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Trial record 86 of 333 for:    DABIGATRAN

A Dose Response Study of Dabigatran Etexilate(BIBR 1048) in Pharmacodynamics and Safety in Patients With Non-valvular Atrial Fibrillation in Comparison to Warfarin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01136408
Recruitment Status : Completed
First Posted : June 3, 2010
Results First Posted : December 17, 2010
Last Update Posted : March 19, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Atrial Fibrillation
Interventions Drug: Dabigatran etexilate
Drug: Warfarin
Enrollment 174
Recruitment Details Eight patients were randomised but not treated with study drug, hence resulting in 174 patients as enrolled and 166 who were actually treated.
Pre-assignment Details  
Arm/Group Title Dabigatran Etexilate 220 mg Daily Dabigatran Etexilate 300 mg Daily Warfarin
Hide Arm/Group Description Dabigatran etexilate 110 mg capsule, twice a day, oral administration Dabigatran etexilate 150 mg capsule, twice a day, oral administration Dose-adjusted warfarin based on target INR values
Period Title: Overall Study
Started 46 58 62
Completed 41 49 57
Not Completed 5 9 5
Reason Not Completed
Adverse Event             4             8             4
Protocol Violation             1             1             1
Arm/Group Title Dabigatran Etexilate 220 mg Daily Dabigatran Etexilate 300 mg Daily Warfarin Total
Hide Arm/Group Description Dabigatran etexilate 110 mg capsule, twice a day, oral administration Dabigatran etexilate 150 mg capsule, twice a day, oral administration Dose-adjusted warfarin based on target INR values Total of all reporting groups
Overall Number of Baseline Participants 46 58 62 166
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 46 participants 58 participants 62 participants 166 participants
69.9  (7.5) 68.3  (9.1) 67.4  (8.8) 68.4  (8.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 58 participants 62 participants 166 participants
Female
10
  21.7%
5
   8.6%
5
   8.1%
20
  12.0%
Male
36
  78.3%
53
  91.4%
57
  91.9%
146
  88.0%
1.Primary Outcome
Title Frequency (Occurrence Rates) of Major Bleeding Event
Hide Description

The percentage of patients with major bleeding event.

Major bleeding was defined as any bleed fulfilling one of the following conditions:

  • Fatal or life-threatening
  • Retroperitoneal, intracranial, intraocular, or intraspinal bleeding (verified by objective testing)
  • Bleeding requiring surgical treatment
  • Clinically overt bleeding leading to a transfusion (erythrocyte component transfusion or whole blood transfusion) of 4.5 units (equal to 2 units in EU/US) or more
  • Clinically overt bleeding leading to a fall in haemoglobin of at least 2 g/dL
Time Frame upto 15 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.
Arm/Group Title Dabigatran Etexilate 220 mg Daily Dabigatran Etexilate 300 mg Daily Warfarin
Hide Arm/Group Description:
Dabigatran etexilate 110 mg capsule, twice a day, oral administration
Dabigatran etexilate 150 mg capsule, twice a day, oral administration
Dose-adjusted warfarin based on target INR values
Overall Number of Participants Analyzed 46 58 62
Measure Type: Number
Unit of Measure: Percentage of patients
0 1.7 3.2
2.Primary Outcome
Title Frequency (Occurrence Rates) of Clinically Relevant Bleeding Event
Hide Description

The percentage of patients with clinically relevant bleeding event.

Any bleed that did not qualify as a major bleed was defined as a minor bleed; minor bleed which fulfilled one of the criteria below was defined as a clinically relevant bleeding event:

  • A skin haematoma of at least 25 sqcm
  • Spontaneous nose bleed lasting for more than 5 minutes
  • Macroscopic haematuria (either spontaneous or, if associated with an intervention, lasting more than 24 hours)
  • Spontaneous rectal bleeding (more than spotting on toilet paper)
  • Gingival bleeding lasting for more than 5 minutes
  • Bleeding leading to hospitalisation
  • Bleeding leading to blood transfusion (erythrocyte component transfusion or whole blood transfusion) of less than 4.5 units (equal to 2 units in EU/US)
  • Any other bleeding considered clinically relevant by the investigator
Time Frame upto 15 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.
Arm/Group Title Dabigatran Etexilate 220 mg Daily Dabigatran Etexilate 300 mg Daily Warfarin
Hide Arm/Group Description:
Dabigatran etexilate 110 mg capsule, twice a day, oral administration
Dabigatran etexilate 150 mg capsule, twice a day, oral administration
Dose-adjusted warfarin based on target INR values
Overall Number of Participants Analyzed 46 58 62
Measure Type: Number
Unit of Measure: Percentage of patients
4.3 8.6 8.1
3.Primary Outcome
Title Frequency (Occurrence Rates) of Nuisance Bleeding Event
Hide Description

The percentage of patients with nuisance bleeding event

Any bleed that did not qualify as a major bleed was defined as a minor bleed; all minor bleeding events not fulfilling one of the criteria below was defined as a nuisance bleeding event:

  • A skin haematoma of at least 25 sqcm
  • Spontaneous nose bleed lasting for more than 5 minutes
  • Macroscopic haematuria (either spontaneous or, if associated with an intervention, lasting more than 24 hours)
  • Spontaneous rectal bleeding (more than spotting on toilet paper)
  • Gingival bleeding lasting for more than 5 minutes
  • Bleeding leading to hospitalisation
  • Bleeding leading to blood transfusion (erythrocyte component transfusion or whole blood transfusion) of less than 4.5 units (equal to 2 units in EU/US)
  • Any other bleeding considered clinically relevant by the investigator
Time Frame Upto 15 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.
Arm/Group Title Dabigatran Etexilate 220 mg Daily Dabigatran Etexilate 300 mg Daily Warfarin
Hide Arm/Group Description:
Dabigatran etexilate 110 mg capsule, twice a day, oral administration
Dabigatran etexilate 150 mg capsule, twice a day, oral administration
Dose-adjusted warfarin based on target INR values
Overall Number of Participants Analyzed 46 58 62
Measure Type: Number
Unit of Measure: Percentage of patients
19.6 29.3 19.4
4.Primary Outcome
Title Incidence and Severity of Adverse Events
Hide Description Intensity of event is categorised as mild, moderate and severe.
Time Frame Upto 15 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.
Arm/Group Title Dabigatran Etexilate 220 mg Daily Dabigatran Etexilate 300 mg Daily Warfarin
Hide Arm/Group Description:
Dabigatran etexilate 110 mg capsule, twice a day, oral administration
Dabigatran etexilate 150 mg capsule, twice a day, oral administration
Dose-adjusted warfarin based on target INR values
Overall Number of Participants Analyzed 46 58 62
Measure Type: Number
Unit of Measure: participants
Mild 28 46 35
Moderate 1 1 4
Severe 0 2 2
5.Primary Outcome
Title Discontinuation of the Study Drug Due to Adverse Events
Hide Description Discontinuation of the study drug due to adverse events.
Time Frame Upto 15 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.
Arm/Group Title Dabigatran Etexilate 220 mg Daily Dabigatran Etexilate 300 mg Daily Warfarin
Hide Arm/Group Description:
Dabigatran etexilate 110 mg capsule, twice a day, oral administration
Dabigatran etexilate 150 mg capsule, twice a day, oral administration
Dose-adjusted warfarin based on target INR values
Overall Number of Participants Analyzed 46 58 62
Measure Type: Number
Unit of Measure: participants
4 8 4
6.Primary Outcome
Title Changes in Laboratory Test Values
Hide Description The number of patients with ALT, AST, alkaline phosphatase, or bilirubin exceeded the upper limit of normal (ULN) range
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.
Arm/Group Title Dabigatran Etexilate 220 mg Daily Dabigatran Etexilate 300 mg Daily Warfarin
Hide Arm/Group Description:

Dabigatran etexilate 110 mg capsule, twice a day, oral administration

Dabigatran etexilate: Dabigatran etexilate 110 mg capsule, twice a day, oral administration

Dabigatran etexilate 150 mg capsule, twice a day, oral administration

Dabigatran etexilate: Dabigatran etexilate 150 mg capsule, twice a day, oral administration

Dose-adjusted warfarin based on target INR values

Warfarin: Dose-adjusted warfarin based on target INR values

Overall Number of Participants Analyzed 46 58 60
Measure Type: Number
Unit of Measure: participants
ALT > 1 x ULN 1 4 4
AST > 1 x ULN 0 4 5
Alkaline phosphatase > 1 x ULN 2 3 1
Total bilirubin > 1 x ULN 6 7 8
7.Secondary Outcome
Title Frequency (Occurrence Rates) of a Composite Clinical Endpoint.
Hide Description Percentage of patients with the composite clinical endpoint (ischemic or haemorrhagic stroke (fatal or non-fatal), transient ischemic attacks, systemic embolism, myocardial infarction (fatal or non-fatal), other major adverse cardiac events, and death)
Time Frame Upto 15 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.
Arm/Group Title Dabigatran Etexilate 220 mg Daily Dabigatran Etexilate 300 mg Daily Warfarin
Hide Arm/Group Description:
Dabigatran etexilate 110 mg capsule, twice a day, oral administration
Dabigatran etexilate 150 mg capsule, twice a day, oral administration
Dose-adjusted warfarin based on target INR values
Overall Number of Participants Analyzed 46 58 62
Measure Type: Number
Unit of Measure: Percentage of patients
0 0 1.6
8.Secondary Outcome
Title Frequency (Occurrence Rates) of Ischemic or Haemorrhagic Stroke (Fatal or Non-fatal)
Hide Description The percentage of patients with ischemic or haemorrhagic stroke (fatal or non-fatal)
Time Frame Upto 15 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.
Arm/Group Title Dabigatran Etexilate 220 mg Daily Dabigatran Etexilate 300 mg Daily Warfarin
Hide Arm/Group Description:
Dabigatran etexilate 110 mg capsule, twice a day, oral administration
Dabigatran etexilate 150 mg capsule, twice a day, oral administration
Dose-adjusted warfarin based on target INR values
Overall Number of Participants Analyzed 46 58 62
Measure Type: Number
Unit of Measure: Percentage of patients
0 0 1.6
9.Secondary Outcome
Title Frequency (Occurrence Rates) of Transient Ischemic Attack
Hide Description The percentage of patients with transient ischemic attack
Time Frame Upto 15 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.
Arm/Group Title Dabigatran Etexilate 220 mg Daily Dabigatran Etexilate 300 mg Daily Warfarin
Hide Arm/Group Description:
Dabigatran etexilate 110 mg capsule, twice a day, oral administration
Dabigatran etexilate 150 mg capsule, twice a day, oral administration
Dose-adjusted warfarin based on target INR values
Overall Number of Participants Analyzed 46 58 62
Measure Type: Number
Unit of Measure: Percentage of patients
0 0 0
10.Secondary Outcome
Title Frequency (Occurrence Rates) of Systemic Embolism
Hide Description The percentage of patients with systemic embolism
Time Frame Upto 15 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.
Arm/Group Title Dabigatran Etexilate 220 mg Daily Dabigatran Etexilate 300 mg Daily Warfarin
Hide Arm/Group Description:
Dabigatran etexilate 110 mg capsule, twice a day, oral administration
Dabigatran etexilate 150 mg capsule, twice a day, oral administration
Dose-adjusted warfarin based on target INR values
Overall Number of Participants Analyzed 46 58 62
Measure Type: Number
Unit of Measure: Percentage of patients
0 0 0
11.Secondary Outcome
Title Frequency (Occurrence Rates) of Myocardial Infarction (Fatal or Non-fatal)
Hide Description The percentage of patients with myocardial infarction (fatal or non-fatal)
Time Frame Upto 15 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.
Arm/Group Title Dabigatran Etexilate 220 mg Daily Dabigatran Etexilate 300 mg Daily Warfarin
Hide Arm/Group Description:
Dabigatran etexilate 110 mg capsule, twice a day, oral administration
Dabigatran etexilate 150 mg capsule, twice a day, oral administration
Dose-adjusted warfarin based on target INR values
Overall Number of Participants Analyzed 46 58 62
Measure Type: Number
Unit of Measure: Percentage of patients
0 0 0
12.Secondary Outcome
Title Frequency (Occurrence Rates) of Other Major Adverse Cardiac Events
Hide Description The percentage of patients with other major adverse cardiac events
Time Frame Upto 15 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.
Arm/Group Title Dabigatran Etexilate 220 mg Daily Dabigatran Etexilate 300 mg Daily Warfarin
Hide Arm/Group Description:
Dabigatran etexilate 110 mg capsule, twice a day, oral administration
Dabigatran etexilate 150 mg capsule, twice a day, oral administration
Dose-adjusted warfarin based on target INR values
Overall Number of Participants Analyzed 46 58 62
Measure Type: Number
Unit of Measure: Percentage of patients
0 0 0
13.Secondary Outcome
Title Frequency (Occurrence Rates) of Death
Hide Description The percentage of patients with death
Time Frame Upto 15 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety set was used for safety endpoints. Full analysis set was used for efficacy endpoints. The safety set comprises all patients who were treated with trial medication at least once. The full analysis set comprises all patients who were randomised and treated with trial medication at least once. No data was imputed.
Arm/Group Title Dabigatran Etexilate 220 mg Daily Dabigatran Etexilate 300 mg Daily Warfarin
Hide Arm/Group Description:
Dabigatran etexilate 110 mg capsule, twice a day, oral administration
Dabigatran etexilate 150 mg capsule, twice a day, oral administration
Dose-adjusted warfarin based on target INR values
Overall Number of Participants Analyzed 46 58 62
Measure Type: Number
Unit of Measure: Percentage of patients
0 0 0
14.Secondary Outcome
Title Anticoagulation Effects Trough aPTT (Activated Partial Thromboplastin Time)
Hide Description The blood coagulation parameter aPTT was assessed in patients allocated to the dabigatran etexilate groups at week 0, prior to drug administration and at the trough at week 1, 4 and 12.
Time Frame Week 0,1,4 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Dabigatran Etexilate 220 mg Daily Dabigatran Etexilate 300 mg Daily
Hide Arm/Group Description:
Dabigatran etexilate 110 mg capsule, twice a day, oral administration
Dabigatran etexilate 150 mg capsule, twice a day, oral administration
Overall Number of Participants Analyzed 46 58
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: seconds
week 0, N=46 , N=58
32.4
(12.7%)
34.0
(25.0%)
week 1, N=41, N=55
40.2
(16.4%)
45.0
(20.7%)
week 4, N=40, N=50
40.9
(16.2%)
45.0
(17.9%)
week 12, N=40, N=48
41.8
(17.3%)
44.1
(18.2%)
15.Secondary Outcome
Title Anticoagulation Effects Trough ECT (Ecarin Clotting Time)
Hide Description The blood coagulation parameter ECT was assessed in patients allocated to the dabigatran etexilate groups at week 0, prior to drug administration and at the trough at week 1, 4 and 12.
Time Frame Week 0,1,4 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Dabigatran Etexilate 220 mg Daily Dabigatran Etexilate 300 mg Daily
Hide Arm/Group Description:
Dabigatran etexilate 110 mg capsule, twice a day, oral administration
Dabigatran etexilate 150 mg capsule, twice a day, oral administration
Overall Number of Participants Analyzed 46 58
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: seconds
week 0, N=46 , N=58
35.6
(9.39%)
36.3
(10.5%)
week 1, N=41, N=55
53.4
(23.5%)
63.2
(35.3%)
week 4, N=40, N=50
51.4
(23.1%)
58.9
(27.7%)
week 12, N=40, N=48
52.7
(24.1%)
56.9
(28.5%)
16.Secondary Outcome
Title Anticoagulation Effects Trough INR (International Normalised Ratio)
Hide Description The blood coagulation parameter INR was assessed in patients allocated to the dabigatran etexilate groups at week 0, prior to drug administration and at the trough at week 1, 4 and 12.
Time Frame Week 0,1,4 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Dabigatran Etexilate 220 mg Daily Dabigatran Etexilate 300 mg Daily
Hide Arm/Group Description:
Dabigatran etexilate 110 mg capsule, twice a day, oral administration
Dabigatran etexilate 150 mg capsule, twice a day, oral administration
Overall Number of Participants Analyzed 46 58
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ratio
week 0, N=46 , N=58
1.87
(35.7%)
2.03
(33.4%)
week 1, N=41, N=55
1.35
(14.0%)
1.49
(20.0%)
week 4, N=40, N=50
1.35
(16.6%)
1.46
(18.0%)
week 12, N=39, N=49
1.43
(21.2%)
1.49
(25.2%)
17.Secondary Outcome
Title Anticoagulation Effects Trough 11-dehydrothromboxane B2
Hide Description Analysis based on concomitant use of aspirin compared to no aspirin users. 11-dehydrothromboxane B2 is measured in urine of patients.
Time Frame Week 0 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Analysis Set
Arm/Group Title Dabigatran Etexilate 220 mg Daily Dabigatran Etexilate 300 mg Daily Warfarin
Hide Arm/Group Description:
Dabigatran etexilate 110 mg capsule, twice a day, oral administration
Dabigatran etexilate 150 mg capsule, twice a day, oral administration
[Not Specified]
Overall Number of Participants Analyzed 43 56 58
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: pg/mg creatinine
week 0 without aspirin, N=34, N=43, N=37
2730
(80.5%)
3190
(65.5%)
3080
(52.3%)
week 0 with aspirin, N=9, N=12, N=20
1890
(49.5%)
1480
(49.9%)
1660
(54.3%)
week 12 without aspirin, N=34, N=42, N=37
3350
(62.8%)
3430
(56.5%)
3520
(53.9%)
week 12 with aspirin, N=9, N=13, N=21
2380
(71.2%)
1830
(30.4%)
1420
(55.3%)
18.Secondary Outcome
Title Steady-state Pharmacokinetics of Total Dabigatran Trough Plasma Concentration
Hide Description [Not Specified]
Time Frame Week 1,4 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Dabigatran Etexilate 220 mg Daily Dabigatran Etexilate 300 mg Daily
Hide Arm/Group Description:
Dabigatran etexilate 110 mg capsule, twice a day, oral administration
Dabigatran etexilate 150 mg capsule, twice a day, oral administration
Overall Number of Participants Analyzed 46 58
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
week 1, N=41, N=55
53.1
(69.0%)
78.1
(75.8%)
week 4, N=40, N=50
55.6
(62.5%)
78.2
(68.1%)
week 12, N=39, N=49
63.0
(62.1%)
75.1
(63.3%)
Time Frame First administration to end of study
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dabigatran Etexilate 220 mg Daily Dabigatran Etexilate 300 mg Daily Warfarin
Hide Arm/Group Description Dabigatran etexilate 110 mg capsule, twice a day, oral administration Dabigatran etexilate 150 mg capsule, twice a day, oral administration Dose-adjusted warfarin based on target INR values
All-Cause Mortality
Dabigatran Etexilate 220 mg Daily Dabigatran Etexilate 300 mg Daily Warfarin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Dabigatran Etexilate 220 mg Daily Dabigatran Etexilate 300 mg Daily Warfarin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/46 (0.00%)   6/58 (10.34%)   5/62 (8.06%) 
Cardiac disorders       
Atrioventricular block third degree  1  0/46 (0.00%)  1/58 (1.72%)  0/62 (0.00%) 
Cardiac arrest  1  0/46 (0.00%)  1/58 (1.72%)  0/62 (0.00%) 
Cardiac failure  1  0/46 (0.00%)  1/58 (1.72%)  0/62 (0.00%) 
Cardiac failure congestive  1  0/46 (0.00%)  1/58 (1.72%)  0/62 (0.00%) 
Gastrointestinal disorders       
Toothache  1  0/46 (0.00%)  0/58 (0.00%)  1/62 (1.61%) 
Infections and infestations       
Pneumonia  1  0/46 (0.00%)  1/58 (1.72%)  1/62 (1.61%) 
Injury, poisoning and procedural complications       
Femur fracture  1  0/46 (0.00%)  0/58 (0.00%)  1/62 (1.61%) 
Laryngeal injury  1  0/46 (0.00%)  0/58 (0.00%)  1/62 (1.61%) 
Musculoskeletal and connective tissue disorders       
Muscle fatigue  1  0/46 (0.00%)  1/58 (1.72%)  0/62 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Prostate cancer  1  0/46 (0.00%)  1/58 (1.72%)  0/62 (0.00%) 
Nervous system disorders       
Dizziness  1  0/46 (0.00%)  0/58 (0.00%)  1/62 (1.61%) 
Haemorrhagic cerebral infarction  1  0/46 (0.00%)  0/58 (0.00%)  1/62 (1.61%) 
Reproductive system and breast disorders       
Prostatic haemorrhage  1  0/46 (0.00%)  1/58 (1.72%)  0/62 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Asthma  1  0/46 (0.00%)  0/58 (0.00%)  1/62 (1.61%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dabigatran Etexilate 220 mg Daily Dabigatran Etexilate 300 mg Daily Warfarin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/46 (19.57%)   25/58 (43.10%)   16/62 (25.81%) 
Gastrointestinal disorders       
Diarrhoea  1  1/46 (2.17%)  4/58 (6.90%)  2/62 (3.23%) 
Abdominal pain upper  1  0/46 (0.00%)  3/58 (5.17%)  0/62 (0.00%) 
Infections and infestations       
Nasopharyngitis  1  5/46 (10.87%)  10/58 (17.24%)  8/62 (12.90%) 
Psychiatric disorders       
Insomnia  1  1/46 (2.17%)  3/58 (5.17%)  0/62 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Epistaxis  1  2/46 (4.35%)  5/58 (8.62%)  3/62 (4.84%) 
Skin and subcutaneous tissue disorders       
Haemorrhage subcutaneous  1  1/46 (2.17%)  7/58 (12.07%)  3/62 (4.84%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01136408     History of Changes
Other Study ID Numbers: 1160.49
First Submitted: May 19, 2010
First Posted: June 3, 2010
Results First Submitted: November 18, 2010
Results First Posted: December 17, 2010
Last Update Posted: March 19, 2014