Agency, Vancouver, Canada

family: Gelmon

full_name: Karen A. Gelmon

given: Karen A.

family: Nielsen

full_name: Torsten O. Nielsen

given: Torsten O.

journal_name: JAMA Oncology

oa_host_type: repository

evidence: oa repository (via OAI-PMH doi match)

host_type: repository

license_normalized: no license

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

ReferenceCitation: Gelmon KA, Boyle FM, Kaufman B, Huntsman DG, Manikhas A, Di Leo A, Martin M, Schwartzberg LS, Lemieux J, Aparicio S, Shepherd LE, Dent S, Ellard SL, Tonkin K, Pritchard KI, Whelan TJ, Nomikos D, Nusch A, Coleman RE, Mukai H, Tjulandin S, Khasanov R, Rizel S, Connor AP, Santillana SL, Chapman JA, Parulekar WR. Lapatinib or Trastuzumab Plus Taxane Therapy for Human Epidermal Growth Factor Receptor 2-Positive Advanced Breast Cancer: Final Results of NCIC CTG MA.31. J Clin Oncol. 2015 May 10;33(14):1574-83. doi: 10.1200/JCO.2014.56.9590. Epub 2015 Mar 16.

name: Karen A. Gelmon, David G. Huntsman, and Samuel Aparicio, British Columbia Cancer Agency, Vancouver Cancer Centre, Vancouver; Susan L. Ellard, British Columbia Cancer Agency, Cancer Centre for the Southern Interior, Kelowna, British Columbia; Julie Lemieux, Centre Hospitalier Affilié Hopital Du St Sacrement, Quebec City, Quebec; Lois E. Shepherd, Dora Nomikos, Judith-Anne W. Chapman, and Wendy R. Parulekar, NCIC Clinical Trials Group, Queen's University, Kingston; Susan Dent, Ottawa Health Research...

family: Boyle

full_name: Frances M. Boyle

given: Frances M.

family: Kaufman

full_name: Bella Kaufman

given: Bella

family: Huntsman

full_name: David G. Huntsman

given: David G.

family: Manikhas

full_name: Alexey Manikhas

given: Alexey

family: Di Leo

full_name: Angelo Di Leo

given: Angelo

family: Martin

full_name: Miguel Martin

given: Miguel

family: Schwartzberg

full_name: Lee S. Schwartzberg

given: Lee S.

family: Lemieux

publisher: American Society of Clinical Oncology (ASCO)

title: Lapatinib or Trastuzumab Plus Taxane Therapy for Human Epidermal Growth Factor Receptor 2–Positive Advanced Breast Cancer: Final Results of NCIC CTG MA.31

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

location_country:
Belgium
Australia
Russian Federation
Taiwan
Ukraine
India
France
Japan
Poland
Thailand
Argentina
Canada
Korea, Republic of
Netherlands
United States
Germany
United Kingdom
Italy
Mexico
Israel
Spain

acronym: COMPLETE (see under A.3 Full title of the trial)

title: A Randomized, Open-Label, Phase III Study of Taxane Based Chemotherapy With Lapatinib or Trastuzumab as First-Line Therapy for Women With HER2/Neu Positive Metastatic Breast Cancer

summary:
RATIONALE: HER2/neu is a receptor (protein) which is found in unusually high amounts in approximately 1 in 5 cancer patients. Scientific evidence suggests that having high amounts of the HER2/neu receptor is important for breast cancer to grow and spread. Women with previously untreated metastatic breast cancer (breast cancer that has spread to other organs) and with high levels of the HER2/neu receptor receive as their usual treatment chemotherapy with one of the approved chemotherapy drugs paclitaxel or docetaxel (called "taxanes") together with another approved drug called "trastuzumab". Chemotherapy drugs, such as paclitaxel and docetaxel, work either by killing tumour cells or by stopping them from dividing. Trastuzumab is an antibody that is given through a vein in the arm and it works by specifically "targeting" the HER2/neu i.e. it attaches to it and "turns it off". Although some of the patients who receive this taxane plus trastuzumab treatment feel better for some months, the cancer usually starts to grow again. Lapatinib is a new drug. Like trastuzumab, it also works by specifically "targeting" the HER2/neu receptor, but it does so in a different way. Lapatinib is not an antibody. It is a pill that is taken daily by mouth. Because lapatinib works in a different way than trastuzumab, it may be worse, as good as or better than trastuzumab in keeping metastatic HER/neu positive cancer from growing. However, this is not known.

Purpose: This randomized Phase III trial is comparing chemotherapy (a taxane) given together with lapatinib with chemotherapy (a taxane) given together with trastuzumab in women with HER2/neu positive breast cancer.


status: Completed

lead_sponsor: Novartis

location_country:
Finland
Greece
Romania
Belgium
Australia
Russian Federation
Czech Republic
France
Poland
Slovakia
Canada
Turkey
South Africa
Sweden
Switzerland
Netherlands
Hungary
Ireland
Germany
United Kingdom
Israel
Estonia

location_facility:
Novaratis Investigative Site
Novartis Investigative Site
Novartis Investigational Site
Austin Health, Department of Neurology

type: EudraCT Number

source: euctr

title: An Extension of the 24-month, Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing Efficacy and Safety of Fingolimod (FTY720) 1.25 mg and 0.5 mg Administered Orally Once Daily Versus Placebo in Patients With Relapsing-remitting Multiple Sclerosis

summary: This extension study of was designed to evaluate the long-term safety, tolerability, and efficacy of fingolimod (FTY720) in patients with multiple sclerosis. The Extension study was an extension to the 24-month Core study (CFTY720D2301/NCT00289978).

status_simplified: Completed


type: Other Identifier

title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based Chemotherapy

summary: This is a phase 3 study to compare the clinical benefit of abiraterone acetate plus prednisone with placebo plus prednisone in patients with metastatic castration-resistant prostate cancer (CRPC) who have failed one or two chemotherapy regimens. At least one of the previous chemotherapies must have contained docetaxel.

ReferenceCitation: Heller G, McCormack R, Kheoh T, Molina A, Smith MR, Dreicer R, Saad F, de Wit R, Aftab DT, Hirmand M, Limon A, Fizazi K, Fleisher M, de Bono JS, Scher HI. Circulating Tumor Cell Number as a Response Measure of Prolonged Survival for Metastatic Castration-Resistant Prostate Cancer: A Comparison With Prostate-Specific Antigen Across Five Randomized Phase III Clinical Trials. J Clin Oncol. 2018 Feb 20;36(6):572-580. doi: 10.1200/JCO.2017.75.2998. Epub 2017 Dec 22.

name: Glenn Heller, Martin Fleisher, and Howard I. Scher, Memorial Sloan Kettering Cancer Center; Howard I. Scher, Weill Cornell Medical College, New York, NY; Robert McCormack, Janssen Research & Development, Raritan, NJ; Thian Kheoh and Arturo Molina, Janssen Research & Development, Los Angeles; Dana T. Aftab, Exelixis, South San Francisco; Mohammad Hirmand, Medivation, San Francisco, CA; Matthew R. Smith, Massachusetts General Hospital, Boston; Ana Limon, Takeda Oncology, Cambridge, MA; Robert Dreicer,...

family: Heller

full_name: Glenn Heller

given: Glenn

family: McCormack

full_name: Robert McCormack

given: Robert

family: Kheoh

full_name: Thian Kheoh

given: Thian

family: Molina

full_name: Arturo Molina

given: Arturo

family: Smith

full_name: Matthew R. Smith

given: Matthew R.

family: Dreicer

full_name: Robert Dreicer

family: Saad

full_name: Fred Saad

given: Fred

family: de Wit

full_name: Ronald de Wit

given: Ronald

family: Aftab

full_name: Dana T. Aftab

given: Dana T.

family: Hirmand

full_name: Mohammad Hirmand

given: Mohammad

family: Limon

full_name: Ana Limon

given: Ana

family: Fizazi

full_name: Karim Fizazi

given: Karim

family: Fleisher

full_name: Martin Fleisher

given: Martin

family: de Bono

full_name: Johann S. de Bono

given: Johann S.

family: Scher

full_name: Howard I. Scher

given: Howard I.

journal_name: Journal of Clinical Oncology

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Chi KN, Kheoh T, Ryan CJ, Molina A, Bellmunt J, Vogelzang NJ, Rathkopf DE, Fizazi K, Kantoff PW, Li J, Azad AA, Eigl BJ, Heng DY, Joshua AM, de Bono JS, Scher HI. A prognostic index model for predicting overall survival in patients with metastatic castration-resistant prostate cancer treated with abiraterone acetate after docetaxel. Ann Oncol. 2016 Mar;27(3):454-60. doi: 10.1093/annonc/mdv594. Epub 2015 Dec 18.

family: Chi

full_name: K.N. Chi

full_name: T. Kheoh

given: T.

family: Ryan

full_name: C.J. Ryan

full_name: A. Molina

given: A.

ReferenceCitation: Fizazi K, Flaig TW, Stöckle M, Scher HI, de Bono JS, Rathkopf DE, Ryan CJ, Kheoh T, Li J, Todd MB, Griffin TW, Molina A, Ohlmann CH. Does Gleason score at initial diagnosis predict efficacy of abiraterone acetate therapy in patients with metastatic castration-resistant prostate cancer? An analysis of abiraterone acetate phase III trials. Ann Oncol. 2016 Apr;27(4):699-705. doi: 10.1093/annonc/mdv545. Epub 2015 Nov 25.

ReferenceCitation: Antoun S, Bayar A, Ileana E, Laplanche A, Fizazi K, di Palma M, Escudier B, Albiges L, Massard C, Loriot Y. High subcutaneous adipose tissue predicts the prognosis in metastatic castration-resistant prostate cancer patients in post chemotherapy setting. Eur J Cancer. 2015 Nov;51(17):2570-7. doi: 10.1016/j.ejca.2015.07.042. Epub 2015 Aug 13.

ReferenceCitation: Xu XS, Ryan CJ, Stuyckens K, Smith MR, Saad F, Griffin TW, Park YC, Yu MK, Vermeulen A, Poggesi I, Nandy P. Correlation between Prostate-Specific Antigen Kinetics and Overall Survival in Abiraterone Acetate-Treated Castration-Resistant Prostate Cancer Patients. Clin Cancer Res. 2015 Jul 15;21(14):3170-7. doi: 10.1158/1078-0432.CCR-14-1549. Epub 2015 Mar 31.

publisher: American Association for Cancer Research (AACR)

title: Correlation between Prostate-Specific Antigen Kinetics and Overall Survival in Abiraterone Acetate–Treated Castration-Resistant Prostate Cancer Patients

ReferenceCitation: Scher HI, Heller G, Molina A, Attard G, Danila DC, Jia X, Peng W, Sandhu SK, Olmos D, Riisnaes R, McCormack R, Burzykowski T, Kheoh T, Fleisher M, Buyse M, de Bono JS. Circulating tumor cell biomarker panel as an individual-level surrogate for survival in metastatic castration-resistant prostate cancer. J Clin Oncol. 2015 Apr 20;33(12):1348-55. doi: 10.1200/JCO.2014.55.3487. Epub 2015 Mar 23.

name: Howard I. Scher, Glenn Heller, Daniel C. Danila, and Martin Fleisher, Memorial Sloan Kettering Cancer Center; Howard I. Scher and Daniel C. Danila, Weill Cornell Medical College; Xiaoyu Jia, Columbia University, New York, NY; Arturo Molina, Janssen Research & Development, Menlo Park; Weimin Peng, Janssen Research & Development, Los Angeles; Thian Kheoh, Janssen Research & Development, San Diego, CA; Gerhardt Attard, Shahneen K. Sandhu, David Olmos, Ruth Riisnaes, and Johann S. de Bono, Institute of...

title: Circulating Tumor Cell Biomarker Panel As an Individual-Level Surrogate for Survival in Metastatic Castration-Resistant Prostate Cancer

ReferenceCitation: Mulders PF, Molina A, Marberger M, Saad F, Higano CS, Chi KN, Li J, Kheoh T, Haqq CM, Fizazi K. Efficacy and safety of abiraterone acetate in an elderly patient subgroup (aged 75 and older) with metastatic castration-resistant prostate cancer after docetaxel-based chemotherapy. Eur Urol. 2014 May;65(5):875-83. doi: 10.1016/j.eururo.2013.09.005. Epub 2013 Sep 20.

title: Efficacy and Safety of Abiraterone Acetate in an Elderly Patient Subgroup (Aged 75 and Older) with Metastatic Castration-resistant Prostate Cancer After Docetaxel-based Chemotherapy

ReferenceCitation: Harland S, Staffurth J, Molina A, Hao Y, Gagnon DD, Sternberg CN, Cella D, Fizazi K, Logothetis CJ, Kheoh T, Haqq CM, de Bono JS, Scher HI; COU-AA-301 Investigators. Effect of abiraterone acetate treatment on the quality of life of patients with metastatic castration-resistant prostate cancer after failure of docetaxel chemotherapy. Eur J Cancer. 2013 Nov;49(17):3648-57. doi: 10.1016/j.ejca.2013.07.144. Epub 2013 Aug 22.

ReferenceCitation: Ryan CJ, Molina A, Li J, Kheoh T, Small EJ, Haqq CM, Grant RP, de Bono JS, Scher HI. Serum androgens as prognostic biomarkers in castration-resistant prostate cancer: results from an analysis of a randomized phase III trial. J Clin Oncol. 2013 Aug 1;31(22):2791-8. doi: 10.1200/JCO.2012.45.4595. Epub 2013 Jul 1.

name: Charles J. Ryan and Eric J. Small, University of California, San Francisco, San Francisco; Arturo Molina, Thian Kheoh, and Christopher M. Haqq, Janssen Research and Development, Los Angeles, CA; Jinhui Li, Janssen Research and Development, Raritan, NJ; Russell P. Grant, Laboratory Corporation of America, Burlington, NC; Howard I. Scher, Memorial Sloan-Kettering Cancer Center and Weill Cornell Medical College, New York, NY; Johann S. de Bono, Institute of Cancer Research and Royal Marsden Hospital, Sutton...

title: Serum Androgens As Prognostic Biomarkers in Castration-Resistant Prostate Cancer: Results From an Analysis of a Randomized Phase III Trial

ReferenceCitation: Logothetis CJ, Basch E, Molina A, Fizazi K, North SA, Chi KN, Jones RJ, Goodman OB, Mainwaring PN, Sternberg CN, Efstathiou E, Gagnon DD, Rothman M, Hao Y, Liu CS, Kheoh TS, Haqq CM, Scher HI, de Bono JS. Effect of abiraterone acetate and prednisone compared with placebo and prednisone on pain control and skeletal-related events in patients with metastatic castration-resistant prostate cancer: exploratory analysis of data from the COU-AA-301 randomised trial. Lancet Oncol. 2012 Dec;13(12):1210-7. doi: 10.1016/S1470-2045(12)70473-4. Epub 2012 Nov 9.

ReferenceCitation: Fizazi K, Scher HI, Molina A, Logothetis CJ, Chi KN, Jones RJ, Staffurth JN, North S, Vogelzang NJ, Saad F, Mainwaring P, Harland S, Goodman OB Jr, Sternberg CN, Li JH, Kheoh T, Haqq CM, de Bono JS; COU-AA-301 Investigators. Abiraterone acetate for treatment of metastatic castration-resistant prostate cancer: final overall survival analysis of the COU-AA-301 randomised, double-blind, placebo-controlled phase 3 study. Lancet Oncol. 2012 Oct;13(10):983-92. doi: 10.1016/S1470-2045(12)70379-0. Epub 2012 Sep 18. Erratum in: Lancet Oncol. 2012 Nov;13(11):e464. Lancet Oncol. 2014 Aug;15(9):e365.

ReferenceCitation: de Bono JS, Logothetis CJ, Molina A, Fizazi K, North S, Chu L, Chi KN, Jones RJ, Goodman OB Jr, Saad F, Staffurth JN, Mainwaring P, Harland S, Flaig TW, Hutson TE, Cheng T, Patterson H, Hainsworth JD, Ryan CJ, Sternberg CN, Ellard SL, Fléchon A, Saleh M, Scholz M, Efstathiou E, Zivi A, Bianchini D, Loriot Y, Chieffo N, Kheoh T, Haqq CM, Scher HI; COU-AA-301 Investigators. Abiraterone and increased survival in metastatic prostate cancer. N Engl J Med. 2011 May 26;364(21):1995-2005. doi: 10.1056/NEJMoa1014618.

title: Abiraterone and Increased Survival in Metastatic Prostate Cancer

location_country:
Austria
United States
Netherlands
Germany
France
Hungary
Australia
Belgium
Ireland
Spain
Canada
United Kingdom


ReferenceCitation: de Velasco G, McKay RR, Lin X, Moreira RB, Simantov R, Choueiri TK. Comprehensive Analysis of Survival Outcomes in Non-Clear Cell Renal Cell Carcinoma Patients Treated in Clinical Trials. Clin Genitourin Cancer. 2017 Dec;15(6):652-660.e1. doi: 10.1016/j.clgc.2017.03.004. Epub 2017 Mar 21.

family: de Velasco

full_name: Guillermo de Velasco

given: Guillermo

family: McKay

full_name: Rana R. McKay

given: Rana R.

family: Lin

full_name: Xun Lin

given: Xun

family: Moreira

full_name: Raphel B. Moreira

given: Raphel B.

family: Simantov

full_name: Ronit Simantov

given: Ronit

family: Choueiri

full_name: Toni K. Choueiri

given: Toni K.

journal_name: Clinical Genitourinary Cancer

title: Comprehensive Analysis of Survival Outcomes in Non–Clear Cell Renal Cell Carcinoma Patients Treated in Clinical Trials

ReferenceCitation: Grünwald V, Lin X, Kalanovic D, Simantov R. Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma. Eur Urol. 2016 Dec;70(6):1006-1015. doi: 10.1016/j.eururo.2016.05.010. Epub 2016 May 26.

family: Grünwald

full_name: Viktor Grünwald

given: Viktor

family: Kalanovic

full_name: Daniel Kalanovic

given: Daniel

journal_name: European Urology

ReferenceCitation: Rini BI, Bellmunt J, Clancy J, Wang K, Niethammer AG, Hariharan S, Escudier B. Randomized phase III trial of temsirolimus and bevacizumab versus interferon alfa and bevacizumab in metastatic renal cell carcinoma: INTORACT trial. J Clin Oncol. 2014 Mar 10;32(8):752-9. doi: 10.1200/JCO.2013.50.5305. Epub 2013 Dec 2.

name: Brian I. Rini, Cleveland Clinic Taussig Cancer Institute, Cleveland, OH; Joaquim Bellmunt, University Hospital del Mar-IMIM, Barcelona, Spain; Jill Clancy, Kongming Wang, Andreas G. Niethammer, Subramanian Hariharan, Pfizer, New York, NY; and Bernard Escudier, Institut Gustave Roussy, Villejuif, France.

family: Rini

full_name: Brian I. Rini

given: Brian I.

family: Bellmunt

full_name: Joaquim Bellmunt

given: Joaquim

family: Clancy

full_name: Jill Clancy

given: Jill

family: Wang

full_name: Kongming Wang

given: Kongming

family: Niethammer

full_name: Andreas G. Niethammer

given: Andreas G.

family: Hariharan

full_name: Subramanian Hariharan

given: Subramanian

family: Escudier

full_name: Bernard Escudier

given: Bernard

publisher_group: American Society of Clinical Oncology (ASCO)

title: Randomized Phase III Trial of Temsirolimus and Bevacizumab Versus Interferon Alfa and Bevacizumab in Metastatic Renal Cell Carcinoma: INTORACT Trial

location_country:
Malaysia
Belgium
Australia
Russian Federation
Czech Republic
Taiwan
Ukraine
India
France
Poland
Slovakia
Argentina
Canada
Korea, Republic of
Colombia
South Africa
Chile
Hong Kong
Netherlands
Singapore
Hungary
Portugal
Germany
United States
United Kingdom
Italy
Brazil
Serbia
Mexico
Spain

location_facility: Clinica de Oncologia de Porto Alegre - Sociedade Simples Ltda.

location_facility: Klinika tuberkulozy a plucnych chorob UK JLF a Martinskej fakultnej nemocince

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Szegedi Tudomanyegyetem, Urologiai Klinika

location_facility: Institute for Oncology and Radiology of Serbia

location_facility: Wojskowy Intsytut Medyczny, Zaklad Medycyny Nuklearnej CSK MON

location_facility: Clínica de Oncologia de Porto Alegre Sociedade Simples Ltda

location_facility: Fundação Pio XII - Hospital de Câncer de Barretos

location_facility: Fakultna Nemocnica s poliklinikou F D Roosevelta

location_facility: N.N. Blokhin Russian Cancer Research Center, Department of Clinical Pharmacology and Chemotherapy

location_facility: University of the Witwatersrand Oncology

location_facility: Centre de Sante et de Services Sociaux de Rimouski - Neigette

location_facility: R.E.Kavetsky Institute of experimental pathology, oncology and radiobiology NAS of Ukraine,Laborator

location_facility: Centrum Onkologii Ziemi Lubelskiej im. sw Jana z Dukli

location_facility: Fakultna Nemocnica s poliklinikou akad L Derera

location_facility: Pamela Youde Nethersole Eastern Hospital

location_facility: Unità Operativa di Oncologia, Azienda Ospedaliera Policlinico di Modena

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre

location_facility: Szpital Kliniczny Przemienienia Panskiego UM im. Karola Marcinkowskiego w Poznaniu

location_facility: Josa Andras Oktato Korhaz Nonprofit Kft.

location_facility: Moscow Scientific Research Oncology Institute P.A. Herzen

location_facility: Jawaharlal Nehru Cancer Hospital, Department of Medical Oncology

location_facility: Cliniques Universitaires de Mont-Godinne UCL

location_facility: Instituto de Oncologia de Piracicaba S/S Ltda

location_facility: Klinika nuklearnej mediciny JLF UK a Martinskej fakultnej nemocnice

location_facility: ProCura - Centro Goiano de Pesquisa Clínica Ltda

location_facility: Uchbobo-naukovyi likuvalnyi kompleks DDMU im. M.Gor'kogo

location_facility: Privolzhskiy District Medical Center of Federal Biomedical Agency

location_facility: Divisione di Urologia, Azienda Ospedaliera Policlinico Consorziale di Bari

location_facility: Wojskowy Intsytut Medyczny, Zaklad Diagnostyki Laboratoryjnej CSK MON

location_facility: Hematology Oncology Services of Arkansas

location_facility: Yonsei University Health System-Severance Hospital

location_facility: "State Institution ""Institute for Occupational Health of the

location_facility: Klinikum Region Hannover, Krankenhaus Siloah

location_facility: Scientific research Institute of Oncology N.N. Petrov

location_facility: Vivantes Klinikum am Urban, Neztwerk fuer Gesundheit GmbH

location_facility: Szpital Specjalistyczny im. L. Rydygiera Sp. z o.o.

location_facility: Sharp Memorial Hospital Investigational Pharmacy

location_facility: Oblasnyy onkologychnyy dispanser, onkourologichne viddilennya, Ivano-Frankivskiy Derzhavniy Medichni

location_facility: Donetskyy Oblasyy protypukhlynnyy Tsenter

location_facility: Farmacia del Comitato Etico Provinciale di Modena

location_facility: Centrum Onkologii, Instytut im. M. Sklodowskiej-Curie

location_facility: Struttura Complessa di Oncologia Medica Ospedale Santa Maria della Misericordia

location_facility: Sezione di Oncologia Medica Centro di Ricerca Clinica

location_facility: N.N. Blokhin Russian Cancer Research Center, Department of Urology

location_facility: Odette Cancer Centre, Sunnybrook Health Sciences Centre

location_facility: Donetske Obl. clinico-teritorial'ne medichne ob'yednannya

location_facility: Klinika pneumologie a ftiziologie FNsP LFUK

location_facility: Wojskowy Instytut Medyczny, Pracownia Badan Cynnosciowych Ukladu Oddechowego, Klinika Chorob Wewnetr

location_facility: Instituto do Cancer do Estado de Sao Paulo Octavio Frias de Oliveira - ICESP

location_facility: Centrum Medyczne Ostrobramska NZOZ "Magodent"

location_facility: Republican Clinical Oncology Dispensary of Minzdrav of Tatarstan Republic

location_facility: Medical Radiology Research Center of the Minzdravsotsrazvitiya of Russia

location_facility: Lakeshore Hospital & Research Center Limited

title: Phase 3b, Randomized, Open-Label Study Of Bevacizumab + Temsirolimus Vs. Bevacizumab + Interferon-Alfa As First-Line Treatment In Subjects With Advanced Renal Cell Carcinoma

summary: Primary objective: Comparison of independently assessed progression free survival (PFS) in subjects administered Bevacizumab + Temsirolimus vs. those administered Bevacizumab + Interferon-Alfa. Secondary objectives: safety, Investigator assessed PFS, objective response rate (independently assessed), and overall survival.


ReferenceType: result

ReferenceCitation: Di Minno G, Cerbone AM, Coppola A, Cimino E, Di Capua M, Pamparana F, Tufano A, Di Minno MN. Longer-acting factor VIII to overcome limitations in haemophilia management: the PEGylated liposomes formulation issue. Haemophilia. 2010 Jan;16 Suppl 1:2-6. doi: 10.1111/j.1365-2516.2009.02155.x. Review.

family: DI MINNO

full_name: G. DI MINNO

given: G.

family: CERBONE

full_name: A. M. CERBONE

given: A. M.

family: COPPOLA

full_name: A. COPPOLA

family: CIMINO

full_name: E. CIMINO

given: E.

family: DI CAPUA

full_name: M. DI CAPUA

given: M.

family: PAMPARANA

full_name: F. PAMPARANA

given: F.

family: TUFANO

full_name: A. TUFANO

full_name: M. N. D. DI MINNO

given: M. N. D.

journal_name: Haemophilia

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Powell J, Martinowitz U, Windyga J, Di Minno G, Hellmann A, Pabinger I, Maas Enriquez M, Schwartz L, Ingerslev J; LipLong Study Investigators. Efficacy and safety of prophylaxis with once-weekly BAY 79-4980 compared with thrice-weekly rFVIII-FS in haemophilia A patients. A randomised, active-controlled, double-blind study. Thromb Haemost. 2012 Nov;108(5):913-22. doi: 10.1160/TH12-03-0188. Epub 2012 Sep 26.

family: Martinowitz

full_name: Uri Martinowitz

given: Uri

family: Windyga

full_name: Jerzy Windyga

given: Jerzy

family: Di Minno

full_name: Giovanni Di Minno

given: Giovanni

family: Hellmann

full_name: Andrzej Hellmann

given: Andrzej

family: Pabinger

full_name: Ingrid Pabinger

given: Ingrid

family: Enriquez

full_name: Monika Enriquez

given: Monika

family: Schwartz

full_name: Lawrence Schwartz

given: Lawrence

family: Ingerslev

full_name: Jørgen Ingerslev

given: Jørgen

family: Powell

full_name: Jerry Powell

given: Jerry

journal_name: Thrombosis and Haemostasis

publisher: Georg Thieme Verlag KG

publisher_dissemination: Georg Thieme

publisher_group: Georg Thieme

publisher_normalized: Georg Thieme

title: Efficacy and safety of prophylaxis with once-weekly BAY 79–4980 compared with thrice-weekly rFVIII-FS in haemophilia A patients

intervention_type: Biological

lead_sponsor: Bayer

location_country:
Romania
Australia
Belgium
Denmark
Taiwan
Croatia
France
Lithuania
Poland
Norway
Argentina
Canada
Turkey
South Africa
Chile
Switzerland
Netherlands
Germany
United States
United Kingdom
Italy
Austria
Israel
New Zealand
Spain
Estonia

title: Randomized, Active-controlled, Double-blind, Parallel Design Study to Evaluate the Efficacy and Safety of a Once-a-week Prophylaxis Treatment With BAY79-4980 Compared to Three Times-per-week Prophylaxis With rFVIII-FS in Previously Treated Patients With Severe Hemophilia A

summary: A study to assess treatment with a new formulation of recombinant factor VIII reconstituted with liposomes (BAY79-4980) to evaluate whether a once-a-week treatment is safe and can prevent bleeds in subjects with severe haemophilia A.


title: A 76-week Prospective, Open-label, Multicenter Study to Evaluate the Long-term Effect of Rivastigmine Capsule and Transdermal Patch on Worsening of the Underlying Motor Symptoms of PD in Patients With Mild to Moderately Severe Dementia Associated With Parkinson's Disease (PDD)

summary: The purpose of this study is to provide long-term safety data for rivastigmine capsule and transdermal patch treatments, in particular the effect of rivastigmine on worsening of the underlying motor symptoms of Parkinson's Disease (PD), in patients with mild to moderately severe dementia associated with PD.

location_country:
Italy
Austria
Netherlands
Germany
France
Argentina
Australia
Belgium
Spain
Turkey
United States
United Kingdom
Canada

location_facility: Veterans Affairs Puget Sound Health Care System

location_facility: Neurology & Neuroscience Associates, Inc.

location_facility: Evanstan Northwestern Healthcare Medical Group


ReferenceType: background

ReferenceCitation: Miller AE, Wolinsky JS, Kappos L, Comi G, Freedman MS, Olsson TP, Bauer D, Benamor M, Truffinet P, O'Connor PW; TOPIC Study Group. Oral teriflunomide for patients with a first clinical episode suggestive of multiple sclerosis (TOPIC): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Neurol. 2014 Oct;13(10):977-86. doi: 10.1016/S1474-4422(14)70191-7. Epub 2014 Sep 2.

lead_sponsor: Sanofi

location_country:
Finland
Romania
Australia
Russian Federation
Denmark
Czech Republic
Ukraine
France
Poland
Lithuania
Canada
Turkey
Chile
Bulgaria
Hungary
United States
United Kingdom
Germany
Austria
Mexico
Estonia

acronym: TOPIC

location_facility:
Investigational Site Number 1407
Investigational Site Number 5410
Investigational Site Number 6807
Investigational Site Number 7703
Investigational Site Number 7105
Investigational Site Number 5304
Investigational Site Number 6810
Investigational Site Number 5404
Investigational Site Number 6405
Investigational Site Number 7709
Investigational Site Number 6004
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Investigational Site Number 8507
Investigational Site Number 8963
Investigational Site Number 7701
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Investigational Site Number 8310
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Investigational Site Number 6602
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Investigational Site Number 5606
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Investigational Site Number 8510
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Investigational Site Number 8937
Investigational Site Number 4004
Investigational Site Number 6805
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Investigational Site Number 7905
Investigational Site Number 5801
Investigational Site Number 6607
Investigational Site Number 5307
Investigational Site Number 7910
Investigational Site Number 6804
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Investigational Site Number 5605
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Investigational Site Number 8705
Investigational Site Number 6612
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Investigational Site Number 7501
Investigational Site Number 8708
Investigational Site Number 6809
Investigational Site Number 5409
Investigational Site Number 6403
Investigational Site Number 8701
Investigational Site Number 5803
Investigational Site Number 5303
Investigational Site Number 1404
Investigational Site Number 7904
Investigational Site Number 5406
Investigational Site Number 8953
Investigational Site Number 7803
Investigational Site Number 6614
Investigational Site Number 8914
Investigational Site Number 8304
Investigational Site Number 6601
Investigational Site Number 8922
Investigational Site Number 8301
Investigational Site Number 7808
Investigational Site Number 8940
Investigational Site Number 7906
Investigational Site Number 8706
Investigational Site Number 6815
Investigational Site Number 8941
Investigational Site Number 7101
Investigational Site Number 8704
Investigational Site Number 6801
Investigational Site Number 8702
Investigational Site Number 6002
Investigational Site Number 7710
Investigational Site Number 5306
Investigational Site Number 8954

title: An International, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Two Year Treatment With Teriflunomide 7 mg Once Daily and 14 mg Once Daily Versus Placebo in Patients With a First Clinical Episode Suggestive of Multiple Sclerosis Plus a Long Term Extension Period

summary:
The primary objective was to demonstrate the effect of teriflunomide (HMR1726) (14 milligram per day [mg/day] and 7 mg/day), in comparison to placebo, for reducing conversion of participants presenting with their first clinical episode consistent with multiple sclerosis (MS) to clinically definite multiple sclerosis (CDMS).

The secondary objectives were:

To demonstrate the effect of teriflunomide, in comparison to placebo, on:

Reducing conversion to definite multiple sclerosis (DMS)
Reducing annualized relapse rate (ARR)
Reducing disease activity/progression as measured by Magnetic Resonance Imaging (MRI)
Reducing accumulation of disability for at least 12 weeks as measured by the Expanded Disability Status Scale (EDSS)
Proportion of disability-free participants as assessed by the EDSS
Reducing participant-reported fatigue
To evaluate the safety and tolerability of teriflunomide
To evaluate the pharmacokinetics (PK) of teriflunomide
Optional pharmacogenomic testing aimed at assessing the association between the main enzyme systems of teriflunomide metabolism and hepatic safety, and other potential associations between gene variations and clinical outcomes


title: Study of Coronary Atheroma by Intravascular Ultrasound: Effect of Rosuvastatin Versus Atorvastatin (SATURN)

acronym: SATURN

summary: A 104-week, randomized, double-blind, parallel group, multi-center Phase IIIb study comparing the effects of treatment with rosuvastatin 40 mg or atorvastatin 80 mg on atherosclerotic disease burden as measured by intravascular ultrasound in patients with coronary artery disease.

ReferenceCitation: Puri R, Nissen SE, Shao M, Ballantyne CM, Barter PJ, Chapman MJ, Erbel R, Libby P, Raichlen JS, Uno K, Kataoka Y, Nicholls SJ. Sex-related differences of coronary atherosclerosis regression following maximally intensive statin therapy: insights from SATURN. JACC Cardiovasc Imaging. 2014 Oct;7(10):1013-22. doi: 10.1016/j.jcmg.2014.04.019. Epub 2014 Sep 17.

family: Puri

full_name: Rishi Puri

given: Rishi

family: Nissen

full_name: Steven E. Nissen

given: Steven E.

family: Shao

full_name: Mingyuan Shao

given: Mingyuan

family: Ballantyne

full_name: Christie M. Ballantyne

given: Christie M.

family: Barter

full_name: Phillip J. Barter

given: Phillip J.

family: Chapman

full_name: M. John Chapman

given: M. John

family: Erbel

full_name: Raimund Erbel

given: Raimund

family: Libby

full_name: Peter Libby

given: Peter

family: Raichlen

full_name: Joel S. Raichlen

given: Joel S.

family: Uno

full_name: Kiyoko Uno

given: Kiyoko

family: Kataoka

full_name: Yu Kataoka

given: Yu

family: Nicholls

full_name: Stephen J. Nicholls

given: Stephen J.

journal_name: JACC: Cardiovascular Imaging

title: Sex-Related Differences of Coronary Atherosclerosis Regression Following Maximally Intensive Statin Therapy

ReferenceCitation: Puri R, Libby P, Nissen SE, Wolski K, Ballantyne CM, Barter PJ, Chapman MJ, Erbel R, Raichlen JS, Uno K, Kataoka Y, Tuzcu EM, Nicholls SJ. Long-term effects of maximally intensive statin therapy on changes in coronary atheroma composition: insights from SATURN. Eur Heart J Cardiovasc Imaging. 2014 Apr;15(4):380-8. doi: 10.1093/ehjci/jet251. Epub 2014 Jan 20.

full_name: R. Puri

given: R.

full_name: P. Libby

given: P.

full_name: S. E. Nissen

given: S. E.

family: Wolski

full_name: K. Wolski

given: K.

full_name: C. M. Ballantyne

given: C. M.

full_name: P. J. Barter

given: P. J.

full_name: M. J. Chapman

given: M. J.

journal_name: European Heart Journal - Cardiovascular Imaging

ReferenceCitation: Puri R, Nissen SE, Libby P, Shao M, Ballantyne CM, Barter PJ, Chapman MJ, Erbel R, Raichlen JS, Uno K, Kataoka Y, Nicholls SJ. C-reactive protein, but not low-density lipoprotein cholesterol levels, associate with coronary atheroma regression and cardiovascular events after maximally intensive statin therapy. Circulation. 2013 Nov 26;128(22):2395-403. doi: 10.1161/CIRCULATIONAHA.113.004243. Epub 2013 Sep 16.

name: From the Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, OH (R.P., S.E.N., K.U., Y.K., S.J.N.); Cardiovascular Division, Brigham and Women’s Hospital, Boston, MA (P.L.); C5Research, Cleveland Clinic, Cleveland, OH (M.S.); Section of Cardiovascular Research, Baylor College of Medicine, and the Methodist DeBakey Heart and Vascular Center, Houston, TX (C.M.B.); Centre for Vascular Research, University of New South Wales, Sydney, Australia (P.J.B.); INSERM Dyslipidaemia and...

publisher: Ovid Technologies (Wolters Kluwer Health)

title: C-Reactive Protein, but not Low-Density Lipoprotein Cholesterol Levels, Associate With Coronary Atheroma Regression and Cardiovascular Events After Maximally Intensive Statin Therapy

ReferenceCitation: Nicholls SJ, Ballantyne CM, Barter PJ, Chapman MJ, Erbel RM, Libby P, Raichlen JS, Uno K, Borgman M, Wolski K, Nissen SE. Effect of two intensive statin regimens on progression of coronary disease. N Engl J Med. 2011 Dec 1;365(22):2078-87. doi: 10.1056/NEJMoa1110874. Epub 2011 Nov 15.

title: Effect of Two Intensive Statin Regimens on Progression of Coronary Disease

location_country:
Italy
Brazil
Mexico
Netherlands
Spain
France
Poland
Hungary
Belgium
Argentina
Australia
Russian Federation
United States
Canada


title: Randomized, Open Label, Phase III Trial Of CP- 751,871 In Combination With Paclitaxel And Carboplatin Versus Paclitaxel And Carboplatin In Patients With Non Small Cell Lung Cancer

summary: Determine whether the addition of CP- 751,871 in combination with paclitaxel plus carboplatin prolongs survival in patients with locally advanced (Stage IIIB with pleural effusion) or metastatic (Stage IV or recurrent) NSCLC of non adenocarcinoma histology.

ReferenceCitation: Langer CJ, Novello S, Park K, Krzakowski M, Karp DD, Mok T, Benner RJ, Scranton JR, Olszanski AJ, Jassem J. Randomized, phase III trial of first-line figitumumab in combination with paclitaxel and carboplatin versus paclitaxel and carboplatin alone in patients with advanced non-small-cell lung cancer. J Clin Oncol. 2014 Jul 1;32(19):2059-66. doi: 10.1200/JCO.2013.54.4932. Epub 2014 Jun 2.

name: Corey J. Langer, University of Pennsylvania; Anthony J. Olszanski, Fox Chase Cancer Center, Philadelphia, PA; Daniel D. Karp, MD Anderson Center, Houston, TX; Rebecca J. Benner, Judith R. Scranton, Pfizer Oncology, Groton, CT; Silvia Novello, University of Turin, Orbassano, Italy; Keunchil Park, Sungkyunkwan University School of Medicine, Seoul, Korea; Maciej Krzakowski, The Maria Sklodowska-Curie Institute of Oncology, Warsaw; Jacek Jassem, Medical University of Gdansk, Gdansk, Poland; Tony Mok, Chinese...

family: Langer

full_name: Corey J. Langer

given: Corey J.

family: Novello

full_name: Silvia Novello

given: Silvia

family: Park

full_name: Keunchil Park

given: Keunchil

family: Krzakowski

full_name: Maciej Krzakowski

given: Maciej

family: Karp

full_name: Daniel D. Karp

given: Daniel D.

family: Mok

full_name: Tony Mok

given: Tony

family: Benner

full_name: Rebecca J. Benner

given: Rebecca J.

family: Scranton

full_name: Judith R. Scranton

given: Judith R.

family: Olszanski

full_name: Anthony J. Olszanski

given: Anthony J.

family: Jassem

full_name: Jacek Jassem

given: Jacek

repository_institution: University of Turin - Institutional Research Information System University of Turin

publisher_normalized: American Society of Clinical Oncology (ASCO)

title: Randomized, Phase III Trial of First-Line Figitumumab in Combination With Paclitaxel and Carboplatin Versus Paclitaxel and Carboplatin Alone in Patients With Advanced Non–Small-Cell Lung Cancer

location_country:
Finland
Greece
Australia
Russian Federation
Czech Republic
Taiwan
Ukraine
India
France
Japan
Poland
Slovakia
Canada
Korea, Republic of
Hong Kong
Switzerland
Bulgaria
Hungary
Puerto Rico
Germany
United States
Italy
Austria
Brazil
Spain
Turkey


ReferenceCitation: Furst DE, Shaikh SA, Greenwald M, Bennett B, Davies O, Luijtens K, Staelens F, Koetse W, Bertin P. Two dosing regimens of certolizumab pegol in patients with active rheumatoid arthritis. Arthritis Care Res (Hoboken). 2015 Feb;67(2):151-60. doi: 10.1002/acr.22496.

family: Furst

full_name: D. E. Furst

given: D. E.

family: Shaikh

full_name: S. A. Shaikh

given: S. A.

name: Desert Medical AdvancesPalm DesertCalifornia

family: Greenwald

full_name: M. Greenwald

given: M.

name: UCB Pharma, Smyrna, and BABennett ConsultingMariettaGeorgia

family: Bennett

full_name: B. Bennett

given: B.

family: Davies

full_name: O. Davies

given: O.

family: Luijtens

full_name: K. Luijtens

family: Staelens

full_name: F. Staelens

given: F.

family: Koetse

full_name: W. Koetse

given: W.

name: CHU Dupuytren Teaching HospitalLimogesFrance

family: Bertin

full_name: P. Bertin

journal_name: Arthritis Care & Research

oa_colors: green hybrid

oa_host_type: publisher;repository

license: cc-by-nc

license_normalized: cc-by-nc

title: Two Dosing Regimens of Certolizumab Pegol in Patients With Active Rheumatoid Arthritis

intervention_type: Other

lead_sponsor: UCB Pharma

location_country:
United States
Canada
France

acronym: DoseFlex

title: A Phase IIIb Open-label run-in Double-blind, Placebo Controlled, Randomized Study to Evaluate the Safety/Efficacy of Certolizumab Pegol Administered Concomitantly With Stable-dose Methotrexate in Patients With Active Rheumatoid Arthritis.

summary: During the run-in period, CZP will be administered at 400 mg (2 injections) at Wks 0, 2, and 4 and 200 mg with placebo (1 injection placebo, 1 injection CZP) at Wks 6, 8, 10, 12, 14 and 16. At Wk 18 patients will be grouped as responders or non-responders based on results of the ACR20 at Week 16.


title: A Randomized, Double-Blind, Double-Dummy, Parallel Group, Phase 3 Efficacy and Safety Study of CGT-2168 Compared With Clopidogrel to Reduce Upper Gastrointestinal Events Including Bleeding and Symptomatic Ulcer Disease

summary:
The purpose of the COGENT-1 clinical trial is to determine whether CGT-2168 (clopidogrel and omeprazole) compared to clopidogrel is safe and effective in reducing the incidence of gastrointestinal bleeding and symptomatic ulcer disease, in the setting of concomitant aspirin therapy.

Antiplatelet therapy is an essential element of care for patients with atherothrombotic disease. Bleeding is a fundamental adverse effect of all antiplatelet drugs including aspirin, clopidogrel and dual antiplatelet regimens.

The gastrointestinal tract is the most common site of bleeding related to antiplatelet therapy, typically in connection with peptic ulcer disease. Recently published studies suggest the use of clopidogrel carries a gastrointestinal bleeding risk similar to that of aspirin or non-aspirin non-steroidal anti-inflammatory drugs. Patients taking any two of these drugs (clopidogrel, aspirin and/or non-aspirin NSAIDs) are exposed to an even higher risk of bleeding and ulcer disease.

Cogentus Pharmaceuticals is launching phase 3 trials of a novel combination product, CGT-2168, which has the potential to significantly reduce this problem and increase patient safety. CGT-2168 combines a standard dosage of clopidogrel and a gastroprotectant (omeprazole) in a once-daily pill that may reduce the likelihood of adverse gastrointestinal events.

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ReferenceCitation: Vaduganathan M, Bhatt DL, Cryer BL, Liu Y, Hsieh WH, Doros G, Cohen M, Lanas A, Schnitzer TJ, Shook TL, Lapuerta P, Goldsmith MA, Laine L, Cannon CP; COGENT Investigators. Proton-Pump Inhibitors Reduce Gastrointestinal Events Regardless of Aspirin Dose in Patients Requiring Dual Antiplatelet Therapy. J Am Coll Cardiol. 2016 Apr 12;67(14):1661-71. doi: 10.1016/j.jacc.2015.12.068. Epub 2016 Mar 21.

family: Vaduganathan

full_name: Muthiah Vaduganathan

given: Muthiah

family: Bhatt

full_name: Deepak L. Bhatt

given: Deepak L.

family: Cryer

full_name: Byron L. Cryer

given: Byron L.

family: Liu

full_name: Yuyin Liu

given: Yuyin

family: Hsieh

full_name: Wen-Hua Hsieh

given: Wen-Hua

family: Doros

full_name: Gheorghe Doros

given: Gheorghe

family: Cohen

full_name: Marc Cohen

given: Marc

family: Lanas

full_name: Angel Lanas

given: Angel

family: Schnitzer

full_name: Thomas J. Schnitzer

given: Thomas J.

family: Shook

full_name: Thomas L. Shook

given: Thomas L.

family: Lapuerta

full_name: Pablo Lapuerta

given: Pablo

family: Goldsmith

full_name: Mark A. Goldsmith

given: Mark A.

family: Laine

full_name: Loren Laine

given: Loren

family: Cannon

full_name: Christopher P. Cannon

given: Christopher P.

journal_name: Journal of the American College of Cardiology

ReferenceCitation: Bhatt DL, Cryer BL, Contant CF, Cohen M, Lanas A, Schnitzer TJ, Shook TL, Lapuerta P, Goldsmith MA, Laine L, Scirica BM, Murphy SA, Cannon CP; COGENT Investigators. Clopidogrel with or without omeprazole in coronary artery disease. N Engl J Med. 2010 Nov 11;363(20):1909-17. doi: 10.1056/NEJMoa1007964. Epub 2010 Oct 6.

family: Contant

full_name: Charles F. Contant

given: Charles F.

title: Clopidogrel with or without Omeprazole in Coronary Artery Disease

location_country:
Italy
United States
Chile
Mexico
Germany
France
Bulgaria
Poland
Slovakia
Romania
Hungary
Australia
Puerto Rico
Canada
Czech Republic
Ukraine

location_facility: Sewickley Valley Medical Group Cardiology

location_facility: "Śląskie Centrum Chorób Serca, III Katedra i Oddział Kliniczny Kardiologii Śląskiego Uniwersytetu Medycznego

location_facility: The Heart and Vascular Institute of Florida

location_facility: Cardiovascular Associates of the Delaware Valley, P.A.

location_facility: Cardiology Assocaites of Orlando d/b/a Orlando Heart Center

location_facility: "Oddział Kardiologii Inwazyjnej i Angiologii z Pr. Hemodynamiki

location_facility: Kardioarytmologichnyi tsentr Zhytomyrs'koi oblasnoi klinichnoi likarni im. O.F. Gorbachevs'kogo, m. Zhytomyr

location_facility: Centre Hospitalier Intercommunal du Val d'Ariège

location_facility: Research Center Phase I-IV of Florida Corp.

location_facility: Mazowieckie Centrum Badań Klinicznych Iwona Czajkowska, Monika Śmietańska s.c.

location_facility: Oblasnyi klinichnyi kardiologichnyi dyspanser, m. Ivano-Frankivsk, Ivano-Frankivskyi derzhavnyi medychnyi universytet, kafedra terapii # 3

location_facility: Wojewódzki Szpital Zespolony, Oddział Kardiologiczny

location_facility: Natsionalnyi naukovyi tsentr "Instytut kardiologii im. akad. M.D. Strazheska" AMN Ukrainy, m. Kyiv, viddilenia symptomatychnykh arterial'nykh gipertenziy

location_facility: Multiprofile Hospital for Active Treatment "Sveta Marina", Clinic of Internal Diseases - 2nd Internal Department

location_facility: Hospital Central "Dr. Ignacio Morones Prieto"

location_facility: Oddział Internistyczno-Kardiologiczny Samodzielny Publiczny Zakład Opieki Zdrowotnej

location_facility: Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András Oktató Kórház

location_facility: Pennsylvania Heart and Vascular Group, P.C.

location_facility: Oddział Wewnetrzny I, Szpital Kolejowy im. dr med. Włodzimierza Roeslera

location_facility: Oddzial Chorób Wewnętrznych III Szpital Specjalistyczny im.Stefana Zeromskiego, SPZOZ w Krakowie

location_facility: South Suburban Health Professional Group, PC

location_facility: Universitatsklinikum Berlin Campus Charite Mitte Med Klinik Kardiologie und Angiologie

location_facility: Trinity Hypertension and Diagnostic Res.

location_facility: Oddział Chorób Wewnętrznych i Farmakologii Klinicznej Samodzielny Publiczny Centralny Szpital Kliniczny im. Prof. Kornela Gibińskiego Śląskiego Uniwersytetu Medycznego w Katowicach

location_facility: Fraser Clinical Trials Inc and Royal Columbian Hospital

location_facility: Poradnia Kardiologiczna, Oddział Chorob Wewnetrznych Szpital Powiatowy w Limanowej

location_facility: Oddział Kardiologiczny Szpital Wolski im. dr Anny Gostyńskiej Samodzielny Publiczny Zakład Opieki Zdrowotnej

location_facility: Winchester Medical Center/ Clinical Research Department

location_facility: Northeast Iowa Medical Education Foundation

location_facility: Alegent Health Clinic Heart and Vascular Specialist

location_facility: Niepubliczny Zakład Opieki Zdrowotnej POLIMEDICA

location_facility: "Oddział Kardiologiczny Publiczny Samodzielny ZOZ Wojewódzkie Centrum Medyczne

location_facility: Clinique de Cardiologie de Trois-Rivieres

location_facility: Szpital Specjalistyczny w Kościerzynie, Oddział Kardiologii

location_facility: 5. Interna klinika LF UK, FNsP Bratislava, Nemocnica Ruzinov

location_facility: Executive Health and Research Associates, Inc.

location_facility: Cardiovascular Research Center of South Florida

location_facility: "Oddział Kardiologiczny Wałbrzyski Ośrodek Kardiologii Interwencyjnej Specjalityczny Szpital im. Dr Alfreda Sokołowskiego

location_facility: Fővárosi Önkormányzat Károlyi Sándor Kórház és Rendelőintézet

location_facility: Oddział Chorób Wewnętrzych i Kardiologii , ZOZ w Debicy

location_facility: Alabama Clinical Research Institute, Inc. (ACRI)

location_facility: Klinika kardiologie Institut klinické a experimentální medicíny

location_facility: Specjalistyczne Centrum Diagnostyczno-Lecznicze Bamberski Dwór

location_facility: Multiprofile Hospital for Active Treatment and Emergency Medicine "Pirogov". Cardiology Clinic

location_facility: II Klinika Choroby Wieńcowej Instytutu Kardiologii im. Prymasa Tysiaclecia Stefana Kardynala Wyszynskiego

location_facility: Hospitalier de l'Universite de Montreal Hotel Dieu

location_facility: Zakład Hemodynamiki, Wojewódzki Szpital Specjalistyczny

location_facility: "Klinika Choroby Wieńcowej Instytut Kardiologii, Collegium Medicum Uniwerytet Jagielloński

location_facility: Comprehensive Cardiology Consultants, Inc.

location_facility: Institutul de Boli Cardiovasculare si Transplan Tg. Mures

location_facility: Multiprofile Hospital for Active Treatment ''Sveti Panteleymon'', 2nd Department. of Internal Diseases - Intensive Cardiology Unit

location_facility: La Pitié Salpétrière Institut de Cardiologie

location_facility: "Samodzielny Szpital Wojewódzki im. Mikołaja Kopernika, Oddział Kardiologiczny

location_facility: Multiprofile Hospital for Active Treatment ''Sveti Georgi'', Cardiology Clinic

location_facility: Azienda Ospedaliera Maggiore Della Carita' Di Novara

location_facility: Jacksonville Center for Clinical Research

location_facility: Oddział Kardiologiczny Szpital Wojewódzki im. Kardynała Stefana Wyszyńskiego

location_facility: Niepubliczny Zakład Opieki Zdrowotnej "Nasz Lekarz", Praktyka Grupowa Lekarzy Rodzinnych z Przychodnią Specjalistyczną

location_facility: Niepubliczny Zakład Opieki Zdrowotnej Specjalista Sp. z o.o.

location_facility: Spitalul Clinic Judetean de Urgenta Bacau

location_facility: Medyczne Centrum Hetmańska, Indywiualna Specjalistyczna Praktyka Lekarska, Dr n. med. Piotr Leszczyński

location_facility: Chest and Critical Care Consultants, A Medical Group

location_facility: Multiprofile Hospital for Active Treatment "Sveta Ekaterina", 1st Department of Internal Diseases

location_facility: Research Associates of Jackson and Apex Cardiology

location_facility: Multiprofile Hospital for Active Treatment - Ruse, 4th Department of Internal Diseases

location_facility: Specjalistyczny Gabinet Lekarski Internistyczno-Kardiologiczny-Cardiology

location_facility: Międzyleski Szpital Specjalistyczny w Warszawie

location_facility: Southeast Texas Clinical Research Center

location_facility: Komunal'na ustanova "Oblasnyi kardiologichnyi dyspanser", viddilenia intensyvnoi terapii, m. Zaporizhzhia

location_facility: National Heart Hospital Department of Cardiology

location_facility: Azienda Ospedaliera della Provincia di Lodi Presidio Ospedaliero di Codogno

location_facility: Szpital Specjalistyczny Św.Jana, Oddział Kardiologii,

location_facility: Buffalo Cardiology and Pulmonary Associates

location_facility: Praxis für Innere Medizin, Gastroenterologie

location_facility: Duluth Clinic / Saint Marys Medical Center

location_facility: TOV "Kardiologichna klinika "Sertse i sudyny" m. Kyiv

location_facility: Nemocnica s poliklinikou Považská Bystrica

location_facility: Zentrum für klinische Prüfungen in der Facharztzentrum Dresden Neustadt GbR

location_facility: Kilniken Maria Hilf GmbH Krankenhaus St. Franziskus

location_facility: Cardiovascular Consultants of South Florida

location_facility: Military Medical Academy, Clinic of Cardiology and Intensive Care

location_facility: Inland Heart and Vascular Medical Associates

location_facility: Gemeinschaftspraxis Innere Medizin und Kardiologie

location_facility: Fovarosi Onkormanyzat Egyesitett Szent Istvan es Szent Laszlo Korhaz - Rendelointezet

location_facility: Publiczny Specjalistyczny Zaklad Opieki Zdrowotnej Oddzial Kardiologiczny

location_facility: Klinikum Region Hannover Krankenhaus Nordstadt

location_facility: Verzosa & Ungab Internal Medicine Associates

location_facility: ZOZ w Oławie, Oddział Chorób Wewnętrznych

location_facility: Centre Hospitalier Universitaire de Quebec (CHOQ) Hotel Dieu de Quebec

location_facility: Klinikum Mannheim GmbH, Universaitatskinikum

location_facility: New England Center for Clinical Research, Inc

location_facility: Centrum Leczenia Chorób Cywilizacyjnych Oddz. Gdynia filla Fikakowo

location_facility: Midwest Cardiovascular Research Foundation

location_facility: Oddział Kardiologii Samodzielny Publiczny Zakład Opieki Zdrowotnej w Sieradzu im. Kardynała Stefana Wyszyńskiego

location_facility: Hospital of the University of Pennsylvania Cardiology Department

location_facility: The University of Texas Medical Branch at Galveston

location_facility: Specjalistyczny Zakład Opieki Zdrowotnej Poradnia lekarzy specjalistów "Jantar"

location_facility: Samodzileny Publiczny Zakład Opieki Zdrowotnej w Puławach, Szpital Specjalistyczny

location_facility: Oddział Kardiologii Wojewódzki Szpital Zespolony

location_facility: Heart Clinic of Louisiana Clinical Research, LLC.

location_facility: "Oddział Kardiologii z Pododdziałem Ostrych Zespołów Wieńcowych i z Ośrodkiem Implantacji Rozruszników Serca,

location_facility: Osrodek Chorob Serca, Klinika Kardiologii 4 Wojskowy Szpital Kliniczny z Poliklinika - Samodzielny Publiczny Zaklad Opieki Zdrowotnej

location_facility: II Oddział Wewnętrzny Samodzielny Publiczny Zakład Opieki Zdrowotnej

location_facility: Cardiac Care and Vascular Medicine, Albert Einstein College of Medicine

location_facility: Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski, Clinic of Cardiology

location_facility: Tokuda Hospital Department of Cardiology

location_facility: 4th Multiprofile Hospital for Active Treatment

location_facility: University Multiprofile Hospital for Active Treatment ''Tsaritsa Ioanna'' - ISUL, Cardiology Clinic

location_facility: Texas Regional Heart Center d/b/a Legacy Heart Center

location_facility: Oddział Kardiologii z Zakładem Diagnostyki Kardiologicznej, Samodzielny Publiczny Zakład Opieki Zdrowotnej, Wojewódzki Szpital im. dr J. Biziela,

location_facility: II.interni klinika kardiologie a angiologie 1. LF UK a VFN v Praze

location_facility: "Oddzial Chorob Wewnetrznych i Kardiologii, Szpital Powiatowy im.Edmunda Biernackiego

location_facility: Specjalistyczna Przychodnia Lekarska "Medikard"

location_facility: Natsionalnyi naukovyi tsentr "Instytut kardiologii im. akad. M.D. Strazheska", viddil reanimatsii ta intensyvnoi terapii, m. Kyiv

location_facility: NZOZ Przychodnia Zadebie, Przychodnia Kardiologiczna

location_facility: McMinn Medical Group (DBA: Athens Medical Group)

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska

location_facility: Niepubliczny Zakład Opieki Zdrowotnej, Centrum Badań Klinicznych

location_facility: Franciscan Health System dba FHS Research Center

location_facility: Hospital Regional de Punta Arenas Dr. Lautaro Navarro

location_facility: Zakład Opieki Zdrowotnej Trójmiejskie Centrum Medyczne Sp. z o.o

location_facility: Oddział Kardiologii, Szpital Specjalistyczny im. J. Dietla

location_facility: Saint Patrick Hospital- International Heart Institute of Montana

location_facility: Therapeutic Research Institute of Orange County

location_facility: "Oddział Kardiologii, Wojewódzki Szpital Zespolony w Skierniewicach, "

location_facility: St. Josef-Hospital Medizinische Klinik II, Kardiologie

location_facility: Oddział Kardiologiczny Wojewódzki Szpital Specjalistyczy w Siedlcach

location_facility: Instituto de Corazón de Querétaro, S.A. de C.V.

location_facility: Centre de Sante et de services sociaux du nord de lanaudiere/CHRDL

location_facility: Good Samaritan Hospital (Medstar Health)

location_facility: Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház

location_facility: "Klinichne obyednannia shvydkoi medychnoi dopomogy, m. Dnipropetrovs'k,Dnipropetrovs'ka derzhavna medychna akademiya, kafedra gospital'noi terapii #2

location_facility: Cardiovascular Care of Northern Carolina

location_facility: Universitäres Herz-und Gefäßzentrum Hamburg"

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny Akademii Medycznej w Warszawie

location_facility: Azienda Ospedaliera Universitaria San Martino-Dipartimento di Medicina Interna e Specialità Mediche

location_facility: National Multiprofile Transport Hospital "Tsar Boris III, Cardiology Clinic

location_facility: Ventura Cardiology Consultants Medical Group, Inc.

location_facility: Wojewódzki Szpital Meijski im. Biziela, Oddział Kardiologii - SPZOZ


title: Effect of Inhalation of a Free Combination of Tiotropium Once Daily 18 Mcg and Salmeterol Twice Daily 50 Mcg Versus a Fixed Combination of Fluticasone and Salmeterol Twice Daily (500/50 Mcg) on Static Lung Volumes and Exercise Tolerance in COPD Patients (a Randomised, Double-blind, Double Dummy, 16 (2 x 8) Weeks, Crossover Study).

summary:
The primary objective of this study is to demonstrate that treatment with a free combination of tiotropium and salmeterol provides superior improvement in static lung volumes and exercise tolerance compared to a fixed combination of fluticasone and salmeterol in patients with COPD.

The secondary objective includes assessment of safety.

ReferenceCitation: Magnussen H, Paggiaro P, Schmidt H, Kesten S, Metzdorf N, Maltais F. Effect of combination treatment on lung volumes and exercise endurance time in COPD. Respir Med. 2012 Oct;106(10):1413-20. doi: 10.1016/j.rmed.2012.05.011. Epub 2012 Jun 28.

family: Magnussen

full_name: Helgo Magnussen

given: Helgo

family: Paggiaro

full_name: Pierluigi Paggiaro

given: Pierluigi

family: Schmidt

full_name: Hendrik Schmidt

given: Hendrik

family: Kesten

full_name: Steven Kesten

given: Steven

family: Metzdorf

full_name: Norbert Metzdorf

given: Norbert

family: Maltais

full_name: François Maltais

given: François

journal_name: Respiratory Medicine

lead_sponsor: Boehringer Ingelheim

location_country:
Italy
Austria
Sweden
Germany
France
Russian Federation
Canada

location_facility: 205.334.4306 Boehringer Ingelheim Investigational Site

location_facility: 205.334.3301A Boehringer Ingelheim Investigational Site

location_facility: 205.334.46002 Boehringer Ingelheim Investigational Site

location_facility: 205.334.4301 Boehringer Ingelheim Investigational Site

location_facility: 205.334.3302A Boehringer Ingelheim Investigational Site

location_facility: 205.334.3306B Boehringer Ingelheim Investigational Site

location_facility: 205.334.4904 Boehringer Ingelheim Investigational Site

location_facility: 205.334.3302B Boehringer Ingelheim Investigational Site

location_facility: 205.334.4902 Boehringer Ingelheim Investigational Site

location_facility: 205.334.4309 Boehringer Ingelheim Investigational Site

location_facility: 205.334.4901 Boehringer Ingelheim Investigational Site

location_facility: 205.334.3306A Boehringer Ingelheim Investigational Site

location_facility: 205.334.1004 Boehringer Ingelheim Investigational Site

location_facility: 205.334.1009 Boehringer Ingelheim Investigational Site

location_facility: 205.334.46003 Boehringer Ingelheim Investigational Site

location_facility: 205.334.39005 Boehringer Ingelheim Investigational Site

location_facility: 205.334.3303A Boehringer Ingelheim Investigational Site

location_facility: 205.334.4907 Boehringer Ingelheim Investigational Site

location_facility: 205.334.1006 Boehringer Ingelheim Investigational Site

location_facility: 205.334.1005 Boehringer Ingelheim Investigational Site

location_facility: 205.334.39002 Boehringer Ingelheim Investigational Site

location_facility: 205.334.39001 Boehringer Ingelheim Investigational Site

location_facility: 205.334.4308 Boehringer Ingelheim Investigational Site

location_facility: 205.334.7001 Boehringer Ingelheim Investigational Site

location_facility: 205.334.7003 Boehringer Ingelheim Investigational Site

location_facility: 205.334.1008 Boehringer Ingelheim Investigational Site

location_facility: 205.334.1001 Boehringer Ingelheim Investigational Site

location_facility: 205.334.3303B Boehringer Ingelheim Investigational Site

location_facility: 205.334.1007 Boehringer Ingelheim Investigational Site

location_facility: 205.334.39006 Boehringer Ingelheim Investigational Site

location_facility: 205.334.3304A Boehringer Ingelheim Investigational Site

location_facility: 205.334.7002 Boehringer Ingelheim Investigational Site

location_facility: 205.334.4908 Boehringer Ingelheim Investigational Site

location_facility: 205.334.4909 Boehringer Ingelheim Investigational Site

location_facility: 205.334.1003 Boehringer Ingelheim Investigational Site

location_facility: 205.334.39007 Boehringer Ingelheim Investigational Site

location_facility: 205.334.4302 Boehringer Ingelheim Investigational Site

location_facility: 205.334.4305 Boehringer Ingelheim Investigational Site

location_facility: 205.334.1010 Boehringer Ingelheim Investigational Site

location_facility: 205.334.3305A Boehringer Ingelheim Investigational Site

location_facility: 205.334.39004 Boehringer Ingelheim Investigational Site

location_facility: 205.334.46001 Boehringer Ingelheim Investigational Site


title: A Randomized Phase IIb Placebo-controlled Study of R-ICE Chemotherapy With and Without SGN-40 (Anti-CD40 Humanized Monoclonal Antibody) for Second-line Treatment of Patients With Diffuse Large B-Cell Lymphoma (DLBCL)

summary: This is a randomized trial to estimate the activity of R-ICE plus SGN-40 vs. R-ICE plus placebo in patients with DLBCL. The study will assess safety and tolerability and will measure any additional clinical benefit observed in patients receiving SGN-40.

ReferenceCitation: Fayad L, Ansell SM, Advani R, Coiffier B, Stuart R, Bartlett NL, Forero-Torres A, Kuliczkowski K, Belada D, Ng E, Drachman JG. Dacetuzumab plus rituximab, ifosfamide, carboplatin and etoposide as salvage therapy for patients with diffuse large B-cell lymphoma relapsing after rituximab, cyclophosphamide, doxorubicin, vincristine and prednisolone: a randomized, double-blind, placebo-controlled phase 2b trial. Leuk Lymphoma. 2015;56(9):2569-78. doi: 10.3109/10428194.2015.1007504. Epub 2015 Feb 26.

family: Fayad

full_name: Luis Fayad

given: Luis

family: Ansell

full_name: Stephen M. Ansell

given: Stephen M.

family: Advani

full_name: Ranjana Advani

given: Ranjana

family: Coiffier

full_name: Bertrand Coiffier

given: Bertrand

family: Stuart

full_name: Robert Stuart

given: Robert

family: Bartlett

full_name: Nancy L. Bartlett

given: Nancy L.

family: Forero-Torres

full_name: Andres Forero-Torres

given: Andres

family: Kuliczkowski

full_name: Kazimierz Kuliczkowski

given: Kazimierz

family: Belada

full_name: David Belada

given: David

family: Ng

full_name: Edmund Ng

given: Edmund

family: Drachman

full_name: Jonathan G. Drachman

given: Jonathan G.

journal_name: Leukemia & Lymphoma

evidence: open (via free pdf)

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

lead_sponsor: Seagen Inc.

location_country:
Italy
Germany
France
Poland
Hungary
Belgium
Australia
Spain
United States
Czech Republic

location_facility: Azienda Ospedaliera Universitaria Senese

location_facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi

location_facility: Winship Cancer Institute, Emory University

location_facility: Azienda Ospedaliera Universitaria San Martino

location_facility: Washington University School of Medicine

location_facility: Groupe Hospitalier Necker - Enfants Malades

location_facility: Cliniques Universitaires UCL de Mont-Goddine

location_facility: H. Duran y Reynals Institue Catala D'Oncologia

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Centre Leon Berard - Centre regional de lutte contre le cancer Rhone-Alpes

location_facility: University of Louisville - James Graham Brown Cancer Center

location_facility: Centrum Onkologii Institut im. Marii Sklodowskiej-Curie

location_facility: Debreceni Egyetem Orvos - es Egeszsegtudomanyi Centrum

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikat Kozpont

location_facility: Petz Aladar Megyei Oktato Korhaz, IInd Department of Internal Medicine


title: Randomised, Placebo-controlled, Multi-centre Study to Assess the Efficacy and Safety of Eltrombopag in Thrombocytopenic Subjects With Hepatitis C Virus (HCV) Infection Who Are Otherwise Eligible to Initiate Antiviral Therapy (Peginterferon Alfa-2a Plus Ribavirin

summary: The purpose of this study is to assess the ability of eltrombopag to maintain a platelet count sufficient to facilitate initiation of antiviral therapy, to minimise antiviral therapy dose reductions and to avoid permanent discontinuation of antiviral therapy. The clinical benefit of eltrombopag will be measured by the proportion of subjects who are able to achieve a Sustained Virological Response (SVR).

ReferenceCitation: Saleh MI, Obeidat AR, Anter HA, Khanfar AA. Eltrombopag dose predictors in thrombocytopenic subjects with hepatitis C virus infection. Clin Exp Pharmacol Physiol. 2015 Oct;42(10):1030-5. doi: 10.1111/1440-1681.12451.

name: Faculty of Pharmacy; The University of Jordan; Amman Jordan

family: Saleh

full_name: Mohammad I Saleh

given: Mohammad I

name: Jordan Royal Medical Services; Amman Jordan

family: Obeidat

full_name: Abdullah R Obeidat

given: Abdullah R

family: Anter

full_name: Hanan A Anter

given: Hanan A

name: Department of Medicine; Division of Haematology and Oncology; The University of Texas Medical Branch; Galveston Texas USA

family: Khanfar

full_name: Anas A Khanfar

given: Anas A

journal_name: Clinical and Experimental Pharmacology and Physiology

ReferenceCitation: Giannini EG, Afdhal NH, Sigal SH, Muir AJ, Reddy KR, Vijayaraghavan S, Elkashab M, Romero-Gómez M, Dusheiko GM, Iyengar M, Vasey SY, Campbell FM, Theodore D. Non-cirrhotic thrombocytopenic patients with hepatitis C virus: Characteristics and outcome of antiviral therapy. J Gastroenterol Hepatol. 2015 Aug;30(8):1301-8. doi: 10.1111/jgh.12942.

name: Department of Internal Medicine University of Genoa  Genoa Italy

family: Giannini

full_name: Edoardo G Giannini

given: Edoardo G

name: Division of Gastroenterology Beth Israel Deaconess Medical Center and Harvard Medical School  Boston Massachusetts USA

family: Afdhal

full_name: Nezam H Afdhal

given: Nezam H

name: Department of Medicine New York University School of Medicine  New York New York USA

family: Sigal

full_name: Samuel H Sigal

given: Samuel H

name: Duke Clinical Research Institute, Division of Gastroenterology Duke University Medical Center  Durham North Carolina USA

family: Muir

full_name: Andrew J Muir

given: Andrew J

name: University of Pennsylvania School of Medicine University of Pennsylvania  Philadelphia Pennsylvania USA

family: Reddy

full_name: K Rajender Reddy

given: K Rajender

name: Department of Medical Gastroenterology Sri Ramachandra University  Chennai India

family: Vijayaraghavan

full_name: Shanthi Vijayaraghavan

given: Shanthi

name: Department of Hepatology Toronto Liver Center  Toronto Canada

family: Elkashab

full_name: Magdy Elkashab

given: Magdy

name: Unit for Medical and Surgical Management of Digestive Diseases and CIBERehd, Valme University Hospital University of Seville  Sevilla Spain

family: Romero‐Gómez

full_name: Manuel Romero‐Gómez

given: Manuel

name: Centre for Hepatology University College London Medical School  London UK

family: Dusheiko

full_name: Geoffrey M Dusheiko

given: Geoffrey M

name: GlaxoSmithKline  Collegeville Pennsylvania USA

family: Iyengar

full_name: Malini Iyengar

given: Malini

family: Vasey

full_name: Sandra Y Vasey

given: Sandra Y

name: GlaxoSmithKline Stockley Park  Uxbridge UK

family: Campbell

full_name: Fiona M Campbell

given: Fiona M

name: GlaxoSmithKline Research Triangle Park  North Carolina USA

family: Theodore

full_name: Dickens Theodore

given: Dickens

journal_name: Journal of Gastroenterology and Hepatology

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

title: Non‐cirrhotic thrombocytopenic patients with hepatitis C virus: Characteristics and outcome of antiviral therapy

ReferenceCitation: Afdhal NH, Dusheiko GM, Giannini EG, Chen PJ, Han KH, Mohsin A, Rodriguez-Torres M, Rugina S, Bakulin I, Lawitz E, Shiffman ML, Tayyab GU, Poordad F, Kamel YM, Brainsky A, Geib J, Vasey SY, Patwardhan R, Campbell FM, Theodore D. Eltrombopag increases platelet numbers in thrombocytopenic patients with HCV infection and cirrhosis, allowing for effective antiviral therapy. Gastroenterology. 2014 Feb;146(2):442-52.e1. doi: 10.1053/j.gastro.2013.10.012. Epub 2013 Oct 12.

title: Eltrombopag Increases Platelet Numbers in Thrombocytopenic Patients With HCV Infection and Cirrhosis, Allowing for Effective Antiviral Therapy

location_country:
Romania
Belgium
Australia
Russian Federation
Czech Republic
Taiwan
Ukraine
India
Pakistan
France
Poland
Thailand
Slovakia
Canada
Korea, Republic of
Hong Kong
Netherlands
Puerto Rico
United States
Germany
United Kingdom
Italy
Brazil
Israel
Spain


ReferenceCitation: Psyrri A, Rampias T, Vermorken JB. The current and future impact of human papillomavirus on treatment of squamous cell carcinoma of the head and neck. Ann Oncol. 2014 Nov;25(11):2101-2115. doi: 10.1093/annonc/mdu265. Epub 2014 Jul 23. Review.

family: Psyrri

full_name: A. Psyrri

given: A.

family: Rampias

full_name: T. Rampias

given: T.

family: Vermorken

full_name: J.B. Vermorken

location_country:
United States
Belgium
France
Spain

location_facility: 1200.28.0001 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0008 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0061A Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0022 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0059A Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0002 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0043 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0006 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0031 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0062A Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0052A Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0009 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0044 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0041 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0012 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0045 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0021 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0017 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0007 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0013 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0055G Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0030 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0010 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0051A Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0004 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0050A Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0058A Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0016 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0032 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0042 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0062B Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0011 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0005 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0020 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0024 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0040 Boehringer Ingelheim Investigational Site

title: A Randomized, Open-label Phase II Study of BIBW 2992 Versus Cetuximab (Erbitux) in Patients With Metastatic or Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC) After Failure of Platinum-containing Therapy With a Cross-over Period for Progressing Patients

summary: The primary objective of this study is to explore the efficacy of BIBW 2992 compared with cetuximab (Erbitux) in patients with metastatic or recurrent head and neck cancer after failure of platinum-containing therapy. In addition, the trial aims to clarify the influence of EGFR genotype on tumor response to the treatment regimens.


title: A 12 Month, Double Blind, Randomized, Placebo-controlled Trial Evaluating the Effect of BIBF 1120 Administered at Oral Doses of 50 mg qd, 50 mg Bid, 100 mg Bid and 150 mg Bid on Forced Vital Capacity Decline During One Year, in Patients With Idiopathic Pulmonary Fibrosis, With Optional Active Treatment Extension Until Last Patient Out.

summary:
The general purpose of this trial is to investigate the efficacy and safety of 4 dose strategies of BIBF 1120 treatment for 12 months, compared to placebo in patients with idiopathic pulmonary fibrosis.

The primary objective of this study is to demonstrate whether at least one dose strategy is superior to placebo in patients with IPF, in modifying the rate of decline of Forced Vital Capacity (FVC).

As a secondary objective, additional parameters will be assessed in order to differentiate between dose strategies on the basis of safety and efficacy

ReferenceCitation: Glaspole I, Bonella F, Bargagli E, Glassberg MK, Caro F, Stansen W, Quaresma M, Orsatti L, Bendstrup E. Efficacy and safety of nintedanib in patients with idiopathic pulmonary fibrosis who are elderly or have comorbidities. Respir Res. 2021 Apr 26;22(1):125. doi: 10.1186/s12931-021-01695-y.

family: Glaspole

full_name: Ian Glaspole

given: Ian

family: Bonella

full_name: Francesco Bonella

given: Francesco

family: Bargagli

full_name: Elena Bargagli

given: Elena

family: Glassberg

full_name: Marilyn K. Glassberg

given: Marilyn K.

family: Caro

full_name: Fabian Caro

given: Fabian

family: Stansen

full_name: Wibke Stansen

given: Wibke

family: Quaresma

full_name: Manuel Quaresma

family: Orsatti

full_name: Leticia Orsatti

given: Leticia

family: Bendstrup

full_name: Elisabeth Bendstrup

given: Elisabeth

currency_apc_doaj: GBP

journal_name: Respiratory Research

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Richeldi L, Kreuter M, Selman M, Crestani B, Kirsten AM, Wuyts WA, Xu Z, Bernois K, Stowasser S, Quaresma M, Costabel U. Long-term treatment of patients with idiopathic pulmonary fibrosis with nintedanib: results from the TOMORROW trial and its open-label extension. Thorax. 2018 Jun;73(6):581-583. doi: 10.1136/thoraxjnl-2016-209701. Epub 2017 Oct 9.

family: Richeldi

full_name: Luca Richeldi

given: Luca

family: Kreuter

full_name: Michael Kreuter

given: Michael

family: Selman

full_name: Moisés Selman

given: Moisés

family: Crestani

full_name: Bruno Crestani

given: Bruno

family: Kirsten

full_name: Anne-Marie Kirsten

given: Anne-Marie

family: Wuyts

full_name: Wim A Wuyts

given: Wim A

family: Xu

full_name: Zuojun Xu

given: Zuojun

family: Bernois

full_name: Katell Bernois

given: Katell

family: Stowasser

full_name: Susanne Stowasser

given: Susanne

repository_institution: University of Oxford - Oxford Academic Notes & Queries

repositories_institution: University of Oxford - Oxford Academic Notes & Queries

ReferenceCitation: Paterniti MO, Bi Y, Rekić D, Wang Y, Karimi-Shah BA, Chowdhury BA. Acute Exacerbation and Decline in Forced Vital Capacity Are Associated with Increased Mortality in Idiopathic Pulmonary Fibrosis. Ann Am Thorac Soc. 2017 Sep;14(9):1395-1402. doi: 10.1513/AnnalsATS.201606-458OC.

name: Division of Pulmonary, Allergy, and Rheumatology Products, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland; and

name: Division of Pharmacometrics, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland

ReferenceCitation: Richeldi L, Costabel U, Selman M, Kim DS, Hansell DM, Nicholson AG, Brown KK, Flaherty KR, Noble PW, Raghu G, Brun M, Gupta A, Juhel N, Klüglich M, du Bois RM. Efficacy of a tyrosine kinase inhibitor in idiopathic pulmonary fibrosis. N Engl J Med. 2011 Sep 22;365(12):1079-87. doi: 10.1056/NEJMoa1103690.

title: Efficacy of a Tyrosine Kinase Inhibitor in Idiopathic Pulmonary Fibrosis

location_country:
Greece
Belgium
Australia
Russian Federation
Czech Republic
Taiwan
France
Argentina
Canada
Korea, Republic of
South Africa
Chile
Netherlands
Bulgaria
Hungary
Ireland
China
Portugal
Germany
United Kingdom
Italy
Brazil
Mexico
Spain
Turkey

location_facility: 1199.30.44005 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.86002 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.3307A Boehringer Ingelheim Investigational Site

location_facility: 1199.30.90001 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.39009 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.56001 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.49004 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.44006 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.52001 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.3305C Boehringer Ingelheim Investigational Site

location_facility: 1199.30.30004 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.34002 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.35108 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.3302A Boehringer Ingelheim Investigational Site

location_facility: 1199.30.49001 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.30002 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.61005 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.3305A Boehringer Ingelheim Investigational Site

location_facility: 1199.30.49002 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.3304C Boehringer Ingelheim Investigational Site

location_facility: 1199.30.49006 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.36005 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.82001 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.39004 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.35107 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.61004 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.32002 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.27002 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.49008 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.88601 National Taiwan University

location_facility: 1199.30.88603 Tri-service General Hospital

location_facility: 1199.30.54002 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.39003 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.07001 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.06004 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.82003 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.44007 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.34001 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.39010 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.27001 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.86001 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.82002 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.36004 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.35105 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.35101 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.44001 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.07002 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.39008 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.32004 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.49007 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.86005 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.36003 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.39013 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.3306A Boehringer Ingelheim Investigational Site

location_facility: 1199.30.30001 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.36001 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.61003 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.06005 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.39001 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.88605 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.39012 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.88606 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.42001 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.27003 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.35301 Mater Misericordiae Hospital

location_facility: 1199.30.82004 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.55001 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.35109 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.36002 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.49009 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.88604 Chang Gung Memorial Hosp-Linkou

location_facility: 1199.30.39011 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.31002 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.49003 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.86004 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.44003 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.90002 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.3301A Boehringer Ingelheim Investigational Site

location_facility: 1199.30.32001 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.86003 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.3305B Boehringer Ingelheim Investigational Site

location_facility: 1199.30.07003 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.49005 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.35106 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.39007 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.42002 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.82005 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.3303A Boehringer Ingelheim Investigational Site

location_facility: 1199.30.55002 Boehringer Ingelheim Investigational Site


title: A Randomized, Double-blind, Parallel Group, Placebo Controlled, Multi Center Dose Ranging Study of Solifenacin Succinate in Combination With Tamsulosin Hydrochloride Compared With Solifenacin Succinate Monotherapy and Tamsulosin Hydrochloride Monotherapy in Males With Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH)

summary: The study will examine the efficacy,safety and tolerability of combination therapy of tamsulosin and solifenacin compared to placebo and monotherapy of tamsulosin and solifenacin in the treatment of males with LUTS associated with BPH.

ReferenceCitation: Van Kerrebroeck P, Haab F, Angulo JC, Vik V, Katona F, Garcia-Hernandez A, Klaver M, Traudtner K, Oelke M. Efficacy and safety of solifenacin plus tamsulosin OCAS in men with voiding and storage lower urinary tract symptoms: results from a phase 2, dose-finding study (SATURN). Eur Urol. 2013 Sep;64(3):398-407. doi: 10.1016/j.eururo.2013.03.031. Epub 2013 Mar 19.

family: Van Kerrebroeck

full_name: Philip Van Kerrebroeck

given: Philip

family: Haab

full_name: François Haab

given: François

family: Angulo

full_name: Javier C. Angulo

given: Javier C.

family: Vik

full_name: Viktor Vik

given: Viktor

family: Katona

full_name: Ferenc Katona

given: Ferenc

family: Garcia-Hernandez

full_name: Alberto Garcia-Hernandez

given: Alberto

family: Klaver

full_name: Monique Klaver

given: Monique

family: Traudtner

full_name: Klaudia Traudtner

given: Klaudia

family: Oelke

full_name: Matthias Oelke

given: Matthias

title: Efficacy and Safety of Solifenacin Plus Tamsulosin OCAS in Men with Voiding and Storage Lower Urinary Tract Symptoms: Results from a Phase 2, Dose-finding Study (SATURN)

lead_sponsor: Astellas Pharma Inc

location_country:
Austria
Sweden
United Kingdom
Netherlands
Spain
Finland
France
Poland
Slovakia
Norway
Hungary
Russian Federation
Portugal
Denmark
Germany
Czech Republic


title: A Randomized, Double-Blind Phase 3 Study Of Gemcitabine Plus AG-013736 Versus Gemcitabine Plus Placebo For The First-Line Treatment Of Patients With Locally Advanced, Unresectable Or Metastatic Pancreatic Cancer.

summary: The purpose of this study is to determine whether investigational study drug, AG-013736, and gemcitabine are effective in the first-line treatment of advanced pancreatic cancer.

ReferenceCitation: Kindler HL, Ioka T, Richel DJ, Bennouna J, Létourneau R, Okusaka T, Funakoshi A, Furuse J, Park YS, Ohkawa S, Springett GM, Wasan HS, Trask PC, Bycott P, Ricart AD, Kim S, Van Cutsem E. Axitinib plus gemcitabine versus placebo plus gemcitabine in patients with advanced pancreatic adenocarcinoma: a double-blind randomised phase 3 study. Lancet Oncol. 2011 Mar;12(3):256-62. doi: 10.1016/S1470-2045(11)70004-3.

family: Kindler

full_name: Hedy L Kindler

given: Hedy L

family: Ioka

full_name: Tatsuya Ioka

given: Tatsuya

family: Richel

full_name: Dirk J Richel

given: Dirk J

family: Bennouna

full_name: Jaafar Bennouna

given: Jaafar

family: Létourneau

full_name: Richard Létourneau

given: Richard

family: Okusaka

full_name: Takuji Okusaka

given: Takuji

family: Funakoshi

full_name: Akihiro Funakoshi

given: Akihiro

family: Furuse

full_name: Junji Furuse

given: Junji

family: Park

full_name: Young Suk Park

given: Young Suk

family: Ohkawa

full_name: Shinichi Ohkawa

given: Shinichi

family: Springett

full_name: Gregory M Springett

given: Gregory M

family: Wasan

full_name: Harpreet S Wasan

given: Harpreet S

family: Trask

full_name: Peter C Trask

given: Peter C

family: Bycott

full_name: Paul Bycott

given: Paul

family: Ricart

full_name: Alejandro D Ricart

given: Alejandro D

family: Kim

full_name: Sinil Kim

given: Sinil

family: Van Cutsem

full_name: Eric Van Cutsem

given: Eric

journal_name: The Lancet Oncology

location_country:
Australia
Belgium
Russian Federation
Taiwan
India
France
Japan
Argentina
Canada
Korea, Republic of
South Africa
Sweden
Hong Kong
Netherlands
Switzerland
Singapore
Hungary
Ireland
Germany
United States
United Kingdom
Italy
Austria
Spain