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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02433366
Other study ID # 1160.149
Secondary ID
Status Completed
Phase N/A
First received March 25, 2015
Last updated February 17, 2016
Start date January 2015
Est. completion date August 2015

Study information

Verified date February 2016
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Bulgaria:Czech Republic:Denmark:France:Germany:Great Britain:Slovakia:Spain:
Study type Observational

Clinical Trial Summary

The key focus of this survey will be to collect data on physicians awareness of the content of the Pradaxa® Prescriber Guide and the extent to which risk awareness is communicated to patients. The data collected with atrial fibrillation patients will show if and how well this information is received and understood.


Description:

Purpose:


Recruitment information / eligibility

Status Completed
Enrollment 1213
Est. completion date August 2015
Est. primary completion date August 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion criteria:

- Pradaxa® prescribers (cardiologists and primary care physicians)

- Patients with atrial fibrillation treated with Pradaxa®

Exclusion criteria:

As defined in Summary of Product Characteristics for patients treated with Pradaxa®

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
Bulgaria Boehringer Ingelheim Investigational Site 81 Dobritch
Bulgaria Boehringer Ingelheim Investigational Site 84 Gabrovo
Bulgaria Boehringer Ingelheim Investigational Site 79 Montana
Bulgaria Boehringer Ingelheim Investigational Site 85 Plovdiv
Bulgaria Boehringer Ingelheim Investigational Site 80 Shumen
Bulgaria Boehringer Ingelheim Investigational Site 86 Sliven
Bulgaria Boehringer Ingelheim Investigational Site 87 Sofia
Bulgaria Boehringer Ingelheim Investigational Site 88 Stara Zagora
Bulgaria Boehringer Ingelheim Investigational Site 82 Varna
Bulgaria Boehringer Ingelheim Investigational Site 83 Veliko Tarnovo
Czech Republic Boehringer Ingelheim Investigational Site 92 ?eská Lípa
Czech Republic Boehringer Ingelheim Investigational Site 93 ?eské Bud?jovice
Czech Republic Boehringer Ingelheim Investigational Site 94 ?eský Krumlov
Czech Republic Boehringer Ingelheim Investigational Site 90 B?eclav
Czech Republic Boehringer Ingelheim Investigational Site 89 Benesov u Prahy
Czech Republic Boehringer Ingelheim Investigational Site 91 Brno
Czech Republic Boehringer Ingelheim Investigational Site 95 Chomutov
Czech Republic Boehringer Ingelheim Investigational Site 96 Domazlice
Czech Republic Boehringer Ingelheim Investigational Site 97 Haví?ov
Czech Republic Boehringer Ingelheim Investigational Site 98 Havlí?k?v Brod
Czech Republic Boehringer Ingelheim Investigational Site 99 Ho?ovice
Czech Republic Boehringer Ingelheim Investigational Site 100 Hradec Králové
Czech Republic Boehringer Ingelheim Investigational Site 101 Ivan?ice
Czech Republic Boehringer Ingelheim Investigational Site 102 Krom??íz
Czech Republic Boehringer Ingelheim Investigational Site 103 Kyjov
Czech Republic Boehringer Ingelheim Investigational Site 104 Liberec
Czech Republic Boehringer Ingelheim Investigational Site 105 Louny
Czech Republic Boehringer Ingelheim Investigational Site 106 Most
Czech Republic Boehringer Ingelheim Investigational Site 107 Nový Bor
Czech Republic Boehringer Ingelheim Investigational Site 108 Odry
Czech Republic Boehringer Ingelheim Investigational Site 109 Olomouc
Czech Republic Boehringer Ingelheim Investigational Site 110 Pardubice
Czech Republic Boehringer Ingelheim Investigational Site 111 Plze?
Czech Republic Boehringer Ingelheim Investigational Site 112 Praha
Czech Republic Boehringer Ingelheim Investigational Site 113 Sternberk
Czech Republic Boehringer Ingelheim Investigational Site 114 Tábor
Czech Republic Boehringer Ingelheim Investigational Site 115 Tehovec
Czech Republic Boehringer Ingelheim Investigational Site 116 Teplice
Czech Republic Boehringer Ingelheim Investigational Site 117 Valasské Mezi?í?í
Denmark Boehringer Ingelheim Investigational Site 69 Copenhagen
France Boehringer Ingelheim Investigational Site 25 Ambleuteuse
France Boehringer Ingelheim Investigational Site 68 Ardres
France Boehringer Ingelheim Investigational Site 26 Arnac pompadour
France Boehringer Ingelheim Investigational Site 27 Audincourt
France Boehringer Ingelheim Investigational Site 28 Bart
France Boehringer Ingelheim Investigational Site 29 Besançon
France Boehringer Ingelheim Investigational Site 30 Buissière galant
France Boehringer Ingelheim Investigational Site 32 Chalus
France Boehringer Ingelheim Investigational Site 31 Charbrignac
France Boehringer Ingelheim Investigational Site 33 Coussac Bonneval
France Boehringer Ingelheim Investigational Site 34 Decines
France Boehringer Ingelheim Investigational Site 35 Eckwersheim
France Boehringer Ingelheim Investigational Site 36 Geneuille
France Boehringer Ingelheim Investigational Site 37 Glandon
France Boehringer Ingelheim Investigational Site 65 Gruson
France Boehringer Ingelheim Investigational Site 38 Halluin
France Boehringer Ingelheim Investigational Site 39 Lanouaille
France Boehringer Ingelheim Investigational Site 67 Le catelet
France Boehringer Ingelheim Investigational Site 40 Le Haillan
France Boehringer Ingelheim Investigational Site 41 Lille
France Boehringer Ingelheim Investigational Site 42 Limoges
France Boehringer Ingelheim Investigational Site 43 Lomme
France Boehringer Ingelheim Investigational Site 44 Lyon
France Boehringer Ingelheim Investigational Site 45 Marseille
France Boehringer Ingelheim Investigational Site 46 Merignac
France Boehringer Ingelheim Investigational Site 47 Nexon
France Boehringer Ingelheim Investigational Site 48 Noaillan
France Boehringer Ingelheim Investigational Site 24 Paris
France Boehringer Ingelheim Investigational Site 49 Pompadour
France Boehringer Ingelheim Investigational Site 50 Saint Martial d'Albarede
France Boehringer Ingelheim Investigational Site 51 Saint Martin Sepert
France Boehringer Ingelheim Investigational Site 52 Saint Saud Lacousserie
France Boehringer Ingelheim Investigational Site 53 Saint Sornin Lavolps
France Boehringer Ingelheim Investigational Site 54 Saint Yrieix la Perche
France Boehringer Ingelheim Investigational Site 55 Saint-Hilaire-les-Places
France Boehringer Ingelheim Investigational Site 56 Schiltigheim
France Boehringer Ingelheim Investigational Site 57 Sochaux
France Boehringer Ingelheim Investigational Site 58 Strasbourg
France Boehringer Ingelheim Investigational Site 59 Talence
France Boehringer Ingelheim Investigational Site 60 Thiviers
France Boehringer Ingelheim Investigational Site 66 Tourcoing
France Boehringer Ingelheim Investigational Site 61 Tourmignies
France Boehringer Ingelheim Investigational Site 62 Villenave d'Ornon
France Boehringer Ingelheim Investigational Site 63 Voujeaucourt
France Boehringer Ingelheim Investigational Site 64 Weyersheim
Germany Boehringer Ingelheim Investigational Site 9 Berlin
Germany Boehringer Ingelheim Investigational Site 3 Bremen
Germany Boehringer Ingelheim Investigational Site 10 Chemnitz
Germany Boehringer Ingelheim Investigational Site 5 Düsseldorf
Germany Boehringer Ingelheim Investigational Site 6 Essen
Germany Boehringer Ingelheim Investigational Site 1 Frankfurt
Germany Boehringer Ingelheim Investigational Site 8 Hannover
Germany Boehringer Ingelheim Investigational Site 14 Heidelberg
Germany Boehringer Ingelheim Investigational Site 11 Leipzig
Germany Boehringer Ingelheim Investigational Site 2 Mannheim
Germany Boehringer Ingelheim Investigational Site 7 Marburg
Germany Boehringer Ingelheim Investigational Site 13 München
Germany Boehringer Ingelheim Investigational Site 4 Nürnberg
Germany Boehringer Ingelheim Investigational Site 12 Rostock
Slovakia Boehringer Ingelheim Investigational Site 122 Banska Bystrica
Slovakia Boehringer Ingelheim Investigational Site 127 Bardejov
Slovakia Boehringer Ingelheim Investigational Site 152 Bratislava
Slovakia Boehringer Ingelheim Investigational Site 146 Cierna nad Tisou
Slovakia Boehringer Ingelheim Investigational Site 149 Cierne Klacany
Slovakia Boehringer Ingelheim Investigational Site 154 Cierny Brod
Slovakia Boehringer Ingelheim Investigational Site 139 Dolne Kockovce
Slovakia Boehringer Ingelheim Investigational Site 141 Horny Vadicov
Slovakia Boehringer Ingelheim Investigational Site 137 Ivanka pri Dunaji
Slovakia Boehringer Ingelheim Investigational Site 140 Jelka
Slovakia Boehringer Ingelheim Investigational Site 159 Kokava nad Rimavicou
Slovakia Boehringer Ingelheim Investigational Site 125 Kosice
Slovakia Boehringer Ingelheim Investigational Site 158 Kostany nad Turcom
Slovakia Boehringer Ingelheim Investigational Site 160 Krasno nad Kysucou
Slovakia Boehringer Ingelheim Investigational Site 134 Lalinok
Slovakia Boehringer Ingelheim Investigational Site 120 Lastovce
Slovakia Boehringer Ingelheim Investigational Site 155 Liptovsky Hradok
Slovakia Boehringer Ingelheim Investigational Site 145 Lucenec
Slovakia Boehringer Ingelheim Investigational Site 144 Nitra
Slovakia Boehringer Ingelheim Investigational Site 119 Nove Mesto nad Vahom
Slovakia Boehringer Ingelheim Investigational Site 150 Nove Zamky
Slovakia Boehringer Ingelheim Investigational Site 124 Odorin
Slovakia Boehringer Ingelheim Investigational Site 142 Oscadnica
Slovakia Boehringer Ingelheim Investigational Site 157 Poprad
Slovakia Boehringer Ingelheim Investigational Site 128 Povazska Bystrica
Slovakia Boehringer Ingelheim Investigational Site 132 Povazsky Chlmec
Slovakia Boehringer Ingelheim Investigational Site 118 Presov
Slovakia Boehringer Ingelheim Investigational Site 138 Puchov
Slovakia Boehringer Ingelheim Investigational Site 143 Radola
Slovakia Boehringer Ingelheim Investigational Site 153 Resov
Slovakia Boehringer Ingelheim Investigational Site 156 Revuca
Slovakia Boehringer Ingelheim Investigational Site 147 Rozkovany
Slovakia Boehringer Ingelheim Investigational Site 131 Rudinka
Slovakia Boehringer Ingelheim Investigational Site 126 Sabinov
Slovakia Boehringer Ingelheim Investigational Site 161 Skalite
Slovakia Boehringer Ingelheim Investigational Site 123 Spisska Nova Ves
Slovakia Boehringer Ingelheim Investigational Site 130 Stranavy
Slovakia Boehringer Ingelheim Investigational Site 121 Trebisov
Slovakia Boehringer Ingelheim Investigational Site 151 Trnava
Slovakia Boehringer Ingelheim Investigational Site 129 Trnove
Slovakia Boehringer Ingelheim Investigational Site 135 Valasska Bela
Slovakia Boehringer Ingelheim Investigational Site 148 Vrable
Slovakia Boehringer Ingelheim Investigational Site 133 Zilina
Slovakia Boehringer Ingelheim Investigational Site 136 Zvolen
Spain Boehringer Ingelheim Investigational Site 23 Baleares
Spain Boehringer Ingelheim Investigational Site 22 Barcelona
Spain Boehringer Ingelheim Investigational Site 15 Ciudad Real
Spain Boehringer Ingelheim Investigational Site 16 Galicia
Spain Boehringer Ingelheim Investigational Site 17 Madrid
Spain Boehringer Ingelheim Investigational Site 18 Murcia
Spain Boehringer Ingelheim Investigational Site 19 Sevilla
Spain Boehringer Ingelheim Investigational Site 20 Valencia
Spain Boehringer Ingelheim Investigational Site 21 Zaragoza
United Kingdom Boehringer Ingelheim Investigational Site 71 Brighton
United Kingdom Boehringer Ingelheim Investigational Site 76 Cheadle
United Kingdom Boehringer Ingelheim Investigational Site 78 Essex
United Kingdom Boehringer Ingelheim Investigational Site 70 London
United Kingdom Boehringer Ingelheim Investigational Site 77 Manchester
United Kingdom Boehringer Ingelheim Investigational Site 74 Middlesex
United Kingdom Boehringer Ingelheim Investigational Site 73 Romford
United Kingdom Boehringer Ingelheim Investigational Site 75 Stockport
United Kingdom Boehringer Ingelheim Investigational Site 72 Surrey

Sponsors (1)

Lead Sponsor Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Bulgaria,  Czech Republic,  Denmark,  France,  Germany,  Slovakia,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Physician`s knowledge and recommendations to their patients on appropriate dosing and minimizing the risk of bleeding when treated with Pradaxa® (questionnaire) day 1 Yes
Primary Patient`s understanding of the disease, bleeding signs, what to do in case of bleeding and how to deal with emergency situations (measuring physician compliance from patient perspective) (questionnaire) day 1 Yes
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