title: An Open Label Follow-up Trial of the Efficacy and Safety of Chronic Administration of the Combination of Telmisartan 40mg + Amlodipine 5mg or the Combination of Telmisartan 80mg + Amlodipine 5mg Tablets Alone or in Combination With Other Antihypertensive Medications in Patients With Hypertension.

summary: The primary objective of this trial is to assess the efficacy and safety of the fixed dose combinations telmisartan 40 mg / amlodipine 5 mg (T40/A5) or telmisartan 80 mg / amlodipine 5 mg (T80/A5) during long-term open-label treatment.

ReferenceCitation: Neldam S, Edwards C, Lang M, Jones R; TEAMSTA-5 and TEAMSTA-10 Investigators. Long-Term Tolerability and Efficacy of Single-Pill Combinations of Telmisartan 40-80 mg Plus Amlodipine 5 or 10 mg in Patients Whose Blood Pressure Was Not Initially Controlled by Amlodipine 5-10 mg: Open-Label, Long-Term Follow-Ups of the TEAMSTA-5 and TEAMSTA-10 Studies. Curr Ther Res Clin Exp. 2012 Feb;73(1-2):65-84. doi: 10.1016/j.curtheres.2012.02.004.

location_country:
Denmark
Taiwan
Finland
Canada
Sweden
Philippines
Korea, Republic of
France
South Africa
Belgium
Norway
Netherlands

location_facility: 1235.7.20009 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.27004 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3302C Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3301N Boehringer Ingelheim Investigational Site

location_facility: 1235.7.20006 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.32002 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.88605 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.35003 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3301L Boehringer Ingelheim Investigational Site

location_facility: 1235.7.35002 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.63001 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.32010 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3302F Boehringer Ingelheim Investigational Site

location_facility: 1235.7.32008 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3305B Boehringer Ingelheim Investigational Site

location_facility: 1235.7.82006 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.45008 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3308F Boehringer Ingelheim Investigational Site

location_facility: 1235.7.20011 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.32005 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.20013 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.35004 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.31006 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.63009 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.27007 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3301D Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3302A Boehringer Ingelheim Investigational Site

location_facility: 1235.7.88601 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.20001 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.27005 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3301F Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3306B Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3309E Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3301E Boehringer Ingelheim Investigational Site

location_facility: 1235.7.31010 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3309D Boehringer Ingelheim Investigational Site

location_facility: 1235.7.88608 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.20003 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3308B Boehringer Ingelheim Investigational Site

location_facility: 1235.7.82001 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.82002 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3301H Boehringer Ingelheim Investigational Site

location_facility: 1235.7.31003 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.32007 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.45001 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3309C Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3306F Boehringer Ingelheim Investigational Site

location_facility: 1235.7.46005 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3301G Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3307D Boehringer Ingelheim Investigational Site

location_facility: 1235.7.63006 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.27006 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.47001 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.82008 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.47003 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.46003 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.82007 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.46002 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3301J Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3302D Boehringer Ingelheim Investigational Site

location_facility: 1235.7.31001 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.27010 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3306D Boehringer Ingelheim Investigational Site

location_facility: 1235.7.47004 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3307E Boehringer Ingelheim Investigational Site

location_facility: 1235.7.45005 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.45002 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3301M Boehringer Ingelheim Investigational Site

location_facility: 1235.7.31004 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.20005 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3301I Boehringer Ingelheim Investigational Site

location_facility: 1235.7.63002 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.45003 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.63003 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.63008 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.20010 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.82005 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.45006 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.63007 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3306A Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3309A Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3307A Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3304B Boehringer Ingelheim Investigational Site

location_facility: 1235.7.20014 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3304A Boehringer Ingelheim Investigational Site

location_facility: 1235.7.27001 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.46004 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3301C Boehringer Ingelheim Investigational Site

location_facility: 1235.7.32004 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.27009 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3308A Boehringer Ingelheim Investigational Site

location_facility: 1235.7.31007 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3305A Boehringer Ingelheim Investigational Site

location_facility: 1235.7.31005 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3301B Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3310A Boehringer Ingelheim Investigational Site

location_facility: 1235.7.27003 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3303C Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3306C Boehringer Ingelheim Investigational Site

location_facility: 1235.7.20008 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.20012 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.47002 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.45007 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3306E Boehringer Ingelheim Investigational Site

location_facility: 1235.7.46001 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3301A Boehringer Ingelheim Investigational Site

location_facility: 1235.7.63005 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.32003 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.88603 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3309F Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3307F Boehringer Ingelheim Investigational Site

location_facility: 1235.7.35001 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.82004 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.27002 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3309B Boehringer Ingelheim Investigational Site

location_facility: 1235.7.45009 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.20007 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3308E Boehringer Ingelheim Investigational Site

location_facility: 1235.7.82003 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.27008 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.31008 Boehringer Ingelheim Investigational Site

location_facility: 1235.7.3304C Boehringer Ingelheim Investigational Site


type: Other Identifier

title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study of Drotrecogin Alfa (Activated) Administered as a Continuous 96-hr Infusion to Adult Patients With Septic Shock

summary: The purpose of this placebo-controlled study is to determine if drotrecogin alfa (activated) treatment provides significant mortality reduction improvement in patients with septic shock compared with placebo treatment in patients receiving the current standard of care for septic shock. This study will also assess the effectiveness of drotrecogin alfa (activated) in reducing 28-day mortality in patients with septic shock and concomitant severe protein C deficiency.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Póvoa P, Salluh JI, Martinez ML, Guillamat-Prats R, Gallup D, Al-Khalidi HR, Thompson BT, Ranieri VM, Artigas A. Clinical impact of stress dose steroids in patients with septic shock: insights from the PROWESS-Shock trial. Crit Care. 2015 Apr 28;19:193. doi: 10.1186/s13054-015-0921-x.

ReferenceCitation: Ranieri VM, Thompson BT, Barie PS, Dhainaut JF, Douglas IS, Finfer S, Gårdlund B, Marshall JC, Rhodes A, Artigas A, Payen D, Tenhunen J, Al-Khalidi HR, Thompson V, Janes J, Macias WL, Vangerow B, Williams MD; PROWESS-SHOCK Study Group. Drotrecogin alfa (activated) in adults with septic shock. N Engl J Med. 2012 May 31;366(22):2055-64. doi: 10.1056/NEJMoa1202290. Epub 2012 May 22.

lead_sponsor: Eli Lilly and Company

location_country:
Brazil
Portugal
Spain
Italy
United Kingdom
Australia
Mexico
Canada
Czech Republic
Finland
Netherlands
New Zealand
Switzerland
United States
France
India
Belgium
Germany

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

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: Long-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Early Parkinson´s Disease (PD).

lead_sponsor: Boehringer Ingelheim

type: EudraCT Number

source: euctr

design_allocation: Non-Randomized

location_country:
Taiwan
Austria
Netherlands
Russian Federation
Finland
Czech Republic
Ukraine
Hungary
United States
France
India
Malaysia
Japan
Germany
Slovakia

location_facility: 248.633.91011 Boehringer Ingelheim Investigational Site

location_facility: 248.633.88601 Boehringer Ingelheim Investigational Site

location_facility: 248.633.35802 Boehringer Ingelheim Investigational Site

location_facility: 248.633.49004 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3301F Boehringer Ingelheim Investigational Site

location_facility: 248.633.3309B Boehringer Ingelheim Investigational Site

location_facility: 248.633.42001 Boehringer Ingelheim Investigational Site

location_facility: 248.633.88603 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3302C Boehringer Ingelheim Investigational Site

location_facility: 248.633.88602 Boehringer Ingelheim Investigational Site

location_facility: 248.633.49016 Boehringer Ingelheim Investigational Site

location_facility: 248.633.43004 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3305B Boehringer Ingelheim Investigational Site

location_facility: 248.633.3306A Boehringer Ingelheim Investigational Site

location_facility: 248.633.81004 Boehringer Ingelheim Investigational Site

location_facility: 248.633.36003 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3303A Boehringer Ingelheim Investigational Site

location_facility: 248.633.49005 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3301C Boehringer Ingelheim Investigational Site

location_facility: 248.633.81009 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3313A Boehringer Ingelheim Investigational Site

location_facility: 248.633.31006 Boehringer Ingelheim Investigational Site

location_facility: 248.633.01016 Boehringer Ingelheim Investigational Site

location_facility: 248.633.01005 Boehringer Ingelheim Investigational Site

location_facility: 248.633.07006 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3301G Boehringer Ingelheim Investigational Site

location_facility: 248.633.3308D Boehringer Ingelheim Investigational Site

location_facility: 248.633.81003 Boehringer Ingelheim Investigational Site

location_facility: 248.633.42004 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3303C Boehringer Ingelheim Investigational Site

location_facility: 248.633.49013 Boehringer Ingelheim Investigational Site

location_facility: 248.633.36007 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3302B Boehringer Ingelheim Investigational Site

location_facility: 248.633.81011 Boehringer Ingelheim Investigational Site

location_facility: 248.633.38005 Boehringer Ingelheim Investigational Site

location_facility: 248.633.42003 Boehringer Ingelheim Investigational Site

location_facility: 248.633.49019 Boehringer Ingelheim Investigational Site

location_facility: 248.633.01001 Boehringer Ingelheim Investigational Site

location_facility: 248.633.31001 Boehringer Ingelheim Investigational Site

location_facility: 248.633.42101 Boehringer Ingelheim Investigational Site

location_facility: 248.633.81012 Boehringer Ingelheim Investigational Site

location_facility: 248.633.36002 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3312B Boehringer Ingelheim Investigational Site

location_facility: 248.633.38002 Boehringer Ingelheim Investigational Site

location_facility: 248.633.81007 Boehringer Ingelheim Investigational Site

location_facility: 248.633.60004 Boehringer Ingelheim Investigational Site

location_facility: 248.633.88605 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3304A Boehringer Ingelheim Investigational Site

location_facility: 248.633.91007 Boehringer Ingelheim Investigational Site

location_facility: 248.633.38004 Boehringer Ingelheim Investigational Site

location_facility: 248.633.81005 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3306F Boehringer Ingelheim Investigational Site

location_facility: 248.633.35803 Boehringer Ingelheim Investigational Site

location_facility: 248.633.49001 Boehringer Ingelheim Investigational Site

location_facility: 248.633.81008 Boehringer Ingelheim Investigational Site

location_facility: 248.633.91005 Boehringer Ingelheim Investigational Site

location_facility: 248.633.07001 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3308B Boehringer Ingelheim Investigational Site

location_facility: 248.633.81013 Boehringer Ingelheim Investigational Site

location_facility: 248.633.36005 Boehringer Ingelheim Investigational Site

location_facility: 248.633.31004 Boehringer Ingelheim Investigational Site

location_facility: 248.633.36004 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3308E Boehringer Ingelheim Investigational Site

location_facility: 248.633.3303B Boehringer Ingelheim Investigational Site

location_facility: 248.633.81002 Boehringer Ingelheim Investigational Site

location_facility: 248.633.38003 Boehringer Ingelheim Investigational Site

location_facility: 248.633.49011 Boehringer Ingelheim Investigational Site

location_facility: 248.633.91002 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3306D Boehringer Ingelheim Investigational Site

location_facility: 248.633.01013 Boehringer Ingelheim Investigational Site

location_facility: 248.633.31003 Boehringer Ingelheim Investigational Site

location_facility: 248.633.81014 Boehringer Ingelheim Investigational Site

location_facility: 248.633.07004 Boehringer Ingelheim Investigational Site

location_facility: 248.633.49015 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3305A Boehringer Ingelheim Investigational Site

location_facility: 248.633.07003 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3301B Boehringer Ingelheim Investigational Site

location_facility: 248.633.01008 Boehringer Ingelheim Investigational Site

location_facility: 248.633.38001 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3311B Boehringer Ingelheim Investigational Site

location_facility: 248.633.36008 Boehringer Ingelheim Investigational Site

location_facility: 248.633.49002 Boehringer Ingelheim Investigational Site

location_facility: 248.633.49017 Boehringer Ingelheim Investigational Site

location_facility: 248.633.49009 Boehringer Ingelheim Investigational Site

location_facility: 248.633.81001 Boehringer Ingelheim Investigational Site

location_facility: 248.633.01009 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3311A Boehringer Ingelheim Investigational Site

location_facility: 248.633.81006 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3306C Boehringer Ingelheim Investigational Site

location_facility: 248.633.3308A Boehringer Ingelheim Investigational Site

location_facility: 248.633.43001 Boehringer Ingelheim Investigational Site

location_facility: 248.633.01012 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3306B Boehringer Ingelheim Investigational Site

location_facility: 248.633.3301A Boehringer Ingelheim Investigational Site

location_facility: 248.633.91009 Boehringer Ingelheim Investigational Site

location_facility: 248.633.91001 Boehringer Ingelheim Investigational Site

location_facility: 248.633.01018 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3312A Boehringer Ingelheim Investigational Site

location_facility: 248.633.01010 Boehringer Ingelheim Investigational Site

location_facility: 248.633.31002 Boehringer Ingelheim Investigational Site

location_facility: 248.633.49003 Boehringer Ingelheim Investigational Site

location_facility: 248.633.49018 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3302A Boehringer Ingelheim Investigational Site

location_facility: 248.633.36006 Boehringer Ingelheim Investigational Site

location_facility: 248.633.42103 Boehringer Ingelheim Investigational Site

location_facility: 248.633.91004 Boehringer Ingelheim Investigational Site

location_facility: 248.633.49007 Boehringer Ingelheim Investigational Site

location_facility: 248.633.49012 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3308C Boehringer Ingelheim Investigational Site

location_facility: 248.633.3309A Boehringer Ingelheim Investigational Site

location_facility: 248.633.35801 Boehringer Ingelheim Investigational Site

location_facility: 248.633.81010 Boehringer Ingelheim Investigational Site

location_facility: 248.633.38006 Boehringer Ingelheim Investigational Site

location_facility: 248.633.01004 Boehringer Ingelheim Investigational Site

location_facility: 248.633.3301D Boehringer Ingelheim Investigational Site

location_facility: 248.633.81015 Boehringer Ingelheim Investigational Site

location_facility: 248.633.42002 Boehringer Ingelheim Investigational Site

location_facility: 248.633.07002 Boehringer Ingelheim Investigational Site

location_facility: 248.633.36001 Boehringer Ingelheim Investigational Site

summary: The general aim of this study is to obtain long-term safety and tolerability data on pramipexole ER, in daily doses from 0.375mg to 4.5mg once daily (q.d), in patients who have previously completed a pramipexole double-blind study in early PD (248.524(NCT00479401) or 248.636(NCT00558025) trial).


title: A Multicenter, Randomized, Double-blind, Assessor-blind, Non-inferiority Study Comparing the Efficacy and Safety of Once-weekly Subcutaneous Biotinylated Idraparinux (SSR126517E) With Oral Adjusted-dose Warfarin in the Prevention of Stroke and Systemic Thromboembolic Events in Patients With Atrial Fibrillation

acronym: BOREALIS-AF

summary: The objective is to evaluate whether once weekly subcutaneous (SC) injection of idrabiotaparinux sodium (biotinylated idraparinux) is at least as efficient to prevent clots in brain and in the other organs than oral international normalized ratio (INR) adjusted-dose warfarin in patients with atrial fibrillation (AF).

status: Terminated

primary_purpose: Prevention

ReferenceType: result

ReferenceCitation: Buller HR, Halperin J, Hankey GJ, Pillion G, Prins MH, Raskob GE. Comparison of idrabiotaparinux with vitamin K antagonists for prevention of thromboembolism in patients with atrial fibrillation: the Borealis-Atrial Fibrillation Study. J Thromb Haemost. 2014 Jun;12(6):824-30. doi: 10.1111/jth.12546.

lead_sponsor: Sanofi

location_country:
Croatia
Spain
Italy
Lithuania
Ukraine
Venezuela
United States
Costa Rica
Peru
South Africa
Philippines
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
Indonesia
Puerto Rico
India
Israel
Panama
Turkey
Mexico
Norway
Malaysia
Sweden
Slovakia
Egypt
Brazil
Canada
Guatemala
Bulgaria
Denmark
Taiwan
Belarus
Greece
Estonia
New Zealand
Finland
Czech Republic
Thailand
Korea, Republic of
France
Chile
Colombia
Netherlands
Morocco

location_facility: Sanofi-Aventis Investigational Site Number 152009

location_facility: Sanofi-Aventis Investigational Site Number 170003

location_facility: Sanofi-Aventis Investigational Site Number 208004

location_facility: Sanofi-Aventis Investigational Site Number 643041

location_facility: Sanofi-Aventis Investigational Site Number 643001

location_facility: Sanofi-Aventis Investigational Site Number 170006

location_facility: Sanofi-Aventis Investigational Site Number 528009

location_facility: Sanofi-Aventis Investigational Site Number 528020

location_facility: Sanofi-Aventis Investigational Site Number 710013

location_facility: Sanofi-Aventis Investigational Site Number 300005

location_facility: Sanofi-Aventis Investigational Site Number 380016

location_facility: Sanofi-Aventis Investigational Site Number 804004

location_facility: Sanofi-Aventis Investigational Site Number 616010

location_facility: Sanofi-Aventis Investigational Site Number 840181

location_facility: Sanofi-Aventis Investigational Site Number 840264

location_facility: Sanofi-Aventis Investigational Site Number 203004

location_facility: Sanofi-Aventis Investigational Site Number 764003

location_facility: Sanofi-Aventis Investigational Site Number 840308

location_facility: Sanofi-Aventis Investigational Site Number 818004

location_facility: Sanofi-Aventis Investigational Site Number 703004

location_facility: Sanofi-Aventis Investigational Site Number 764001

location_facility: Sanofi-Aventis Investigational Site Number 752002

location_facility: Sanofi-Aventis Investigational Site Number 840275

location_facility: Sanofi-Aventis Investigational Site Number 840012

location_facility: Sanofi-Aventis Investigational Site Number 484011

location_facility: Sanofi-Aventis Investigational Site Number 840066

location_facility: Sanofi-Aventis Investigational Site Number 410011

location_facility: Sanofi-Aventis Investigational Site Number 840265

location_facility: Sanofi-Aventis Investigational Site Number 643005

location_facility: Sanofi-Aventis Investigational Site Number 036005

location_facility: Sanofi-Aventis Investigational Site Number 840241

location_facility: Sanofi-Aventis Investigational Site Number 643008

location_facility: Sanofi-Aventis Investigational Site Number 840127

location_facility: Sanofi-Aventis Investigational Site Number 792004

location_facility: Sanofi-Aventis Investigational Site Number 376007

location_facility: Sanofi-Aventis Investigational Site Number 804014

location_facility: Sanofi-Aventis Investigational Site Number 840123

location_facility: Sanofi-Aventis Investigational Site Number 710001

location_facility: Sanofi-Aventis Investigational Site Number 710017

location_facility: Sanofi-Aventis Investigational Site Number 840272

location_facility: Sanofi-Aventis Investigational Site Number 840073

location_facility: Sanofi-Aventis Investigational Site Number 724007

location_facility: Sanofi-Aventis Investigational Site Number 250001

location_facility: Sanofi-Aventis Investigational Site Number 840165

location_facility: Sanofi-Aventis Investigational Site Number 840104

location_facility: Sanofi-Aventis Investigational Site Number 356017

location_facility: Sanofi-Aventis Investigational Site Number 840161

location_facility: Sanofi-Aventis Investigational Site Number 840249

location_facility: Sanofi-Aventis Investigational Site Number 840129

location_facility: Sanofi-Aventis Investigational Site Number 840236

location_facility: Sanofi-Aventis Investigational Site Number 528030

location_facility: Sanofi-Aventis Investigational Site Number 840306

location_facility: Sanofi-Aventis Investigational Site Number 124014

location_facility: Sanofi-Aventis Investigational Site Number 840304

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status_simplified: Unknown


acronym: MAGELLAN

title: Multicenter, Randomized, Parallel-group Efficacy and Safety Study for the Prevention of Venous Thromboembolism in Hospitalized Medically Ill Patients Comparing Rivaroxaban With Enoxaparin. The MAGELLAN Study

lead_sponsor: Bayer

ReferenceCitation: Cohen AT, Spiro TE, Büller HR, Haskell L, Hu D, Hull R, Mebazaa A, Merli G, Schellong S, Spyropoulos A, Tapson V. Extended-duration rivaroxaban thromboprophylaxis in acutely ill medical patients: MAGELLAN study protocol. J Thromb Thrombolysis. 2011 May;31(4):407-16. doi: 10.1007/s11239-011-0549-x.

ReferenceCitation: Cohen AT, Spiro TE, Büller HR, Haskell L, Hu D, Hull R, Mebazaa A, Merli G, Schellong S, Spyropoulos AC, Tapson V; MAGELLAN Investigators. Rivaroxaban for thromboprophylaxis in acutely ill medical patients. N Engl J Med. 2013 Feb 7;368(6):513-23. doi: 10.1056/NEJMoa1111096.

ReferenceCitation: Sharma A, Chatterjee S, Lichstein E, Mukherjee D. Extended thromboprophylaxis for medically ill patients with decreased mobility: does it improve outcomes? J Thromb Haemost. 2012 Oct;10(10):2053-60. doi: 10.1111/j.1538-7836.2012.04874.x. Review.

ReferenceCitation: Mebazaa A, Spiro TE, Büller HR, Haskell L, Hu D, Hull R, Merli G, Schellong SW, Spyropoulos AC, Tapson VF, De Sanctis Y, Cohen AT. Predicting the risk of venous thromboembolism in patients hospitalized with heart failure. Circulation. 2014 Jul 29;130(5):410-8. doi: 10.1161/CIRCULATIONAHA.113.003126. Epub 2014 Jun 26.

ReferenceCitation: Cohen AT, Spiro TE, Spyropoulos AC, Desanctis YH, Homering M, Büller HR, Haskell L, Hu D, Hull R, Mebazaa A, Merli G, Schellong S, Tapson VF, Burton P; MAGELLAN Study Group. D-dimer as a predictor of venous thromboembolism in acutely ill, hospitalized patients: a subanalysis of the randomized controlled MAGELLAN trial. J Thromb Haemost. 2014 Apr;12(4):479-87. doi: 10.1111/jth.12515.

ReferenceCitation: Spyropoulos AC, Raskob GE, Cohen AT, Ageno W, Weitz JI, Spiro TE, Lu W, Lipardi C, Albers GW, Elliott CG, Halperin JL, Hiatt WR, Maynard G, Steg PG, Sugarmann C, Barnathan ES. Association of Bleeding Severity With Mortality in Extended Thromboprophylaxis of Medically Ill Patients in the MAGELLAN and MARINER Trials. Circulation. 2022 May 10;145(19):1471-1479. doi: 10.1161/CIRCULATIONAHA.121.057847. Epub 2022 Apr 7.

ReferenceCitation: Raskob GE, Spyropoulos AC, Spiro TE, Lu W, Yuan Z, Levitan B, Suh E, Barnathan ES. Benefit-Risk of Rivaroxaban for Extended Thromboprophylaxis After Hospitalization for Medical Illness: Pooled Analysis From MAGELLAN and MARINER. J Am Heart Assoc. 2021 Nov 16;10(22):e021579. doi: 10.1161/JAHA.121.021579. Epub 2021 Nov 10.

ReferenceCitation: Raskob GE, Spyropoulos AC, Cohen AT, Weitz JI, Ageno W, De Sanctis Y, Lu W, Xu J, Albanese J, Sugarmann C, Weber T, Lipardi C, Spiro TE, Barnathan ES. Association Between Asymptomatic Proximal Deep Vein Thrombosis and Mortality in Acutely Ill Medical Patients. J Am Heart Assoc. 2021 Feb;10(5):e019459. doi: 10.1161/JAHA.120.019459. Epub 2021 Feb 15.

ReferenceCitation: Jamil A, Jamil U, Singh K, Khan F, Chi G. Extended Thromboprophylaxis With Betrixaban or Rivaroxaban for Acutely Ill Hospitalized Medical Patients: Meta-Analysis of Prespecified Subgroups. Crit Pathw Cardiol. 2021 Mar 1;20(1):16-24. doi: 10.1097/HPC.0000000000000232.

ReferenceCitation: Weitz JI, Raskob GE, Spyropoulos AC, Spiro TE, De Sanctis Y, Xu J, Lu W, Suh E, Argenti D, Yang H, Albanese J, Lipardi C, Barnathan ES. Thromboprophylaxis with Rivaroxaban in Acutely Ill Medical Patients with Renal Impairment: Insights from the MAGELLAN and MARINER Trials. Thromb Haemost. 2020 Mar;120(3):515-524. doi: 10.1055/s-0039-1701009. Epub 2020 Jan 23.

ReferenceCitation: Chi G, Goldhaber SZ, Kittelson JM, Turpie AGG, Hernandez AF, Hull RD, Gold A, Curnutte JT, Cohen AT, Harrington RA, Gibson CM. Effect of extended-duration thromboprophylaxis on venous thromboembolism and major bleeding among acutely ill hospitalized medical patients: a bivariate analysis. J Thromb Haemost. 2017 Oct;15(10):1913-1922. doi: 10.1111/jth.13783. Epub 2017 Sep 4.

ReferenceCitation: Marszalek J, Mehrsefat S, Chi G. The risk of stroke among acutely ill hospitalized medical patients: lessons from recent trials on extended-duration thromboprophylaxis. Expert Rev Hematol. 2017 Aug;10(8):679-684. doi: 10.1080/17474086.2017.1343662. Epub 2017 Jun 21.

location_country:
Croatia
Luxembourg
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Peru
Belgium
Japan
Romania
South Africa
Poland
Hong Kong
Portugal
Slovenia
Austria
Australia
Russian Federation
Argentina
Indonesia
India
Israel
Turkey
Mexico
Norway
Malaysia
Singapore
Sweden
Slovakia
Brazil
Canada
Switzerland
Hungary
China
Germany
Bulgaria
Denmark
Taiwan
Greece
Latvia
Estonia
New Zealand
Finland
Czech Republic
Thailand
Korea, Republic of
France
Chile
Colombia
Netherlands
Pakistan

location_facility: 1st Affiliated Hosp., Med College Xi'an Jiaotong Univ.

location_facility: Hospital de Agudos "Dr. Carlos Bocalandro"

location_facility: The 1st Affiliated Hosp of the 4th Military Med Uni

location_facility: National Hospital Organization Ibaraki Higashi Hospital

summary: This study will evaluate if extended therapy with oral rivaroxaban can prevent blood clots in the leg and lung that can occur with patients hospitalized for acute medical illness, and compare these results with those of the standard enoxaparin dose and duration regimen. The safety of rivaroxaban will also be studied.


title: A Non-Interventional, Post Authorisation Safety Study, to Continuously Monitor Safety and Pregnancy Outcomes in a Cohort of At-Risk Essential Thrombocythaemia (ET) Subjects Exposed to Xagrid Compared to Other Conventional Cytoreductive Treatments

summary: This is an observational safety study being conducted in Europe comparing patients taking Xagrid to patients taking other cytoreductive treatments. The plan is to enrol at least 750 subjects taking Xagrid with up to 3000 subjects taking other cytoreductive therapies. The study will collect follow up data for 5 years for each patient enrolled that will focus on collecting data related to pre-defined events (PDEs) and Suspected Serious Adverse Reactions (SSARs).

study_start_date_type: Actual

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Birgegård G, Besses C, Griesshammer M, Gugliotta L, Harrison CN, Hamdani M, Wu J, Achenbach H, Kiladjian JJ. Treatment of essential thrombocythemia in Europe: a prospective long-term observational study of 3649 high-risk patients in the Evaluation of Anagrelide Efficacy and Long-term Safety study. Haematologica. 2018 Jan;103(1):51-60. doi: 10.3324/haematol.2017.174672. Epub 2017 Oct 27.

ReferenceCitation: Gugliotta L, Besses C, Griesshammer M, Harrison C, Kiladjian JJ, Coll R, Smith J, Abhyankar B, Birgegård G. Combination therapy of hydroxycarbamide with anagrelide in patients with essential thrombocythemia in the evaluation of Xagrid(R) efficacy and long-term safety study. Haematologica. 2014 Apr;99(4):679-87. doi: 10.3324/haematol.2012.083097. Epub 2013 Dec 13.

ReferenceCitation: Besses C, Kiladjian JJ, Griesshammer M, Gugliotta L, Harrison C, Coll R, Smith J, Abhyankar B, Birgegård G. Cytoreductive treatment patterns for essential thrombocythemia in Europe. Analysis of 3643 patients in the EXELS study. Leuk Res. 2013 Feb;37(2):162-8. doi: 10.1016/j.leukres.2012.11.004. Epub 2012 Nov 29.

ReferenceCitation: Kiladjian JJ, Besses C, Griesshammer M, Gugliotta L, Harrison C, Coll R, Smith J, Birgegård G. Efficacy and safety of cytoreductive therapies in patients with essential thrombocythaemia aged >80 years: an interim analysis of the EXELS study. Clin Drug Investig. 2013 Jan;33(1):55-63. doi: 10.1007/s40261-012-0042-0.

lead_sponsor: Shire

location_country:
Denmark
Portugal
Spain
Greece
Ireland
Italy
Netherlands
Finland
United Kingdom
Sweden
France
Norway
Germany
Cyprus

location_facility: Padiglione ex-oncologico Ospedale S.Maria

location_facility: Hospital Clinico Universitario Salamanca

location_facility: Praxis und Tagesklinik fur Internistische Onkologie

location_facility: Schwerpunktpraxis fur Hamatologie und Internistische Onkologie

location_facility: Gemeinschaftspraxis fur Hamatologie und Internistische Onkologie

location_facility: Praxis Dr. Heinrich, Dr. Brudler, Dr. Bangerter

location_facility: Azienda Ospedaliera Ospedali Riuniti Foggia

location_facility: Consorcio Hospital General Universitario de Valencia

location_facility: CHU de Limoges - Hopital Universitaire Dupuytren

location_facility: Hospital Clinico Universitario de Santiago

location_facility: CHU de Grenoble Hopital Albert Michallon

location_facility: Ippokration Hospital D Clinic of Internal Medicine