title: A Phase III, Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of 10 mg ZD4054 (Zibotentan) in Combination With Docetaxel in Comparison With Docetaxel in Patients With Metastatic Hormone-resistant Prostate Cancer

acronym: ENTHUSE M1C

summary:
Enthuse M1C is a large phase III clinical trial studying the safety and efficacy of ZD4054 (Zibotentan) in combination with docetaxel (Taxotere) in patients with metastatic hormone resistant prostate cancer (HRPC).

This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can further improve survival compared with docetaxel alone.

ZD4054 (Zibotentan) is a new type of agent, which is thought to slow tumour growth and spread by blocking Endothelin A receptor activity. This trial will look at the effects of ZD4054 (Zibotentan) in hormone resistant prostate cancer patients with bone metastases compared with docetaxel.

All patients participating in this clinical trial will receive docetaxel chemotherapy, which is a commonly used chemotherapy to treat prostate cancer in addition to other existing prostate cancer therapies.

Half the patients will receive ZD4054 (Zibotentan), and half the patients will receive placebo in addition to docetaxel and other prostate cancer therapy. By participating in this trial there is a 50% chance that patients will receive an agent that may further slow the progression of the tumour.

No patients will be deprived of standard prostate cancer therapy.

ReferenceCitation: Fizazi K, Higano CS, Nelson JB, Gleave M, Miller K, Morris T, Nathan FE, McIntosh S, Pemberton K, Moul JW. Phase III, randomized, placebo-controlled study of docetaxel in combination with zibotentan in patients with metastatic castration-resistant prostate cancer. J Clin Oncol. 2013 May 10;31(14):1740-7. doi: 10.1200/JCO.2012.46.4149. Epub 2013 Apr 8. Erratum In: J Clin Oncol. 2014 Oct 20;32(30):3461. Fizazi, Karim S [Corrected to Fizazi, Karim].

publisher_dissemination: American Society of Clinical Oncology (ASCO)

location_country:
Finland
Germany
Poland
Argentina
Australia
Brazil
Canada
Serbia
France
Czech Republic
Portugal
Hungary
Switzerland
United States
India
Romania
Peru
Italy
United Kingdom
Netherlands
Korea, Republic of
Spain
South Africa
Taiwan
Russian Federation
Sweden


intervention_type: Drug

lead_sponsor: Astellas Pharma Inc

summary: The purpose of this study is to determine whether alefacept is effective and well tolerated when used with a combination of tacrolimus, mycophenolate mofetil and steroids versus a combination therapy of placebo, tacrolimus and steroids in the prevention of kidney transplant rejection.

status: Completed

title: Efficacy and Safety of Alefacept in Combination With Tacrolimus, Mycophenolate Mofetil and Steroids in de Novo Kidney Transplantation - a Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study

primary_purpose: Prevention

type: EudraCT Number

source: euctr

enrollment_type: Actual

design_allocation: Randomized

study_completion_date_type: Actual

location_country:
Germany
Italy
Poland
Hungary
United Kingdom
Sweden
Netherlands
Austria
Belgium
Spain
Czech Republic
France

study_type: Interventional

lead_sponsor_type: industriel

status_simplified: Completed


study_start_date_type: Actual

lead_sponsor: Novartis Pharmaceuticals

summary:
The patients received either Pasireotide LAR or Octreotide LAR for one year of treatment.

The objective of this study was to compare the proportion of patients with a reduction of mean GH level to <2.5 µg/L and the normalization of IGF-1 to within normal limits (age and sex related) between the two treatment groups (pasireotide LAR and octreotide LAR) at 12 months.

Following one year of treatment patients could proceed into the study extension.

Patients who did not respond to the treatment they were randomized to (based on month 12 assessment results) were switched to the other treatment arm at month 13.

ReferenceType: derived

ReferenceCitation: Bronstein MD, Fleseriu M, Neggers S, Colao A, Sheppard M, Gu F, Shen CC, Gadelha M, Farrall AJ, Hermosillo Resendiz K, Ruffin M, Chen Y, Freda P; Pasireotide C2305 Study Group. Switching patients with acromegaly from octreotide to pasireotide improves biochemical control: crossover extension to a randomized, double-blind, Phase III study. BMC Endocr Disord. 2016 Apr 2;16:16. doi: 10.1186/s12902-016-0096-8.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: Erasmus University Rotterdam - EUR Research Repository

repository_institution: Erasmus University, Rotterdam - RePub

repository_institution: University of Edinburgh - Edinburgh Research Explorer

evidence: oa repository (via pmcid lookup)

license_normalized: no license

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

ReferenceCitation: Shanik MH, Cao PD, Ludlam WH. HISTORICAL RESPONSE RATES OF SOMATOSTATIN ANALOGUES IN THE TREATMENT OF ACROMEGALY: A SYSTEMATIC REVIEW. Endocr Pract. 2016 Mar;22(3):350-6. doi: 10.4158/EP15913.RA. Epub 2015 Oct 5.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

ReferenceCitation: Sheppard M, Bronstein MD, Freda P, Serri O, De Marinis L, Naves L, Rozhinskaya L, Hermosillo Resendiz K, Ruffin M, Chen Y, Colao A. Pasireotide LAR maintains inhibition of GH and IGF-1 in patients with acromegaly for up to 25 months: results from the blinded extension phase of a randomized, double-blind, multicenter, Phase III study. Pituitary. 2015 Jun;18(3):385-94. doi: 10.1007/s11102-014-0585-6. Erratum In: Pituitary. 2015 Jun;18(3):395-6.

oa_colors: green hybrid

evidence: open (via page says license)

repositories_concat: PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: Springer

location_facility: Swedish Medical Center Dept.ofSeattle Neuroscience(2)

location_facility: University of Texas Southwestern Medical Center Danziger Research Bldg.

location_facility: University of Texas/MD Anderson Cancer Center Regulatory -12

location_facility: University of Michigan Comprehensive Cancer Center Deptof Endocrinology&Diabetes

location_facility: Northport VA Medical Center CSOM230C2305

location_facility: Cedars Sinai Medical Center The Pituitary Center

location_facility: Columbia University Medical Center- New York Presbyterian Dept. of CU Collegeof Phys&Sur

location_facility: Stanford University Medical Center Stanford Cancer Center (3)

location_facility: University of California at Los Angeles Division of Endocrinology

location_facility: Oregon Health & Sciences University DeptofOregonHealth&Sciences(3)

location_facility: Johns Hopkins University School of Medicine Dept.ofJohnsHopkinsUniv.

title: A Multicenter, Randomized, Blinded Study to Assess Safety and Efficacy of Pasireotide LAR vs. Octreotide LAR in Patients With Active Acromegaly

primary_purpose: Treatment

location_country:
Germany
Poland
Argentina
Brazil
Turkey
Czechia
Canada
France
Colombia
Hungary
Denmark
Switzerland
United States
Belgium
China
Italy
Norway
United Kingdom
Sweden
Netherlands
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Israel


lead_sponsor: H. Lundbeck A/S

summary: The primary purpose of this study is to assess the efficacy in treating patients with Major Depressive Disorder of one or more doses of Lu AA24530 relative to placebo

ReferenceCitation: Belzeaux R, Gorgievski V, Fiori LM, Lopez JP, Grenier J, Lin R, Nagy C, Ibrahim EC, Gascon E, Courtet P, Richard-Devantoy S, Berlim M, Chachamovich E, Theroux JF, Dumas S, Giros B, Rotzinger S, Soares CN, Foster JA, Mechawar N, Tall GG, Tzavara ET, Kennedy SH, Turecki G. GPR56/ADGRG1 is associated with response to antidepressant treatment. Nat Commun. 2020 Apr 2;11(1):1635. doi: 10.1038/s41467-020-15423-5.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inserm

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

ReferenceCitation: Belzeaux R, Fiori LM, Lopez JP, Boucekine M, Boyer L, Blier P, Farzan F, Frey BN, Giacobbe P, Lam RW, Leri F, MacQueen GM, Milev R, Muller DJ, Parikh SV, Rotzinger S, Soares CN, Uher R, Foster JA, Kennedy SH, Turecki G. Predicting Worsening Suicidal Ideation With Clinical Features and Peripheral Expression of Messenger RNA and MicroRNA During Antidepressant Treatment. J Clin Psychiatry. 2019 May 7;80(3):18m12556. doi: 10.4088/JCP.18m12556.

oa_host_type: repository

repository_institution: McGill - eScholarship@McGill

version: submittedVersion

unpaywall_oa_status: green

publisher_dissemination: Physicians Postgraduate Press, Inc

title: Randomised, Double-blind, Parallel-group, Placebo-controlled, Active-referenced, Dose-finding Study of Lu AA24530 in Major Depressive Disorder

location_country:
Finland
France
Lithuania
Russian Federation
India
Norway
Australia
Sweden
Austria
Belgium
Korea, Republic of
Malaysia
Canada
Ukraine
Serbia
Philippines
Czech Republic


title: A Randomized, Double Blind, Placebo Controlled, Multicenter Study to Determine the Effect of QVA149 on Mean 24-hours Heart Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD)

summary: An investigational inhalation product (QVA149) for the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD) is being developed. This 14 day study will investigate the effect on heart rate and cardiovascular effects to ensure the product is safe.

lead_sponsor: Novartis

location_country: Germany Italy Australia Belgium Spain Turkey Canada France

location_facility:
Novartis investigator site
Novartis Investigator Site
Novartis Investigator site


type: Other Identifier

title: A Phase III, Randomized, Double-blind Trial of TMC278 25 mg q.d. Versus Efavirenz 600mg q.d. in Combination With a Fixed Background Regimen Consisting of Tenofovir Disoproxil Fumarate and Emtricitabine in Antiretroviral-naive HIV-1 Infected Subjects.

summary: The purpose of this trial is to compare the effectiveness, safety and tolerability of TMC278 given at a dose of 25 mg once daily versus efavirenz (EFV) at a dose of 600 mg once daily, when combined with a fixed background regimen consisting of emtricitabine (FTC) + tenofovir disoproxil fumarate (TDF), in HIV-1 infected patients who have not yet taken any anti-HIV drugs. The following evaluations will be done: antiviral activity, immunologic changes, and viral geno-/phenotype evolution, relationship of Pharmacokinetics (PK) and PK/Pharmacodynamics, medical resource utilization and treatment adherence.

ReferenceCitation: Rimsky L, Van Eygen V, Hoogstoel A, Stevens M, Boven K, Picchio G, Vingerhoets J. 96-Week resistance analyses of rilpivirine in treatment-naive, HIV-1-infected adults from the ECHO and THRIVE Phase III trials. Antivir Ther. 2013;18(8):967-77. doi: 10.3851/IMP2636. Epub 2013 May 28.

oa_host_type: publisher

evidence: open (via free pdf)

unpaywall_oa_status: bronze

publisher_dissemination: SAGE Publications

ReferenceCitation: Nelson M, Amaya G, Clumeck N, Arns da Cunha C, Jayaweera D, Junod P, Li T, Tebas P, Stevens M, Buelens A, Vanveggel S, Boven K; ECHO and THRIVE Study Groups. Efficacy and safety of rilpivirine in treatment-naive, HIV-1-infected patients with hepatitis B virus/hepatitis C virus coinfection enrolled in the Phase III randomized, double-blind ECHO and THRIVE trials. J Antimicrob Chemother. 2012 Aug;67(8):2020-8. doi: 10.1093/jac/dks130. Epub 2012 Apr 24.

ReferenceCitation: Molina JM, Cahn P, Grinsztejn B, Lazzarin A, Mills A, Saag M, Supparatpinyo K, Walmsley S, Crauwels H, Rimsky LT, Vanveggel S, Boven K; ECHO study group. Rilpivirine versus efavirenz with tenofovir and emtricitabine in treatment-naive adults infected with HIV-1 (ECHO): a phase 3 randomised double-blind active-controlled trial. Lancet. 2011 Jul 16;378(9787):238-46. doi: 10.1016/S0140-6736(11)60936-7.

lead_sponsor: Tibotec Pharmaceuticals, Ireland

location_country:
Argentina
Australia
Brazil
Thailand
Canada
France
Portugal
Denmark
United States
Romania
Puerto Rico
United Kingdom
Netherlands
Austria
Mexico
Spain
South Africa
Taiwan
Russian Federation
Sweden


acronym: ODIN

summary: The purpose of this study is to test if being treated with darunavir/ritonavir (DRV/rtv) 800/100 mg daily is as effective as being treated with DRV/rtv 600/100 mg twice daily, in early antiretroviral (ARV)-experienced patients when given along with selected optimized background regimen (OBR).

ReferenceCitation: Lathouwers E, De La Rosa G, Van de Casteele T, Baeten B, Tomaka F, De Meyer S, Picchio G. Virological analysis of once-daily and twice-daily darunavir/ritonavir in the ODIN trial of treatment-experienced patients. Antivir Ther. 2013;18(3):289-300. doi: 10.3851/IMP2569. Epub 2013 Apr 4.

title: A Randomized, Open-label Trial to Compare the Efficacy, Safety and Tolerability of DRV/Rtv (800mg/100mg) q.d Versus DRV/Rtv (600mg/100mg) b.i.d in Early Treatment-experienced HIV-1 Infected Subjects

location_country:
Germany
Argentina
Australia
Brazil
Thailand
Chile
France
Hungary
United States
Romania
Malaysia
Puerto Rico
Guatemala
United Kingdom
Austria
Spain
Panama
South Africa
Taiwan


title: A Randomized, Double-blinded Study to Evaluate the Safety and Effect on Sustained Virological Response of HCV Polymerase Inhibitor Pro-drug in Combination With PEGASYS Plus Copegus, Compared With the Currently Approved Combination of PEGASYS Plus Copegus, in Treatment-naïve Patients With Chronic he

summary: This 7 arm study will determine the optimal treatment combination, based on efficacy and safety. Patients with chronic hepatitis C (CHC), genotype 1, will be randomized to one of 7 treatment groups. Groups 1, 2, 4, 5 and 6 will receive triple combination treatment with HCV polymerase inhibitor pro-drug (at doses of 500, 1000 or 1500mg po bid) plus PEGASYS (90 or 180 micrograms sc weekly) plus Copegus (1000 or 1200mg po qd) for 24 weeks, followed by 24 weeks of open label Standard of Care (PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd). Group 3 will receive HCV polymerase inhibitor pro-drug 500mg po bid plus PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd for 24 weeks; after 24 weeks, those achieving a rapid virological response (RVR) will stop all medication, and non-RVR patients will remain on triple combination for an additional 24 weeks. Group 7 will receive standard of care (SOC) for 48 weeks. There will be a 24 week period of treatment-free follow-up for all treatment groups. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

ReferenceCitation: Nelson DR, Zeuzem S, Andreone P, Ferenci P, Herring R, Jensen DM, Marcellin P, Pockros PJ, Rodriguez-Torres M, Rossaro L, Rustgi VK, Sepe T, Sulkowski M, Thomason IR, Yoshida EM, Chan A, Hill G. Balapiravir plus peginterferon alfa-2a (40KD)/ribavirin in a randomized trial of hepatitis C genotype 1 patients. Ann Hepatol. 2012 Jan-Feb;11(1):15-31.

lead_sponsor: Hoffmann-La Roche

location_country:
Germany
Italy
Australia
Austria
United States
Spain
Canada
Puerto Rico
France


title: A Prospective, Randomized, Open-labelled, Multi-centre Trial Comparing the Safety and Efficacy of Ritonavir-boosted Aptivus (Tipranavir, TPV/r) to That of Prezista® (Darunavir, DRV/r) in Three-class (NRTI, NNRTI, and PI) Treatment-experienced Patients With Resistance to More Than One PI. POTENT: PrOspecTive EvaluatioN of Tipranavir vs. Darunavir in Treatment Experienced Patients

summary: The objective of this study is to compare the efficacy and safety of Tipranavir/ritonavir (TPV/r, 500mg/200mg twice daily) to the safety and efficacy of Darunavir/ritonavir (DRV/r 600 mg /100 mg twice daily) in combination with investigator selected optimised background regimens in patients who are three-class (Nucleoside reverse transcriptase inhibitors (NRTI), Nonnucleoside reverse transcriptase inhibitors (NNRTI), and Protease inhibitor (PI)) treatment-experienced (a minimum of 3-months duration for each class) with resistance to more than one PI on the screening virtual phenotype resistance testing.

status: Terminated

ReferenceCitation: Elgadi MM, Piliero PJ. Boosted tipranavir versus darunavir in treatment-experienced patients: observational data from the randomized POTENT trial. Drugs R D. 2011 Dec 1;11(4):295-302. doi: 10.2165/11596340-000000000-00000.

lead_sponsor: Boehringer Ingelheim

location_country:
Germany
Italy
Bahamas
Portugal
Belgium
United States
Spain
Thailand
Greece
Canada
Puerto Rico
France

location_facility: 1182.71.4903 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.6605 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3301A Boehringer Ingelheim Investigational Site

location_facility: 1182.71.6601 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.1003 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.1126 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.1006 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3306A Boehringer Ingelheim Investigational Site

location_facility: 1182.71.4907 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.6603 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3312A Boehringer Ingelheim Investigational Site

location_facility: 1182.71.1109 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3206 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3901 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3203 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3202 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3504 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.6604 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3907 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.1115 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3405 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3407 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.1116 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3205 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3305A Boehringer Ingelheim Investigational Site

location_facility: 1182.71.1108 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.1001 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3308A Boehringer Ingelheim Investigational Site

location_facility: 1182.71.1002 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.1124 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3001 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3402 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3002 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3503 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3303A Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3916 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3408 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.1129 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3919 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3502 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3908 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.1118 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3403 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.6606 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.1010 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.6602 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3310A Boehringer Ingelheim Investigational Site

location_facility: 1182.71.1101 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3003 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.1016 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.1104 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3912 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.4902 Boehringer Ingelheim Investigational Site

location_facility: 1182.71.3401 Boehringer Ingelheim Investigational Site

status_simplified: Unknown


title: A Phase II Multicenter, Open-Label Study of YM155 in Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Subjects

summary: A study in subjects with a type of B cell lymphoma (DLBCL)to evaluate the response rate, efficacy, safety and tolerability of YM155

design_allocation: Non-Randomized

location_country:
United States
Spain
Canada
France


title: A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Alpha Therapies

summary: This study will assess the safety and efficacy of rituximab combined with MTX in participants with active rheumatoid arthritis (RA) who have had an inadequate response to anti-Tumor Necrosis (TNF) alpha therapy. The anticipated time in the study is up to 2 years and the target sample size is 500 participants. Eligible participants may receive re-treatment with rituximab under a separate protocol WA17531.

ReferenceCitation: Lal P, Su Z, Holweg CT, Silverman GJ, Schwartzman S, Kelman A, Read S, Spaniolo G, Monroe JG, Behrens TW, Townsend MJ. Inflammation and autoantibody markers identify rheumatoid arthritis patients with enhanced clinical benefit following rituximab treatment. Arthritis Rheum. 2011 Dec;63(12):3681-91. doi: 10.1002/art.30596.

ReferenceCitation: Keystone E, Burmester GR, Furie R, Loveless JE, Emery P, Kremer J, Tak PP, Broder MS, Yu E, Cravets M, Magrini F, Jost F. Improvement in patient-reported outcomes in a rituximab trial in patients with severe rheumatoid arthritis refractory to anti-tumor necrosis factor therapy. Arthritis Rheum. 2008 Jun 15;59(6):785-93. doi: 10.1002/art.23715.

sponsor_collaborators:
Hoffmann-La Roche
Biogen

location_country:
Germany
Ireland
Italy
Israel
Norway
United Kingdom
Netherlands
Belgium
United States
Canada
France


title: Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy (Bronchodilation) and Safety of 4 Weeks of Treatment of Orally Inhaled BI 1744 CL (4 Doses) Delivered by the Respimat® Inhaler in Patients With Asthma

summary: The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL inhalation solution delivered by the Respimat® inhaler for four weeks in patients with asthma. The selection of the optimum dose(s) will be based on bronchodilator efficacy (how well it helps your breathing), safety evaluations and pharmacokinetic evaluations (the amount of the medication found in your blood).

ReferenceCitation: O'Byrne PM, D'Urzo T, Beck E, Flezar M, Gahlemann M, Hart L, Blahova Z, Toorawa R, Beeh KM. Dose-finding evaluation of once-daily treatment with olodaterol, a novel long-acting beta2-agonist, in patients with asthma: results of a parallel-group study and a crossover study. Respir Res. 2015 Aug 18;16(1):97. doi: 10.1186/s12931-015-0249-8.

repository_institution: University of Toronto - TSpace

repository_normalized: localhost

repositories:
PubMed Central
localhost

repositories_concat: PubMed Central;localhost

repositories_institution:
PubMed Central - Europe PMC
University of Toronto - TSpace

location_country:
United States
Canada
Germany
France

location_facility: 1222.6.038 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.007 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.009 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.3308A Boehringer Ingelheim Investigational Site

location_facility: 1222.6.016 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.3305A Boehringer Ingelheim Investigational Site

location_facility: 1222.6.034 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.002 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.012 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.3302A Boehringer Ingelheim Investigational Site

location_facility: 1222.6.069 Allergy Associates Medical Group

location_facility: 1222.6.3301A Boehringer Ingelheim Investigational Site

location_facility: 1222.6.064 Arthur F. Gelb Medical Corporation, Lakewood

location_facility: 1222.6.003 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.066 Allergy & Asthma Medical Group and Rsrch Ctr, APC

location_facility: 1222.6.015 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.073 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.062 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.3304A Boehringer Ingelheim Investigational Site

location_facility: 1222.6.013 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.068 National Jewish Medical Center

location_facility: 1222.6.006 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.067 Northeast Medical Research Associates, Inc

location_facility: 1222.6.008 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.005 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.031 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.072 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.032 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.036 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.3303A Boehringer Ingelheim Investigational Site

location_facility: 1222.6.017 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.004 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.037 Boehringer Ingelheim Investigational Site

location_facility: 1222.6.3306A Boehringer Ingelheim Investigational Site

location_facility: 1222.6.011 Boehringer Ingelheim Investigational Site


title: A Multicentre, Randomised, Double-Blind, Tacrolimus Dual Therapy-Controlled, Parallel Group, Multiple Oral Dose Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of FK778 in Liver Transplant Patients Receiving Standard Tacrolimus (FK506) and Steroids Therapy

summary: A proof of concept study to evaluate the safety and effectiveness of FK778 in liver transplant patients.

location_country:
Germany
Italy
Hungary
United Kingdom
Netherlands
Austria
Belgium
Switzerland
Spain
Canada
Czech Republic
France


title: A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis

acronym: CONFIRM

summary:
To determine if treatment with BG00012 can decrease the number of MS relapses during a certain time period. Other goals of the study are 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 MS to get worse.

Other objectives of the study are to determine the safety and tolerability of BG00012, as well as the effect it may have on tests and evaluations used to assess MS. Additionally, glatiramer acetate is being used to compare its benefits and risks with placebo and BG00012.

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.

license: cc-by-nc

license_normalized: cc-by-nc

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.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher_dissemination: 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: Fernandez O, 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.

evidence: open (via crossref license)

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.

publisher_dissemination: Informa

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: 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.

ReferenceCitation: Fox RJ, Miller DH, Phillips JT, Hutchinson M, Havrdova E, Kita M, Yang M, Raghupathi K, Novas M, Sweetser MT, Viglietta V, Dawson KT; CONFIRM Study Investigators. Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis. N Engl J Med. 2012 Sep 20;367(12):1087-97. doi: 10.1056/NEJMoa1206328. Erratum In: N Engl J Med. 2012 Oct 25;367(17):1673.

location_country: Macedonia, The Former Yugoslav Republic of


title: An Open-label, Randomized, Multi-center, Parallel Group Non-inferiority Study of Subcutaneous Injections of RO0503821 Given Once Monthly vs. Darbepoetin Alfa Given According to Local Label in Patients With Chronic Kidney Disease Who Are Not on Dialysis.

summary: This 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa in the treatment of anemia in patients with chronic kidney disease who are not on dialysis and who are receiving subcutaneous darbepoetin alfa maintenance therapy. Patients will be randomized either to remain on darbepoetin alfa therapy as per local label, or to switch to monthly subcutaneous Mircera, at a starting dose of 120, 200 or 360 micrograms, depending on the weekly dose of darbepoetin alfa administered prior to the first dose of Mircera. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

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


title: A Randomized, Phase 3 Study Of Sunitinib In Combination With Capecitabine Compared With Capecitabine In Patients With Previously Treated Breast Cancer

summary: The treatment received with sunitinib plus capecitabine could delay tumor growth longer than with treatment with capecitabine alone.

ReferenceCitation: Crown JP, Dieras V, Staroslawska E, Yardley DA, Bachelot T, Davidson N, Wildiers H, Fasching PA, Capitain O, Ramos M, Greil R, Cognetti F, Fountzilas G, Blasinska-Morawiec M, Liedtke C, Kreienberg R, Miller WH Jr, Tassell V, Huang X, Paolini J, Kern KA, Romieu G. Phase III trial of sunitinib in combination with capecitabine versus capecitabine monotherapy for the treatment of patients with pretreated metastatic breast cancer. J Clin Oncol. 2013 Aug 10;31(23):2870-8. doi: 10.1200/JCO.2012.43.3391. Epub 2013 Jul 15.

lead_sponsor: Pfizer

location_country:
France
Germany
Ireland
Italy
Poland
Norway
United Kingdom
Denmark
Romania
Netherlands
Austria
Belgium
United States
Spain
Greece
Canada
Russian Federation
Czech Republic


title: A Phase III Randomized, Double-Blind Study Of Sunitinib (SU011248, SUTENT) Versus Placebo In Patients With Progressive Advanced/Metastatic Well-Differentiated Pancreatic Islet Cell Tumors

summary:
This study randomized patients with advanced pancreatic islet cell tumors to receive either sunitinib or placebo. Patients who were randomized to sunitinib received 37.5 mg of sunitinib daily, those randomized to placebo received a tablet that looked similar but had no active drug. Neither the patient or the doctor knew whether the patient was receiving sunitinib or placebo. Patients were followed to determine the status and size of their tumors, survival, quality of life and safety of the drug.

The study was designed to detect a 50% improvement in median PFS[Progression Free Survival] with 90% power and was to enroll 340 subjects. An interim analysis was planned when 130 events had occurred, and the final analysis was to be conducted when 260 events had occurred.

Study A6181111 was stopped early during the enrollment period because of a clear and clinically meaningful improvement in efficacy for the sunitinib treatment arm as recommended by the DMC [Data Monitoring Committee]. The actual number of subjects enrolled was 171 and the actual number of PFS events recorded was 81 PFS events. The decision to terminate the study was not based on safety concerns related to sunitinib administration.

ReferenceCitation: Fazio N, Kulke M, Rosbrook B, Fernandez K, Raymond E. Updated Efficacy and Safety Outcomes for Patients with Well-Differentiated Pancreatic Neuroendocrine Tumors Treated with Sunitinib. Target Oncol. 2021 Jan;16(1):27-35. doi: 10.1007/s11523-020-00784-0. Epub 2021 Jan 7.

ReferenceCitation: Lamarca A, Barriuso J, Kulke M, Borbath I, Lenz HJ, Raoul JL, Meropol NJ, Lombard-Bohas C, Posey J, Faivre S, Raymond E, Valle JW. Determination of an optimal response cut-off able to predict progression-free survival in patients with well-differentiated advanced pancreatic neuroendocrine tumours treated with sunitinib: an alternative to the current RECIST-defined response. Br J Cancer. 2018 Jan;118(2):181-188. doi: 10.1038/bjc.2017.402. Epub 2017 Nov 21.

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

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

repository_institution: Oxford - Oxford Academix

repositories_concat: PubMed Central;jdc.jefferson.edu

repositories_institution:
Oxford - Oxford Academix
PubMed Central - Europe PMC

ReferenceCitation: Vinik A, Bottomley A, Korytowsky B, Bang YJ, Raoul JL, Valle JW, Metrakos P, Horsch D, Mundayat R, Reisman A, Wang Z, Chao RC, Raymond E. Patient-Reported Outcomes and Quality of Life with Sunitinib Versus Placebo for Pancreatic Neuroendocrine Tumors: Results From an International Phase III Trial. Target Oncol. 2016 Dec;11(6):815-824. doi: 10.1007/s11523-016-0462-5.

ReferenceCitation: Faivre S, Niccoli P, Castellano D, Valle JW, Hammel P, Raoul JL, Vinik A, Van Cutsem E, Bang YJ, Lee SH, Borbath I, Lombard-Bohas C, Metrakos P, Smith D, Chen JS, Ruszniewski P, Seitz JF, Patyna S, Lu DR, Ishak KJ, Raymond E. Sunitinib in pancreatic neuroendocrine tumors: updated progression-free survival and final overall survival from a phase III randomized study. Ann Oncol. 2017 Feb 1;28(2):339-343. doi: 10.1093/annonc/mdw561.

license: publisher-specific-oa

license_normalized: publisher-specific

ReferenceCitation: Raymond E, Dahan L, Raoul JL, Bang YJ, Borbath I, Lombard-Bohas C, Valle J, Metrakos P, Smith D, Vinik A, Chen JS, Horsch D, Hammel P, Wiedenmann B, Van Cutsem E, Patyna S, Lu DR, Blanckmeister C, Chao R, Ruszniewski P. Sunitinib malate for the treatment of pancreatic neuroendocrine tumors. N Engl J Med. 2011 Feb 10;364(6):501-13. doi: 10.1056/NEJMoa1003825. Erratum In: N Engl J Med. 2011 Mar 17;364(11):1082.

location_country:
Germany
Italy
United Kingdom
Australia
Belgium
United States
Korea, Republic of
Spain
Taiwan
Canada
France


title: The Official Title is A Multi-center, Randomized, Parallel-group, Double-blind, Placebo Controlled Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma.

summary: To compare the efficacy of oral CC-5013 in combination with oral pulse high-dose dexamethasone to that of placebo and oral high-dose pulse dexamethasone as treatment for subjects with relapsed or refractory multiple myeloma."

ReferenceType: result

ReferenceCitation: Dimopoulos M, Spencer A, Attal M, Prince HM, Harousseau JL, Dmoszynska A, San Miguel J, Hellmann A, Facon T, Foa R, Corso A, Masliak Z, Olesnyckyj M, Yu Z, Patin J, Zeldis JB, Knight RD; Multiple Myeloma (010) Study Investigators. Lenalidomide plus dexamethasone for relapsed or refractory multiple myeloma. N Engl J Med. 2007 Nov 22;357(21):2123-32. doi: 10.1056/NEJMoa070594. Erratum In: N Engl J Med. 2009 Jul 30;361(5):544.

ReferenceCitation: San-Miguel JF, Dimopoulos MA, Stadtmauer EA, Rajkumar SV, Siegel D, Bravo ML, Olesnyckyj M, Knight RD, Zeldis JB, Harousseau JL, Weber DM. Effects of lenalidomide and dexamethasone treatment duration on survival in patients with relapsed or refractory multiple myeloma treated with lenalidomide and dexamethasone. Clin Lymphoma Myeloma Leuk. 2011 Feb;11(1):38-43. doi: 10.3816/CLML.2010.n.120.

ReferenceCitation: Zangari M, Tricot G, Polavaram L, Zhan F, Finlayson A, Knight R, Fu T, Weber D, Dimopoulos MA, Niesvizky R, Fink L. Survival effect of venous thromboembolism in patients with multiple myeloma treated with lenalidomide and high-dose dexamethasone. J Clin Oncol. 2010 Jan 1;28(1):132-5. doi: 10.1200/JCO.2009.23.0169. Epub 2009 Nov 9.

ReferenceCitation: Wang M, Dimopoulos MA, Chen C, Cibeira MT, Attal M, Spencer A, Rajkumar SV, Yu Z, Olesnyckyj M, Zeldis JB, Knight RD, Weber DM. Lenalidomide plus dexamethasone is more effective than dexamethasone alone in patients with relapsed or refractory multiple myeloma regardless of prior thalidomide exposure. Blood. 2008 Dec 1;112(12):4445-51. doi: 10.1182/blood-2008-02-141614. Epub 2008 Sep 17.

lead_sponsor: Celgene

location_country:
Germany
Ireland
Italy
Poland
Israel
United Kingdom
Australia
Sweden
Switzerland
Austria
Belgium
Spain
Greece
Ukraine
France

location_facility: University Hospital GalwayHaematology Department

location_facility: Peter MacCallum Cancer Centre Divsion of Haematology/Medical Oncology

location_facility: University Hospital of Salzburg St Johanns Spital

location_facility: Universitatsklinik ChariteMedizinische Fakultaet der HumboldtUniversitaet zu Berlin

location_facility: Tel Aviv Sourasky Medical Center Department of Hematology

location_facility: Universitaetsklinikum Heidelberg Medizinische Klinik und Poliklinik V

location_facility: Institute of Hematology and Transfusiology of the UAMS Department of blood diseases

location_facility: Sahlgrenska University Hospital Department of Hematology and Coagulation

location_facility: Kiev Bone Marrow Transplantation Center Bone Marrow Department

location_facility: Haematology Dept, 4th Floor Thomas Guy House

location_facility: Belfast City HospitalHaematology Department

location_facility: Azienda Sanitaria Ospedaliera Molinette S. Giovanni Battista

location_facility: Institute of Haematology and Blood Transfusion

location_facility: Policlinico Universitario a Gesttione diretta di Udine

location_facility: Centre Hospitalier Universitaire Vaudois (CHUV)

location_facility: Hospital Universtario Marques de Valdecilla

location_facility: Dnepropetrovsk City Clinical Hospital #4

location_facility: Universitatsklinik Muenster Medizinische Klinik A

location_facility: Institute of Blood Pathology and Transfusion Medicine of the UAMS Hematology Department

location_facility: Hope Directorate Haematology Oncology Service St. James Hospital

location_facility: Universitaetsklinikum Dusseldorf Klinik fuer Haematologie

location_facility: Institute of Internal Diseases University of Medicine


title: A Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.

summary: The objective of this trial is to evaluate the safety and efficacy of Xyrem® compared to placebo for the treatment of fibromyalgia in a randomized, double blind, placebo controlled, parallel group trial.

ReferenceCitation: Bennett RM, Benson B, Choy EH, Hackshaw KV, Alvarez-Horine S, Wang, YG, Spaeth M. Effects of Sodium Oxybate on Pain, Function, and PGIC in Fibromyalgia: Results From an International, 14-Week, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial. [AAPM abstract 186]. Pain Med. 2010;11(2):317.

ReferenceCitation: Swick TJ, Spaeth M, Choy EH, Alvarez-Horine S, Wang YG, Benson B, Bennett R. Sodium Oxybate Reduces Pain and Improves Function and PGIC in Fibromyalgia: Results From an International, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial [AAN abstract P03.293]. Neurology. 2010;74(suppl 2):A280.

ReferenceCitation: Bennett RM, Rosenthal N, Lai C, Benson B, Wang YG, Alegre C, Perrot S.. Functionality and Quality of Life Are Improved in Fibromyalgia Patients Treated With Sodium Oxybate: Results From a Phase 3 International Trial. In: American Psychiatric Association New Research Abstracts to the 2010 Annual Meeting; May 22-26, 2010; New Orleans, LA. Abstract NR7-49.

ReferenceCitation: Swick TJ, Curtis C, Benson B, Lai C, Wang YG, Rothman J, Sarzi-Puttini P. Fibromyalgia Patients Have Impaired Sleep and Daytime Functioning at Baseline: Data From an International Phase 3 Trial of Sodium Oxybate [APSS abstract 0882]. Sleep. 2010;33(suppl):A295.

ReferenceCitation: Swick TJ, Lai C, Benson B, Wang YG, Sarzi-Puttini P. Fibromyalgia Pain, Fatigue, and Sleep Improve With Sodium Oxybate Treatment: A 14-Week Randomized, Double-Blind, Placebo-Controlled International Trial [APSS abstract 0883]. Sleep. 2010;33(suppl):A295.

ReferenceCitation: Choy E, Alegre C, Sarzi-Puttini P, van Seventer R, Wang YG, Guinta D, Lai C, Bennett R and the Oxybate in Fibromyalgia 06-009 Study Group. The Effects of Sodium Oxybate on Sleep Disturbance, Fatigue, and Functioning in Fibromyalgia: Results From a Phase 3, Randomized, Double-Blind, Placebo-Controlled International Trial [FRI10411]. Ann Rheum Dis. 2010;69(suppl 3):449.

ReferenceCitation: Spaeth M, Perrot S, Samborski W, Bazzichi L, van de Laar M, Guinta D, Wang YG, Lai C, Bennett R and Sodium Oxybate in Fibromyalgia 06-009 Study Group. Sodium Oxybate Treatment Improves Pain, Function, and Patient Global Impression of Change (PGIC) in Fibromyalgia Patients: Results From an International, Randomized, Double-Blind, Placebo-Controlled Trial. Ann Rheum Dis. 2010;69(suppl 3):449

lead_sponsor: Jazz Pharmaceuticals

location_country:
Germany
Italy
Poland
United Kingdom
Netherlands
United States
Spain
France

location_facility: Hopital Claude Huriez Service de medecine Interne

location_facility: Investigative Clinical Research of Indiana, LLC

location_facility: Oregon Health Sciences University School of Medicine

location_facility: Florida Medical Clinic, P.A., Clinical Research Division

location_facility: Medycznej w Poznaniu SPZOZ Samodzielny Publiczny Szpital Kliniczny

location_facility: Rheumazentrum am Krankenhaus Bad Doberan

location_facility: Fibromyalgia Treatment Centers of America

location_facility: Royal National Hospital for Rheumatic Diseases NHS

location_facility: Gemeinschaftspraxis fur Anasthesie und spezielle Schmerztherapie

location_facility: Arthritis & Osteoporosis Center of South Texas

location_facility: Center for Musculoskeletal Pain Research

location_facility: Professional Clinical Research at Crystal Lake Health Center

location_facility: Central Kentucky Research Associates,Inc.

location_facility: Centre Catherine de Sienne unite d evaluation et de traitment de la douleur CHU Nord

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Katedra i Klinka Chorob Wewnetrznych i Reumatologii Ortopedyczno-rehabilitacyjny Szpital Kliniczny

location_facility: Ohio State U, Immunology/Rheumatology William Davis Medical Research Center

location_facility: Hospital Universitario de Gran Canaria Dr. Negrin

location_facility: Mediscch Sprectrum Twente T a.v. Anita mooij-van Dis

location_facility: Dept of Internal Medicine/Rheumatology The Brody Sch of Medicine at ECU

location_facility: Azienda Ospedaliera Universitaria Pisana-Ospedale Santa Chiara

location_facility: North Shore University Hospital, North Shore Pain Services

location_facility: Cleveland Neuro-Sleep Research Institute Inc.

location_facility: Clinical Research Group of St. Petersburg, Inc.

location_facility: Arthritis and Osteoporosis Clinic, Research Center of Central Texas

location_facility: Professional Clinical Research at Cyrstal Lake Health Center

location_facility: Hopital Hotel Dieu service de medecine interne

location_facility: University of Texas Health Science Center

location_facility: Barnsley District General Hospital, Rheumatology Department

location_facility: Praxis fur Innere Medizin und Rheumatologie

location_facility: North Orange County Research Institute, Inc.


title: A Phase 3, Active (Warfarin) Controlled, Randomized, Double-Blind, Parallel Arm Study to Evaluate Efficacy and Safety of Apixaban in Preventing Stroke and Systemic Embolism in Subjects With Nonvalvular Atrial Fibrillation

acronym: ARISTOTLE

summary: The trial seeks to determine if apixaban, an investigational anticoagulant (blood-thinner) is as effective as standard therapy (warfarin) in preventing stroke and systemic embolism in subjects with atrial fibrillation and risk factors for stroke.

ReferenceCitation: Jamieson MJ, Byon W, Dettloff RW, Crawford M, Gargalovic PS, Merali SJ, Onorato J, Quintero AJ, Russ C. Apixaban Use in Obese Patients: A Review of the Pharmacokinetic, Interventional, and Observational Study Data. Am J Cardiovasc Drugs. 2022 Nov;22(6):615-631. doi: 10.1007/s40256-022-00524-x. Epub 2022 May 16.

ReferenceCitation: Pol T, Hijazi Z, Lindback J, Oldgren J, Alexander JH, Connolly SJ, Eikelboom JW, Ezekowitz MD, Granger CB, Lopes RD, Yusuf S, Siegbahn A, Wallentin L. Using multimarker screening to identify biomarkers associated with cardiovascular death in patients with atrial fibrillation. Cardiovasc Res. 2022 Jul 20;118(9):2112-2123. doi: 10.1093/cvr/cvab262.

repository_institution: Uppsala University - Uppsala University Publications

repositories_concat: DiVA.org;PubMed Central

repositories_institution: Uppsala University - Uppsala University Publications

publisher_dissemination: Oxford University Press

ReferenceCitation: Pol T, Hijazi Z, Lindback J, Alexander JH, Bahit MC, De Caterina R, Eikelboom JW, Ezekowitz MD, Gersh BJ, Granger CB, Hylek EM, Lopes R, Siegbahn A, Wallentin L. Evaluation of the prognostic value of GDF-15, ABC-AF-bleeding score and ABC-AF-death score in patients with atrial fibrillation across different geographical areas. Open Heart. 2021 Mar;8(1):e001471. doi: 10.1136/openhrt-2020-001471.

repository_institution: KTH Royal Institute of Technology - KTH Publication Database DiVA

repositories_institution: KTH Royal Institute of Technology - KTH Publication Database DiVA

publisher_dissemination: British Medical Journal

ReferenceCitation: Hijazi Z, Wallentin L, Lindback J, Alexander JH, Connolly SJ, Eikelboom JW, Ezekowitz MD, Granger CB, Lopes RD, Pol T, Yusuf S, Oldgren J, Siegbahn A. Screening of Multiple Biomarkers Associated With Ischemic Stroke in Atrial Fibrillation. J Am Heart Assoc. 2020 Dec 15;9(24):e018984. doi: 10.1161/JAHA.120.018984. Epub 2020 Dec 9.

ReferenceCitation: Wallentin L, Lindback J, Eriksson N, Hijazi Z, Eikelboom JW, Ezekowitz MD, Granger CB, Lopes RD, Yusuf S, Oldgren J, Siegbahn A. Angiotensin-converting enzyme 2 (ACE2) levels in relation to risk factors for COVID-19 in two large cohorts of patients with atrial fibrillation. Eur Heart J. 2020 Nov 1;41(41):4037-4046. doi: 10.1093/eurheartj/ehaa697.

oa_colors: green other

evidence: open (via free article)

ReferenceCitation: Hijazi Z, Granger CB, Hohnloser SH, Westerbergh J, Lindback J, Alexander JH, Keltai M, Parkhomenko A, Lopez-Sendon JL, Lopes RD, Siegbahn A, Wallentin L. Association of Different Estimates of Renal Function With Cardiovascular Mortality and Bleeding in Atrial Fibrillation. J Am Heart Assoc. 2020 Sep 15;9(18):e017155. doi: 10.1161/JAHA.120.017155. Epub 2020 Aug 31.

ReferenceCitation: Zeitouni M, Giczewska A, Alexander JH. Reply: Specifics of Dose Modification in ARISTOTLE. J Am Coll Cardiol. 2020 Jul 7;76(1):128-129. doi: 10.1016/j.jacc.2020.05.013. No abstract available.

ReferenceCitation: Rosjo H, Hijazi Z, Omland T, Westerbergh J, Lyngbakken MN, Alexander JH, Gersh BJ, Granger CB, Hylek EM, Lopes RD, Siegbahn A, Wallentin L. Cardiac troponin is associated with cardiac outcomes in men and women with atrial fibrillation, insights from the ARISTOTLE trial. J Intern Med. 2020 Aug;288(2):248-259. doi: 10.1111/joim.13072. Epub 2020 May 18.

repository_institution: University of Oslo - Duo Research Archive

repositories_institution: University of Oslo - Duo Research Archive

ReferenceCitation: Zeitouni M, Giczewska A, Lopes RD, Wojdyla DM, Christersson C, Siegbahn A, De Caterina R, Steg PG, Granger CB, Wallentin L, Alexander JH; ARISTOTLE Investigators. Clinical and Pharmacological Effects of Apixaban Dose Adjustment in the ARISTOTLE Trial. J Am Coll Cardiol. 2020 Mar 17;75(10):1145-1155. doi: 10.1016/j.jacc.2019.12.060.

ReferenceCitation: Stanifer JW, Pokorney SD, Chertow GM, Hohnloser SH, Wojdyla DM, Garonzik S, Byon W, Hijazi Z, Lopes RD, Alexander JH, Wallentin L, Granger CB. Apixaban Versus Warfarin in Patients With Atrial Fibrillation and Advanced Chronic Kidney Disease. Circulation. 2020 Apr 28;141(17):1384-1392. doi: 10.1161/CIRCULATIONAHA.119.044059. Epub 2020 Mar 12.

ReferenceCitation: Garcia DA, Fisher DA, Mulder H, Wruck L, De Caterina R, Halvorsen S, Granger CB, Held C, Wallentin L, Alexander JH, Lopes RD. Gastrointestinal bleeding in patients with atrial fibrillation treated with Apixaban or warfarin: Insights from the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) trial. Am Heart J. 2020 Mar;221:1-8. doi: 10.1016/j.ahj.2019.10.013. Epub 2019 Oct 31.

ReferenceCitation: Dalgaard F, Mulder H, Wojdyla DM, Lopes RD, Held C, Alexander JH, De Caterina R, Washam JB, Hylek EM, Garcia DA, Gersh BJ, Wallentin L, Granger CB, Al-Khatib SM. Patients With Atrial Fibrillation Taking Nonsteroidal Anti-Inflammatory Drugs and Oral Anticoagulants in the ARISTOTLE Trial. Circulation. 2020 Jan 7;141(1):10-20. doi: 10.1161/CIRCULATIONAHA.119.041296. Epub 2019 Nov 21.

ReferenceCitation: Goldstein SA, Green J, Huber K, Wojdyla DM, Lopes RD, Alexander JH, Vinereanu D, Wallentin L, Granger CB, Al-Khatib SM. Characteristics and Outcomes of Atrial Fibrillation in Patients With Thyroid Disease (from the ARISTOTLE Trial). Am J Cardiol. 2019 Nov 1;124(9):1406-1412. doi: 10.1016/j.amjcard.2019.07.046. Epub 2019 Aug 7.

ReferenceCitation: Guimaraes PO, Pokorney SD, Lopes RD, Wojdyla DM, Gersh BJ, Giczewska A, Carnicelli A, Lewis BS, Hanna M, Wallentin L, Vinereanu D, Alexander JH, Granger CB. Efficacy and safety of apixaban vs warfarin in patients with atrial fibrillation and prior bioprosthetic valve replacement or valve repair: Insights from the ARISTOTLE trial. Clin Cardiol. 2019 May;42(5):568-571. doi: 10.1002/clc.23178. Epub 2019 Apr 9.

ReferenceCitation: Washam JB, Hohnloser SH, Lopes RD, Wojdyla DM, Vinereanu D, Alexander JH, Gersh BJ, Hanna M, Horowitz J, Hylek EM, Xavier D, Verheugt FWA, Wallentin L, Granger CB; ARISTOTLE Committees and Investigators. Interacting medication use and the treatment effects of apixaban versus warfarin: results from the ARISTOTLE Trial. J Thromb Thrombolysis. 2019 Apr;47(3):345-352. doi: 10.1007/s11239-019-01823-y.

ReferenceCitation: Hohnloser SH, Fudim M, Alexander JH, Wojdyla DM, Ezekowitz JA, Hanna M, Atar D, Hijazi Z, Bahit MC, Al-Khatib SM, Lopez-Sendon JL, Wallentin L, Granger CB, Lopes RD. Efficacy and Safety of Apixaban Versus Warfarin in Patients With Atrial Fibrillation and Extremes in Body Weight. Circulation. 2019 May 14;139(20):2292-2300. doi: 10.1161/CIRCULATIONAHA.118.037955.

ReferenceCitation: Alexander KP, Brouwer MA, Mulder H, Vinereanu D, Lopes RD, Proietti M, Al-Khatib SM, Hijazi Z, Halvorsen S, Hylek EM, Verheugt FWA, Alexander JH, Wallentin L, Granger CB; ARISTOTLE Investigators. Outcomes of apixaban versus warfarin in patients with atrial fibrillation and multi-morbidity: Insights from the ARISTOTLE trial. Am Heart J. 2019 Feb;208:123-131. doi: 10.1016/j.ahj.2018.09.017. Epub 2018 Nov 22.

ReferenceCitation: Sandhu RK, Ezekowitz JA, Hijazi Z, Westerbergh J, Aulin J, Alexander JH, Granger CB, Halvorsen S, Hanna MS, Lopes RD, Siegbahn A, Wallentin L. Obesity paradox on outcome in atrial fibrillation maintained even considering the prognostic influence of biomarkers: insights from the ARISTOTLE trial. Open Heart. 2018 Nov 1;5(2):e000908. doi: 10.1136/openhrt-2018-000908. eCollection 2018.

ReferenceCitation: Christersson C, Wallentin L, Andersson U, Alexander JH, Alings M, De Caterina R, Gersh BJ, Granger CB, Halvorsen S, Hanna M, Huber K, Hylek EM, Lopes RD, Oh BH, Siegbahn A. Effect of apixaban compared with warfarin on coagulation markers in atrial fibrillation. Heart. 2019 Feb;105(3):235-242. doi: 10.1136/heartjnl-2018-313351. Epub 2018 Sep 12.

ReferenceCitation: Horowitz JD, De Caterina R, Heresztyn T, Alexander JH, Andersson U, Lopes RD, Steg PG, Hylek EM, Mohan P, Hanna M, Jansky P, Granger CB, Wallentin L; ARISTOTLE Investigators. Asymmetric and Symmetric Dimethylarginine Predict Outcomes in Patients With Atrial Fibrillation: An ARISTOTLE Substudy. J Am Coll Cardiol. 2018 Aug 14;72(7):721-733. doi: 10.1016/j.jacc.2018.05.058.

ReferenceCitation: Sharma A, Hijazi Z, Andersson U, Al-Khatib SM, Lopes RD, Alexander JH, Held C, Hylek EM, Leonardi S, Hanna M, Ezekowitz JA, Siegbahn A, Granger CB, Wallentin L. Use of Biomarkers to Predict Specific Causes of Death in Patients With Atrial Fibrillation. Circulation. 2018 Oct 16;138(16):1666-1676. doi: 10.1161/CIRCULATIONAHA.118.034125.

ReferenceCitation: Kopin D, Jones WS, Sherwood MW, Wojdyla DM, Wallentin L, Lewis BS, Verheugt FWA, Vinereanu D, Bahit MC, Halvorsen S, Huber K, Parkhomenko A, Granger CB, Lopes RD, Alexander JH. Percutaneous coronary intervention and antiplatelet therapy in patients with atrial fibrillation receiving apixaban or warfarin: Insights from the ARISTOTLE trial. Am Heart J. 2018 Mar;197:133-141. doi: 10.1016/j.ahj.2017.11.005. Epub 2017 Nov 10.

ReferenceCitation: Pol T, Held C, Westerbergh J, Lindback J, Alexander JH, Alings M, Erol C, Goto S, Halvorsen S, Huber K, Hanna M, Lopes RD, Ruzyllo W, Granger CB, Hijazi Z. Dyslipidemia and Risk of Cardiovascular Events in Patients With Atrial Fibrillation Treated With Oral Anticoagulation Therapy: Insights From the ARISTOTLE (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation) Trial. J Am Heart Assoc. 2018 Feb 1;7(3):e007444. doi: 10.1161/JAHA.117.007444.

ReferenceCitation: Goto S, Merrill P, Wallentin L, Wojdyla DM, Hanna M, Avezum A, Easton JD, Harjola VP, Huber K, Lewis BS, Parkhomenko A, Zhu J, Granger CB, Lopes RD, Alexander JH. Antithrombotic therapy use and clinical outcomes following thrombo-embolic events in patients with atrial fibrillation: insights from ARISTOTLE. Eur Heart J Cardiovasc Pharmacother. 2018 Apr 1;4(2):75-81. doi: 10.1093/ehjcvp/pvy002.

ReferenceCitation: Vinereanu D, Wang A, Mulder H, Lopes RD, Jansky P, Lewis BS, Gersh BJ, Avezum A, Hanna M, Held C, Wallentin L, Granger CB, Alexander JH. Outcomes in anticoagulated patients with atrial fibrillation and with mitral or aortic valve disease. Heart. 2018 Aug;104(15):1292-1299. doi: 10.1136/heartjnl-2017-312272. Epub 2018 Jan 19.

ReferenceCitation: Rao MP, Vinereanu D, Wojdyla DM, Alexander JH, Atar D, Hylek EM, Hanna M, Wallentin L, Lopes RD, Gersh BJ, Granger CB; Apixaban for Reduction in Stroke Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) Investigators. Clinical Outcomes and History of Fall in Patients with Atrial Fibrillation Treated with Oral Anticoagulation: Insights From the ARISTOTLE Trial. Am J Med. 2018 Mar;131(3):269-275.e2. doi: 10.1016/j.amjmed.2017.10.036. Epub 2017 Nov 6.

ReferenceCitation: Vinereanu D, Lopes RD, Mulder H, Gersh BJ, Hanna M, de Barros E Silva PGM, Atar D, Wallentin L, Granger CB, Alexander JH; ARISTOTLE Investigators. Echocardiographic Risk Factors for Stroke and Outcomes in Patients With Atrial Fibrillation Anticoagulated With Apixaban or Warfarin. Stroke. 2017 Dec;48(12):3266-3273. doi: 10.1161/STROKEAHA.117.017574. Epub 2017 Oct 31.

ReferenceCitation: Hijazi Z, Oldgren J, Lindback J, Alexander JH, Connolly SJ, Eikelboom JW, Ezekowitz MD, Held C, Hylek EM, Lopes RD, Yusuf S, Granger CB, Siegbahn A, Wallentin L; ARISTOTLE and RE-LY Investigators. A biomarker-based risk score to predict death in patients with atrial fibrillation: the ABC (age, biomarkers, clinical history) death risk score. Eur Heart J. 2018 Feb 7;39(6):477-485. doi: 10.1093/eurheartj/ehx584.

ReferenceCitation: Hijazi Z, Lindahl B, Oldgren J, Andersson U, Lindback J, Granger CB, Alexander JH, Gersh BJ, Hanna M, Harjola VP, Hylek EM, Lopes RD, Siegbahn A, Wallentin L. Repeated Measurements of Cardiac Biomarkers in Atrial Fibrillation and Validation of the ABC Stroke Score Over Time. J Am Heart Assoc. 2017 Jun 23;6(6):e004851. doi: 10.1161/JAHA.116.004851.

ReferenceCitation: Lopes RD, Guimaraes PO, Kolls BJ, Wojdyla DM, Bushnell CD, Hanna M, Easton JD, Thomas L, Wallentin L, Al-Khatib SM, Held C, Gabriel Melo de Barros E Silva P, Alexander JH, Granger CB, Diener HC. Intracranial hemorrhage in patients with atrial fibrillation receiving anticoagulation therapy. Blood. 2017 Jun 1;129(22):2980-2987. doi: 10.1182/blood-2016-08-731638. Epub 2017 Mar 29.

ReferenceCitation: Cowper PA, Sheng S, Lopes RD, Anstrom KJ, Stafford JA, Davidson-Ray L, Al-Khatib SM, Ansell J, Dorian P, Husted S, McMurray JJV, Steg PG, Alexander JH, Wallentin L, Granger CB, Mark DB. Economic Analysis of Apixaban Therapy for Patients With Atrial Fibrillation From a US Perspective: Results From the ARISTOTLE Randomized Clinical Trial. JAMA Cardiol. 2017 May 1;2(5):525-534. doi: 10.1001/jamacardio.2017.0065.

ReferenceCitation: Hu PT, Lopes RD, Stevens SR, Wallentin L, Thomas L, Alexander JH, Hanna M, Lewis BS, Verheugt FW, Granger CB, Jones WS. Efficacy and Safety of Apixaban Compared With Warfarin in Patients With Atrial Fibrillation and Peripheral Artery Disease: Insights From the ARISTOTLE Trial. J Am Heart Assoc. 2017 Jan 17;6(1):e004699. doi: 10.1161/JAHA.116.004699.

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

ReferenceCitation: Bahit MC, Lopes RD, Wojdyla DM, Held C, Hanna M, Vinereanu D, Hylek EM, Verheugt F, Goto S, Alexander JH, Wallentin L, Granger CB. Non-major bleeding with apixaban versus warfarin in patients with atrial fibrillation. Heart. 2017 Apr;103(8):623-628. doi: 10.1136/heartjnl-2016-309901. Epub 2016 Oct 24.

repository_institution: University of Oxford - Oxford Academic Notes & Queries

repositories_institution: University of Oxford - Oxford Academic Notes & Queries

ReferenceCitation: Oldgren J, Hijazi Z, Lindback J, Alexander JH, Connolly SJ, Eikelboom JW, Ezekowitz MD, Granger CB, Hylek EM, Lopes RD, Siegbahn A, Yusuf S, Wallentin L; RE-LY and ARISTOTLE Investigators. Performance and Validation of a Novel Biomarker-Based Stroke Risk Score for Atrial Fibrillation. Circulation. 2016 Nov 29;134(22):1697-1707. doi: 10.1161/CIRCULATIONAHA.116.022802. Epub 2016 Aug 28.

ReferenceCitation: Alexander JH, Andersson U, Lopes RD, Hijazi Z, Hohnloser SH, Ezekowitz JA, Halvorsen S, Hanna M, Commerford P, Ruzyllo W, Huber K, Al-Khatib SM, Granger CB, Wallentin L; Apixaban for Reduction of Stroke and Other Thromboembolic Complications in Atrial Fibrillation (ARISTOTLE) Investigators. Apixaban 5 mg Twice Daily and Clinical Outcomes in Patients With Atrial Fibrillation and Advanced Age, Low Body Weight, or High Creatinine: A Secondary Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2016 Sep 1;1(6):673-81. doi: 10.1001/jamacardio.2016.1829.

ReferenceCitation: Hijazi Z, Hohnloser SH, Andersson U, Alexander JH, Hanna M, Keltai M, Parkhomenko A, Lopez-Sendon JL, Lopes RD, Siegbahn A, Granger CB, Wallentin L. Efficacy and Safety of Apixaban Compared With Warfarin in Patients With Atrial Fibrillation in Relation to Renal Function Over Time: Insights From the ARISTOTLE Randomized Clinical Trial. JAMA Cardiol. 2016 Jul 1;1(4):451-60. doi: 10.1001/jamacardio.2016.1170.

ReferenceCitation: Jaspers Focks J, Brouwer MA, Wojdyla DM, Thomas L, Lopes RD, Washam JB, Lanas F, Xavier D, Husted S, Wallentin L, Alexander JH, Granger CB, Verheugt FW. Polypharmacy and effects of apixaban versus warfarin in patients with atrial fibrillation: post hoc analysis of the ARISTOTLE trial. BMJ. 2016 Jun 15;353:i2868. doi: 10.1136/bmj.i2868.

ReferenceCitation: Hijazi Z, Oldgren J, Lindback J, Alexander JH, Connolly SJ, Eikelboom JW, Ezekowitz MD, Held C, Hylek EM, Lopes RD, Siegbahn A, Yusuf S, Granger CB, Wallentin L; ARISTOTLE and RE-LY Investigators. The novel biomarker-based ABC (age, biomarkers, clinical history)-bleeding risk score for patients with atrial fibrillation: a derivation and validation study. Lancet. 2016 Jun 4;387(10035):2302-2311. doi: 10.1016/S0140-6736(16)00741-8. Epub 2016 Apr 4.

ReferenceCitation: Hijazi Z, Lindback J, Alexander JH, Hanna M, Held C, Hylek EM, Lopes RD, Oldgren J, Siegbahn A, Stewart RA, White HD, Granger CB, Wallentin L; ARISTOTLE and STABILITY Investigators. The ABC (age, biomarkers, clinical history) stroke risk score: a biomarker-based risk score for predicting stroke in atrial fibrillation. Eur Heart J. 2016 May 21;37(20):1582-90. doi: 10.1093/eurheartj/ehw054. Epub 2016 Feb 25.

ReferenceCitation: Hijazi Z, Aulin J, Andersson U, Alexander JH, Gersh B, Granger CB, Hanna M, Horowitz J, Hylek EM, Lopes RD, Siegbahn A, Wallentin L; ARISTOTLE Investigators. Biomarkers of inflammation and risk of cardiovascular events in anticoagulated patients with atrial fibrillation. Heart. 2016 Apr;102(7):508-17. doi: 10.1136/heartjnl-2015-308887. Epub 2016 Feb 2.

ReferenceCitation: Rao MP, Halvorsen S, Wojdyla D, Thomas L, Alexander JH, Hylek EM, Hanna M, Bahit MC, Lopes RD, De Caterina R, Erol C, Goto S, Lanas F, Lewis BS, Husted S, Gersh BJ, Wallentin L, Granger CB; Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) Steering Committee and Investigators. Blood Pressure Control and Risk of Stroke or Systemic Embolism in Patients With Atrial Fibrillation: Results From the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) Trial. J Am Heart Assoc. 2015 Dec 1;4(12):e002015. doi: 10.1161/JAHA.115.002015. Erratum In: J Am Heart Assoc. 2021 Feb 16;10(4):e014653.

ReferenceCitation: Vinereanu D, Stevens SR, Alexander JH, Al-Khatib SM, Avezum A, Bahit MC, Granger CB, Lopes RD, Halvorsen S, Hanna M, Husted S, Hylek EM, Margulescu AD, Wallentin L, Atar D. Clinical outcomes in patients with atrial fibrillation according to sex during anticoagulation with apixaban or warfarin: a secondary analysis of a randomized controlled trial. Eur Heart J. 2015 Dec 7;36(46):3268-75. doi: 10.1093/eurheartj/ehv447. Epub 2015 Sep 14.

ReferenceCitation: Avezum A, Lopes RD, Schulte PJ, Lanas F, Gersh BJ, Hanna M, Pais P, Erol C, Diaz R, Bahit MC, Bartunek J, De Caterina R, Goto S, Ruzyllo W, Zhu J, Granger CB, Alexander JH. Apixaban in Comparison With Warfarin in Patients With Atrial Fibrillation and Valvular Heart Disease: Findings From the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) Trial. Circulation. 2015 Aug 25;132(8):624-32. doi: 10.1161/CIRCULATIONAHA.114.014807. Epub 2015 Jun 23.

ReferenceCitation: Held C, Hylek EM, Alexander JH, Hanna M, Lopes RD, Wojdyla DM, Thomas L, Al-Khalidi H, Alings M, Xavier D, Ansell J, Goto S, Ruzyllo W, Rosenqvist M, Verheugt FW, Zhu J, Granger CB, Wallentin L. Clinical outcomes and management associated with major bleeding in patients with atrial fibrillation treated with apixaban or warfarin: insights from the ARISTOTLE trial. Eur Heart J. 2015 May 21;36(20):1264-72. doi: 10.1093/eurheartj/ehu463. Epub 2014 Dec 12.

ReferenceCitation: Hijazi Z, Siegbahn A, Andersson U, Lindahl B, Granger CB, Alexander JH, Atar D, Gersh BJ, Hanna M, Harjola VP, Horowitz J, Husted S, Hylek EM, Lopes RD, McMurray JJ, Wallentin L. Comparison of cardiac troponins I and T measured with high-sensitivity methods for evaluation of prognosis in atrial fibrillation: an ARISTOTLE substudy. Clin Chem. 2015 Feb;61(2):368-78. doi: 10.1373/clinchem.2014.226936. Epub 2014 Dec 1.

ReferenceCitation: Garcia D, Alexander JH, Wallentin L, Wojdyla DM, Thomas L, Hanna M, Al-Khatib SM, Dorian P, Ansell J, Commerford P, Flaker G, Lanas F, Vinereanu D, Xavier D, Hylek EM, Held C, Verheugt FW, Granger CB, Lopes RD. Management and clinical outcomes in patients treated with apixaban vs warfarin undergoing procedures. Blood. 2014 Dec 11;124(25):3692-8. doi: 10.1182/blood-2014-08-595496. Epub 2014 Oct 15.

ReferenceCitation: Wallentin L, Hijazi Z, Andersson U, Alexander JH, De Caterina R, Hanna M, Horowitz JD, Hylek EM, Lopes RD, Asberg S, Granger CB, Siegbahn A; ARISTOTLE Investigators. Growth differentiation factor 15, a marker of oxidative stress and inflammation, for risk assessment in patients with atrial fibrillation: insights from the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) trial. Circulation. 2014 Nov 18;130(21):1847-58. doi: 10.1161/CIRCULATIONAHA.114.011204. Epub 2014 Oct 7.

ReferenceCitation: Hijazi Z, Siegbahn A, Andersson U, Granger CB, Alexander JH, Atar D, Gersh BJ, Mohan P, Harjola VP, Horowitz J, Husted S, Hylek EM, Lopes RD, McMurray JJ, Wallentin L; ARISTOTLE Investigators. High-sensitivity troponin I for risk assessment in patients with atrial fibrillation: insights from the Apixaban for Reduction in Stroke and other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) trial. Circulation. 2014 Feb 11;129(6):625-34. doi: 10.1161/CIRCULATIONAHA.113.006286. Epub 2013 Nov 13.

ReferenceCitation: Flaker G, Lopes RD, Al-Khatib SM, Hermosillo AG, Hohnloser SH, Tinga B, Zhu J, Mohan P, Garcia D, Bartunek J, Vinereanu D, Husted S, Harjola VP, Rosenqvist M, Alexander JH, Granger CB; ARISTOTLE Committees and Investigators. Efficacy and safety of apixaban in patients after cardioversion for atrial fibrillation: insights from the ARISTOTLE Trial (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation). J Am Coll Cardiol. 2014 Mar 25;63(11):1082-7. doi: 10.1016/j.jacc.2013.09.062. Epub 2013 Nov 6.

ReferenceCitation: Hijazi Z, Wallentin L, Siegbahn A, Andersson U, Alexander JH, Atar D, Gersh BJ, Hanna M, Harjola VP, Horowitz JD, Husted S, Hylek EM, Lopes RD, McMurray JJ, Granger CB; ARISTOTLE Investigators. High-sensitivity troponin T and risk stratification in patients with atrial fibrillation during treatment with apixaban or warfarin. J Am Coll Cardiol. 2014 Jan 7-14;63(1):52-61. doi: 10.1016/j.jacc.2013.07.093. Epub 2013 Sep 19.

repository_institution: Australian Catholic University - Research Bank

repositories_institution: Australian Catholic University - Research Bank

ReferenceCitation: Alexander JH, Levy E, Lawrence J, Hanna M, Waclawski AP, Wang J, Califf RM, Wallentin L, Granger CB. Documentation of study medication dispensing in a prospective large randomized clinical trial: experiences from the ARISTOTLE Trial. Am Heart J. 2013 Sep;166(3):559-65. doi: 10.1016/j.ahj.2013.05.025. Epub 2013 Aug 15.

ReferenceCitation: Garcia DA, Wallentin L, Lopes RD, Thomas L, Alexander JH, Hylek EM, Ansell J, Hanna M, Lanas F, Flaker G, Commerford P, Xavier D, Vinereanu D, Yang H, Granger CB. Apixaban versus warfarin in patients with atrial fibrillation according to prior warfarin use: results from the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation trial. Am Heart J. 2013 Sep;166(3):549-58. doi: 10.1016/j.ahj.2013.05.016. Epub 2013 Jul 25.

ReferenceCitation: Wallentin L, Lopes RD, Hanna M, Thomas L, Hellkamp A, Nepal S, Hylek EM, Al-Khatib SM, Alexander JH, Alings M, Amerena J, Ansell J, Aylward P, Bartunek J, Commerford P, De Caterina R, Erol C, Harjola VP, Held C, Horowitz JD, Huber K, Husted S, Keltai M, Lanas F, Lisheng L, McMurray JJ, Oh BH, Rosenqvist M, Ruzyllo W, Steg PG, Vinereanu D, Xavier D, Granger CB; Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) Investigators. Efficacy and safety of apixaban compared with warfarin at different levels of predicted international normalized ratio control for stroke prevention in atrial fibrillation. Circulation. 2013 Jun 4;127(22):2166-76. doi: 10.1161/CIRCULATIONAHA.112.142158. Epub 2013 May 2.

ReferenceCitation: McMurray JJ, Ezekowitz JA, Lewis BS, Gersh BJ, van Diepen S, Amerena J, Bartunek J, Commerford P, Oh BH, Harjola VP, Al-Khatib SM, Hanna M, Alexander JH, Lopes RD, Wojdyla DM, Wallentin L, Granger CB; ARISTOTLE Committees and Investigators. Left ventricular systolic dysfunction, heart failure, and the risk of stroke and systemic embolism in patients with atrial fibrillation: insights from the ARISTOTLE trial. Circ Heart Fail. 2013 May;6(3):451-60. doi: 10.1161/CIRCHEARTFAILURE.112.000143. Epub 2013 Apr 10.

ReferenceCitation: Hijazi Z, Wallentin L, Siegbahn A, Andersson U, Christersson C, Ezekowitz J, Gersh BJ, Hanna M, Hohnloser S, Horowitz J, Huber K, Hylek EM, Lopes RD, McMurray JJ, Granger CB. N-terminal pro-B-type natriuretic peptide for risk assessment in patients with atrial fibrillation: insights from the ARISTOTLE Trial (Apixaban for the Prevention of Stroke in Subjects With Atrial Fibrillation). J Am Coll Cardiol. 2013 Jun 4;61(22):2274-84. doi: 10.1016/j.jacc.2012.11.082. Epub 2013 Apr 3.

ReferenceCitation: Lopes RD, Al-Khatib SM, Wallentin L, Yang H, Ansell J, Bahit MC, De Caterina R, Dorian P, Easton JD, Erol C, Ezekowitz JA, Gersh BJ, Granger CB, Hohnloser SH, Horowitz J, Hylek EM, McMurray JJ, Mohan P, Vinereanu D, Alexander JH. Efficacy and safety of apixaban compared with warfarin according to patient risk of stroke and of bleeding in atrial fibrillation: a secondary analysis of a randomised controlled trial. Lancet. 2012 Nov 17;380(9855):1749-58. doi: 10.1016/S0140-6736(12)60986-6. Epub 2012 Oct 2. Erratum In: Lancet. 2013 Jan 19;381(9862):204.

ReferenceCitation: Easton JD, Lopes RD, Bahit MC, Wojdyla DM, Granger CB, Wallentin L, Alings M, Goto S, Lewis BS, Rosenqvist M, Hanna M, Mohan P, Alexander JH, Diener HC; ARISTOTLE Committees and Investigators. Apixaban compared with warfarin in patients with atrial fibrillation and previous stroke or transient ischaemic attack: a subgroup analysis of the ARISTOTLE trial. Lancet Neurol. 2012 Jun;11(6):503-11. doi: 10.1016/S1474-4422(12)70092-3. Epub 2012 May 8. Erratum In: Lancet Neurol. 2012 Dec;11(12):1021.

ReferenceCitation: Granger CB, Alexander JH, McMurray JJ, Lopes RD, Hylek EM, Hanna M, Al-Khalidi HR, Ansell J, Atar D, Avezum A, Bahit MC, Diaz R, Easton JD, Ezekowitz JA, Flaker G, Garcia D, Geraldes M, Gersh BJ, Golitsyn S, Goto S, Hermosillo AG, Hohnloser SH, Horowitz J, Mohan P, Jansky P, Lewis BS, Lopez-Sendon JL, Pais P, Parkhomenko A, Verheugt FW, Zhu J, Wallentin L; ARISTOTLE Committees and Investigators. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2011 Sep 15;365(11):981-92. doi: 10.1056/NEJMoa1107039. Epub 2011 Aug 27.

location_country:
Finland
Germany
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location_facility: Central Maine Heart & Vascular Institute

location_facility: St Francis Medical Group - Indiana Heart Physicians

location_facility: Cardiovascular Associates Of The Delaware Valley, P.A.

location_facility: Family Practice Center Of Wadsworth, Inc.

location_facility: Neccr Internal Medicine & Cardiology Associates,Llc

location_facility: Cardiology Associates Of Fort Lauderdale, P.A.

location_facility: University Of Oklahoma Health Sciences Center

location_facility: Fox Valley Clinical Research Center, Llc

location_facility: Midatlantic Cardiovascular Associates, Pa

location_facility: Sacramento Heart And Vascular Medical Associates

location_facility: Oregon Medical Group - Clinical Research

location_facility: Amarillo Heart Clinical Research Institute Inc.

location_facility: The Heart & Vascular Institute Of Florida

location_facility: Rogue Valley Physicians - Clinical Research Group

location_facility: Internal Medical Associates of Grand Island, P.C

location_facility: Desert Med Grp Inc, Dba Desert Oasis Healthcare Med Group

location_facility: Aurora Denver Cardiology Associates, P.C.

location_facility: The Carl & Edyth Lindner Center For R&E At The Christ Hosp

location_facility: Cpt. James A Lovell Federal Health Care Center

location_facility: University Of New Mexico/University Hospital

location_facility: Desert Cardiology Consultants Medical Group, Inc

location_facility: The Heart And Vascular Institute Of Florida

location_facility: Cardiovascular Specialist Of South Florida

location_facility: Castlerock Clinical Research Consultants, Llc

location_facility: Saint Luke'S Lipid And Diabetes Research Center

location_facility: Thoracic And Cardiovascular Healthcare Foundation

location_facility: Cardivasclular Consultants Medical Group

location_facility: Cardiovascular Specialists Of Central Maryland, P.A.

location_facility: Internal Medical Associates Of Grand Island, P.C

location_facility: The Methodist Hospital Neurology Institute

location_facility: Cardiology Associates Of Green Bay Ltd-Bellin Hospital

location_facility: Internal Medicine Physicians Associates, P.C.

location_facility: Miami International Cardiology Consultants

location_facility: George Washington University Medical Faculty Associates

location_facility: Arrhythmia Consultants Of The Central Coast Medical Group

location_facility: The University Of Texas Md Anderson Cancer Center

location_facility: Va Greater Los Angeles Healthcare System

location_facility: University Of Texas Health Science Center At Tyler

location_facility: Jacksonville Center For Clinical Research

location_facility: Midatlantic Cardiovascular Associates, P.A.

location_facility: Regional Medical Center And Diagnostic Clinics

location_facility: Advanced Cardiovascular Health Specialists, Pc

location_facility: The Univ. Of Texas Health Science Ctr. At Tyler

location_facility: Illinois Heart & Lung Research Center, Sc

location_facility: Cardiovascular Associates Of The Delware Valley, P.A.

location_facility: Atlanta Institute For Medical Research, Inc


summary: The purpose of this study was to evaluate whether everolimus 10 mg / day added to treatment with depot octreotide prolongs progression free survival compared to treatment with octreotide alone in patients with advanced carcinoid tumor.

ReferenceCitation: Pavel ME, Baudin E, Oberg KE, Hainsworth JD, Voi M, Rouyrre N, Peeters M, Gross DJ, Yao JC. Efficacy of everolimus plus octreotide LAR in patients with advanced neuroendocrine tumor and carcinoid syndrome: final overall survival from the randomized, placebo-controlled phase 3 RADIANT-2 study. Ann Oncol. 2017 Jul 1;28(7):1569-1575. doi: 10.1093/annonc/mdx193. Erratum In: Ann Oncol. 2019 Dec 1;30(12):2010.

repository_institution: PubMed Central - Europe PMC

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

repository_normalized: irua

version: acceptedVersion

repositories:
PubMed Central
irua

repositories_concat: PubMed Central;irua

ReferenceCitation: Fazio N, Granberg D, Grossman A, Saletan S, Klimovsky J, Panneerselvam A, Wolin EM. Everolimus plus octreotide long-acting repeatable in patients with advanced lung neuroendocrine tumors: analysis of the phase 3, randomized, placebo-controlled RADIANT-2 study. Chest. 2013 Apr;143(4):955-962. doi: 10.1378/chest.12-1108.

ReferenceCitation: Pavel ME, Hainsworth JD, Baudin E, Peeters M, Horsch D, Winkler RE, Klimovsky J, Lebwohl D, Jehl V, Wolin EM, Oberg K, Van Cutsem E, Yao JC; RADIANT-2 Study Group. Everolimus plus octreotide long-acting repeatable for the treatment of advanced neuroendocrine tumours associated with carcinoid syndrome (RADIANT-2): a randomised, placebo-controlled, phase 3 study. Lancet. 2011 Dec 10;378(9808):2005-2012. doi: 10.1016/S0140-6736(11)61742-X. Epub 2011 Nov 25.

location_facility: LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Deptof LSU Health Sciences (2)

location_facility: University of Wisconsin / Paul P. Carbone Comp Cancer Center GI Oncology Research Center

location_facility: New York Oncology Hematology, P.C. Dept. of New York Oncology. PC

location_facility: Indiana University Dept.of IndianaUniv.CancerCtr

location_facility: Highlands Oncology Group The Center for Chest Care

location_facility: Cancer Centers of Connecticut Southington Location

location_facility: Mayo Clinic - Rochester Division of Hematology

location_facility: Sammons Cancer Center - Texas Oncology Sammons Cancer Center (SC)

location_facility: Eastern Connecticut Hematology & Oncology Associates Dept. of ECHO

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

location_facility: Virginia Oncology Associates VOA - Lake Wright

location_facility: Duke University Medical Center Dept. of Duke Cancer Center

location_facility: Texas Oncology, P.A. Forth Worth -- 12th Avenue

location_facility: South Texas Institute of Cancer S. Tex Inst.- Corpus Christi

location_facility: Rocky Mountain Cancer Centers Dept of Rocky Mountain (2)

location_facility: Kansas City Cancer Center KCCC Business Office

location_facility: Central Indiana Cancer Centers CICC - South

location_facility: University of Iowa Medical Center Internal Medicine

location_facility: Northwest Cancer Specialists Compass Oncology -BKM

location_facility: Ocala Oncology Center Dept. of Ocala Oncology Center

location_facility: University of Arizona / Arizona Cancer Center Deptof Uof A/Arizona Cancer(2)

location_facility: Norton Cancer Institute Clinical Research Program

location_facility: University of Colorado Dept. of Univ. of Colorado

location_facility: Washington University School Of Medicine-Siteman Cancer Ctr Division of Oncology

location_facility: Hematology Oncology Services of Arkansas

location_facility: University of Kansas Cancer Center Deptof Uof Kansas CancerCenter

location_facility: University of California at Los Angeles UCLA New SC Address

location_facility: Texas Oncology, P.A. Central Austin Cancer Center

location_facility: Dartmouth Hitchcock Medical Center Medical Oncology

location_facility: New York University Medical Center NYU Medical Center (2)

location_facility: Cancer Care and Hematology Specialists of Chicagoland Niles

location_facility: Hematology Oncology PC Dept.of Hematology Oncology(2)

location_facility: University of Texas/MD Anderson Cancer Center Gastrointestinal Med. Oncology

title: A Randomized, Double-blind Placebo-controlled, Multicenter Phase III Study in Patients With Advanced Carcinoid Tumor Receiving Octreotide Depot and Everolimus 10 mg/Day or Octreotide Depot and Placebo

location_country:
Finland
France
Germany
Italy
Slovakia
United Kingdom
Australia
Sweden
Netherlands
Belgium
United States
Spain
Greece
Canada
Czech Republic


title: A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With Abatacept in Subjects With Active Ulcerative Colitis (UC) Who Have Had an Inadequate Clinical Response and/or Intolerance to Medical Therapy

summary: The purpose of this clinical research study is to learn if abatacept can improve signs and symptoms of active ulcerative colitis in patients who have not had an adequate response to other therapies. The safety of this treatment will also be studied

ReferenceCitation: Sandborn WJ, Colombel JF, Sands BE, Rutgeerts P, Targan SR, Panaccione R, Bressler B, Geboes K, Schreiber S, Aranda R, Gujrathi S, Luo A, Peng Y, Salter-Cid L, Hanauer SB. Abatacept for Crohn's disease and ulcerative colitis. Gastroenterology. 2012 Jul;143(1):62-69.e4. doi: 10.1053/j.gastro.2012.04.010. Epub 2012 Apr 12.

lead_sponsor: Bristol-Myers Squibb

location_country:
Germany
Ireland
Poland
Australia
Brazil
Canada
France
Czech Republic
Switzerland
United States
India
Belgium
Puerto Rico
Italy
United Kingdom
Netherlands
Mexico
Korea, Republic of
South Africa

location_facility: Hospital Of The University Of Pennsylvania

location_facility: Oklahoma Foundation For Digestive Research

location_facility: Center For Digestive & Liver Diseases, Inc.

location_facility: Gastroenterology Center Of The Midsouth, P.C.

location_facility: University Of Kentucky Chandler Medical Center

location_facility: Charlotte Gastroenterology & Hepatology, Pllc

location_facility: Gastrointestinal & Liver Diseases Consultants

location_facility: Litchfield County Gastroenterology Assoc.

location_facility: Kansas City Gastroenterology And Hepatology


title: Duloxetine Versus Placebo in the Long-Term Treatment of Patients With Late-Life Major Depression

summary: The purpose of this study is to compare the efficacy and safety of duloxetine 60 mg once daily to placebo on depression in elderly patients (greater than or equal to 65 years of age). Patients who do not respond in the first 13 weeks will be eligible for rescue using pre-defined criteria. Patients randomized to duloxetine 60 mg/day meeting the rescue criteria will be increased to 120 mg/day. Patients randomized to the placebo arm meeting the rescue criteria will be assigned to duloxetine 60 mg/day.

ReferenceCitation: Harada E, Kato M, Fujikoshi S, Wohlreich MM, Berggren L, Tokuoka H. Changes in energy during treatment of depression: an analysis of duloxetine in double-blind placebo-controlled trials. Int J Clin Pract. 2015 Oct;69(10):1139-48. doi: 10.1111/ijcp.12658. Epub 2015 May 16.

publisher_dissemination: Hindawi

ReferenceCitation: Nelson JC, Oakes TM, Liu P, Ahl J, Bangs ME, Raskin J, Perahia DG, Robinson MJ. Assessment of falls in older patients treated with duloxetine: a secondary analysis of a 24-week randomized, placebo-controlled trial. Prim Care Companion CNS Disord. 2013;15(1):PCC.12m01419. doi: 10.4088/PCC.12m01419. Epub 2012 Jan 3.

ReferenceCitation: Oakes TM, Katona C, Liu P, Robinson M, Raskin J, Greist JH. Safety and tolerability of duloxetine in elderly patients with major depressive disorder: a pooled analysis of two placebo-controlled studies. Int Clin Psychopharmacol. 2013 Jan;28(1):1-11. doi: 10.1097/YIC.0b013e32835b09cd.

lead_sponsor: Eli Lilly and Company

sponsor_collaborators:
Eli Lilly and Company
Boehringer Ingelheim

location_country:
United States
Mexico
Puerto Rico
France

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.


lead_sponsor: Genzyme, a Sanofi Company

summary: This study is being carried out to assess if adding ZD6474 to best supportive care (BSC) is more effective than best supportive care alone, for the treatment of patients with non-small cell lung cancer, whose disease has recurred after previous chemotherapy and an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR TKI). ZD6474 is a new anti-cancer drug in development that works in a different way to standard chemotherapy drugs. It targets the growth of new blood vessels to a tumour and thereby might slow the rate at which the tumour may grow. Early studies indicate that ZD6474 has a positive effect on the time that a tumour may take to progress to a further stage. Approximately 930 patients will take part in this study. It will be conducted in hospitals and clinics in North and South America, Europe and Asia.

ReferenceCitation: Platt A, Morten J, Ji Q, Elvin P, Womack C, Su X, Donald E, Gray N, Read J, Bigley G, Blockley L, Cresswell C, Dale A, Davies A, Zhang T, Fan S, Fu H, Gladwin A, Harrod G, Stevens J, Williams V, Ye Q, Zheng L, de Boer R, Herbst RS, Lee JS, Vasselli J. A retrospective analysis of RET translocation, gene copy number gain and expression in NSCLC patients treated with vandetanib in four randomized Phase III studies. BMC Cancer. 2015 Mar 23;15:171. doi: 10.1186/s12885-015-1146-8.

title: A Phase III Study to Assess the Efficacy of ZD6474 (ZACTIMA™) Plus Best Supportive Care Versus Best Supportive Care in Patients With Locally Advanced or Metastatic (Stage IIIB-IV) Non-Small Cell Lung Cancer After Therapy With an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR TKI)

location_country:
Germany
Argentina
Australia
Thailand
Canada
France
Hong Kong
United States
Belgium
China
Peru
Philippines
Italy
United Kingdom
Singapore
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Taiwan
Israel


summary: This study will assess the rate of objective confirmed tumor response of irinotecan in combination with temozolomide in children with recurrent or refractory medulloblastoma and in children with newly diagnosed high-grade glioma.

title: Phase 2 Single-Arm, Open Label Study Of Irinotecan In Combination With Temozolomide In Children With Recurrent Or Refractory Medulloblastoma And In Children With Newly Diagnosed High-Grade Glioma.

location_country:
Italy
Poland
United Kingdom
Denmark
Australia
Belgium
Spain
France


title: SPIRIT V: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Coronary Artery Lesions

acronym: SPIRIT V

summary: The purpose of this Clinical Evaluation is a continuation in the assessment of the performance of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in the treatment of patients with de novo coronary artery lesions.

ReferenceCitation: Genereux P, Rutledge DR, Palmerini T, Caixeta A, Kedhi E, Hermiller JB, Wang J, Krucoff MW, Jones-McMeans J, Sudhir K, Simonton CA, Serruys PW, Stone GW. Stent Thrombosis and Dual Antiplatelet Therapy Interruption With Everolimus-Eluting Stents: Insights From the Xience V Coronary Stent System Trials. Circ Cardiovasc Interv. 2015 May;8(5):e001362. doi: 10.1161/CIRCINTERVENTIONS.114.001362.

ReferenceCitation: Ringel RE, Gauvreau K, Moses H, Jenkins KJ. Coarctation of the Aorta Stent Trial (COAST): study design and rationale. Am Heart J. 2012 Jul;164(1):7-13. doi: 10.1016/j.ahj.2012.04.008. Epub 2012 Jun 20.

ReferenceCitation: Grube E, Chevalier B, Guagliumi G, Smits PC, Stuteville M, Dorange C, Papeleu P, Kaul U, Dzavik V. The SPIRIT V diabetic study: a randomized clinical evaluation of the XIENCE V everolimus-eluting stent vs the TAXUS Liberte paclitaxel-eluting stent in diabetic patients with de novo coronary artery lesions. Am Heart J. 2012 May;163(5):867-875.e1. doi: 10.1016/j.ahj.2012.02.006. Epub 2012 Apr 11.

lead_sponsor: Abbott Medical Devices

location_country:
Germany
Ireland
New Zealand
Thailand
Canada
France
Czech Republic
Portugal
Switzerland
India
Belgium
China
Malaysia
Italy
United Kingdom
Singapore
Sweden
Netherlands
Austria
Spain
Greece
South Africa
Israel

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Hadassah-Hebrew University Medical Center

location_facility: Emodinamica Cardiologia Azienda ULSS 12 Veneziana, Ospedale Civile Umberto 1

location_facility: University health Network - Toronto Gen Hospital

location_facility: All India Institute of Medical Science - AIIMS

location_facility: Institute of Cardiovascular Disease M.M.M.

intervention_type: Device


title: Once-daily Oral Direct Factor Xa Inhibitor BAY59-7939 in Patients With Acute Symptomatic Deep-vein Thrombosis The Einstein-DVT Dose-finding Study. A Phase II Evaluation.

summary: The purpose of this study is to determine the optimal dose of BAY 59-7939 and to compare the safety and effectiveness of this new drug with the standard way of treatment of deep vein thrombosis (heparin infusion plus one of the vitamin K antagonists), taking into account new events of thrombosis and pulmonary embolism and bleeding risk.

ReferenceCitation: Buller HR, Lensing AW, Prins MH, Agnelli G, Cohen A, Gallus AS, Misselwitz F, Raskob G, Schellong S, Segers A; Einstein-DVT Dose-Ranging Study investigators. A dose-ranging study evaluating once-daily oral administration of the factor Xa inhibitor rivaroxaban in the treatment of patients with acute symptomatic deep vein thrombosis: the Einstein-DVT Dose-Ranging Study. Blood. 2008 Sep 15;112(6):2242-7. doi: 10.1182/blood-2008-05-160143. Epub 2008 Jul 11.

lead_sponsor: Bayer

collaborators: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

location_country:
France
Italy
Poland
Israel
Denmark
Australia
Brazil
Netherlands
Sweden
United States
South Africa
Canada
Czech Republic


title: Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months Administration of SB-683699 in Subjects With Relapsing-Remitting Multiple Sclerosis

summary: SB-683699 is an oral medication that is thought to reduce the number of active white blood cells entering the brain; these white blood cells are part of the disease process for MS. This study will look at whether different doses of SB-683699 are effective and safe in patients with relapsing remitting MS.

ReferenceCitation: Miller DH, Weber T, Grove R, Wardell C, Horrigan J, Graff O, Atkinson G, Dua P, Yousry T, Macmanus D, Montalban X. Firategrast for relapsing remitting multiple sclerosis: a phase 2, randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2012 Feb;11(2):131-9. doi: 10.1016/S1474-4422(11)70299-X. Epub 2012 Jan 5.

lead_sponsor: GlaxoSmithKline

location_country:
Finland
Germany
Italy
Poland
New Zealand
Norway
United Kingdom
Australia
Netherlands
Austria
Spain
Canada
Russian Federation
France


title: Phase III Randomized, Multi Center Study Of Sunitinib Malate (SU 011248) Or Capecitabine In Subjects With Advanced Breast Cancer Who Failed Both A Taxane And An Anthracycline Chemotherapy Regimen Or Failed With A Taxane And For Whom Further Anthracycline Therapy Is Not Indicated

summary: To compare efficacy and safety of Sunitinib and Capecitabine in subjects with advanced breast cancer who failed both a taxane and an anthracycline chemotherapy regimen or failed with a taxane and for whom further anthracycline therapy is not indicated

location_country:
Germany
Argentina
Australia
Brazil
Japan
Turkey
Chile
Canada
France
Colombia
Hong Kong
India
Peru
Philippines
Italy
United Kingdom
Singapore
Mexico
Korea, Republic of
Spain
South Africa
Taiwan
Bulgaria


title: A Phase II Open Label, Randomized, 3 Arm Trial of 2 Schedules of Ixabepilone Plus Bevacizumab and Paclitaxel Plus Bevacizumab as First Line Therapy for Locally Recurrent or Metastatic Breast Cancer

summary: The purpose of this clinical research study is to learn if ixabepilone plus bevacizumab is effective in shrinking or stopping the growth of cancer when given as first-line chemotherapy in participants with metastatic breast cancer. The study will also assess the safety of this combination treatment.

lead_sponsor: R-Pharm

location_country:
Italy
United Kingdom
United States
Spain
France

location_facility: Weill Medical College Of Cornell University

location_facility: East Valley Hematology And Oncology Medical Group

location_facility: University Of Iowa Hospitals And Clinics


title: A Multi-Center, Phase 2, Open-Label Study of (RS)-10-Propargyl-10-Deazaaminopterin (Pralatrexate) With Vitamin B12 and Folic Acid Supplementation in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma

acronym: PROPEL

summary:
Primary

• Determine the efficacy of pralatrexate with concurrent vitamin B12 and folic acid supplementation when administered to patients with relapsed or refractory peripheral T-cell lymphoma (PTCL)

Secondary

Determine the safety of pralatrexate with concurrent vitamin B12 and folic acid supplementation when administered to patients with relapsed or refractory PTCL
Determine the pharmacokinetic (PK) profile of pralatrexate when administered with vitamin B12 and folic acid supplementation

lead_sponsor: Acrotech Biopharma Inc.

location_country:
Italy
United Kingdom
Belgium
United States
Canada
France

location_facility: The Cancer Center at Hackensack University Medical Center

location_facility: University of Iowa Hospitals and Clinics

location_facility: Washington University School of Medicine

location_facility: Ospedale Sant'Orsola - Policlinico Sant'Orsola


title: A Randomized, Double-blind Study Comparing the Efficacy and Safety of a Fixed Combination of Fenofibrate and Metformin vs Metformin Alone in Patients With Type 2 Diabetes Mellitus and Dyslipidemia Not Appropriately Controlled With a Statin.

summary: To demonstrate in patients with T2DM and dyslipidemia not appropriately controlled with a statin and receiving metformin, the superiority of a fixed combination of fenofibrate and metformin vs metformin alone on TG and additionally, if the superiority on TG is established, to demonstrate the superiority on HDL-C

lead_sponsor: Solvay Pharmaceuticals

location_country:
Lithuania
Poland
India
Slovakia
Hungary
Czech Republic
France


title: A Randomized, Double-Blind Trial Comparing the Efficacy and Safety of a Fixed Combination of Fenofibrate and Metformin vs Rosiglitazone in Patients With Type 2 Diabetes Mellitus and Dyslipidemia

summary: Under conditions of first-line drug treatment in antidiabetic drug naïve/drug free patients with type 2 diabetes mellitus and dyslipidemia, to show that :- the efficacy of a fixed combination (FC) of fenofibrate and metformin on glycemic control is not inferior to that of rosiglitazone and the efficacy of FC of fenofibrate and metformin on triglyceride control is superior to that of rosiglitazone.

enrollment_type: Anticipated

location_country: Finland Germany Poland Romania Netherlands Croatia Ukraine France

location_facility:
Site 613
Site 409
Site 813
Site 612
Site105
Site 305
Site 605
Site103
Site 401
Site 410
Site 411
Site 503
Site 807
Site 507
Site 207
Site 306
Site104
Site 608
Site 403
Site 804
Site101
Site 704
Site 205
Site 500
Site 302
Site 408
Site 603
Site 303
Site 206
Site 607
Site 700
Site 812
Site 208
Site 805
Site 810
Site 606
Site 402
Site 412
Site 407
Site 600
Site 705
Site 307
Site 504
Site 505
Site 509
Site100
Site 508
Site 602
Site 701
Site 406
Site 702
Site 301
Site102
Site 400
Site 304
Site 413
Site 502
Site 506
Site 404
Site 610
Site 809
Site 802
Site 800
Site 703
Site 808
Site 601
Site 811
Site 803
Site 405
Site 604


title: A Phase II, Open-Label, Randomized, Multicenter Trial of GW786034 (Pazopanib) in Combination With Lapatinib (GW572016) Compared to Lapatinib Alone as First Line Therapy in Subjects With Advanced or Metastatic Breast Cancer With ErbB2 Fluorescence In Situ Hybridization (FISH) Positive Tumors

summary: This study is being conducted to compare the efficacy and safety of pazopanib in combination with lapatinib with that of lapatinib alone in subjects with locally advanced or metastatic breast cancer whose tumors overexpress the ErbB2 protein.

ReferenceType: background

ReferenceCitation: Johnston SR, Gomez H, Stemmer SM, Richie M, Durante M, Pandite L, Goodman V, Slamon D. A randomized and open-label trial evaluating the addition of pazopanib to lapatinib as first-line therapy in patients with HER2-positive advanced breast cancer. Breast Cancer Res Treat. 2013 Feb;137(3):755-66. doi: 10.1007/s10549-012-2399-4. Epub 2013 Jan 3.

ReferenceCitation: de Jonge MJ, Hamberg P, Verweij J, Savage S, Suttle AB, Hodge J, Arumugham T, Pandite LN, Hurwitz HI. Phase I and pharmacokinetic study of pazopanib and lapatinib combination therapy in patients with advanced solid tumors. Invest New Drugs. 2013 Jun;31(3):751-9. doi: 10.1007/s10637-012-9885-8. Epub 2012 Oct 6.

location_country:
Poland
India
Hungary
Israel
Singapore
United Kingdom
Mexico
United States
Korea, Republic of
Thailand
Malaysia
Pakistan
Peru
Canada
Russian Federation
France