title: Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety, and Tolerability of Tezosentan in Patients With Acute Heart Failure.

acronym: VERITAS 1

summary: The randomized patients with acute heart failure will be stratified based on the presence or absence of a Swan-Ganz catheter and assigned to receive either tezosentan 5 mg/h for the first 30 minutes and 1 mg/h thereafter or matching placebo in a 1:1 manner. The duration of the treatment is 24 hours up to 72 hours. The duration of the follow-up period is 30 days after treatment initiation for death, re-hospitalizations and SAEs followed by a follow-up period of 5 months for vital status.

ReferenceCitation: Cotter G, Davison BA, Milo O, Bourge RC, Cleland JG, Jondeau G, Krum H, O'Connor CM, Metra M, Parker JD, Torre-Amione G, van Veldhuisen DJ, Kobrin I, Rainisio M, Senger S, Edwards C, McMurray JJ, Teerlink JR; VERITAS Investigators. Predictors and Associations With Outcomes of Length of Hospital Stay in Patients With Acute Heart Failure: Results From VERITAS. J Card Fail. 2016 Oct;22(10):815-22. doi: 10.1016/j.cardfail.2015.12.017. Epub 2015 Dec 22.

ReferenceCitation: McMurray JJ, Teerlink JR, Cotter G, Bourge RC, Cleland JG, Jondeau G, Krum H, Metra M, O'Connor CM, Parker JD, Torre-Amione G, van Veldhuisen DJ, Lewsey J, Frey A, Rainisio M, Kobrin I; VERITAS Investigators. Effects of tezosentan on symptoms and clinical outcomes in patients with acute heart failure: the VERITAS randomized controlled trials. JAMA. 2007 Nov 7;298(17):2009-19.

lead_sponsor: Idorsia Pharmaceuticals Ltd.

location_country:
Denmark
Poland
United Kingdom
Greece
Austria
Switzerland
United States
France
Israel
Germany

location_facility: Klinika Chorob Serca, Akademia Medyczna w Gdansku

location_facility: Advanced Heart Failure and Transplant Service, Palo Alto VA Health Care System, Cardiology Section

location_facility: Hopitaux Universitaires de Strasbourg, Hopital Hautepierre

location_facility: Campus Virchow-Klinikum, Medizinishe Klinik mit Schwerpunkt Kardiologie

location_facility: Centre Hospitalier Universitaire Vaudois (CHUV)

location_facility: AKH University of Vienna, Abt. Medizinische Kardiologie

location_facility: Medizinische Klinik I, Universitatsklinikum Aachen

location_facility: I Klinika Kardiolgii, Collegium Medicum UJ

location_facility: Georg-August-Universitat Gottingen, Zentrum fur Innere Med

location_facility: Hopital Ambroise Pare, Service de Cardiologie

location_facility: The Heart Hospital at Alledgheny General, Division of Cardiology

location_facility: Institute of Cardiology College, College of Medicine of Jagellonian University

location_facility: Cardio Centro Ticino, Servizio Cardiovasculare

location_facility: Klinika Kardiologii i Chorob Wewnetrznych, Samodzielny Publiczny Szpital

location_facility: Dept. of Cardiology, University of Athens, Alexandra Hospital


status: Completed

primary_purpose: Treatment

intervention_type: Drug

acronym: Pediatric commitment 1month-4years

title: Open-label, Single-arm, Multi-center, Pharmacokinetic, Safety and Tolerability Study of Levetiracetam Intravenous Infusion in Children (1 Month- 4 Years Old) With Epilepsy

study_completion_date_type: Actual

lead_sponsor: UCB Pharma SA

type: EudraCT Number

source: euctr

study_type: Interventional

ReferenceType: result

ReferenceCitation: Weinstock A, Ruiz M, Gerard D, Toublanc N, Stockis A, Farooq O, Dilley D, Karmon Y, Elgie MJ, Schiemann-Delgado J. Prospective Open-Label, Single-Arm, Multicenter, Safety, Tolerability, and Pharmacokinetic Studies of Intravenous Levetiracetam in Children With Epilepsy. J Child Neurol. 2013 Nov;28(11):1423-1429. Epub 2013 Mar 26.

enrollment_type: Actual

location_country:
Belgium
United States
France
Turkey
Mexico
Germany

summary: Keppra injection is approved in the US as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy. The objective of the current study is to assess the safety, tolerability, and pharmacokinetics, of this formulation in children aged 1 month to 4 years.

lead_sponsor_type: industriel

status_simplified: Completed


title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of AST-120 for Prevention of Chronic Kidney Disease Progression in Patients With Moderate to Severe Chronic Kidney Disease

summary: 1) To evaluate the effectiveness of AST-120 (spherical carbon adsorbent) added to standard-of-care therapy in moderate to severe Chronic Kidney Disease (CKD), on time to first occurrence of any event of the triple composite outcome of initiation of dialysis, kidney transplant or doubling of serum creatinine (sCr) when compared with placebo; 2) To evaluate the safety and tolerability of long-term AST-120 therapy in patients with CKD; 3) To evaluate the effects of AST-120 versus placebo, on other measures of renal function.

design_allocation: Randomized

ReferenceCitation: Schulman G, Berl T, Beck GJ, Remuzzi G, Ritz E, Arita K, Kato A, Shimizu M. Randomized Placebo-Controlled EPPIC Trials of AST-120 in CKD. J Am Soc Nephrol. 2015 Jul;26(7):1732-46. doi: 10.1681/ASN.2014010042. Epub 2014 Oct 27.

ReferenceType: derived

ReferenceCitation: Schulman G, Berl T, Beck GJ, Remuzzi G, Ritz E, Shimizu M, Kikuchi M, Shobu Y. Risk factors for progression of chronic kidney disease in the EPPIC trials and the effect of AST-120. Clin Exp Nephrol. 2018 Apr;22(2):299-308. doi: 10.1007/s10157-017-1447-0. Epub 2017 Jul 24.

ReferenceCitation: Schulman G, Berl T, Beck GJ, Remuzzi G, Ritz E, Shimizu M, Shobu Y, Kikuchi M. The effects of AST-120 on chronic kidney disease progression in the United States of America: a post hoc subgroup analysis of randomized controlled trials. BMC Nephrol. 2016 Sep 30;17(1):141.

lead_sponsor: Mitsubishi Tanabe Pharma Corporation

location_country:
Poland
Brazil
Italy
Russian Federation
Argentina
Canada
Ukraine
Puerto Rico
United States
France
Mexico
Czechia


title: A Phase 2 Randomized, Multicenter, Active Comparator-Controlled Trial to Evaluate the Safety and Efficacy of Co-administration of CP-690,550 and Mycophenolate Mofetil / Mycophenolate Sodium in De Novo Renal Allograft Recipients

summary: A new immunosuppressive drug, based on the inhibition of an important enzyme in the immune system called JAK3, is being developed by Pfizer to prevent transplant rejection. In this research study, a JAK3 inhibitor or cyclosporine will be given to new kidney transplant patients for 12 months. Patients will be assigned to one of three treatment groups after receiving a kidney transplant. Two of the treatment groups will receive 2 different dosing regimens of the JAK3 inhibitor that will be taken by mouth. The third treatment group will be a standard-of-care control arm. Patients will continue to take the assigned study medication for 12 months as well as other standard transplant medications such as prednisone.

primary_purpose: Prevention

lead_sponsor: Pfizer

location_country:
Poland
Brazil
Portugal
Spain
Italy
Australia
Netherlands
Canada
Czech Republic
Korea, Republic of
United States
France
Belgium
Norway
Germany


acronym: MAZE

title: A Randomized, Multi-centre, Double-blind Study, to Compare the Efficacy and Safety of Zonisamide and Carbamazepine as Monotherapy, in Newly Diagnosed Partial Epilepsy

lead_sponsor: Eisai Inc.

ReferenceCitation: Baulac M, Brodie MJ, Patten A, Segieth J, Giorgi L. Efficacy and tolerability of zonisamide versus controlled-release carbamazepine for newly diagnosed partial epilepsy: a phase 3, randomised, double-blind, non-inferiority trial. Lancet Neurol. 2012 Jul;11(7):579-88. doi: 10.1016/S1474-4422(12)70105-9. Epub 2012 Jun 8.

location_country:
Denmark
Poland
Taiwan
Serbia
Spain
Greece
Italy
Australia
Russian Federation
United Kingdom
Sweden
Hungary
Korea, Republic of
France
India
South Africa
Germany
Slovakia

summary: This is a two-arm, randomized, double-blind, non-inferiority study using a flexible dosing regime to allow optimal zonisamide or carbamazepine therapy for individual subjects. Assessment of eligibility will take place at the Screening Visit. The subjects will be randomized to either the carbamazepine or zonisamide arm at the Randomization Visit (T1). T1 must occur as soon as possible (and at least within 14 days) of the Screening Visit in order to optimize subject care.


ipd_sharing: Yes

status: Terminated

intervention_type: Biological

acronym: MAGE3-AS15-NSC-001 (ADJ-Chemo)

title: Cancer Immunotherapeutic GSK1572932A as Adjuvant Therapy for Patients With MAGE-A3-positive Non-Small Cell Lung Cancer

lead_sponsor: GlaxoSmithKline

design_allocation: Non-Randomized

study_start_date_type: Actual

ReferenceCitation: Pujol JL, Vansteenkiste JF, De Pas TM, Atanackovic D, Reck M, Thomeer M, Douillard JY, Fasola G, Potter V, Taylor P, Bosquée L, Scheubel R, Jarnjak S, Debois M, de Sousa Alves P, Louahed J, Brichard VG, Lehmann FF. Safety and Immunogenicity of MAGE-A3 Cancer Immunotherapeutic with or without Adjuvant Chemotherapy in Patients with Resected Stage IB to III MAGE-A3-Positive Non-Small-Cell Lung Cancer. J Thorac Oncol. 2015 Oct;10(10):1458-67. doi: 10.1097/JTO.0000000000000653.

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.

location_country:
United Kingdom
Italy
Canada
France
Belgium
Germany

summary: The purpose of this clinical trial is to find out how successfully non-small-cell lung cancer patients are able to give an immune response to injections of the immunotherapeutic product GSK1572932A, and to find out more about the safety of this treatment. A course of eight injections will be administered over 21 weeks; including screening for suitability and all tests, the duration of the study for a patient will be 30-35 weeks. During this period various tests will be performed, including physical examinations and blood tests. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

status_simplified: Unknown


title: A Randomized, Open-Label, Controlled, Phase II Trial of Combination Chemotherapy With or Without Panitumumab as First-line Treatment of Subjects With Metastatic or Recurrent Head and Neck Cancer, and Cross-over Second-line Panitumumab Monotherapy of Subjects Who Fail the Combination Chemotherapy…

lead_sponsor: Amgen

ReferenceType: background

ReferenceCitation: Wirth LJ. PARTNER: a study of panitumumab plus chemotherapy for first-line treatment of advanced head and neck cancer. Commun Oncol. 2008;5(Supp 14):1-4.

location_country:
Spain
Austria
Lithuania
Puerto Rico
France
United States
Belgium
Slovakia
Czechia

summary: This is a randomized, open-label, 2-arm, controlled, phase 2, multi-center, estimation clinical trial of docetaxel and cisplatin combination chemotherapy with and without panitumumab in the first-line treatment of subjects with metastatic or recurrent head and neck cancer, as well as a cross-over second-line panitumumab monotherapy of subjects who fail the chemotherapy only arm. This study will be conducted in the United States. Approximately 150 subjects with histologically or cytologically confirmed metastatic and/or recurrent SCCHN.


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

lead_sponsor: Novo Nordisk A/S

ReferenceCitation: Thalange N, Bereket A, Larsen J, Hiort LC, Peterkova V. Treatment with insulin detemir or NPH insulin in children aged 2-5 yr with type 1 diabetes mellitus. Pediatr Diabetes. 2011 Nov;12(7):632-41. doi: 10.1111/j.1399-5448.2010.00750.x. Epub 2011 Mar 21.

ReferenceCitation: Thalange N, Bereket A, Larsen J, Hiort LC, Peterkova V. Insulin analogues in children with Type 1 diabetes: a 52-week randomized clinical trial. Diabet Med. 2013 Feb;30(2):216-25. doi: 10.1111/dme.12041.

ReferenceCitation: Thalange N, Bereket A, Jensen LB, Hiort LC, Peterkova V. Development of Insulin Detemir/Insulin Aspart Cross-Reacting Antibodies Following Treatment with Insulin Detemir: 104-week Study in Children and Adolescents with Type 1 Diabetes Aged 2-16 Years. Diabetes Ther. 2016 Dec;7(4):713-724. Epub 2016 Sep 6.

location_country: Macedonia, The Former Yugoslav Republic of

summary:
This trial is conducted in Europe.

The aim of this research is to compare the efficacy and safety of treatment with NPH insulin and insulin detemir. You will be treated with either insulin detemir or NPH insulin once or twice daily as basal insulin. Additionally you will receive insulin aspart as bolus insulin


title: A Phase II/III Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo on a Background of Mycophenolate Mofetil and Glucocorticosteroids in Subjects With Active Proliferative Glomerulonephritis Due to Systemic Lupus Erythematosus (SLE)

summary: The purpose of this clinical research study is to learn if addition of abatacept is safe and improves the effectiveness of treatment of patients with active lupus nephritis who are also taking mycophenolate mofetil (MMF) and corticosteroids.

ReferenceCitation: Wolf BJ, Spainhour JC, Arthur JM, Janech MG, Petri M, Oates JC. Development of Biomarker Models to Predict Outcomes in Lupus Nephritis. Arthritis Rheumatol. 2016 Aug;68(8):1955-63. doi: 10.1002/art.39623.

ReferenceCitation: Furie R, Nicholls K, Cheng TT, Houssiau F, Burgos-Vargas R, Chen SL, Hillson JL, Meadows-Shropshire S, Kinaszczuk M, Merrill JT. Efficacy and safety of abatacept in lupus nephritis: a twelve-month, randomized, double-blind study. Arthritis Rheumatol. 2014 Feb;66(2):379-89. doi: 10.1002/art.38260.

ReferenceCitation: Wofsy D, Hillson JL, Diamond B. Comparison of alternative primary outcome measures for use in lupus nephritis clinical trials. Arthritis Rheum. 2013 Jun;65(6):1586-91. doi: 10.1002/art.37940.

ReferenceCitation: Wofsy D, Hillson JL, Diamond B. Abatacept for lupus nephritis: alternative definitions of complete response support conflicting conclusions. Arthritis Rheum. 2012 Nov;64(11):3660-5. doi: 10.1002/art.34624.

lead_sponsor: Bristol-Myers Squibb

location_country:
Poland
Taiwan
Brazil
Hong Kong
United Kingdom
Russian Federation
Australia
Mexico
Argentina
Canada
Korea, Republic of
United States
France
China
India
Belgium
South Africa
Turkey

location_facility: The Feinstein Institute For Medical Research

location_facility: University Of North Carolina At Chapel Hill


title: A Phase Ib/II Study Investigating the Combination of Everolimus With Trastuzumab and Paclitaxel in Patients With HER2-overexpressing Metastatic Breast Cancer

summary:
Phase I: will look at different dose levels and regimens of everolimus combined with weekly trastuzumab and paclitaxel therapy in patients with HER-2 overexpressing metastatic breast cancer.

Phase II: will assess the efficacy and safety of the 10mg daily dose of everolimus combined with weekly trastuzumab and paclitaxel therapy in patients with HER-2 overexpressing metastatic breast cancer.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Spain
United States
France
Belgium
Netherlands

location_facility: University of California at Los Angeles Dept.of UCLA Dept.ofMed.

location_facility: Cancer Centers of the Carolinas CC of C -Eastside

location_facility: Emory University School of Medicine/Winship Cancer Institute Dept. of Hematology (2)

location_facility: Wilshire Oncology Medical Group La Verne

location_facility: Peninsula Regional Medical Center Deptof Oncology and Hematology

location_facility: Compassionate Cancer Care Medical Group Dept.ofCCCMG

location_facility: Washington University School Of Medicine-Siteman Cancer Ctr StudyCoordinator:CRAD001J2101

location_facility: Loma Linda University Dept.ofLomaLindaCancerCent(3)


acronym: OPTIMA

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)

lead_sponsor: Abbott

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.

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.

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.

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.

location_country:
Spain
United Kingdom
United States
South Africa
Belgium
Poland
Austria
Australia
Argentina
Puerto Rico
Mexico
Norway
Sweden
Slovakia
Canada
Hungary
Germany
New Zealand
Czech Republic
France
Netherlands

location_facility:
Site Reference ID/Investigator# 4534
Site Reference ID/Investigator# 3921
Site Reference ID/Investigator# 7174
Site Reference ID/Investigator# 3918
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Site Reference ID/Investigator# 3923
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Site Reference ID/Investigator# 3922
Site Reference ID/Investigator# 3920
Site Reference ID/Investigator# 11222
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Site Reference ID/Investigator# 7506
Site Reference ID/Investigator# 9323
Site Reference ID/Investigator# 7500
Site Reference ID/Investigator# 3982
Site Reference ID/Investigator# 6834
Site Reference ID/Investigator# 3961
Site Reference ID/Investigator# 8488
Site Reference ID/Investigator# 8511
Site Reference ID/Investigator# 3914
Site Reference ID/Investigator# 3979
Site Reference ID/Investigator# 3916
Site Reference ID/Investigator# 6542
Site Reference ID/Investigator# 3969
Site Reference ID/Investigator# 3954
Site Reference ID/Investigator# 3891
Site Reference ID/Investigator# 4545
Site Reference ID/Investigator# 3905
Site Reference ID/Investigator# 4546
Site Reference ID/Investigator# 7607
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Site Reference ID/Investigator# 4600
Site Reference ID/Investigator# 3909
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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.

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. Erratum in: Ther Adv Neurol Disord. 2020 Oct 21;13:1756286420968357.

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.

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.

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.

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.

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;:.

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.

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.

lead_sponsor: Biogen


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

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.

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.

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.

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.

location_country:
Denmark
Poland
Portugal
Spain
Austria
Australia
New Zealand
Argentina
Canada
Czech Republic
Switzerland
Hungary
United States
France
Israel
Belgium
Norway
Germany

location_facility:
Site Ref # / Investigator 5197
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Site Ref # / Investigator 3739
Site Ref # / Investigator 7477
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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.

lead_sponsor: Bayer

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


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.

lead_sponsor: Eli Lilly and Company

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

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.

lead_sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

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


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)

lead_sponsor: Centocor, Inc.

location_country:
Spain
United Kingdom
Austria
United States
France
Belgium
Germany

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.

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.

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


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.

location_country:
United States
Italy
Spain
France


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

location_country:
Spain
Italy
Argentina
United States
France
Peru
Belgium

location_facility: University Of Texas Md Anderson Cancer Ctr


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.

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.

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.

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


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.

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

location_facility: Northwestern University Feinberg School Of Medicine

location_facility: University Of Miami Miller School Of Medicine

location_facility: The Cancer Center At Hackensack University Medical Center

location_facility: University Of Iowa Hospitals And Clinics

location_facility: Penn State Milton S. Hershey Medical Center


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


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.

lead_sponsor: United Therapeutics

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

location_facility: Mater Misericordiae University Hospital Ltd

location_facility: University of Maryland School of Medicine

location_facility: Vancouver Coastal Health Respiratory Clinic

location_facility: National Tuberculosis and Lung Disease Research Institute

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

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 Arizona Health Science Center

location_facility: Stanford University, Pulmonary and Critical Care


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

location_facility: SoonChunHyang University Bucheon Hospital

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

location_facility: University of Michigan Health System - 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:
Taiwan
Hong Kong
Russian Federation
Netherlands
Czech Republic
Ukraine
Sweden
Korea, Republic of
France
South Africa
Germany
Slovakia

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:
Spain
Australia
Canada
United States
France
South Africa


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.

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.

lead_sponsor: AstraZeneca

location_country: Poland Romania Canada Hungary France Turkey Belgium Czechia


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.

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.

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

location_facility: Orszagos Idegsebeszeti Tudomanyos Intezet

location_facility: Pecs University of Science, Clinic of Neurology

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

location_facility: Universitaetslinkum Ulm Poliklinik fuer Neurologie

location_facility: District Antiepileptic Centre City Clinical Hospital # 71

location_facility: Specjalistyczna Przychodnia Lekarska Medikard

location_facility: Oddzial Neurologii -- Klinika Neurologii ICZMP

location_facility: Zentrum Epilepsie Erlangen (ZEE) der Universitaet Erlangen

location_facility: NZOZ Przychodnia Internistyczno - Stomatologiczna "Kendron"

location_facility: Instytut Psychiatrii i Neurologii II Oddzial Neurologii

location_facility: Orszagos Pszichiatriai es Neurologiai Intezet

location_facility: Odessa Regional Clinical Hospital Center for Neurology and Neurosurgery

location_facility: Wojewodzki Szpital Specjalistyczny im.Mikolaja Kopernika

location_facility: Hopital Civil de Steasbourg Clinique Neurologie

location_facility: Universitaet Giessen / Marburg Neurologie

location_facility: Pavlov State Medical University Clinic and Department of Neurology

location_facility: Hospital Universitario Lozano Blesa Neurology Service

location_facility: Prywatna Wielospecjalistyczna Lecznica Medyczna "Zycie"

location_facility: Psychosomatic Center of Dnepropetr. Regional Clinic

location_facility: Epilepsy Center of Municipal Clinical Psychoneurological Hospital

location_facility: University of Bonn -- Department for Epileptplogy

location_facility: General Hospital Middelheim -- Department of Neurology

location_facility: Universitaetsklinik Mainz Neurologische Klinik

location_facility: Universitaire Ziekenhuizen Gasthuisberg -- Department 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.

location_country:
United Kingdom
Italy
Canada
United States
France
Belgium
Germany

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

location_facility: Hospital Clinic i Provincial de Barcelona

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

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

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

location_facility: Wojskowy Szpital Kliniczny z Poliklinika Oddzial Gastroenterologii

location_facility: Szpital Kolejowy w Pruszkowie Oddzial Wewnetrzny

location_facility: Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza

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

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


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.

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.

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.

lead_sponsor: Pfizer


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.

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

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


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


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 .

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

location_facility: Azienda Ospedaliera Universita di Ferrara

location_facility: Boehringer Ingelheim Investigational Site


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.

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


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.

lead_sponsor: Janssen Pharmaceutica N.V., Belgium

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


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.

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


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.

lead_sponsor: GlaxoSmithKline

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


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.

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

location_facility: Orszagos Idegsebeszeti Tudomanyos Intezet

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

location_facility: District Antiepileptic Centre City Clinical Hospital # 71

location_facility: Specjalistyczna Przychodnia Lekarska Medikard

location_facility: Zentrum Epilepsie Erlangen (ZEE) der Universitaet Erlangen

location_facility: NZOZ Przychodnia Internistyczno - Stomatologiczna "Kendron"

location_facility: Instytut Psychiatrii i Neurologii II Oddzial Neurologii

location_facility: Katedra i Klinika Neurologii Slaskiej Akademii Medycznej

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

location_facility: Wojewodzki Szpital Specjalistyczny im.Mikolaja Kopernika

location_facility: Universitaet Giessen / Marburg Neurologie

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

location_facility: Prywatna Wielospecjalistyczna Lecznica Medyczna "Zycie"

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

location_facility: Walton Centre for Neurology & Neurosurgery

location_facility: Psychosomatic Center of Dnepropetr. Regional Clinic

location_facility: Epilepsy Center of Municipal Clinical Psychoneurological Hospital

location_facility: University of Bonn -- Department for Epileptplogy

location_facility: Interregional Clinical Diagnostic Centre


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.

lead_sponsor: Ipsen

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

location_facility: Hôpital Cochin - Service d'Endocrinologie

location_facility: Johns Hopkins University School of Medicine

location_facility: Hôpital Lariboisière - Service de Médecine B


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.

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

location_facility: Wake Forest University School of Medicine

location_facility: Hospital Saint Louis, Université Paris VII

location_facility: University Hospital Nijmegen - St. Radboud

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

location_facility: Eastern Canada Cutaneous Research Associates


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


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:
Russian Federation
Australia
Canada
Puerto Rico
United States
France
Germany

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


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.

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:
Spain
Italy
United Kingdom
Canada
United States
France
Belgium
Germany

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

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.

location_facility: Department of Cancer Studies & Molecular Medicine

location_facility: University of Wisconsin Hospital and Clinics

location_facility: Hospital Clinic I Provincial de Barcelona

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

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

location_facility: Maine Center for Cancer Medicine and Blood Disorders

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

location_facility: Universitair Ziekenhuis Gent/Dienst Gastroenterologie

location_facility: H Lee Moffitt Cancer Center & Research Institute


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.

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.

lead_sponsor: Abbott

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

location_facility:
Site Reference ID/Investigator# 1679
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Site Reference ID/Investigator# 2187
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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

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


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.

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

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.

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.

lead_sponsor: UCB Pharma

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

intervention_type: Other


title: An Extension Study of Iron Chelation Therapy With Deferasirox (ICL670)in β-thalassemia Patients With Transfusional Iron Overload

summary:
A 1-year randomized Phase III core trial (NCT00061750) using deferoxamine as the comparator was conducted to investigate the efficacy of deferasirox in regularly transfused patients with β-thalassemia 2 years of age and older. Patients who successfully completed this main trial may continue in this extension trial to receive chelation therapy with deferasirox for an additional 4 years.

The objective of this study is to assess the efficacy and long-term safety of deferasirox in regularly transfused patients with β-thalassemia 2 years of age and older.

ReferenceCitation: Cappellini MD, Bejaoui M, Agaoglu L, Canatan D, Capra M, Cohen A, Drelichman G, Economou M, Fattoum S, Kattamis A, Kilinc Y, Perrotta S, Piga A, Porter JB, Griffel L, Dong V, Clark J, Aydinok Y. Iron chelation with deferasirox in adult and pediatric patients with thalassemia major: efficacy and safety during 5 years' follow-up. Blood. 2011 Jul 28;118(4):884-93. doi: 10.1182/blood-2010-11-316646. Epub 2011 May 31. Erratum in: Blood. 2011 Nov 3;118(18):5060.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Brazil
United Kingdom
Greece
Italy
Argentina
Canada
Tunisia
United States
France
Turkey
Belgium
Germany

location_facility: Children's Hospital and Research Center at Oakland

location_facility: Children's Hospital Boston, Dept of Hematology