A Prospective, Open Label Study Evaluating Two Management Strategies on Gastrointestinal Symptoms in Patients Newly on Treatment With Pradaxa for the Prevention of Stroke and Systemic Embolism With Non-valvular Atrial Fibrillation

PHASE4CompletedINTERVENTIONAL
Enrollment

1,067

Participants

Timeline

Start Date

December 31, 2011

Primary Completion Date

July 31, 2014

Study Completion Date

July 31, 2014

Conditions
Atrial Fibrillation
Interventions
DRUG

pantoprazole

40 mg q.a.m, p.o.

DRUG

Pradaxa (dabigatran etexilate)

150 mg or 75 mg b.i.d. (150 mg or 110 mg b.i.d. in Canada)

DRUG

Pradaxa, within 30 minutes after a meal

Patients randomized to this intervention would be instructed to take their dabigatran 30 minutes after a meal

DRUG

Pradaxa (dabigatran etexilate)

150 mg or 75 mg b.i.d. (150 mg or 110 mg b.i.d. in Canada)

Trial Locations (103)

Unknown

1160.128.1046 Boehringer Ingelheim Investigational Site, Birmingham

1160.128.1045 Boehringer Ingelheim Investigational Site, Huntsville

1160.128.1003 Boehringer Ingelheim Investigational Site, Mobile

1160.128.1093 Boehringer Ingelheim Investigational Site, Chandler

1160.128.1067 Boehringer Ingelheim Investigational Site, Hot Springs

1160.128.1103 Boehringer Ingelheim Investigational Site, Mesa

1160.128.1094 Boehringer Ingelheim Investigational Site, Newport Beach

1160.128.1042 Boehringer Ingelheim Investigational Site, San Diego

1160.128.1005 Boehringer Ingelheim Investigational Site, Colorado Spring

1160.128.1023 Boehringer Ingelheim Investigational Site, Denver

1160.128.1016 Boehringer Ingelheim Investigational Site, Bridgeport

1160.128.1066 Boehringer Ingelheim Investigational Site, Bridgeport

1160.128.1018 Boehringer Ingelheim Investigational Site, Guilford

1160.128.1050 Boehringer Ingelheim Investigational Site, Norwalk

1160.128.1057 Boehringer Ingelheim Investigational Site, Waterbury

1160.128.1085 Boehringer Ingelheim Investigational Site, Washington D.C.

1160.128.1111 Boehringer Ingelheim Investigational Site, Atlantis

1160.128.1032 Boehringer Ingelheim Investigational Site, Brandon

1160.128.1021 Boehringer Ingelheim Investigational Site, Coral Springs

1160.128.1027 Boehringer Ingelheim Investigational Site, Daytona Beach

1160.128.1019 Boehringer Ingelheim Investigational Site, Jacksonville

1160.128.1062 Boehringer Ingelheim Investigational Site, Jacksonville

1160.128.1054 Boehringer Ingelheim Investigational Site, Largo

1160.128.1097 Boehringer Ingelheim Investigational Site, Miami

1160.128.1109 Boehringer Ingelheim Investigational Site, Miami

1160.128.1087 Boehringer Ingelheim Investigational Site, Orlando

1160.128.1058 Boehringer Ingelheim Investigational Site, Pensacola

1160.128.1007 Boehringer Ingelheim Investigational Site, Port Charlotte

1160.128.1060 Boehringer Ingelheim Investigational Site, Rockledge

1160.128.1096 Boehringer Ingelheim Investigational Site, Columbus

1160.128.1068 Boehringer Ingelheim Investigational Site, Roswell

1160.128.1076 Boehringer Ingelheim Investigational Site, Coeur d'Alene

1160.128.1073 Boehringer Ingelheim Investigational Site, Melrose Park

1160.128.1048 Boehringer Ingelheim Investigational Site, Winfield

1160.128.1105 Boehringer Ingelheim Investigational Site, Hammond

1160.128.1029 Boehringer Ingelheim Investigational Site, Indianapolis

1160.128.1079 Boehringer Ingelheim Investigational Site, Overland Park

1160.128.1008 Boehringer Ingelheim Investigational Site, Baton Rouge

1160.128.1025 Boehringer Ingelheim Investigational Site, Auburn

1160.128.1100 Boehringer Ingelheim Investigational Site, Biddeford

1160.128.1041 Boehringer Ingelheim Investigational Site, Columbia

1160.128.1012 Boehringer Ingelheim Investigational Site, Salisbury

1160.128.1015 Boehringer Ingelheim Investigational Site, Rochester Hills

1160.128.1004 Boehringer Ingelheim Investigational Site, Tupelo

1160.128.1014 Boehringer Ingelheim Investigational Site, Columbia

1160.128.1047 Boehringer Ingelheim Investigational Site, Kansas City

1160.128.1075 Boehringer Ingelheim Investigational Site, St Louis

1160.128.1069 Boehringer Ingelheim Investigational Site, Great Falls

1160.128.1011 Boehringer Ingelheim Investigational Site, Kalispell

1160.128.1092 Boehringer Ingelheim Investigational Site, Lincoln

1160.128.1059 Boehringer Ingelheim Investigational Site, Omaha

1160.128.1039 Boehringer Ingelheim Investigational Site, Elmer

1160.128.1035 Boehringer Ingelheim Investigational Site, Flemington

1160.128.1036 Boehringer Ingelheim Investigational Site, Albuquerque

1160.128.1063 Boehringer Ingelheim Investigational Site, Hawthorne

1160.128.1078 Boehringer Ingelheim Investigational Site, Mineola

1160.128.1001 Boehringer Ingelheim Investigational Site, Poughkeepsie

1160.128.1022 Boehringer Ingelheim Investigational Site, Asheville

1160.128.1052 Boehringer Ingelheim Investigational Site, Gastonia

1160.128.1071 Boehringer Ingelheim Investigational Site, Statesville

1160.128.1091 Boehringer Ingelheim Investigational Site, Gallipolis

1160.128.1107 Boehringer Ingelheim Investigational Site, Oklahoma City

1160.128.1053 Boehringer Ingelheim Investigational Site, Bend

1160.128.1033 Boehringer Ingelheim Investigational Site, Hillsboro

1160.128.1037 Boehringer Ingelheim Investigational Site, Altoona

1160.128.1034 Boehringer Ingelheim Investigational Site, Camp Hill

1160.128.1010 Boehringer Ingelheim Investigational Site, Langhorne

1160.128.1056 Boehringer Ingelheim Investigational Site, Pittsburgh

1160.128.1065 Boehringer Ingelheim Investigational Site, Uniontown

1160.128.1043 Boehringer Ingelheim Investigational Site, Charleston

1160.128.1040 Boehringer Ingelheim Investigational Site, Rapid City

1160.128.1006 Boehringer Ingelheim Investigational Site, Austin

1160.128.1104 Boehringer Ingelheim Investigational Site, Houston

1160.128.1061 Boehringer Ingelheim Investigational Site, McKinney

1160.128.1090 Boehringer Ingelheim Investigational Site, New Braunfels

1160.128.1082 Boehringer Ingelheim Investigational Site, San Antonio

1160.128.1102 Boehringer Ingelheim Investigational Site, Layton

1160.128.1077 Boehringer Ingelheim Investigational Site, Danville

1160.128.1064 Boehringer Ingelheim Investigational Site, Falls Church

1160.128.1110 Boehringer Ingelheim Investigational Site, Manassas

1160.128.1099 Boehringer Ingelheim Investigational Site, Norfolk

1160.128.1160 Boehringer Ingelheim Investigational Site, Calgary

1160.128.1159 Boehringer Ingelheim Investigational Site, Edmonton

1160.128.1152 Boehringer Ingelheim Investigational Site, Red Deer

1160.128.1153 Boehringer Ingelheim Investigational Site, Spruce Grove

1160.128.1167 Boehringer Ingelheim Investigational Site, Coquitlam

1160.128.1158 Boehringer Ingelheim Investigational Site, Victoria

1160.128.1154 Boehringer Ingelheim Investigational Site, Saint John

1160.128.1166 Boehringer Ingelheim Investigational Site, Bay Roberts

1160.128.1151 Boehringer Ingelheim Investigational Site, Brampton

1160.128.1168 Boehringer Ingelheim Investigational Site, Cambridge

1160.128.1164 Boehringer Ingelheim Investigational Site, Collingwood

1160.128.1173 Boehringer Ingelheim Investigational Site, Corunna

1160.128.1171 Boehringer Ingelheim Investigational Site, Greater Sudbury

1160.128.1156 Boehringer Ingelheim Investigational Site, Hamilton

1160.128.1157 Boehringer Ingelheim Investigational Site, Kitchener

1160.128.1155 Boehringer Ingelheim Investigational Site, London

1160.128.1170 Boehringer Ingelheim Investigational Site, Peterborough

1160.128.1165 Boehringer Ingelheim Investigational Site, Sarnia

1160.128.1169 Boehringer Ingelheim Investigational Site, Sarnia

1160.128.1161 Boehringer Ingelheim Investigational Site, Stayner

1160.128.1162 Boehringer Ingelheim Investigational Site, Toronto

1160.128.1172 Boehringer Ingelheim Investigational Site, Saskatoon

Sponsors
All Listed Sponsors
lead

Boehringer Ingelheim

INDUSTRY

NCT01493557 - A Prospective, Open Label Study Evaluating Two Management Strategies on Gastrointestinal Symptoms in Patients Newly on Treatment With Pradaxa for the Prevention of Stroke and Systemic Embolism With Non-valvular Atrial Fibrillation | Biotech Hunter | Biotech Hunter