ReferenceCitation: Smolen J, Fleischmann R, Aletaha D, Li Y, Zhou Y, Sainsbury I, Galindo IL. Disease activity improvements with optimal discriminatory ability between treatment arms: applicability in early and established rheumatoid arthritis clinical trials. Arthritis Res Ther. 2019 Nov 10;21(1):231. doi: 10.1186/s13075-019-2005-9.

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ReferenceCitation: Smolen JS, van Vollenhoven RF, Florentinus S, Chen S, Suboticki JL, Kavanaugh A. Predictors of disease activity and structural progression after treatment with adalimumab plus methotrexate or continued methotrexate monotherapy in patients with early rheumatoid arthritis and suboptimal response to methotrexate. Ann Rheum Dis. 2018 Nov;77(11):1566-1572. doi: 10.1136/annrheumdis-2018-213502. Epub 2018 Aug 3.

full_name: Josef S Smolen

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family: van Vollenhoven

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ReferenceCitation: Kavanaugh A, van Vollenhoven RF, Fleischmann R, Emery P, Sainsbury I, Florentinus S, Chen S, Guérette B, Kupper H, Smolen JS. Testing treat-to-target outcomes with initial methotrexate monotherapy compared with initial tumour necrosis factor inhibitor (adalimumab) plus methotrexate in early rheumatoid arthritis. Ann Rheum Dis. 2018 Feb;77(2):289-292. doi: 10.1136/annrheumdis-2017-211871. Epub 2017 Nov 16.

repositories_institution: University of Oxford - Oxford Academic Notes & Queries

ReferenceCitation: Keystone EC, Breedveld FC, van der Heijde D, van Vollenhoven RF, Emery P, Smolen JS, Sainsbury I, Florentinus S, Kupper H, Chen K, Kavanaugh A. Achieving comprehensive disease control in patients with early and established rheumatoid arthritis treated with adalimumab plus methotrexate versus methotrexate alone. RMD Open. 2017 Sep 26;3(2):e000445. doi: 10.1136/rmdopen-2017-000445. eCollection 2017.

ReferenceCitation: Burmester GR, Landewé R, Genovese MC, Friedman AW, Pfeifer ND, Varothai NA, Lacerda AP. Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis. Ann Rheum Dis. 2017 Feb;76(2):414-417. doi: 10.1136/annrheumdis-2016-209322. Epub 2016 Jun 23.

ReferenceCitation: Smolen JS, Emery P, Fleischmann R, van Vollenhoven RF, Pavelka K, Durez P, Guérette B, Kupper H, Redden L, Arora V, Kavanaugh A. Adjustment of therapy in rheumatoid arthritis on the basis of achievement of stable low disease activity with adalimumab plus methotrexate or methotrexate alone: the randomised controlled OPTIMA trial. Lancet. 2014 Jan 25;383(9914):321-32. doi: 10.1016/S0140-6736(13)61751-1. Epub 2013 Oct 26. Erratum in: Lancet. 2014 Jan 25;383(9914):308.

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title: A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation With Methotrexate and Adalimumab Combination Therapy in Patients With Early Rheumatoid Arthritis (OPTIMA)

summary: This study compared the safety and efficacy of combination therapy with adalimumab plus methotrexate (MTX) to that of MTX monotherapy (i.e., placebo plus MTX) in subjects with early rheumatoid arthritis (RA).


title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Comparison Study to Determine the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis

acronym: DEFINE

summary:
To determine if treatment with BG00012 can decrease the number of MS relapses during a certain time period. To determine if, over time, BG00012 treatment can decrease the number of certain types of brain lesions commonly seen in MS patients and slow down the time it takes for the disease to get worse.

The purpose of this study is also to determine the safety of BG00012 and how well it is tolerated. Another goal is to see what effect BG00012 may have on tests and evaluations used to assess MS.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Gold R, Arnold DL, Bar-Or A, Fox RJ, Kappos L, Chen C, Parks B, Miller C. Safety and efficacy of delayed-release dimethyl fumarate in patients with relapsing-remitting multiple sclerosis: 9 years' follow-up of DEFINE, CONFIRM, and ENDORSE. Ther Adv Neurol Disord. 2020 May 12;13:1756286420915005. doi: 10.1177/1756286420915005. eCollection 2020.

name: Department of Neurology, St. Josef-Hospital, Ruhr University Bochum, Bochum, Germany

family: Gold

full_name: Ralf Gold

given: Ralf

sequence: first

name: Montreal Neurological Institute, McGill University and NeuroRx Research, Montreal, QC, Canada

family: Arnold

full_name: Douglas L. Arnold

given: Douglas L.

sequence: additional

name: Center for Neuroinflammation and Experimental Therapeutics and Department of Neurology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA

family: Bar-Or

full_name: Amit Bar-Or

given: Amit

family: Fox

full_name: Robert J. Fox

given: Robert J.

name: Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research, Biomedicine and Biomedical Engineering, University Hospital and University, Basel, Switzerland

family: Kappos

full_name: Ludwig Kappos

given: Ludwig

family: Chen

full_name: Chongshu Chen

given: Chongshu

family: Parks

full_name: Becky Parks

given: Becky

name: Biogen, 225 Binney Street, Cambridge, MA 02142, USA

family: Miller

full_name: Catherine Miller

given: Catherine

bso_classification: Medical research

currency_apc_doaj: USD

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Therapeutic Advances in Neurological Disorders

oa_colors: green gold

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host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

title: Safety and efficacy of delayed-release dimethyl fumarate in patients with relapsing-remitting multiple sclerosis: 9 years’ follow-up of DEFINE, CONFIRM, and ENDORSE

ReferenceCitation: Mehta D, Miller C, Arnold DL, Bame E, Bar-Or A, Gold R, Hanna J, Kappos L, Liu S, Matta A, Phillips JT, Robertson D, von Hehn CA, Campbell J, Spach K, Yang L, Fox RJ. Effect of dimethyl fumarate on lymphocytes in RRMS: Implications for clinical practice. Neurology. 2019 Apr 9;92(15):e1724-e1738. doi: 10.1212/WNL.0000000000007262. Epub 2019 Mar 27.

family: Mehta

full_name: Devangi Mehta

given: Devangi

family: Bame

full_name: Eris Bame

given: Eris

family: Hanna

full_name: Jerome Hanna

given: Jerome

publisher: Ovid Technologies (Wolters Kluwer Health)

ReferenceCitation: Fox RJ, Gold R, Phillips JT, Okwuokenye M, Zhang A, Marantz JL. Efficacy and Tolerability of Delayed-release Dimethyl Fumarate in Black, Hispanic, and Asian Patients with Relapsing-Remitting Multiple Sclerosis: Post Hoc Integrated Analysis of DEFINE and CONFIRM. Neurol Ther. 2017 Dec;6(2):175-187. doi: 10.1007/s40120-017-0077-5. Epub 2017 Aug 2.

ReferenceCitation: Fernández Ó, Giovannoni G, Fox RJ, Gold R, Phillips JT, Potts J, Okwuokenye M, Marantz JL. Efficacy and Safety of Delayed-release Dimethyl Fumarate for Relapsing-remitting Multiple Sclerosis in Prior Interferon Users: An Integrated Analysis of DEFINE and CONFIRM. Clin Ther. 2017 Aug;39(8):1671-1679. doi: 10.1016/j.clinthera.2017.06.012. Epub 2017 Jul 25.

ReferenceCitation: Fox RJ, Chan A, Zhang A, Xiao J, Levison D, Lewin JB, Edwards MR, Marantz JL. Comparative effectiveness using a matching-adjusted indirect comparison between delayed-release dimethyl fumarate and fingolimod for the treatment of multiple sclerosis. Curr Med Res Opin. 2017 Feb;33(2):175-183. doi: 10.1080/03007995.2016.1248380. Epub 2016 Nov 10.

name: Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic, Cleveland, OH, USA;

name: Department of Neurology, University Hospital Bern and University of Bern, Bern, Switzerland;

ReferenceCitation: Gold R, Giovannoni G, Phillips JT, Fox RJ, Zhang A, Marantz JL. Sustained Effect of Delayed-Release Dimethyl Fumarate in Newly Diagnosed Patients with Relapsing-Remitting Multiple Sclerosis: 6-Year Interim Results From an Extension of the DEFINE and CONFIRM Studies. Neurol Ther. 2016 Jun;5(1):45-57. doi: 10.1007/s40120-016-0042-8. Epub 2016 Mar 1.

title: Sustained Effect of Delayed-Release Dimethyl Fumarate in Newly Diagnosed Patients with Relapsing–Remitting Multiple Sclerosis: 6-Year Interim Results From an Extension of the DEFINE and CONFIRM Studies

ReferenceCitation: Giovannoni G, Gold R, Fox RJ, Kappos L, Kita M, Yang M, Sarda SP, Zhang R, Viglietta V, Havrdova E. Relapses Requiring Intravenous Steroid Use and Multiple-Sclerosis-related Hospitalizations: Integrated Analysis of the Delayed-release Dimethyl Fumarate Phase III Studies. Clin Ther. 2015 Nov 1;37(11):2543-51. doi: 10.1016/j.clinthera.2015.09.011. Epub 2015 Oct 31.

title: Relapses Requiring Intravenous Steroid Use and Multiple-Sclerosis–related Hospitalizations: Integrated Analysis of the Delayed-release Dimethyl Fumarate Phase III Studies

ReferenceCitation: Nakamura K, Brown RA, Narayanan S, Collins DL, Arnold DL; Alzheimer's Disease Neuroimaging Initiative. Diurnal fluctuations in brain volume: Statistical analyses of MRI from large populations. Neuroimage. 2015 Sep;118:126-32. doi: 10.1016/j.neuroimage.2015.05.077. Epub 2015 Jun 3.

ReferenceCitation: Kita M, Fox RJ, Gold R, Giovannoni G, Phillips JT, Sarda SP, Kong J, Viglietta V, Sheikh SI, Okwuokenye M, Kappos L. Effects of delayed-release dimethyl fumarate (DMF) on health-related quality of life in patients with relapsing-remitting multiple sclerosis: an integrated analysis of the phase 3 DEFINE and CONFIRM studies. Clin Ther. 2014 Dec 1;36(12):1958-1971. doi: 10.1016/j.clinthera.2014.08.013. Epub 2014 Oct 12. Erratum in: Clin Ther. 2018 Mar 7;:.

title: Effects of Delayed-Release Dimethyl Fumarate (DMF) on Health-Related Quality of Life in Patients With Relapsing-Remitting Multiple Sclerosis: An Integrated Analysis of the Phase 3 DEFINE and CONFIRM Studies

ReferenceCitation: Fox RJ, Kita M, Cohan SL, Henson LJ, Zambrano J, Scannevin RH, O'Gorman J, Novas M, Dawson KT, Phillips JT. BG-12 (dimethyl fumarate): a review of mechanism of action, efficacy, and safety. Curr Med Res Opin. 2014 Feb;30(2):251-62. doi: 10.1185/03007995.2013.849236. Epub 2013 Oct 22. Review.

name:
Mellen Center for Multiple Sclerosis Treatment and Research
Cleveland Clinic, Cleveland, OHUSA

name:
Virginia Mason Medical Center,
Seattle, WA, USA

name:
Providence Multiple Sclerosis Center, Providence Brain and Spine Institute
Portland, ORUSA

name:
Swedish Neuroscience Institute
Issaquah, WAUSA

name:
Multiple Sclerosis Program, Baylor Institute for Immunology Research
Dallas, TXUSA

ReferenceCitation: Gold R, Kappos L, Arnold DL, Bar-Or A, Giovannoni G, Selmaj K, Tornatore C, Sweetser MT, Yang M, Sheikh SI, Dawson KT; DEFINE Study Investigators. Placebo-controlled phase 3 study of oral BG-12 for relapsing multiple sclerosis. N Engl J Med. 2012 Sep 20;367(12):1098-107. Erratum in: N Engl J Med. 2012 Dec 13;367(24):2362.

location_country: Macedonia, The Former Yugoslav Republic of


ReferenceCitation: Ryan C, Sobell JM, Leonardi CL, Lynde CW, Karunaratne M, Valdecantos WC, Hendrickson BA. Safety of Adalimumab Dosed Every Week and Every Other Week: Focus on Patients with Hidradenitis Suppurativa or Psoriasis. Am J Clin Dermatol. 2018 Jun;19(3):437-447. doi: 10.1007/s40257-017-0341-6.

family: Ryan

full_name: Caitriona Ryan

given: Caitriona

family: Sobell

full_name: Jeffrey M. Sobell

given: Jeffrey M.

family: Leonardi

full_name: Craig L. Leonardi

given: Craig L.

family: Lynde

full_name: Charles W. Lynde

given: Charles W.

family: Karunaratne

full_name: Mahinda Karunaratne

given: Mahinda

family: Valdecantos

full_name: Wendell C. Valdecantos

given: Wendell C.

family: Hendrickson

full_name: Barbara A. Hendrickson

given: Barbara A.

journal_name: American Journal of Clinical Dermatology

oa_colors: green hybrid

evidence: open (via page says license)

evidence: oa repository (via OAI-PMH title and first author match)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: Dr Steevens Hospital Library - Lenus, The Irish Health Repository

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Wolf D, D'Haens G, Sandborn WJ, Colombel JF, Van Assche G, Robinson AM, Lazar A, Zhou Q, Petersson J, Thakkar RB. Escalation to weekly dosing recaptures response in adalimumab-treated patients with moderately to severely active ulcerative colitis. Aliment Pharmacol Ther. 2014 Sep;40(5):486-97. doi: 10.1111/apt.12863. Epub 2014 Jul 15.

name: Atlanta Gastroenterology Associates; Atlanta GA USA

family: Wolf

full_name: D. Wolf

given: D.

name: Academic Medical Center; Amsterdam The Netherlands

name: Imelda GI Clinical Research Center; Bonheiden Belgium

family: D'Haens

full_name: G. D'Haens

given: G.

name: University of California San Diego; La Jolla CA USA

family: Sandborn

full_name: W. J. Sandborn

given: W. J.

name: Icahn School of Medicine at Mount Sinai; New York NY USA

family: Colombel

full_name: J.-F. Colombel

family: Van Assche

full_name: G. Van Assche

family: Robinson

full_name: A. M. Robinson

given: A. M.

name: AbbVie Deutschland GmbH & Co. KG; Ludwigshafen Germany

family: Lazar

full_name: A. Lazar

given: A.

family: Zhou

full_name: Q. Zhou

given: Q.

family: Petersson

full_name: J. Petersson

given: J.

family: Thakkar

full_name: R. B. Thakkar

given: R. B.

ReferenceCitation: Feagan BG, Sandborn WJ, Lazar A, Thakkar RB, Huang B, Reilly N, Chen N, Yang M, Skup M, Mulani P, Chao J. Adalimumab therapy is associated with reduced risk of hospitalization in patients with ulcerative colitis. Gastroenterology. 2014 Jan;146(1):110-118.e3. doi: 10.1053/j.gastro.2013.09.032. Epub 2013 Sep 22.

title: Adalimumab Therapy Is Associated With Reduced Risk of Hospitalization in Patients With Ulcerative Colitis

ReferenceCitation: Sandborn WJ, Colombel JF, D'Haens G, Van Assche G, Wolf D, Kron M, Lazar A, Robinson AM, Yang M, Chao JD, Thakkar R. One-year maintenance outcomes among patients with moderately-to-severely active ulcerative colitis who responded to induction therapy with adalimumab: subgroup analyses from ULTRA 2. Aliment Pharmacol Ther. 2013 Jan;37(2):204-13. doi: 10.1111/apt.12145. Epub 2012 Nov 23.

name: University of California San Diego; La Jolla; CA; USA

name: Centre Hospitalier Universitaire de Lille; Lille; France

name: Atlanta Gastroenterology Associates; Atlanta; GA; USA

name: Abbott GmbH & Co. KG; Ludwigshafen; Germany

name: Abbott Laboratories; Abbott Park; IL; USA

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title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Moderately to Severely Active Ulcerative Colitis

summary: This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of the human anti-tumor necrosis factor (TNF) monoclonal antibody adalimumab (ADA) in patients with moderately to severely active ulcerative colitis (UC).


title: Controlled, Double-Blind, Randomized, Dose-ranging Study of Once-daily Regimen of BAY59-7939 in the Prevention of VTE in Patients Undergoing Elective Total Hip Replacement- ODIXaHIP-OD

acronym: ODIXaHIP-OD

summary: The purpose of this study is to assess different doses of a new drug (BAY 59-7939), taken as a tablet, are safe and can help prevent blood clots forming after a hip replacement operation. Patients undergoing hip replacement surgery are at risk of developing blood clots. To reduce this risk treatment to prevent clots forming is routinely given. The current treatments can include injections under the skin or other treatments that need frequent blood tests to monitor levels of drug in the body. Therefore there is a need for new drugs, which are easier to give and need less monitoring.

primary_purpose: Prevention

lead_sponsor: Bayer

location_country:
Italy
Austria
Sweden
Netherlands
France
Poland
Israel
Norway
Belgium
Spain
Denmark
Germany
United Kingdom

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


type: Other Identifier

title: A Phase 3, Open-Label, Parallel-Group Study to Compare Two Dosing Algorithms for Preprandial Human Insulin Inhalation Powder (HIIP) in Insulin-Naive Patients With Type 2 Diabetes Mellitus

summary:
This randomized, multicenter, open-label, active-comparator, 2-arm, parallel-group, 6 month study with approximately 360 patients will compare the efficacy of two treatment regimens (Algorithm A versus Algorithm B) in insulin-naive patients with type 2 diabetes not optimally controlled by one or more oral antihyperglycemic medications. Patients will be assigned randomly to receive one of the following treatment groups:

Algorithm A is defined as a simplified diabetes management regimen starting with a fixed dose of HIIP (also known as AIR® Inhaled Insulin)(AIR® is a registered trademark of Alkermes,Inc.), titrating 2 times per week based on 2 times per week 4 point blood glucose values for the first month and titrating 1 time per week based on once weekly 4-point blood glucose values for the remainder of the study, increasing total daily dose by a maximum of 6 U per day.

Algorithm B is defined as an intensive diabetes management regimen, starting with an adjusted dose of AIR® Inhaled Insulin, titrating 2 times per week based on daily 4 point blood glucose values, with sustained monitoring of dose and blood glucose throughout the study, increasing total daily dose by a maximum of 8 U per day.

ReferenceCitation: Naegeli AN, Hayes RP. Expectations about and experiences with insulin therapy contribute to diabetes treatment satisfaction in insulin-naïve patients with type 2 diabetes. Int J Clin Pract. 2010 Jun;64(7):908-16. doi: 10.1111/j.1742-1241.2010.02363.x. Epub 2010 Mar 30.

family: Naegeli

full_name: A. N. Naegeli

given: A. N.

family: Hayes

full_name: R. P. Hayes

given: R. P.

journal_name: International Journal of Clinical Practice

oa_host_type: repository

license: cc-by

license_normalized: cc-by

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: Eli Lilly and Company

location_country:
Austria
India
Mexico
France
Argentina
Belgium
Puerto Rico
Spain
United States

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: A Phase 2/3, Multicenter, Double-Blind, Randomized, Controlled Study Of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2)/Calcium Phosphate Matrix (CPM) In Closed Diaphyseal Tibial Fracture

summary: The primary objective of this study is to assess whether a single dose of rhBMP-2/CPM administered at the fracture site via percutaneous injection, in combination with standard of care, accelerates fracture union and return to normal function in subjects who have a closed diaphyseal tibial fracture when compared to standard of care alone.

status: Terminated

lead_sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

location_country:
Brazil
United States
Sweden
India
Serbia
United Kingdom
Mexico
Germany
Finland
France
Poland
Slovenia
Romania
Argentina
Australia
Spain
Canada
Latvia

status_simplified: Unknown


lead_sponsor: Centocor, Inc.

location_country:
Austria
Germany
France
Belgium
Spain
United States
United Kingdom

type: EudraCT Number

source: euctr

title: A Phase 2, Multicenter, Open-Label Study of CNTO 328 (Anti-IL-6 Monoclonal Antibody) in Combination With Mitoxantrone Versus Mitoxantrone in Subjects With Metastatic Hormone-Refractory Prostate Cancer (HRPC)

summary: The purpose of this study is to assess the safety and efficacy of siltuximab administered in combination with mitoxantrone and prednisone in participants with metastatic (spread of cancer cells from one part of the body to another) hormone-refractory (not responding to treatment) prostate cancer (abnormal tissue that grows and spreads in the body) (HRPC).


title: A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment With Ropinirole CR as Adjunctive Therapy in Patients With Parkinson's Disease Who Are Not Optimally Controlled on L-dopa

summary: The purpose of this double-blind, placebo controlled study is to evaluate the safety and effectiveness of an investigational Parkinson's disease drug in patients with advanced disease who are not well-controlled on their L-dopa medication.

ReferenceType: background

ReferenceCitation: B P Hersh, S A Factor, L Giorgi Ropinirole 24-hour prolonged release improves motor function and activities of daily living as an adjunct to L-dopa in Parkinson's Disease. Eur J Neurol. September 2006/Suppl 2: 13/S2-P2202

ReferenceCitation: F Stocchi, B Hersh, N Earl, B Scott Safety and tolerability of ropinirole 24-hour prolonged release in patients with early and advanced Parkinson's Disease. Movement Disorders, November 2006; 21 (Suppl.15) S572/P894.

ReferenceCitation: F Stocchi, M A Stacy, L Giorgi, N L Earl Safety and tolerability of ropinirole 24-hour prolonged release as adjuctive therapy to L-dopa in patients with Parkinson's Disease. Eur J Neurol. September 2006/Suppl 2-13/a2P2201

ReferenceCitation: Reichmann H, Cooper J, Rolfe K, Martinez-Martin P. Sleep Duration and "on" Time during Different Periods of the Day and Night in Patients with Advanced Parkinson's Disease Receiving Adjunctive Ropinirole Prolonged Release. Parkinsons Dis. 2011;2011:354760. doi: 10.4061/2011/354760. Epub 2011 May 11.

ReferenceCitation: Ray Chaudhuri K, Martinez-Martin P, Rolfe KA, Cooper J, Rockett CB, Giorgi L, Ondo WG. Improvements in nocturnal symptoms with ropinirole prolonged release in patients with advanced Parkinson's disease. Eur J Neurol. 2012 Jan;19(1):105-13. doi: 10.1111/j.1468-1331.2011.03442.x. Epub 2011 Jun 23.

ReferenceCitation: K Sethi, N Earl, R Hauser Ropinirole 24-hour prolonged release improves disease-specific and global symptoms when used as adjunctive therapy to L-dopa in patients with advanced Parkinson's Disease. Movement Disorders, November 2006; 21 (Suppl.15) S570/P887

ReferenceCitation: M A Stacy, K D Sethi, N L Earl Ropinirole 24-hour prolonged release improves sleep but does not increase daytime sleepiness when used as adjunctive therapy in patients with Parkinson's Disease not optimally controlled by L-dopa. Movement Disorders, November 2006 S15/9.21:1543-1559

ReferenceCitation: M Stacy, R Pahwa, N Earl Ropinirole 24-hour prolonged release reduces "off" time and reduces the need for L-dopa when used as adjunctive therapy in patients with advanced Parkinson's Disease Movement Disorders, November 2006: 21 (Suppl 15) S596/P972

ReferenceCitation: R A Hauser, M A Stacy, B P Hersh Ropinirole 24 hour prolonged release reduces off time and improves depression when used as adjunctive therapy in patients with Parkinson's disease not optimally controlled with L-dopa Movement Disorders S15-21-P8

ReferenceCitation: R Pahwa, F Stocchi, M A Stacy Ropinirole 24-hour prolonged release is effective in sparing L-dopa dose and improving symptoms as adjuctive therapy in Parkinson's Disease. Eur J Neurol, September 2005/Suppl 2:s2-P2203

ReferenceCitation: R Pahwa, M Stacy, E Elmer, S Isaacson Ropinirole 24-hour prolonged release provides efficacy as early as Week 2 when used as adjunctive therapy to L-dopa in patients with advanced Parkinson's Disease Movement Disorders, November 2006: 21 (Suppl 15) S595/P968.

ReferenceCitation: Pahwa R, Stacy MA, Factor SA, Lyons KE, Stocchi F, Hersh BP, Elmer LW, Truong DD, Earl NL; EASE-PD Adjunct Study Investigators. Ropinirole 24-hour prolonged release: randomized, controlled study in advanced Parkinson disease. Neurology. 2007 Apr 3;68(14):1108-15.

ReferenceCitation: R Pahwa, S Factor, L Elmer Ropinirole 24 hour prolonged release reduces awake time spent "off" in patients with Parkinson's disease not optimally controlled with L-dopa. Neurology, April 2006. 66 (Suppl 2): A292. P05.135

ReferenceCitation: R Pahwa, SA Factor, L Elmer Ropinirole 24 hour prolonged release reduces "off" time in patients with Parkinson's disease not optimally controlled with L-dopa. Eur J Neurol, September 2006/Suppl2, 13/s2:P2154.

ipd_sharing: Yes

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

lead_sponsor: GlaxoSmithKline

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


title: A Phase 2 Efficacy And Safety Study Of SU011248 In Patients With Non-Small Cell Lung Cancer And Brain Metastases

summary: This study will evaluate the safety, tolerability and efficacy of SU011248 in patients with non-small cell lung cancer with brain metastases.

design_allocation: Non-Randomized

lead_sponsor: Pfizer

location_country:
Italy
United States
France
Spain


title: Phase II Study of Dasatinib (BMS-354825) for Advanced Estrogen/Progesterone Receptor-Positive or Her2/Neu-Positive Breast Cancer

summary: This study will determine whether the investigational drug dasatinib is effective in treatment of women with progressive advanced ER+/PR+ or Her2/neu+ breast cancer

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
Peru
France
Belgium
Argentina
Spain
United States

location_facility: University Of Texas Md Anderson Cancer Ctr

location_facility: University Of North Carolina At Chapel Hill


title: A Randomized, Double-blind, Placebo-controlled Phase III Study, to Evaluate the Efficacy, Safety and Tolerability of Eltrombopag Olamine (SB-497115-GR), a Thrombopoietin Receptor Agonist, Administered for 6 Months as Oral Tablets Once Daily in Adult Subjects With Previously Treated Chronic ITP.

acronym: RAISE

summary: The rationale for this Phase III study is to evaluate the 6 month safety and efficacy of eltrombopag in the treatment of previously treated subjects with chronic ITP. The starting dose of eltrombopag, 50 mg, once daily was selected based upon the observed efficacy, safety and pharmacokinetics in a dose-finding Study (TRA100773). This Phase III study is a randomized, double-blind, placebo-controlled, Phase III study, to evaluate efficacy, safety and tolerability of eltrombopag, initially administered as 50 mg oral tablets once daily for six months in adult subjects with previously treated chronic ITP. Subjects will be randomized 2:1, eltrombopag to placebo, and will be stratified based upon splenectomy status, use of ITP medication at baseline and baseline platelet count less than or equal to 15,000/µL. Subjects will receive study medication for 6 months, during which the dose of study medication may be adjusted based upon individual platelet counts. In addition, subjects may taper off concomitant ITP medications and may receive any rescue treatments as dictated by local standard of care. After discontinuation of study medication, subjects will complete follow-up visits at weeks 1, 2, 4 and months 3 and 6.

ReferenceCitation: Cheng G, Saleh MN, Marcher C, Vasey S, Mayer B, Aivado M, Arning M, Stone NL, Bussel JB. Eltrombopag for management of chronic immune thrombocytopenia (RAISE): a 6-month, randomised, phase 3 study. Lancet. 2011 Jan 29;377(9763):393-402. doi: 10.1016/S0140-6736(10)60959-2. Epub 2010 Aug 23. Erratum in: Lancet. 2011 Jan 29;377(9763):382.

ReferenceCitation: Haselboeck J, Pabinger I, Ay C, Koder S, Panzer S. Platelet activation and function during eltrombopag treatment in immune thrombocytopenia. Ann Hematol. 2012 Jan;91(1):109-13. doi: 10.1007/s00277-011-1249-5. Epub 2011 May 7.

ReferenceCitation: Hayes S, Ouellet D, Zhang J, Wire MB, Gibiansky E. Population PK/PD modeling of eltrombopag in healthy volunteers and patients with immune thrombocytopenic purpura and optimization of response-guided dosing. J Clin Pharmacol. 2011 Oct;51(10):1403-17. doi: 10.1177/0091270010383019. Epub 2010 Dec 8.

ReferenceCitation: Tarantino MD, Fogarty P, Mayer B, Vasey SY, Brainsky A. Efficacy of eltrombopag in management of bleeding symptoms associated with chronic immune thrombocytopenia. Blood Coagul Fibrinolysis. 2013 Apr;24(3):284-96. doi: 10.1097/MBC.0b013e32835fac99.

family: Tarantino

full_name: Michael D. Tarantino

given: Michael D.

family: Fogarty

full_name: Patrick Fogarty

given: Patrick

family: Mayer

full_name: Bhabita Mayer

given: Bhabita

family: Vasey

full_name: Sandra Y. Vasey

given: Sandra Y.

family: Brainsky

full_name: Andres Brainsky

given: Andres

journal_name: Blood Coagulation & Fibrinolysis

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Fogarty PF, Tarantino MD, Brainsky A, Signorovitch J, Grotzinger KM. Selective validation of the WHO Bleeding Scale in patients with chronic immune thrombocytopenia. Curr Med Res Opin. 2012 Jan;28(1):79-87. doi: 10.1185/03007995.2011.644849. Epub 2011 Dec 20.

name:
Hospital of the University of Pennsylvania
Philadelphia, PAUSA

full_name: Patrick F. Fogarty

given: Patrick F.

name:
The Bleeding and Clotting Disorders Institute
Peoria, ILUSA

name:
GlaxoSmithKline
Collegeville, PAUSA

name:
Analysis Group, Inc.
Boston, MAUSA

family: Signorovitch

full_name: James Signorovitch

given: James

family: Grotzinger

full_name: Kelly M. Grotzinger

given: Kelly M.

journal_name: Current Medical Research and Opinion

publisher: Informa Healthcare

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

ReferenceCitation: Signorovitch J, Brainsky A, Grotzinger KM. Validation of the FACIT-fatigue subscale, selected items from FACT-thrombocytopenia, and the SF-36v2 in patients with chronic immune thrombocytopenia. Qual Life Res. 2011 Dec;20(10):1737-44. doi: 10.1007/s11136-011-9912-9. Epub 2011 May 1.

journal_name: Quality of Life Research

publisher_dissemination: Springer

publisher_group: Springer

location_country:
Peru
Finland
Greece
Russian Federation
Denmark
Czech Republic
Taiwan
Ukraine
India
France
Poland
Slovakia
Canada
Hong Kong
Netherlands
Vietnam
China
Germany
United States
United Kingdom
Italy
Austria
Tunisia
New Zealand
Spain


title: A Phase II Open Label Study of Brivanib (BMS582664), Administered Orally At A Dose of 800 mg Daily In Subjects With Unresectable, Locally Advanced or Metastatic Hepatocellular Carcinoma Who Have Received Either No Prior Systemic Therapy or One Prior Regimen of Angiogenesis Inhibitor Therapy

summary: The purpose of this clinical research study is to learn if BMS-582664 can shrink or slow the growth of advanced liver cancer. The safety of this treatment will also be studied.

ReferenceCitation: Park JW, Finn RS, Kim JS, Karwal M, Li RK, Ismail F, Thomas M, Harris R, Baudelet C, Walters I, Raoul JL. Phase II, open-label study of brivanib as first-line therapy in patients with advanced hepatocellular carcinoma. Clin Cancer Res. 2011 Apr 1;17(7):1973-83. doi: 10.1158/1078-0432.CCR-10-2011. Epub 2011 Feb 24.

family: Park

full_name: Joong-Won Park

given: Joong-Won

family: Finn

full_name: Richard S. Finn

given: Richard S.

family: Kim

full_name: Jun Suk Kim

given: Jun Suk

family: Karwal

full_name: Mark Karwal

given: Mark

family: Li

full_name: Ruby K. Li

given: Ruby K.

family: Ismail

full_name: Fuad Ismail

given: Fuad

family: Thomas

full_name: Melanie Thomas

given: Melanie

family: Harris

full_name: Rosemarie Harris

given: Rosemarie

family: Baudelet

full_name: Christine Baudelet

given: Christine

family: Walters

full_name: Ian Walters

given: Ian

family: Raoul

full_name: Jean-Luc Raoul

given: Jean-Luc

journal_name: Clinical Cancer Research

publisher: American Association for Cancer Research (AACR)

title: Phase II, Open-Label Study of Brivanib as First-Line Therapy in Patients with Advanced Hepatocellular Carcinoma

location_country:
Hong Kong
Philippines
France
Malaysia
Singapore
United States
Korea, Republic of
Taiwan

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Northwestern University Feinberg School Of Medicine

location_facility: University Of Iowa Hospitals And Clinics

location_facility: The Cancer Center At Hackensack University Medical Center

location_facility: University Of Miami Miller School Of Medicine


title: The Effect of Teriparatide Compared With Risedronate on Back Pain in Postmenopausal Women With Osteoporotic Vertebral Fractures

summary: The purpose of the study is to determine if daily teriparatide reduces back pain more effectively than weekly risedronate in women with osteoporosis who have chronic back pain due to a spinal bone fracture.

location_country:
Italy
Brazil
Sweden
Mexico
Spain
Germany
France
Belgium
Argentina
Australia
Puerto Rico
United States
Canada


title: A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination With an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects With Pulmonary Arterial Hypertension

summary:
This study was an international, multi-center, randomized, double-blind, placebo-controlled study in subjects with PAH who were currently receiving approved therapy for their PAH (i.e., endothelin receptor antagonist and/or phosphodiesterase-5 inhibitor). Study visits occurred at 4 week intervals for 16 weeks; the key measure of efficacy was the 6-minute walk test. Study procedures included routine blood tests, medical history, physical exams, disease evaluation, and exercise tests. One optional substudy was also a part of FREEDOM-C at select centers - a hemodynamic substudy with a right heart catheterization at Baseline and Week 16.

Patients who completed all assessments for 16-weeks were also eligible to enter an open-label, extension phase study (FREEDOM - EXT).

ReferenceCitation: Tapson VF, Torres F, Kermeen F, Keogh AM, Allen RP, Frantz RP, Badesch DB, Frost AE, Shapiro SM, Laliberte K, Sigman J, Arneson C, Galiè N. Oral treprostinil for the treatment of pulmonary arterial hypertension in patients on background endothelin receptor antagonist and/or phosphodiesterase type 5 inhibitor therapy (the FREEDOM-C study): a randomized controlled trial. Chest. 2012 Dec;142(6):1383-1390. doi: 10.1378/chest.11-2212.

family: Tapson

full_name: Victor F. Tapson

given: Victor F.

family: Torres

full_name: Fernando Torres

given: Fernando

family: Kermeen

full_name: Fiona Kermeen

given: Fiona

family: Keogh

full_name: Anne M. Keogh

given: Anne M.

family: Allen

full_name: Roblee P. Allen

given: Roblee P.

family: Frantz

full_name: Robert P. Frantz

given: Robert P.

family: Badesch

full_name: David B. Badesch

given: David B.

family: Frost

full_name: Adaani E. Frost

given: Adaani E.

family: Shapiro

full_name: Shelley M. Shapiro

given: Shelley M.

family: Laliberte

full_name: Kevin Laliberte

given: Kevin

family: Sigman

full_name: Jeffrey Sigman

given: Jeffrey

family: Arneson

full_name: Carl Arneson

given: Carl

family: Galiè

full_name: Nazzareno Galiè

given: Nazzareno

journal_name: Chest

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Oral Treprostinil for the Treatment of Pulmonary Arterial Hypertension in Patients on Background Endothelin Receptor Antagonist and/or Phosphodiesterase Type 5 Inhibitor Therapy (The FREEDOM-C Study)

lead_sponsor: United Therapeutics

location_country:
Italy
Austria
United States
Netherlands
Germany
France
Poland
Israel
Ireland
Australia
Belgium
Spain
Canada
United Kingdom

location_facility: University of Arizona Health Science Center

location_facility: Vancouver Coastal Health Respiratory Clinic

location_facility: National Tuberculosis and Lung Disease Research Institute

location_facility: Stanford University, Pulmonary and Critical Care

location_facility: The University of Texas Health Science Center at San Antonio

location_facility: Mater Misericordiae University Hospital Ltd

location_facility: Mary M Parkes Center for Asthma, Allergy and Pulmonary Care

location_facility: Baylor College of Medicine, Pulmonary & Critical Care

location_facility: University of Maryland School of Medicine


title: Long-term Open-label Study in Patients With Interstitial Lung Disease Associated With Systemic Sclerosis Who Completed the Protocol AC-052-330.

acronym: BUILD 2 OL

summary: This study will asses the long term safety and efficacy of oral bosentan to patients suffering from Interstitial Lung Disease.

lead_sponsor: Actelion

location_country:
Italy
United States
Sweden
Switzerland
Netherlands
France
Korea, Republic of
Israel
Germany
United Kingdom
Canada

location_facility: SoonChunHyang University Bucheon Hospital

location_facility: University of Michigan Health System - Division of Pulmonary & Critical Care Medicine

location_facility: University of Washington - Division of Pulmonary & Critical Care Medicine

location_facility: University of Illinois College of Medicine


title: Reduced Factorial Design, Randomized, Double Blind Trial Comparing Combinations of Telmisartan 20 or 80 mg and Simvastatin 20 or 40 mg With Single Component Therapies in the Treatment of Hypertension and Dyslipidemia

summary:
This study will investigate two registered drugs, one for the treatment of high blood pressure and one for the treatment of elevated cholesterol. High blood pressure (hypertension) is a common medical condition affecting millions of people worldwide. A wide variety of effective drug treatments is available to reduce blood pressure. Elevated cholesterol (hypercholesterolemia) is a common medical condition affecting people worldwide. A wide variety of effective drug treatments is available to reduce cholesterol levels.

Hypertension and hypercholesterolemia often occur together. They are both important risk factors for the development of heart and vessel diseases (e.g. heart attack or stroke). Current guidelines advise treatment of high blood pressure and elevated cholesterol to reduce the risk of cardiovascular diseases. This study will test the simultaneous use of a drug to reduce blood pressure and a drug to reduce elevated cholesterol. Both drugs are registered and are effective. The drug for treatment of high blood pressure is telmisartan Micardis). The drug for treatment of elevated cholesterol is simvastatin (Zocor). Since hypertension and hypercholesterolemia frequently occur together, the purpose of this study is to investigate whether both drugs can be used simultaneously. A low dose and a high dose of these drugs will be used. It will be investigated whether each of the drugs is still as effective when given together, at the same time of day, with the other drug.

lead_sponsor: Boehringer Ingelheim

location_country:
South Africa
Sweden
Hong Kong
Netherlands
France
Slovakia
Russian Federation
Germany
Czech Republic
Korea, Republic of
Taiwan
Ukraine

location_facility: Julius Center for Patient oriented Research

location_facility: Boehringer Ingelheim Investigational Site


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study Evaluating PD-0299685 for Treatment of Vasomotor Symptoms Associated With Menopause

summary: The primary purpose of this study is to determine if PD-0299685 is effective and safe in the treatment of vasomotor symptoms (hot flashes / flushes) associated with menopause.

location_country:
South Africa
United States
France
Australia
Spain
Canada


title: Phase II Study to Evaluate the Efficacy and Tolerability of Fulvestrant 250mg, 250mg Plus 250mg Loading Regimen and 500mg in Postmenopausal Women With ER +ve Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy

acronym: FINDER II

summary: This study will assess the relationship between fulvestrant dose and efficacy in postmenopausal women with oestrogen receptor positive advanced breast cancer.

study_start_date_type: Actual

ReferenceCitation: Pritchard KI, Rolski J, Papai Z, Mauriac L, Cardoso F, Chang J, Panasci L, Ianuli C, Kahan Z, Fukase K, Lindemann JP, Macpherson MP, Neven P. Results of a phase II study comparing three dosing regimens of fulvestrant in postmenopausal women with advanced breast cancer (FINDER2). Breast Cancer Res Treat. 2010 Sep;123(2):453-61. doi: 10.1007/s10549-010-1022-9. Epub 2010 Jul 15.

family: Pritchard

full_name: Kathleen I. Pritchard

given: Kathleen I.

family: Rolski

full_name: Janusz Rolski

given: Janusz

family: Papai

full_name: Zsuzsanna Papai

given: Zsuzsanna

family: Mauriac

full_name: Louis Mauriac

given: Louis

family: Cardoso

full_name: Fatima Cardoso

given: Fatima

family: Chang

full_name: Jose Chang

given: Jose

family: Panasci

full_name: Lawrence Panasci

given: Lawrence

family: Ianuli

full_name: Carmen Ianuli

given: Carmen

family: Kahan

full_name: Zsuzsanna Kahan

family: Fukase

full_name: Kenjiro Fukase

given: Kenjiro

family: Lindemann

full_name: Justin P. O. Lindemann

given: Justin P. O.

family: Macpherson

full_name: Merran P. Macpherson

given: Merran P.

family: Neven

full_name: Patrick Neven

given: Patrick

journal_name: Breast Cancer Research and Treatment

lead_sponsor: AstraZeneca

location_country: France Czechia Poland Romania Hungary Belgium Turkey Canada


title: Comparison of Efficacy and Safety of Insulin Detemir and NPH Insulin in Children and Adolescents With Type 1 Diabetes

summary: The trial is conducted in Europe and Middle East. The aim of the trial is to compare the use of Insulin Detemir once or twice daily combined with mealtime Insulin Aspart against that of NPH Insulin once or twice daily combined with mealtime Insulin Aspart. The trial involves children and adolescents with Type 1 Diabetes.

ReferenceType: result

ReferenceCitation: Robertson KJ, Schoenle E, Gucev Z, Mordhorst L, Gall MA, Ludvigsson J. Insulin detemir compared with NPH insulin in children and adolescents with Type 1 diabetes. Diabet Med. 2007 Jan;24(1):27-34.

lead_sponsor: Novo Nordisk A/S

location_country: Macedonia, The Former Yugoslav Republic of


title: A Multicenter, Open-Label, Long-Term, Safety, Tolerability and Efficacy Study of Retigabine in Adult Epilepsy Patients With Partial-Onset Seizures (Extension of Study VRX-RET-E22-302)

summary: This Phase 3 trial is an open-label extension study of the placebo-controlled, double-blind VRX-RET-E22-302 trial. Patients who have completed the VRX-RET-E22-302 trial and who meet inclusion and exclusion criteria will be treated with 600-1200 mg/day of retigabine as an adjunct therapy to their current antiepileptic drugs (AEDs) or vagal nerve stimulation. Treatment will be continued until the subject withdraws from the study or until the program is discontinued. Patients will be recruited from 55-60 sites in Europe, Israel, Australia, and South Africa. The primary objective of the study is to evaluate the safety and tolerability of long-term therapy with retigabine administered as adjunctive therapy in adult epilepsy patients with partial-onset seizures, who completed the double-blind Study VRX-RET-E22-302. Secondary objectives are: to evaluate efficacy of long-term treatment with retigabine and patient quality of life and to evaluate whether retinal pigmentation, unexplained vision loss, pigmentation of non-retinal ocular tissue, and discoloration of nails, lips, skin or mucosa change over time after discontinuation of retigabine.

location_country:
South Africa
France
Poland
Israel
Hungary
Belgium
Australia
Russian Federation
Spain
Germany
United Kingdom
Ukraine

location_facility: Orszagos Pszichiatriai es Neurologiai Intezet

location_facility: District Antiepileptic Centre City Clinical Hospital # 71

location_facility: Pecs University of Science, Clinic of Neurology

location_facility: NZOZ Przychodnia Internistyczno - Stomatologiczna "Kendron"

location_facility: Instytut Psychiatrii i Neurologii II Oddzial Neurologii

location_facility: Epilepsy Center of Municipal Clinical Psychoneurological Hospital

location_facility: University of Bonn -- Department for Epileptplogy

location_facility: Oddzial Neurologii -- Klinika Neurologii ICZMP

location_facility: Hopital Civil de Steasbourg Clinique Neurologie

location_facility: Universitaetsklinik Mainz Neurologische Klinik

location_facility: Odessa Regional Clinical Hospital Center for Neurology and Neurosurgery

location_facility: Universitaire Ziekenhuizen Gasthuisberg -- Department Neurology

location_facility: Orszagos Idegsebeszeti Tudomanyos Intezet

location_facility: Universitaetslinkum Ulm Poliklinik fuer Neurologie

location_facility: Prywatna Wielospecjalistyczna Lecznica Medyczna "Zycie"

location_facility: Institute of Neurology, Psychiatry and Narcology of AMS, Ukr

location_facility: Universitaet Giessen / Marburg Neurologie

location_facility: Hospital Universitario Lozano Blesa Neurology Service

location_facility: Zentrum Epilepsie Erlangen (ZEE) der Universitaet Erlangen

location_facility: Specjalistyczna Przychodnia Lekarska Medikard

location_facility: Pavlov State Medical University Clinic and Department of Neurology

location_facility: Wojewodzki Szpital Specjalistyczny im.Mikolaja Kopernika

location_facility: Psychosomatic Center of Dnepropetr. Regional Clinic

location_facility: General Hospital Middelheim -- Department of Neurology


title: Extension Study of Iron Chelation Therapy With Deferasirox in β-thalassemia and Other Patients With Rare Chronic Anemia and Transfusional Iron Overload

summary:
A 1-year randomized Phase II core trial was conducted to investigate the efficacy of deferasirox in regularly transfused patients with β-thalassemia and other rare chronic anemia 2 years of age and older. Patients who successfully completed the main trial may continue in the extension trial to receive chelation therapy with deferasirox for up to 3 years. Extension was prolonged to 4 years.

The objective of this study is to assess the long-term safety and efficacy of deferasirox in these patient groups.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
United States
Germany
France
Belgium
Canada
United Kingdom

location_facility: Children's Hospital and Research center at Oakland


title: A Multicentre, Randomised, Double Blind, Double Dummy, Active Comparator Controlled, Parallel Group Study of COLAL-PRED® in the Treatment of Moderate Acute Ulcerative Colitis

summary: The purpose of this study is to investigate whether a novel dosage form of a prednisolone ester, called COLAL-PRED®, is useful in the treatment of ulcerative colitis.

lead_sponsor: Alizyme

location_country:
Italy
South Africa
Sweden
United Kingdom
France
Poland
Israel
Hungary
Belgium
Australia
Russian Federation
Spain
Denmark
Germany
Czech Republic

location_facility: Centrum Onkologii-Instytutu im. Marii Skłodowskiej-Curie Klinika Gastroenterologii

location_facility: Samodzielny Publiczny Szpital Kliniczny, Klinika Gastroenterologii i Chorob Wewnetrznych

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie Klinika Gastroenterologii

location_facility: Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie Katedra i Klinika Gastroenterologii i Chorób Przemiany Materii

location_facility: SPSK Nr 1 im. Prof. Tadeusza Sokolowskiego Pomorskiej Akademii Medycznej Klinika Gastroenterologii i Chorob Wewnetrznych

location_facility: Wojskowy Szpital Kliniczny z Poliklinika Oddzial Gastroenterologii

location_facility: SP ZOZ Uniwersytecki Szpital Kliniczny Nr 5 im. gen. dyw. Boleslawa Szareckiego Uniwersytetu Medycznego w Lodzi Oddział Gastroenterologii i Chorob Wewnetrznych

location_facility: Szpital Kolejowy w Pruszkowie Oddzial Wewnetrzny


title: A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial With 40-Week Follow-Up Evaluating The Safety And Efficacy Of Varenicline Tartrate For Smoking Cessation In Patients With Mild-To-Moderate Chronic Obstructive Pulmonary Disease

summary: This study is to be conducted in subjects with mild-to-moderate COPD who are cigarette smokers with the intent of demonstrating differences in smoking cessation between varenicline and placebo.

ReferenceCitation: Tashkin DP, Rennard S, Taylor Hays J, Lawrence D, Marton JP, Lee TC. Lung function and respiratory symptoms in a 1-year randomized smoking cessation trial of varenicline in COPD patients. Respir Med. 2011 Nov;105(11):1682-90. doi: 10.1016/j.rmed.2011.04.016. Epub 2011 May 31.

family: Tashkin

full_name: D.P. Tashkin

family: Rennard

full_name: S. Rennard

given: S.

family: Taylor Hays

full_name: J. Taylor Hays

given: J.

family: Lawrence

full_name: D. Lawrence

given: D.

family: Marton

full_name: J.P. Marton

family: Lee

full_name: T.C. Lee

journal_name: Respiratory Medicine

oa_host_type: publisher

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

ReferenceCitation: Tashkin DP, Rennard S, Hays JT, Ma W, Lawrence D, Lee TC. Effects of varenicline on smoking cessation in patients with mild to moderate COPD: a randomized controlled trial. Chest. 2011 Mar;139(3):591-599. doi: 10.1378/chest.10-0865. Epub 2010 Sep 23.

full_name: Donald P. Tashkin

given: Donald P.

full_name: Stephen Rennard

given: Stephen

family: Hays

given: J. Taylor

family: Ma

full_name: Wendy Ma

given: Wendy

full_name: David Lawrence

given: David

full_name: Theodore C. Lee

given: Theodore C.

title: Effects of Varenicline on Smoking Cessation in Patients With Mild to Moderate COPD

ReferenceCitation: Ryerson CJ, Berkeley J, Carrieri-Kohlman VL, Pantilat SZ, Landefeld CS, Collard HR. Depression and functional status are strongly associated with dyspnea in interstitial lung disease. Chest. 2011 Mar;139(3):609-616. doi: 10.1378/chest.10-0608. Epub 2010 Aug 5.

family: Ryerson

full_name: Christopher J. Ryerson

given: Christopher J.

family: Berkeley

full_name: Jane Berkeley

given: Jane

family: Carrieri-Kohlman

full_name: Virginia L. Carrieri-Kohlman

given: Virginia L.

family: Pantilat

full_name: Steven Z. Pantilat

given: Steven Z.

family: Landefeld

full_name: C. Seth Landefeld

given: C. Seth

family: Collard

full_name: Harold R. Collard

title: Depression and Functional Status Are Strongly Associated With Dyspnea in Interstitial Lung Disease


title: A Phase 3, Randomized, 6-Month, Double-Blind Trial in Subjects With Bipolar I Disorder to Evaluate the Continued Safety and Maintenance of Effect of Ziprasidone Plus a Mood Stabilizer (vs Placebo Plus a Mood Stabilizer) Following a Minimum of 2 Months of Response to Open-Label Treatment With Both Agents

summary: The purpose of this study is to determine if ziprasidone plus a mood stabilizer will continue to be a safe and effective treatment regimen for adults with Bipolar I Disorder (manic or mixed symptoms) after they have achieved 8 consecutive weeks of symptom improvement on the regimen.

ReferenceCitation: Bowden CL, Vieta E, Ice KS, Schwartz JH, Wang PP, Versavel M. Ziprasidone plus a mood stabilizer in subjects with bipolar I disorder: a 6-month, randomized, placebo-controlled, double-blind trial. J Clin Psychiatry. 2010 Feb;71(2):130-7. doi: 10.4088/JCP.09m05482yel. Epub 2010 Jan 26.

family: Bowden

full_name: Charles L. Bowden

given: Charles L.

family: Vieta

full_name: Eduard Vieta

given: Eduard

family: Ice

full_name: Kathleen S. Ice

given: Kathleen S.

family: Schwartz

full_name: Jeffrey H. Schwartz

given: Jeffrey H.

family: Wang

full_name: Paul P. Wang

given: Paul P.

family: Versavel

full_name: Mark Versavel

given: Mark

bso_classification: Social sciences

journal_name: The Journal of Clinical Psychiatry

publisher: Physicians Postgraduate Press, Inc

publisher_dissemination: Physicians Postgraduate Press, Inc

publisher_group: Physicians Postgraduate Press, Inc

publisher_normalized: Physicians Postgraduate Press, Inc

title: Ziprasidone Plus a Mood Stabilizer in Subjects With Bipolar I Disorder

lead_sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

location_country:
Italy
United States
Chile
Guatemala
India
Hong Kong
Mexico
France
Venezuela
Russian Federation
Spain
Germany
Taiwan


title: A 6-Month, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Safety, Tolerability, and Efficacy Study of 3 Doses of Lecozotan (SRA-333) SR in Outpatients With Mild to Moderate Alzheimer's Disease Treated With a Cholinesterase Inhibitor

summary: The purpose of the study is to determine the safety, tolerability, and efficacy of 3 doses of lecozotan in combination with a cholinesterase inhibitor in patients with mild to moderate Alzheimer's disease (AD).

location_country:
Italy
United States
South Africa
Finland
France
Poland
Argentina
Australia
Spain
Canada
United Kingdom


title: An Open-label Follow-up Trial of the Efficacy and Safety of Chronic Administration of the Fixed Dose Combination of Telmisartan 80 mg + Hydrochlorothiazide 25 mg Tablets Alone or in Combination With Other Antihypertensive Medications in Patients With Hypertension.

summary: The primary objective is to assess the efficacy and safety of the fixed dose combination of telmisartan 80 mg + hydrochlorothiazide 25 mg (T80/H25) alone or in addition to other antihypertensive therapies during open-label, long-term treatment.

ReferenceCitation: Neldam S, Edwards C. Long-term, open-label evaluation of the safety and efficacy of telmisartan 80 mg/hydrochlorothiazide 25 mg fixed-dose combination alone or with other antihypertensive medication. Expert Opin Pharmacother. 2009 Feb;10(3):345-52. doi: 10.1517/14656560802707937 .

family: Neldam

full_name: Steen Neldam

given: Steen

family: Edwards

full_name: Colin Edwards

given: Colin

journal_name: Expert Opinion on Pharmacotherapy

location_country:
Italy
South Africa
Sweden
Hong Kong
Netherlands
Switzerland
Finland
France
Malaysia
Norway
Ireland
Spain
Denmark
Germany
Korea, Republic of
Taiwan

location_facility: Boehringer Ingelheim Investigational Site

location_facility: Azienda Ospedaliera Universita di Ferrara


title: A Phase II Study of Lapatinib for Brain Metastases in Subjects With ErbB2-Positive Breast Cancer Following Trastuzumab-based Systemic Therapy and Cranial Radiotherapy

summary: Determine how safe and effective lapatinib is when used to treat patients with ErbB2 overexpressing breast cancer that has spread to the brain and is still progressing there even after radiation treatment using WBRT (whole brain radiotherapy) or SRS (stereotactic radiosurgery) to the brain. Lapatinib is an oral drug that will be taken every day. Tests for safety and efficacy will be performed every 4 weeks or 8 weeks (depending on the test) during the course of the study.

ReferenceCitation: Sutherland S, Ashley S, Miles D, Chan S, Wardley A, Davidson N, Bhatti R, Shehata M, Nouras H, Camburn T, Johnston SR. Treatment of HER2-positive metastatic breast cancer with lapatinib and capecitabine in the lapatinib expanded access programme, including efficacy in brain metastases--the UK experience. Br J Cancer. 2010 Mar 16;102(6):995-1002. doi: 10.1038/sj.bjc.6605586. Epub 2010 Feb 23.

family: Sutherland

full_name: S Sutherland

given: S

family: Ashley

full_name: S Ashley

family: Miles

full_name: D Miles

given: D

family: Chan

full_name: S Chan

family: Wardley

full_name: A Wardley

given: A

family: Davidson

full_name: N Davidson

given: N

family: Bhatti

full_name: R Bhatti

given: R

family: Shehata

full_name: M Shehata

given: M

family: Nouras

full_name: H Nouras

given: H

family: Camburn

full_name: T Camburn

given: T

family: Johnston

full_name: S R D Johnston

given: S R D

journal_name: British Journal of Cancer

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

license: implied-oa

license_normalized: implied-oa

title: Treatment of HER2-positive metastatic breast cancer with lapatinib and capecitabine in the lapatinib expanded access programme, including efficacy in brain metastases – the UK experience

ipd_sharing: Undecided

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:
Italy
Austria
United States
Sweden
India
Switzerland
Germany
France
Japan
Greece
Poland
Australia
Belgium
Spain
Canada
United Kingdom
Taiwan


title: Randomized, Open-Label, Comparative Parallel Group Study to Assess Efficacy and Safety on Flexible Dosages of OROS Hydromorphone Once-Daily Compared to Sustained Release Oxycodone Twice Daily in Subjects With Chronic Non-malignant Pain Requiring Continuous Opioid Therapy.

summary: The purpose of this study is to compare the effectiveness and safety of sustained- release hydromorphone, formulated to release slowly over time, taken once daily, and controlled- release oxycodone taken twice daily, in patients with chronic non-cancer pain. The study will also determine the dose of sustained-release hydromorphone that provides a level of pain control that is equal to the pain control provided by control-released oxycodone (equi-analgesic dosage).

ReferenceCitation: Binsfeld H, Szczepanski L, Waechter S, Richarz U, Sabatowski R. A randomized study to demonstrate noninferiority of once-daily OROS(®) hydromorphone with twice-daily sustained-release oxycodone for moderate to severe chronic noncancer pain. Pain Pract. 2010 Sep-Oct;10(5):404-15. doi: 10.1111/j.1533-2500.2009.00342.x.

family: Binsfeld

full_name: Heinrich Binsfeld

given: Heinrich

family: Szczepanski

full_name: Leszek Szczepanski

given: Leszek

family: Waechter

full_name: Sandra Waechter

given: Sandra

family: Richarz

full_name: Ute Richarz

given: Ute

family: Sabatowski

full_name: Rainer Sabatowski

given: Rainer

journal_name: Pain Practice

title: A Randomized Study to Demonstrate Noninferiority of Once-Daily OROS® Hydromorphone with Twice-Daily Sustained-Release Oxycodone for Moderate to Severe Chronic Noncancer Pain

lead_sponsor: Janssen Pharmaceutica N.V., Belgium

location_country:
Sweden
Switzerland
France
Poland
Slovakia
Slovenia
Norway
Denmark
Germany
Czech Republic


title: A Randomized Phase 2 Study Of SU011248 Versus Standard-Of-Care For Patients With Previously Treated, Advanced, Triple Receptor Negative (ER, PR, HER2) Breast Cancer

summary: The purpose of this study is to compare progression free survival for SU011248 [sutent (sunitinib malate)] versus standard of care therapy in patients with previously treated, advanced, triple receptor negative (ER, PR, HER2) locally recurrent or metastatic breast cancer.

ReferenceCitation: Curigliano G, Pivot X, Cortés J, Elias A, Cesari R, Khosravan R, Collier M, Huang X, Cataruozolo PE, Kern KA, Goldhirsch A. Randomized phase II study of sunitinib versus standard of care for patients with previously treated advanced triple-negative breast cancer. Breast. 2013 Oct;22(5):650-6. doi: 10.1016/j.breast.2013.07.037. Epub 2013 Aug 17.

family: Curigliano

full_name: Giuseppe Curigliano

given: Giuseppe

family: Pivot

full_name: Xavier Pivot

given: Xavier

family: Cortés

full_name: Javer Cortés

given: Javer

family: Elias

full_name: Anthony Elias

given: Anthony

family: Cesari

full_name: Rossano Cesari

given: Rossano

family: Khosravan

full_name: Reza Khosravan

given: Reza

family: Collier

full_name: Mary Collier

given: Mary

family: Huang

full_name: Xin Huang

given: Xin

family: Cataruozolo

full_name: Patricia E. Cataruozolo

given: Patricia E.

family: Kern

full_name: Kenneth A. Kern

given: Kenneth A.

family: Goldhirsch

full_name: Aron Goldhirsch

given: Aron

journal_name: The Breast

location_country:
Italy
United Kingdom
Germany
France
Bulgaria
Hungary
Spain
Turkey
United States
Czech Republic
Canada
Ukraine


title: A Randomized, Double Blind, Double Dummy, Parallel Group, Placebo Controlled Study to Evaluate the Pharmacodynamic and Pharmacokinetic Response and Safety and Tolerability of SB424323 (250mg, 375mg and 500 mg) Administered Twice Daily for 16 Weeks, on Top of Asprin (325mg, qd) in Men and Women With Non Valvular Atrial Fibrillation at a Low or Intermediate Risk for Stroke

summary: This study will allow determination of the pharmacokinetic and pharmacodynamics of SB424323 in a relevant population. The data from this study will be used along with other data to aid in choosing the most appropriate dose for the later phase study.

location_country:
Greece
Romania
Belgium
Denmark
Taiwan
India
France
Thailand
Norway
Argentina
Canada
Korea, Republic of
Sweden
Netherlands
Hungary
United States
Germany
United Kingdom
Italy
Brazil
Mexico
New Zealand
Spain
Estonia
Latvia


title: A Prospective Randomised Study to Compare a Fixed Dose Combination of Telmisartan 80 mg Plus Hydrochlorothiazide 25 mg With a Fixed Dose Combination of Telmisartan 80 mg Plus Hydrochlorothiazide 12.5 mg in Patients With Uncontrolled Hypertension Who Fail to Respond Adequately to Treatment With a Fixed Dose Combination of Telmisartan 80 mg Plus Hydrochlorothiazide 12.5 mg

summary: The primary objective of this trial is to demonstrate that a fixed dose combination of telmisartan 80 mg plus hydrochlorothiazide 25 mg (T80/H25) is superior in reducing blood pressure after eight weeks compared with a fixed dose combination of telmisartan 80 mg plus hydrochlorothiazide 12.5 mg (T80/H12.5) in patients who fail to respond to six weeks treatment with T80/H12.5.

location_facility: Hospital General de Mostoles - Medicina Interna


title: Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Phase 3 Study - Determine Efficacy and Safety of Two Doses of Retigabine (900 Mg/Day and 600 Mg/Day) Used as Adjunctive Therapy in Refractory Epilepsy Patients With Partial-Onset Seizures

summary: This Phase 3 study is being conducted to evaluate the efficacy and safety of retigabine dosed at 900 mg/day and 600 mg/day, in three equally divided doses, compared with placebo in patients with epilepsy who are receiving up to three established antiepileptic drugs (AEDs).

ReferenceCitation: Brodie MJ, Lerche H, Gil-Nagel A, Elger C, Hall S, Shin P, Nohria V, Mansbach H; RESTORE 2 Study Group. Efficacy and safety of adjunctive ezogabine (retigabine) in refractory partial epilepsy. Neurology. 2010 Nov 16;75(20):1817-24. doi: 10.1212/WNL.0b013e3181fd6170. Epub 2010 Oct 13.

ReferenceCitation: Tompson DJ, Crean CS. Clinical pharmacokinetics of retigabine/ezogabine. Curr Clin Pharmacol. 2013 Nov;8(4):319-31. Review.

ReferenceCitation: Brickel N, Gandhi P, VanLandingham K, Hammond J, DeRossett S. The urinary safety profile and secondary renal effects of retigabine (ezogabine): a first-in-class antiepileptic drug that targets KCNQ (K(v)7) potassium channels. Epilepsia. 2012 Apr;53(4):606-12. doi: 10.1111/j.1528-1167.2012.03441.x. Epub 2012 Mar 16. Review.

ReferenceCitation: Porter RJ, Burdette DE, Gil-Nagel A, Hall ST, White R, Shaikh S, DeRossett SE. Retigabine as adjunctive therapy in adults with partial-onset seizures: integrated analysis of three pivotal controlled trials. Epilepsy Res. 2012 Aug;101(1-2):103-12. doi: 10.1016/j.eplepsyres.2012.03.010. Epub 2012 Apr 16.

family: Porter

full_name: Roger J. Porter

given: Roger J.

family: Burdette

full_name: David E. Burdette

given: David E.

family: Gil-Nagel

full_name: Antonio Gil-Nagel

given: Antonio

family: Hall

full_name: Susan T. Hall

given: Susan T.

family: White

full_name: Robin White

given: Robin

family: Shaikh

full_name: Soraya Shaikh

given: Soraya

family: DeRossett

full_name: Sarah E. DeRossett

given: Sarah E.

journal_name: Epilepsy Research

title: Retigabine as adjunctive therapy in adults with partial-onset seizures: Integrated analysis of three pivotal controlled trials

location_country:
South Africa
Germany
France
Poland
Israel
Hungary
Belgium
Australia
Russian Federation
Spain
United States
United Kingdom
Ukraine

location_facility: Katedra i Klinika Neurologii Slaskiej Akademii Medycznej

location_facility: District Antiepileptic Centre City Clinical Hospital # 71

location_facility: NZOZ Przychodnia Internistyczno - Stomatologiczna "Kendron"

location_facility: Instytut Psychiatrii i Neurologii II Oddzial Neurologii

location_facility: Epilepsy Center of Municipal Clinical Psychoneurological Hospital

location_facility: University of Bonn -- Department for Epileptplogy

location_facility: Universitaetsklinik Mainz Neurologische Klinik

location_facility: Universitaire Ziekenhuizen Gasthuisberg -- Department Neurology

location_facility: Orszagos Idegsebeszeti Tudomanyos Intezet

location_facility: Prywatna Wielospecjalistyczna Lecznica Medyczna "Zycie"

location_facility: Universitaet Giessen / Marburg Neurologie

location_facility: Institute of Neurology, Psychiatry and Narcology of AMS, Ukr

location_facility: Walton Centre for Neurology & Neurosurgery

location_facility: Zentrum Epilepsie Erlangen (ZEE) der Universitaet Erlangen

location_facility: Specjalistyczna Przychodnia Lekarska Medikard

location_facility: Wojewodzki Szpital Specjalistyczny im.Mikolaja Kopernika

location_facility: Interregional Clinical Diagnostic Centre

location_facility: St.Petersburg State Medical University n.a. I.P.Pavlov

location_facility: Clinic of Nervous Diseases of Sechenov's Moscow Med. Academy

location_facility: A. Z. Middelheim -- Department of Neurology


title: Phase II, Multicentre, Randomized, Double-blind Study in Acromegalic Patients Evaluating the Efficacy and Safety of a Single Deep Subcutaneous Administration of Lanreotide Autogel (60, 90 or 120mg) Versus Placebo Followed by a Single Blind Fixed Dose Phase Evaluating the Pharmacokinetic, Pharmacodynamic, Efficacy and Safety Profile of Multiple Deep Subcutaneous Administrations of Lanreotide Autogel (60, 90 & 120mg) Ending in Open Label Dose Titration Phase.

summary: The purpose of this study is to compare the effectiveness of lanreotide autogel to placebo after a single injection. Effectiveness and safety were then also assessed following four fixed-dose injections and after one year of treatment given at titrated doses.

ReferenceCitation: Melmed S, Cook D, Schopohl J, Goth MI, Lam KS, Marek J. Rapid and sustained reduction of serum growth hormone and insulin-like growth factor-1 in patients with acromegaly receiving lanreotide Autogel therapy: a randomized, placebo-controlled, multicenter study with a 52 week open extension. Pituitary. 2010;13(1):18-28. doi: 10.1007/s11102-009-0191-1. Epub 2009 Jul 29.

family: Melmed

full_name: Shlomo Melmed

given: Shlomo

family: Cook

full_name: David Cook

given: David

family: Schopohl

full_name: Jochen Schopohl

given: Jochen

family: Goth

full_name: Miklos I. Goth

given: Miklos I.

family: Lam

full_name: Karen S. L. Lam

given: Karen S. L.

family: Marek

full_name: Josef Marek

given: Josef

journal_name: Pituitary

version: submittedVersion

title: Rapid and sustained reduction of serum growth hormone and insulin-like growth factor-1 in patients with acromegaly receiving lanreotide Autogel® therapy: a randomized, placebo-controlled, multicenter study with a 52 week open extension

lead_sponsor: Ipsen

location_country:
United States
Hong Kong
Netherlands
France
Czechia
Hungary
Germany
United Kingdom

location_facility: Hôpital Lariboisière - Service de Médecine B

location_facility: Hôpital Cochin - Service d'Endocrinologie

location_facility: Johns Hopkins University School of Medicine


title: An Open-Label, Multicenter Study to Evaluate the Safety and Tolerability of Repeat Courses of Intramuscular Administration of Alefacept (LFA-3/IgG1 Fusion Protein) in Patients With Chronic Plaque Psoriasis

summary: The purpose of this study is to determine whether repeat courses of alefacept, administered intramuscularly, are safe when given to chronic plaque psoriasis patients who are receiving standard dermatology treatments.

lead_sponsor: Biogen

location_country:
Austria
Switzerland
Netherlands
Germany
France
Denmark
United States
United Kingdom
Canada

location_facility: University of Medicine and Dentistry Robert Wood Jonhson Medical School

location_facility: Wake Forest University School of Medicine

location_facility: Eastern Canada Cutaneous Research Associates

location_facility: University Hospital Nijmegen - St. Radboud

location_facility: Hospital Saint Louis, Université Paris VII


title: A Phase II Randomised, Double-Blind, Stratified, Multi-Centre Trial Comparing the Nolvadex 20 Mg And Placebo Combination To The Nolvadex 20 Mg and ZD1839 (IRESSA™) 250 MG Combination In Patients With Metastatic Breast Cancer And Estrogen Receptor (ER) and/or Progesterone (PR) Positive Tumours

summary: This study is being carried out to see if ZD1839 is effective in treating metastatic breast cancer in combination with Nolvadex, and if so, how it compares with Nolvadex alone.

location_country:
Brazil
South Africa
Germany
France
Belgium
Argentina
Australia
Spain
Denmark
United States
United Kingdom
Canada


title: A 12-Month, Open-Label, Flexible-Dosage (100 to 250 mg/Day) Extension Study of the Safety and Efficacy of Armodafinil (CEP-10953) in the Treatment of Patients With Excessive Sleepiness Associated With Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder (With an Open-Ended Extension Period)

summary: A 12 Month, Open-Label, Flexible Dosage Extension Study of the Safety and Efficacy of Armodafinil (CEP-10953) in the Treatment of Patients with Excessive Sleepiness Associated with Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder

lead_sponsor: Cephalon

location_country:
United States
Germany
France
Australia
Puerto Rico
Russian Federation
Canada

location_facility:
Canadian Sleep Institute
Sleep Disorders Center
Toronto Western Hospital
Sleep Clinic
Hopital Antoine Beclere
Ohio Sleep Medicine-Neurosci
Capital Region Sleep Disorders
Sentara Norfolk General Hospit
Klinikum der Philipps
VA Medical CenterSleep Diagnos
Omega Medical Research
Dept Veterans Affairs Dayton
Swedish Sleep Medicine Institute
Advanced Clinical Research Ins
Psypharma Clinical Research
Lowcountry Lung and Critical
Royal Prince Alfred Hospital
Sleep Medicine Institute
University of Freiburg
Sleep and Neuropsychiatry Cent
Central Carolina Neurology Sle
Center for Sleep Disorders
PAB Clinical Research
North Coast Clinical Trials
Peoria Pulmonary Associates
St. Alexius Medical Center
West Parry Sound Health Center
Montefiore Medical Center
City Clinical Hospital 83
SomniCare Sleep Institute
SleepMed of South Carolina
Henry Lahmeyer, MD
Topeka Pulmonary
Radiant Research Salt Lake
Sleep-Wake Disorder Center
Washington University School o
St. Petersburg Sleep Disorder
Neurotrials Research of New Or
Northshore Research Associates
Clinical Rsch Center of Nevada
Hospital Henri-Mondor
Allegiance Research Specialist
Community Research Management
Sleep Disorders Ctr of Alabama
Consolidated Clinical Trials
Duke University Hospital
Vince and Associates Clinical
Southwest Cleveland Sleep Cent
Monash Medical Center
CNS Research Institute
University of Iowa Hospitals
Cleveland Clinic Foundation
Ottawa Hospital
Chest Medicine Associates DBA
McLean Hospital
Neurotrials Research
Center for Sleep/Wake Disorder
Houston Sleep Center
Multifunction Center of Neurol
Stanford University
BMR HealthQuest
Hephata Klinik
Vital re:Search
Tri State Sleep Disorders Cent
Graves Gilbert Clinic
Regional Pulmonary and Sleep
Sadler Clinic
Clinical Pharmaceutical Trials
St. George Hospital
Neurocare, Inc.
Radiant Research Marietta
Sleep Clinic of San Francisco
Neurology Associates of Hickor
University of Regensburg
Clinilabs / Sleep Disorders In
SLEEPMED, Inc.
Sleep Disorders Center of GA
Hopital Guy de Chauliac
Pacific Sleep Medicine Service
Community Research
Central Arkansas Research
FutureSearch Trials
All Trials Clinical Research
Radiant Research San Diego
Niagara Clinical Research
Melbourne Sleep Disorders Ctr.
Universitaires de Strasbourg
New York University
Baycrest Hospital
St. Thomas Sleep Disorders Cen
Clinical Hospital Russian Scie
St. Johns Medical Plaza Sleep
City Clinical Hospital 33
Pulmonary Associates, PA
Southwestern Research
St. Vincent Mercy Medical Cent
Westmead Hospital
Wake Research Associates


title: A RANDOMIZED PHASE 2 STUDY OF THE ANTI-ANGIOGENESIS AGENT AG-013736 IN COMBINATION WITH GEMCITABINE IN PATIENTS WITH CHEMOTHERAPY-NAIVE ADVANCED PANCREATIC CANCER PRECEDED BY A PHASE 1 PORTION

summary: This is a Phase 2 study being conducted at multiple centers in the United States, Europe and Canada. Patients having pancreatic cancer that is locally advanced or that has spread to other parts of the body (i.e., metastatic) are eligible to participate. Patients must have not had any prior systemic treatment for advanced disease. The purpose of the study is to test whether the angiogenesis inhibitor Axitinib [AG-013736] in combination with gemcitabine is an effective treatment for advanced pancreatic cancer vs. gemcitabine alone by overall survival.

ReferenceCitation: Spano JP, Chodkiewicz C, Maurel J, Wong R, Wasan H, Barone C, Létourneau R, Bajetta E, Pithavala Y, Bycott P, Trask P, Liau K, Ricart AD, Kim S, Rixe O. Efficacy of gemcitabine plus axitinib compared with gemcitabine alone in patients with advanced pancreatic cancer: an open-label randomised phase II study. Lancet. 2008 Jun 21;371(9630):2101-8. doi: 10.1016/S0140-6736(08)60661-3. Epub 2008 May 29.

family: Spano

full_name: Jean-Philippe Spano

given: Jean-Philippe

family: Chodkiewicz

full_name: Catherine Chodkiewicz

given: Catherine

family: Maurel

full_name: Joan Maurel

given: Joan

family: Wong

full_name: Ralph Wong

given: Ralph

family: Wasan

full_name: Harpreet Wasan

given: Harpreet

family: Barone

full_name: Carlo Barone

given: Carlo

family: Létourneau

full_name: Richard Létourneau

given: Richard

family: Bajetta

full_name: Emilio Bajetta

given: Emilio

family: Pithavala

full_name: Yazdi Pithavala

given: Yazdi

family: Bycott

full_name: Paul Bycott

given: Paul

family: Trask

full_name: Peter Trask

given: Peter

family: Liau

full_name: Katherine Liau

given: Katherine

family: Ricart

full_name: Alejandro D Ricart

given: Alejandro D

family: Kim

full_name: Sinil Kim

given: Sinil

family: Rixe

full_name: Olivier Rixe

given: Olivier

journal_name: The Lancet

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

location_country:
Italy
United States
Germany
France
Belgium
Spain
Canada
United Kingdom

location_facility: Fondazione IRCCS, Istituto Nazionale Tumori, Oncologia Medica B

location_facility: Maine Center for Cancer Medicine and Blood Disorders

location_facility: Department of Cancer Studies & Molecular Medicine

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: Unita Operativa, Oncologia Medica, Istituto di Medicina Interna e Geriatria

location_facility: Universitair Ziekenhuis Gent/Dienst Gastroenterologie

location_facility: Medizinische Klinik mit Schwerpunkt Haematologie und Onkologie, Charité-Universitaetsmedizin Berlin

location_facility: University of Wisconsin Hospital and Clinics

location_facility: East Bay Medical Oncology/Hematology Medical Associates Inc.

location_facility: H Lee Moffitt Cancer Center & Research Institute

location_facility: East Bay Medical Oncology/Hematology Medical Associates, Inc.

location_facility: Piedmont Hematology Oncology Association

location_facility: Arch Medical Services, Inc. d/b/a The Center for Cancer Care and Research

location_facility: Southeast Nebraska Cancer Center, Southeast Nebraska Hematology and Oncology Consultants, P.C.


title: A Multicenter Open-Label Continuation Study in Moderate to Severe Chronic Plaque Psoriasis Subjects Who Completed a Preceding Psoriasis Clinical Study With Adalimumab

summary: The two objectives of this study were to evaluate long-term efficacy and safety of adalimumab treatment in participants who had moderate to severe chronic plaque psoriasis and to evaluate the effectiveness of adalimumab retreatment in participants who had therapeutic response to adalimumab and were then withdrawn from adalimumab treatment.

ReferenceCitation: Gordon K, Papp K, Poulin Y, Gu Y, Rozzo S, Sasso EH. Long-term efficacy and safety of adalimumab in patients with moderate to severe psoriasis treated continuously over 3 years: results from an open-label extension study for patients from REVEAL. J Am Acad Dermatol. 2012 Feb;66(2):241-51. doi: 10.1016/j.jaad.2010.12.005. Epub 2011 Jul 14.

family: Gordon

full_name: Kenneth Gordon

given: Kenneth

family: Papp

full_name: Kim Papp

given: Kim

family: Poulin

full_name: Yves Poulin

given: Yves

family: Gu

full_name: Yihua Gu

given: Yihua

family: Rozzo

full_name: Stephen Rozzo

given: Stephen

family: Sasso

full_name: Eric H. Sasso

given: Eric H.

journal_name: Journal of the American Academy of Dermatology

title: Long-term efficacy and safety of adalimumab in patients with moderate to severe psoriasis treated continuously over 3 years: Results from an open-label extension study for patients from REVEAL

ReferenceCitation: Papp K, Crowley J, Ortonne JP, Leu J, Okun M, Gupta SR, Gu Y, Langley RG. Adalimumab for moderate to severe chronic plaque psoriasis: efficacy and safety of retreatment and disease recurrence following withdrawal from therapy. Br J Dermatol. 2011 Feb;164(2):434-41. doi: 10.1111/j.1365-2133.2010.10139.x.

full_name: K. Papp

given: K.

family: Crowley

full_name: J. Crowley

given: J.

family: Ortonne

full_name: J.-P. Ortonne

family: Leu

full_name: J. Leu

family: Okun

full_name: M. Okun

given: M.

family: Gupta

full_name: S.R. Gupta

full_name: Y. Gu

given: Y.

family: Langley

full_name: R.G. Langley

journal_name: British Journal of Dermatology

lead_sponsor: Abbott

location_country:
Austria
United States
Switzerland
Germany
France
Poland
Belgium
Puerto Rico
Spain
Canada

location_facility:
Site Reference ID/Investigator# 1629
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title: A Retrospective Study to Describe the Incidence of Moderate to Severe Allergic Reactions to Factor IX in Patients With Hemophilia B

summary:
Retrospective, multicenter study in patients with hemophilia B. This study will be placed at 20 to 50 hemophilia treatment centers in North America and the EU, and is designed to estimate the frequency of Class II and III allergic reactions in association with the administration of any FIX concentrate.

Following informed consent and eligibility, historical patient information including demographics, allergy history, hemophilia history, frequency and severity of allergic reaction(s), number of exposure days with products causing allergic reactions, exposure days to blood products including FIX concentrates, treatment for allergic reaction(s), outcome of event(s), any other adverse event(s) occuring within 48 hours of onset of allergic reaction(s), rechallenge and outcome, switch to another FIX product (if applicable) and outcome, current status of patient, and results of any special studies (eg, skin or RAST testing, alloantibody analyses, ect) will be collected.

study_type: Observational

time_perspective: Retrospective

lead_sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

location_country:
Italy
Austria
United States
Germany
France
Belgium
Spain
Canada
United Kingdom


title: Long-Term, Open Label Safety Study of Atomoxetine Hydrochloride in Patients, 6 Years and Older With Attention-Deficit/Hyperactivity Disorder

summary:
To learn about the safety and any side effects of atomoxetine when given to children and adolescents for about 5 years (long-term) and to learn whether atomoxetine can help children and adolescents with attention-deficit/hyperactivity disorder (ADHD) who take the drug for about 5 years (long-term).

Study participants can be atomoxetine naive, atomoxetine experienced whose therapy has been interrupted or, atomoxetine experienced on a known stable dose.

ReferenceCitation: Michelson D, Read HA, Ruff DD, Witcher J, Zhang S, McCracken J. CYP2D6 and clinical response to atomoxetine in children and adolescents with ADHD. J Am Acad Child Adolesc Psychiatry. 2007 Feb;46(2):242-51.

lead_sponsor: Eli Lilly and Company

location_country:
Italy
United States
South Africa
Sweden
Netherlands
Germany
France
Israel
Norway
Belgium
Australia
Puerto Rico
Canada
United Kingdom

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: A Double-Blind, Randomized, Multicenter, Placebo-controlled, In-Patient, Maximum 34 Day Study of Levetiracetam Oral Solution (20-50 mg/kg/Day) as Adjunctive Treatment of Refractory Partial Onset Seizures in Pediatric Epileptic Subjects Ranging in Age From 1 Month to Less Than 4 Years of Age

summary: To evaluate the safety and efficacy of levetiracetam used as adjunctive treatment in pediatric subjects age 1 month to less than 4 years with partial onset seizures. Subjects will be evaluated with 48 hour inpatient video electroencephalograms (a selection and an evaluation). Other neuropsychological clinical assessments will be performed during the 34 day length of the study.

ReferenceCitation: Piña-Garza JE, Nordli DR Jr, Rating D, Yang H, Schiemann-Delgado J, Duncan B; Levetiracetam N01009 Study Group. Adjunctive levetiracetam in infants and young children with refractory partial-onset seizures. Epilepsia. 2009 May;50(5):1141-9. doi: 10.1111/j.1528-1167.2008.01981.x. Epub 2009 Feb 21.

family: Piña-Garza

full_name: Jesus Eric Piña-Garza

given: Jesus Eric

family: Nordli Jr

full_name: Douglas R. Nordli Jr

given: Douglas R.

family: Rating

full_name: Dietz Rating

given: Dietz

family: Yang

full_name: Haichen Yang

given: Haichen

family: Schiemann-Delgado

full_name: Jimmy Schiemann-Delgado

given: Jimmy

family: Duncan

full_name: Benjamin Duncan

given: Benjamin

name: on behalf of the Levetiracetam N01009 Study Group

journal_name: Epilepsia

ReferenceCitation: Piña-Garza JE, Schiemann-Delgado J, Yang H, Duncan B, Hadac J, Hunter SJ. Adjunctive levetiracetam in patients aged 1 month to <4 years with partial-onset seizures: subpopulation analysis of a prospective, open-label extension study of up to 48 weeks. Clin Ther. 2010 Oct;32(11):1935-50. doi: 10.1016/j.clinthera.2010.09.017.

family: Hadac

full_name: Jan Hadac

given: Jan

family: Hunter

full_name: Scott J. Hunter

given: Scott J.

journal_name: Clinical Therapeutics

title: Adjunctive levetiracetam in patients aged 1 month to <4 years with partial-onset seizures: Subpopulation analysis of a prospective, open-label extension study of up to 48 weeks

lead_sponsor: UCB Pharma

location_country:
Italy
United States
Brazil
Mexico
Germany
France
Czechia
Poland
Romania
Hungary
Belgium
Argentina
Russian Federation
Canada
United Kingdom

intervention_type: Other