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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

Primary Purpose

Atrial Fibrillation

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

pantoprazole

Pradaxa (dabigatran etexilate)

Pradaxa, within 30 minutes after a meal

Pradaxa (dabigatran etexilate)

About this trial

This is an interventional prevention trial for Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

Documented non-valvular atrial fibrillation (NVAF) for whom Pradaxa® (dabigatran etexilate) is indicated per the current local label, but who have not received treatment with Pradaxa® (dabigatran etexilate), or who have not been started on Pradaxa® (dabigatran etexilate) more than 7 days prior to potential enrolment in the study. NVAF may be documented by 12-lead electrocardiogram, rhythm strip, pacemaker/ implantable cardioverter defibrillator (ICD) electrograms or Holter monitoring
Male and female patients, age greater than or equal to 18 years at entry
Written, informed consent

Exclusion criteria:

History within 2 weeks of any of the following gastrointestinal (GI) disorders: heartburn, indigestion, gastritis, upper abdominal pain or discomfort, or gastroesophageal reflux requiring the use of proton pump inhibitors, histamine-2 receptor blockers or antacids. Patients with nausea and/or vomiting within the 2 weeks are not excluded if the symptoms were clearly associated with a self-limited acute or febrile illness. Short-term use of PPIs, as prophylaxis, in a hospital setting for the prevention of stress ulcers is acceptable. Calcium carbonate supplements for calcium replacement is not exclusionary (as long as these products are being used as calcium supplementation/replacement and are not being used to treat or relieve GIS.)
GI bleeding within one year or any history of symptomatic or endoscopically documented gastroduodenal ulcer or diverticulitis, unless the cause has been permanently eliminated by medical therapy or by surgery(e.g., patients with peptic ulcer disease with endoscopically proven cure after therapy or lower GI bleeding due to diverticulosis cured by segmental colectomy are not excluded.)
not applicable
Contraindication to pantoprazole or other proton pump inhibitors, e.g. omeprazole, lansoprazole, rabeprazole, atnoprazole, esomeprazole
Contraindication to Pradaxa® (dabigatran etexilate) or known hypersensitivity to Pradaxa® (dabigatran etexilate) or its excipients
Hemorrhagic disorder, bleeding diathesis or active pathological bleeding
Need for anticoagulant treatment for disorders other than atrial fibrillation
Current treatment with rifampin
Creatinine clearance <15ml/min (in Canada, <30ml/min), or patients on renal replacement therapy (dialysis)
Pre-menopausal women (last menstruation less than or equal to 1 year prior to informed consent) who: are nursing or pregnant, or are of child bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study. Acceptable methods of birth control include abstinence, tubal ligation, transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral implantable or injectable contraceptives, double barrier method and vasectomized partner.
Patients who have received an investigational drug in the past 30 days or are participating in another drug study
Patients considered unreliable by the investigator concerning the requirements for follow-up during the study
Any condition the investigator believes would not allow safe participation in the study
Contraindication in patients with mechanical heart valves. The use of Pradaxa in the setting of other forms of valvular heart disease, including the presence of a bio-prosthetic valve, is not recommended.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Active Comparator

Arm Label

Pradaxa (dabigaran etexilate)

Pradaxa and pantoprazole

Pradaxa, 30 minutes after a meal

Arm Description

Patients with non valvular atrial fibrillation for whom Pradaxa is indicated in accordance with the current local label, not previously treated with Pradaxa, will be provided 3 months of treatment for the prevention of stroke and systemic embolism. Patients who report gastrointestinal symptoms (GIS) will be randomized to one of two management strategies, and data documenting the intensity and duration of the GIS will be collected.

Patients that develop gastrointestinal symptoms (GIS) will be randomized 1:1 to either pantoprazole 40 mg q.a.m., p.o., or taking Pradaxa (dabigatran etexilate) within 30 minutes after a meal

Outcomes

Primary Outcome Measures

The Rate of Complete Effectiveness of Initial GIS Management Strategy

The percentage of patients experiencing complete relief of gastrointestinal symptoms (GIS) when taking pantoprazole 40 mg once daily in the morning (q.a.m.) vs. administration of Pradaxa® (dabigatran etexilate) within 30 minutes after a meal at 4 weeks. Complete effectiveness is defined as at the time of evaluation, both primary GIS and secondary GIS are all resolved.

Secondary Outcome Measures

Rate of Partial Effectiveness of Initial GIS Management Strategies

The percentage of patients experiencing partial relief of gastrointestinal symptoms (GIS) when taking pantoprazole 40 mg once daily in the morning (q.a.m.) and patients taking Pradaxa® (dabigatran etexilate) within 30 minutes after a meal at 4 weeks. Partial effectiveness is defined as at the time of evaluation, either primary GIS is improved; or primary GIS is resolved, but there were still un-resolved secondary GIS.

Combined Rate of Complete or Partial Effectiveness of Initial GIS Management Strategies

The percentage of patients experiencing complete or partial effectiveness of gastrointestinal symptoms (GIS) when taking pantoprazole 40 mg once daily in the morning (q.a.m.) vs. administration of Pradaxa ® (dabigatran etexilate) within 30 minutes after a meal at 4 weeks. Complete effectiveness is defined as at the time of evaluation, both primary GIS and secondary GIS are all resolved. Partial effectiveness is defined as at the time of evaluation, either primary GIS is improved; or primary GIS is resolved, but there were still un-resolved secondary GIS.

Rate of Complete Effectiveness of Combined GIS Management Strategies

The percentage of patients experiencing complete relief of combined gastrointestinal symptoms (GIS) when taking pantoprazole 40 mg once daily in the morning (q.a.m.) vs. administration of Pradaxa ® (dabigatran etexilate) within 30 minutes after a meal. Complete effectiveness is defined as at the time of evaluation, both primary GIS and secondary GIS are all resolved.

Rate of Partial Effectiveness of Combined GIS Management Strategies

The percentage of patients experiencing partial relief of gastrointestinal symptoms (GIS) when taking pantoprazole 40 mg once daily in the morning (q.a.m.) vs. administration of Pradaxa ® (dabigatran etexilate) within 30 minutes after a meal at 4 weeks. Partial effectiveness is defined as at the time of evaluation, either primary GIS is improved; or primary GIS is resolved, but there were still un-resolved secondary GIS.

Combined Rate of Complete or Partial Effectiveness of Combined GIS Management Strategies

The percentage of patients experiencing combined of complete or partial relief of gastrointestinal symptoms (GIS) when taking pantoprazole 40 mg once daily in the morning (q.a.m.) vs. administration of Pradaxa ® (dabigatran etexilate) within 30 minutes after a meal. Complete effectiveness is defined as at the time of evaluation, both primary GIS and secondary GIS are all resolved. Partial effectiveness is defined as at the time of evaluation, either primary GIS is improved; or primary GIS is resolved, but there were still un-resolved secondary GIS.

Rates of Complete Effectiveness of GIS at Each Visit.

The percentage of patients experiencing complete effectiveness of gastrointestinal symptoms (GIS) at each visit by management strategy. Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy.

Rates of Partial Effectiveness of GIS at Each Visit.

The percentage of patients experiencing partial effectiveness of gastrointestinal symptoms (GIS) at each visit by management strategy. Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy.

Rates of Complete or Partial Effectiveness of GIS at Each Visit.

The percentage of patients experiencing complete or partial effectiveness of gastrointestinal symptoms (GIS) at each visit by management strategy. Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy.

Time Between Symptom Onset and First Observed Complete or Partial Effectiveness and Between Symptom Onset and Last Observed Symptom

Time between symptom onset and first observed complete or partial effectiveness and between symptom onset and last observed symptom by management strategy.

Full Information

NCT ID

NCT01493557

First Posted

December 12, 2011

Last Updated

September 2, 2015

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT01493557

Brief Title

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

Official Title

A Prospective, Open Label Study Evaluating the Efficacy of Two Management Strategies (Pantoprazole 40 mg q.a.m. and Taking Pradaxa® With Food (Within 30 Minutes After a Meal) on Gastrointestinal Symptoms (GIS) in Patients Newly on Treatment With Pradaxa® 150 mg b.i.d., 110 mg b.i.d. or 75 mg b.i.d. for the Prevention of Stroke and Systemic Embolism in Patients With Non-valvular Atrial Fibrillation (NVAF)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Completed

Study Start Date

December 2011 (undefined)

Primary Completion Date

July 2014 (Actual)

Study Completion Date

July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary

This is a prospective and open label study that aims to enroll approximately 1200 patients with non-valvular atrial fibrillation (NVAF) not previously treated with Pradaxa® and free of gastrointestinal symptoms (GIS) for at least 2 weeks prior to enrolment. Approximately 125 sites in North America will be recruited. Patients who report GIS during the 3 month treatment period will be randomized to one of two management strategies, and data documenting the intensity and duration of the GIS will be collected.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1067 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pradaxa (dabigaran etexilate)

Arm Type

Other

Arm Description

Arm Title

Pradaxa and pantoprazole

Arm Type

Active Comparator

Arm Description

Patients that develop gastrointestinal symptoms (GIS) will be randomized 1:1 to either pantoprazole 40 mg q.a.m., p.o., or taking Pradaxa (dabigatran etexilate) within 30 minutes after a meal

Arm Title

Pradaxa, 30 minutes after a meal

Arm Type

Active Comparator

Arm Description

Patients that develop gastrointestinal symptoms (GIS) will be randomized 1:1 to either pantoprazole 40 mg q.a.m., p.o., or taking Pradaxa (dabigatran etexilate) within 30 minutes after a meal

Intervention Type

Drug

Intervention Name(s)

pantoprazole

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Pradaxa (dabigatran etexilate)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Pradaxa, within 30 minutes after a meal

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Pradaxa (dabigatran etexilate)

Intervention Description

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

Primary Outcome Measure Information:

Title

The Rate of Complete Effectiveness of Initial GIS Management Strategy

Description

Time Frame

Week 4

Secondary Outcome Measure Information:

Title

Rate of Partial Effectiveness of Initial GIS Management Strategies

Description

Time Frame

Week 4

Title

Combined Rate of Complete or Partial Effectiveness of Initial GIS Management Strategies

Description

Time Frame

Week 4

Title

Rate of Complete Effectiveness of Combined GIS Management Strategies

Description

Time Frame

Week 8

Title

Rate of Partial Effectiveness of Combined GIS Management Strategies

Description

Time Frame

Week 8

Title

Combined Rate of Complete or Partial Effectiveness of Combined GIS Management Strategies

Description

Time Frame

Week 8

Title

Rates of Complete Effectiveness of GIS at Each Visit.

Description

Time Frame

Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 & Week 8

Title

Rates of Partial Effectiveness of GIS at Each Visit.

Description

Time Frame

Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 & Week 8

Title

Rates of Complete or Partial Effectiveness of GIS at Each Visit.

Description

Time Frame

Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 & Week 8

Title

Time Between Symptom Onset and First Observed Complete or Partial Effectiveness and Between Symptom Onset and Last Observed Symptom

Description

Time between symptom onset and first observed complete or partial effectiveness and between symptom onset and last observed symptom by management strategy.

Time Frame

Week 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Documented non-valvular atrial fibrillation (NVAF) for whom Pradaxa® (dabigatran etexilate) is indicated per the current local label, but who have not received treatment with Pradaxa® (dabigatran etexilate), or who have not been started on Pradaxa® (dabigatran etexilate) more than 7 days prior to potential enrolment in the study. NVAF may be documented by 12-lead electrocardiogram, rhythm strip, pacemaker/ implantable cardioverter defibrillator (ICD) electrograms or Holter monitoring Male and female patients, age greater than or equal to 18 years at entry Written, informed consent Exclusion criteria: History within 2 weeks of any of the following gastrointestinal (GI) disorders: heartburn, indigestion, gastritis, upper abdominal pain or discomfort, or gastroesophageal reflux requiring the use of proton pump inhibitors, histamine-2 receptor blockers or antacids. Patients with nausea and/or vomiting within the 2 weeks are not excluded if the symptoms were clearly associated with a self-limited acute or febrile illness. Short-term use of PPIs, as prophylaxis, in a hospital setting for the prevention of stress ulcers is acceptable. Calcium carbonate supplements for calcium replacement is not exclusionary (as long as these products are being used as calcium supplementation/replacement and are not being used to treat or relieve GIS.) GI bleeding within one year or any history of symptomatic or endoscopically documented gastroduodenal ulcer or diverticulitis, unless the cause has been permanently eliminated by medical therapy or by surgery(e.g., patients with peptic ulcer disease with endoscopically proven cure after therapy or lower GI bleeding due to diverticulosis cured by segmental colectomy are not excluded.) not applicable Contraindication to pantoprazole or other proton pump inhibitors, e.g. omeprazole, lansoprazole, rabeprazole, atnoprazole, esomeprazole Contraindication to Pradaxa® (dabigatran etexilate) or known hypersensitivity to Pradaxa® (dabigatran etexilate) or its excipients Hemorrhagic disorder, bleeding diathesis or active pathological bleeding Need for anticoagulant treatment for disorders other than atrial fibrillation Current treatment with rifampin Creatinine clearance <15ml/min (in Canada, <30ml/min), or patients on renal replacement therapy (dialysis) Pre-menopausal women (last menstruation less than or equal to 1 year prior to informed consent) who: are nursing or pregnant, or are of child bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study. Acceptable methods of birth control include abstinence, tubal ligation, transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral implantable or injectable contraceptives, double barrier method and vasectomized partner. Patients who have received an investigational drug in the past 30 days or are participating in another drug study Patients considered unreliable by the investigator concerning the requirements for follow-up during the study Any condition the investigator believes would not allow safe participation in the study Contraindication in patients with mechanical heart valves. The use of Pradaxa in the setting of other forms of valvular heart disease, including the presence of a bio-prosthetic valve, is not recommended.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Boehringer Ingelheim

Organizational Affiliation

Boehringer Ingelheim

Official's Role

Study Chair

Facility Information:

Facility Name

1160.128.1046 Boehringer Ingelheim Investigational Site

City

Birmingham

State/Province

Alabama

Country

United States

Facility Name

1160.128.1045 Boehringer Ingelheim Investigational Site

City

Huntsville

State/Province

Alabama

Country

United States

Facility Name

1160.128.1003 Boehringer Ingelheim Investigational Site

City

Mobile

State/Province

Alabama

Country

United States

Facility Name

1160.128.1093 Boehringer Ingelheim Investigational Site

City

Chandler

State/Province

Arizona

Country

United States

Facility Name

1160.128.1067 Boehringer Ingelheim Investigational Site

City

Hot Springs

State/Province

Arkansas

Country

United States

Facility Name

1160.128.1103 Boehringer Ingelheim Investigational Site

City

Mesa

State/Province

California

Country

United States

Facility Name

1160.128.1094 Boehringer Ingelheim Investigational Site

City

Newport Beach

State/Province

California

Country

United States

Facility Name

1160.128.1042 Boehringer Ingelheim Investigational Site

City

San Diego

State/Province

California

Country

United States

Facility Name

1160.128.1005 Boehringer Ingelheim Investigational Site

City

Colorado Spring

State/Province

Colorado

Country

United States

Facility Name

1160.128.1023 Boehringer Ingelheim Investigational Site

City

Denver

State/Province

Colorado

Country

United States

Facility Name

1160.128.1016 Boehringer Ingelheim Investigational Site

City

Bridgeport

State/Province

Connecticut

Country

United States

Facility Name

1160.128.1066 Boehringer Ingelheim Investigational Site

City

Bridgeport

State/Province

Connecticut

Country

United States

Facility Name

1160.128.1018 Boehringer Ingelheim Investigational Site

City

Guilford

State/Province

Connecticut

Country

United States

Facility Name

1160.128.1050 Boehringer Ingelheim Investigational Site

City

Norwalk

State/Province

Connecticut

Country

United States

Facility Name

1160.128.1057 Boehringer Ingelheim Investigational Site

City

Waterbury

State/Province

Connecticut

Country

United States

Facility Name

1160.128.1085 Boehringer Ingelheim Investigational Site

City

Washington

State/Province

District of Columbia

Country

United States

Facility Name

1160.128.1111 Boehringer Ingelheim Investigational Site

City

Atlantis

State/Province

Florida

Country

United States

Facility Name

1160.128.1032 Boehringer Ingelheim Investigational Site

City

Brandon

State/Province

Florida

Country

United States

Facility Name

1160.128.1021 Boehringer Ingelheim Investigational Site

City

Coral Springs

State/Province

Florida

Country

United States

Facility Name

1160.128.1027 Boehringer Ingelheim Investigational Site

City

Daytona Beach

State/Province

Florida

Country

United States

Facility Name

1160.128.1019 Boehringer Ingelheim Investigational Site

City

Jacksonville

State/Province

Florida

Country

United States

Facility Name

1160.128.1062 Boehringer Ingelheim Investigational Site

City

Jacksonville

State/Province

Florida

Country

United States

Facility Name

1160.128.1054 Boehringer Ingelheim Investigational Site

City

Largo

State/Province

Florida

Country

United States

Facility Name

1160.128.1097 Boehringer Ingelheim Investigational Site

City

Miami

State/Province

Florida

Country

United States

Facility Name

1160.128.1109 Boehringer Ingelheim Investigational Site

City

Miami

State/Province

Florida

Country

United States

Facility Name

1160.128.1087 Boehringer Ingelheim Investigational Site

City

Orlando

State/Province

Florida

Country

United States

Facility Name

1160.128.1058 Boehringer Ingelheim Investigational Site

City

Pensacola

State/Province

Florida

Country

United States

Facility Name

1160.128.1007 Boehringer Ingelheim Investigational Site

City

Port Charlotte

State/Province

Florida

Country

United States

Facility Name

1160.128.1060 Boehringer Ingelheim Investigational Site

City

Rockledge

State/Province

Florida

Country

United States

Facility Name

1160.128.1096 Boehringer Ingelheim Investigational Site

City

Columbus

State/Province

Georgia

Country

United States

Facility Name

1160.128.1068 Boehringer Ingelheim Investigational Site

City

Roswell

State/Province

Georgia

Country

United States

Facility Name

1160.128.1076 Boehringer Ingelheim Investigational Site

City

Coeur d' Alene

State/Province

Idaho

Country

United States

Facility Name

1160.128.1073 Boehringer Ingelheim Investigational Site

City

Melrose Park

State/Province

Illinois

Country

United States

Facility Name

1160.128.1048 Boehringer Ingelheim Investigational Site

City

Winfield

State/Province

Illinois

Country

United States

Facility Name

1160.128.1105 Boehringer Ingelheim Investigational Site

City

Hammond

State/Province

Indiana

Country

United States

Facility Name

1160.128.1029 Boehringer Ingelheim Investigational Site

City

Indianapolis

State/Province

Indiana

Country

United States

Facility Name

1160.128.1079 Boehringer Ingelheim Investigational Site

City

Overland Park

State/Province

Kansas

Country

United States

Facility Name

1160.128.1008 Boehringer Ingelheim Investigational Site

City

Baton Rouge

State/Province

Louisiana

Country

United States

Facility Name

1160.128.1025 Boehringer Ingelheim Investigational Site

City

Auburn

State/Province

Maine

Country

United States

Facility Name

1160.128.1100 Boehringer Ingelheim Investigational Site

City

Biddeford

State/Province

Maine

Country

United States

Facility Name

1160.128.1041 Boehringer Ingelheim Investigational Site

City

Columbia

State/Province

Maryland

Country

United States

Facility Name

1160.128.1012 Boehringer Ingelheim Investigational Site

City

Salisbury

State/Province

Maryland

Country

United States

Facility Name

1160.128.1015 Boehringer Ingelheim Investigational Site

City

Rochester Hills

State/Province

Michigan

Country

United States

Facility Name

1160.128.1004 Boehringer Ingelheim Investigational Site

City

Tupelo

State/Province

Mississippi

Country

United States

Facility Name

1160.128.1014 Boehringer Ingelheim Investigational Site

City

Columbia

State/Province

Missouri

Country

United States

Facility Name

1160.128.1047 Boehringer Ingelheim Investigational Site

City

Kansas City

State/Province

Missouri

Country

United States

Facility Name

1160.128.1075 Boehringer Ingelheim Investigational Site

City

St. Louis

State/Province

Missouri

Country

United States

Facility Name

1160.128.1069 Boehringer Ingelheim Investigational Site

City

Great Falls

State/Province

Montana

Country

United States

Facility Name

1160.128.1011 Boehringer Ingelheim Investigational Site

City

Kalispell

State/Province

Montana

Country

United States

Facility Name

1160.128.1092 Boehringer Ingelheim Investigational Site

City

Lincoln

State/Province

Nebraska

Country

United States

Facility Name

1160.128.1059 Boehringer Ingelheim Investigational Site

City

Omaha

State/Province

Nebraska

Country

United States

Facility Name

1160.128.1039 Boehringer Ingelheim Investigational Site

City

Elmer

State/Province

New Jersey

Country

United States

Facility Name

1160.128.1035 Boehringer Ingelheim Investigational Site

City

Flemington

State/Province

New Jersey

Country

United States

Facility Name

1160.128.1036 Boehringer Ingelheim Investigational Site

City

Albuquerque

State/Province

New Mexico

Country

United States

Facility Name

1160.128.1063 Boehringer Ingelheim Investigational Site

City

Hawthorne

State/Province

New York

Country

United States

Facility Name

1160.128.1078 Boehringer Ingelheim Investigational Site

City

Mineola

State/Province

New York

Country

United States

Facility Name

1160.128.1001 Boehringer Ingelheim Investigational Site

City

Poughkeepsie

State/Province

New York

Country

United States

Facility Name

1160.128.1022 Boehringer Ingelheim Investigational Site

City

Asheville

State/Province

North Carolina

Country

United States

Facility Name

1160.128.1052 Boehringer Ingelheim Investigational Site

City

Gastonia

State/Province

North Carolina

Country

United States

Facility Name

1160.128.1071 Boehringer Ingelheim Investigational Site

City

Statesville

State/Province

North Carolina

Country

United States

Facility Name

1160.128.1091 Boehringer Ingelheim Investigational Site

City

Gallipolis

State/Province

Ohio

Country

United States

Facility Name

1160.128.1107 Boehringer Ingelheim Investigational Site

City

Oklahoma City

State/Province

Oklahoma

Country

United States

Facility Name

1160.128.1053 Boehringer Ingelheim Investigational Site

City

Bend

State/Province

Oregon

Country

United States

Facility Name

1160.128.1033 Boehringer Ingelheim Investigational Site

City

Hillsboro

State/Province

Oregon

Country

United States

Facility Name

1160.128.1037 Boehringer Ingelheim Investigational Site

City

Altoona

State/Province

Pennsylvania

Country

United States

Facility Name

1160.128.1034 Boehringer Ingelheim Investigational Site

City

Camp Hill

State/Province

Pennsylvania

Country

United States

Facility Name

1160.128.1010 Boehringer Ingelheim Investigational Site

City

Langhorne

State/Province

Pennsylvania

Country

United States

Facility Name

1160.128.1056 Boehringer Ingelheim Investigational Site

City

Pittsburgh

State/Province

Pennsylvania

Country

United States

Facility Name

1160.128.1065 Boehringer Ingelheim Investigational Site

City

Uniontown

State/Province

Pennsylvania

Country

United States

Facility Name

1160.128.1043 Boehringer Ingelheim Investigational Site

City

Charleston

State/Province

South Carolina

Country

United States

Facility Name

1160.128.1040 Boehringer Ingelheim Investigational Site

City

Rapid City

State/Province

South Dakota

Country

United States

Facility Name

1160.128.1006 Boehringer Ingelheim Investigational Site

City

Austin

State/Province

Texas

Country

United States

Facility Name

1160.128.1104 Boehringer Ingelheim Investigational Site

City

Houston

State/Province

Texas

Country

United States

Facility Name

1160.128.1061 Boehringer Ingelheim Investigational Site

City

McKinney

State/Province

Texas

Country

United States

Facility Name

1160.128.1090 Boehringer Ingelheim Investigational Site

City

New Braunfels

State/Province

Texas

Country

United States

Facility Name

1160.128.1082 Boehringer Ingelheim Investigational Site

City

San Antonio

State/Province

Texas

Country

United States

Facility Name

1160.128.1102 Boehringer Ingelheim Investigational Site

City

Layton

State/Province

Utah

Country

United States

Facility Name

1160.128.1077 Boehringer Ingelheim Investigational Site

City

Danville

State/Province

Virginia

Country

United States

Facility Name

1160.128.1064 Boehringer Ingelheim Investigational Site

City

Falls Church

State/Province

Virginia

Country

United States

Facility Name

1160.128.1110 Boehringer Ingelheim Investigational Site

City

Manassas

State/Province

Virginia

Country

United States

Facility Name

1160.128.1099 Boehringer Ingelheim Investigational Site

City

Norfolk

State/Province

Virginia

Country

United States

Facility Name

1160.128.1160 Boehringer Ingelheim Investigational Site

City

Calgary

State/Province

Alberta

Country

Canada

Facility Name

1160.128.1159 Boehringer Ingelheim Investigational Site

City

Edmonton

State/Province

Alberta

Country

Canada

Facility Name

1160.128.1152 Boehringer Ingelheim Investigational Site

City

Red Deer

State/Province

Alberta

Country

Canada

Facility Name

1160.128.1153 Boehringer Ingelheim Investigational Site

City

Spruce Grove

State/Province

Alberta

Country

Canada

Facility Name

1160.128.1167 Boehringer Ingelheim Investigational Site

City

Coquitlam

State/Province

British Columbia

Country

Canada

Facility Name

1160.128.1158 Boehringer Ingelheim Investigational Site

City

Victoria

State/Province

British Columbia

Country

Canada

Facility Name

1160.128.1154 Boehringer Ingelheim Investigational Site

City

Saint John

State/Province

New Brunswick

Country

Canada

Facility Name

1160.128.1166 Boehringer Ingelheim Investigational Site

City

Bay Roberts

State/Province

Newfoundland and Labrador

Country

Canada

Facility Name

1160.128.1151 Boehringer Ingelheim Investigational Site

City

Brampton

State/Province

Ontario

Country

Canada

Facility Name

1160.128.1168 Boehringer Ingelheim Investigational Site

City

Cambridge

State/Province

Ontario

Country

Canada

Facility Name

1160.128.1164 Boehringer Ingelheim Investigational Site

City

Collingwood

State/Province

Ontario

Country

Canada

Facility Name

1160.128.1173 Boehringer Ingelheim Investigational Site

City

Corunna

State/Province

Ontario

Country

Canada

Facility Name

1160.128.1156 Boehringer Ingelheim Investigational Site

City

Hamilton

State/Province

Ontario

Country

Canada

Facility Name

1160.128.1157 Boehringer Ingelheim Investigational Site

City

Kitchener

State/Province

Ontario

Country

Canada

Facility Name

1160.128.1155 Boehringer Ingelheim Investigational Site

City

London

State/Province

Ontario

Country

Canada

Facility Name

1160.128.1170 Boehringer Ingelheim Investigational Site

City

Peterborough

State/Province

Ontario

Country

Canada

Facility Name

1160.128.1165 Boehringer Ingelheim Investigational Site

City

Sarnia

State/Province

Ontario

Country

Canada

Facility Name

1160.128.1169 Boehringer Ingelheim Investigational Site

City

Sarnia

State/Province

Ontario

Country

Canada

Facility Name

1160.128.1161 Boehringer Ingelheim Investigational Site

City

Stayner

State/Province

Ontario

Country

Canada

Facility Name

1160.128.1171 Boehringer Ingelheim Investigational Site

City

Sudbury

State/Province

Ontario

Country

Canada

Facility Name

1160.128.1162 Boehringer Ingelheim Investigational Site

City

Toronto

State/Province

Ontario

Country

Canada

Facility Name

1160.128.1172 Boehringer Ingelheim Investigational Site

City

Saskatoon

State/Province

Saskatchewan

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

27709460

Citation

O'Dea D, Whetteckey J, Ting N. A Prospective, Randomized, Open-Label Study to Evaluate Two Management Strategies for Gastrointestinal Symptoms in Patients Newly on Treatment with Dabigatran. Cardiol Ther. 2016 Dec;5(2):187-201. doi: 10.1007/s40119-016-0071-5. Epub 2016 Oct 5.

Results Reference

derived

Links:

URL

http://trials.boehringer-ingelheim.com

Description

Related Info

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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

Atrial Fibrillation

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial