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Twice-daily Oral Direct Thrombin Inhibitor Dabigatran Etexilate in the Long Term Prevention of Recurrent Symptomatic VTE (RE-SONATE)

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ClinicalTrials.gov Identifier: NCT00558259
Recruitment Status : Completed
First Posted : November 14, 2007
Results First Posted : March 2, 2012
Last Update Posted : June 27, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Prevention
Condition Venous Thromboembolism
Interventions Drug: dabigatran etexilate 150 mg twice daily (BID)
Drug: matching placebo twice daily (BID)
Enrollment 1353
Recruitment Details  
Pre-assignment Details There were 3 patients randomised to placebo who received Dabigatran only. For all analyses of efficacy, these patients are analysed as randomised. For all analyses of safety, these patients are analysed as treated.
Arm/Group Title Dabigatran Placebo
Hide Arm/Group Description Dabigatran 150mg bid (twice daily) Matching placebo
Period Title: Overall Study
Started 681 [1] 662 [2]
Completed 610 [3] 563 [3]
Not Completed 71 99
Reason Not Completed
Adverse Event             50             81
Protocol Violation             9             5
Withdrawal by Subject             12             13
[1]
Number who started treatment. There were 4 patients randomised to Dabigatran and not treated.
[2]
Number who started treatment. There were 6 patients randomised to placebo and not treated.
[3]
Completed treatment.
Arm/Group Title Dabigatran Placebo Total
Hide Arm/Group Description Dabigatran 150mg bid Matching placebo Total of all reporting groups
Overall Number of Baseline Participants 681 662 1343
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 681 participants 662 participants 1343 participants
56.1  (15.5) 55.5  (15.1) 55.8  (15.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 681 participants 662 participants 1343 participants
Female
300
  44.1%
298
  45.0%
598
  44.5%
Male
381
  55.9%
364
  55.0%
745
  55.5%
Body mass index (BMI) continuous  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 681 participants 662 participants 1343 participants
28.45  (5.44) 28.41  (5.56) 28.43  (5.50)
1.Primary Outcome
Title Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Including Unexplained Death During the Intended Treatment Period
Hide Description Symptomatic recurrent VTE is the composite of recurrent deep vein thrombosis (DVT) , fatal or non-fatal pulmonary embolism (PE). Whilst the endpoint is time to event, the measured values present the number of participant with event and the hazard ratio presents the time to event.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) and analysed as randomised. FAS is defined as randomised and treated.
Arm/Group Title Dabigatran Placebo
Hide Arm/Group Description:
Dabigatran 150mg bid
Matching placebo
Overall Number of Participants Analyzed 681 662
Measure Type: Number
Unit of Measure: Participants
3 37
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran, Placebo
Comments Dabigatran vs placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.08
Confidence Interval 95%
0.02 to 0.25
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.05
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Excluding Unexplained Death During the Intended Treatment Period
Hide Description Symptomatic recurrent VTE is the composite of recurrent deep vein thrombosis (DVT) , fatal or non-fatal pulmonary embolism (PE). Whilst the endpoint is time to event, the measured values present the number of participant with event and the hazard ratio presents the time to event.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS and analysed as randomised.
Arm/Group Title Dabigatran Placebo
Hide Arm/Group Description:
Dabigatran 150mg bid
Matching placebo
Overall Number of Participants Analyzed 681 662
Measure Type: Number
Unit of Measure: Participants
3 35
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran, Placebo
Comments Dabigatran vs placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.08
Confidence Interval 95%
0.03 to 0.27
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.05
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Centrally Confirmed Symptomatic Recurrent Deep Venous Thrombotic (DVT) Events During the Intended Treatment Period
Hide Description Number of the participants with centrally confirmed symptomatic recurrent deep venous thrombotic (DVT) events during the intended treatment period were described.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS and analysed as randomised.
Arm/Group Title Dabigatran Placebo
Hide Arm/Group Description:
Dabigatran 150mg bid
Matching placebo
Overall Number of Participants Analyzed 681 662
Measure Type: Number
Unit of Measure: Participants
2 23
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dabigatran
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of participants with events
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
0.04 to 1.06
Estimation Comments The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants experiencing DVT in Dabigatran group.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of participants with events
Estimated Value 3.5
Confidence Interval (2-Sided) 95%
2.21 to 5.17
Estimation Comments The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants experiencing DVT in placebo group.
4.Secondary Outcome
Title Centrally Confirmed Symptomatic Pulmonary Embolism (PE) Events During the Intended Treatment Period
Hide Description Number of participants with centrally confirmed symptomatic pulmonary embolism (PE) events during the intended treatment period were described.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS and analysed as randomised.
Arm/Group Title Dabigatran Placebo
Hide Arm/Group Description:
Dabigatran 150mg bid
Matching placebo
Overall Number of Participants Analyzed 681 662
Measure Type: Number
Unit of Measure: Participants
1 14
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran, Placebo
Comments Dabigatran vs. Placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dabigatran
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of participants with events
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
0.00 to 0.82
Estimation Comments The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants experiencing PE in Dabigatran group.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of participants with events
Estimated Value 2.1
Confidence Interval (2-Sided) 95%
1.16 to 3.52
Estimation Comments The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants experiencing PE in placebo group.
5.Secondary Outcome
Title Centrally Confirmed Unexplained Deaths During the Intended Treatment Period
Hide Description Number of participants with centrally confirmed unexplained deaths during the intended treatment period were described.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS and analysed as randomised.
Arm/Group Title Dabigatran Placebo
Hide Arm/Group Description:
Dabigatran 150mg bid
Matching placebo
Overall Number of Participants Analyzed 681 662
Measure Type: Number
Unit of Measure: participants
0 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran, Placebo
Comments Dabigatran vs. Placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2428
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dabigatran
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of participants with events
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
0.00 to 0.54
Estimation Comments The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants with unexplained death in Dabigatran group.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of participants with events
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
0.04 to 1.09
Estimation Comments The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants with unexplained death in placebo group.
6.Secondary Outcome
Title Centrally Confirmed Bleeding Event During the Treatment Period
Hide Description

Major bleeding events (MBE) had to fulfil at least 1 of the following criteria:

  • Fatal bleeding
  • Associated with a fall in haemoglobin of ≥2 g/dL
  • Led to the transfusion of ≥2 units packed cells or whole blood
  • Occurred in a critical site: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal

Other clinically relevant bleeding was defined as overt bleeding not meeting the criteria for an MBE but associated with medical intervention, unscheduled contact with a physician, (temporary) cessation of study treatment, or associated with discomfort such as pain, or impairment of activities of daily life.

Examples of these bleedings were:

  • Bleeding that compromised haemodynamics
  • Bleeding that led to hospitalisation

Trivial bleeding events were defined as all other bleeding events that did not fulfil the criteria of MBEs or CRBEs.

All bleeding events include MBEs, CRBEs, and trivial bleeding events.

Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS and analysed as treated. There were 3 participants who were randomised to placebo but treated with dabigatran only.
Arm/Group Title Dabigatran Placebo
Hide Arm/Group Description:
Dabigatran 150mg bid
Matching placebo
Overall Number of Participants Analyzed 684 659
Measure Type: Number
Unit of Measure: participants
MBE 2 0
MBE or CRBE 36 12
All Bleeding 72 39
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran, Placebo
Comments Dabigatran vs. Placebo - Analysis of time to first occurrence of an MBE during the treatment period - FAS - as treated.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4998
Comments As the Cox model did not converge due to too few events, hazard ratios are not estimable.
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dabigatran
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of participants with events
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
0.04 to 1.05
Estimation Comments The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants experiencing MBE in Dabigatran group.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of participants with events
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
0.00 to 0.56
Estimation Comments The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants experiencing MBE in placebo group.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Dabigatran, Placebo
Comments Dabigatran vs. Placebo- Analysis of time to first occurrence of a MBE or CRBE during the treatment period - FAS - as treated.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0013
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 2.92
Confidence Interval (2-Sided) 95%
1.52 to 5.60
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.97
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Dabigatran, Placebo
Comments Dabigatran vs. Placebo- Analysis of time to first occurrence of any bleeding event during the treatment period - FAS - as treated
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0027
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.82
Confidence Interval (2-Sided) 95%
1.23 to 2.68
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.36
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Centrally Confirmed Cardiovascular Events During the Treatment Period
Hide Description Cardiovascular events that occurred during the treatment period + 3 days were summarised by treatment groups.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS and analysed as treated. There were 3 participants who were randomised to placebo but treated with dabigatran only.
Arm/Group Title Dabigatran Placebo
Hide Arm/Group Description:
Dabigatran 150mg bid
Matching placebo
Overall Number of Participants Analyzed 684 659
Measure Type: Number
Unit of Measure: participants
3 2
8.Secondary Outcome
Title Laboratory Measures, Especially Liver Function Tests (LFTs)
Hide Description Number of participants with possible clinically significant abnormalities during the treatment period.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS − As Treated Assignment
Arm/Group Title Dabigatran Placebo
Hide Arm/Group Description:
Dabigatran 150mg bid
Matching placebo
Overall Number of Participants Analyzed 684 659
Measure Type: Number
Unit of Measure: participants
AST increase (N=655, 629) 2 2
ALT increase (N=655, 629) 3 5
Alkaline phosphatase increase (N=658, 629) 0 0
Total bilirubin increase (N=658, 628) 1 1
Time Frame 6 months
Adverse Event Reporting Description There were 3 patients who were randomised to placebo but who were treated with dabigatran only.
 
Arm/Group Title Dabigatran Placebo
Hide Arm/Group Description Dabigatran 150mg bid Matching placebo
All-Cause Mortality
Dabigatran Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Dabigatran Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   47/684 (6.87%)   60/659 (9.10%) 
Blood and lymphatic system disorders     
Anaemia  1  1/684 (0.15%)  0/659 (0.00%) 
Splenomegaly  1  0/684 (0.00%)  1/659 (0.15%) 
Cardiac disorders     
Acute myocardial infarction  1  1/684 (0.15%)  1/659 (0.15%) 
Angina pectoris  1  0/684 (0.00%)  1/659 (0.15%) 
Atrial fibrillation  1  0/684 (0.00%)  2/659 (0.30%) 
Cardiac failure  1  1/684 (0.15%)  0/659 (0.00%) 
Hypertensive heart disease  1  0/684 (0.00%)  1/659 (0.15%) 
Ear and labyrinth disorders     
Vertigo  1  0/684 (0.00%)  1/659 (0.15%) 
Eye disorders     
Amaurosis fugax  1  1/684 (0.15%)  0/659 (0.00%) 
Optic ischaemic neuropathy  1  1/684 (0.15%)  0/659 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1  1/684 (0.15%)  0/659 (0.00%) 
Abdominal pain upper  1  1/684 (0.15%)  0/659 (0.00%) 
Colitis  1  1/684 (0.15%)  0/659 (0.00%) 
Colonic polyp  1  1/684 (0.15%)  0/659 (0.00%) 
Enteritis  1  1/684 (0.15%)  0/659 (0.00%) 
Gastric ulcer  1  0/684 (0.00%)  1/659 (0.15%) 
Gastric ulcer haemorrhage  1  1/684 (0.15%)  0/659 (0.00%) 
Gastritis  1  1/684 (0.15%)  0/659 (0.00%) 
Haematemesis  1  0/684 (0.00%)  1/659 (0.15%) 
Inguinal hernia  1  0/684 (0.00%)  2/659 (0.30%) 
Nausea  1  1/684 (0.15%)  1/659 (0.15%) 
Rectal haemorrhage  1  1/684 (0.15%)  0/659 (0.00%) 
Vomiting  1  1/684 (0.15%)  1/659 (0.15%) 
General disorders     
Chest pain  1  2/684 (0.29%)  1/659 (0.15%) 
Oedema  1  1/684 (0.15%)  0/659 (0.00%) 
Pain  1  0/684 (0.00%)  1/659 (0.15%) 
Polyp  1  1/684 (0.15%)  0/659 (0.00%) 
Pyrexia  1  0/684 (0.00%)  2/659 (0.30%) 
Unevaluable event  1  0/684 (0.00%)  1/659 (0.15%) 
Hepatobiliary disorders     
Cholestasis  1  1/684 (0.15%)  0/659 (0.00%) 
Infections and infestations     
Abscess limb  1  1/684 (0.15%)  0/659 (0.00%) 
Anal abscess  1  0/684 (0.00%)  1/659 (0.15%) 
Arthritis infective  1  0/684 (0.00%)  1/659 (0.15%) 
Lobar pneumonia  1  1/684 (0.15%)  0/659 (0.00%) 
Pneumonia  1  2/684 (0.29%)  2/659 (0.30%) 
Salmonella bacteraemia  1  0/684 (0.00%)  1/659 (0.15%) 
Salmonellosis  1  0/684 (0.00%)  1/659 (0.15%) 
Urinary tract infection  1  1/684 (0.15%)  0/659 (0.00%) 
Injury, poisoning and procedural complications     
Fall  1  1/684 (0.15%)  2/659 (0.30%) 
Femur fracture  1  1/684 (0.15%)  0/659 (0.00%) 
Head injury  1  0/684 (0.00%)  1/659 (0.15%) 
Joint injury  1  0/684 (0.00%)  1/659 (0.15%) 
Post procedural haemorrhage  1  1/684 (0.15%)  0/659 (0.00%) 
Radius fracture  1  2/684 (0.29%)  0/659 (0.00%) 
Rib fracture  1  0/684 (0.00%)  3/659 (0.46%) 
Scapula fracture  1  0/684 (0.00%)  1/659 (0.15%) 
Skin laceration  1  0/684 (0.00%)  1/659 (0.15%) 
Thermal burn  1  1/684 (0.15%)  0/659 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/684 (0.15%)  0/659 (0.00%) 
Arthrofibrosis  1  1/684 (0.15%)  0/659 (0.00%) 
Back pain  1  2/684 (0.29%)  0/659 (0.00%) 
Intervertebral disc protrusion  1  1/684 (0.15%)  0/659 (0.00%) 
Musculoskeletal chest pain  1  0/684 (0.00%)  1/659 (0.15%) 
Musculoskeletal pain  1  0/684 (0.00%)  1/659 (0.15%) 
Osteoarthritis  1  2/684 (0.29%)  0/659 (0.00%) 
Rheumatoid arthritis  1  0/684 (0.00%)  1/659 (0.15%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma pancreas  1  1/684 (0.15%)  0/659 (0.00%) 
Breast neoplasm  1  0/684 (0.00%)  1/659 (0.15%) 
Chronic lymphocytic leukaemia  1  0/684 (0.00%)  1/659 (0.15%) 
Colon cancer  1  1/684 (0.15%)  0/659 (0.00%) 
Gastric cancer  1  1/684 (0.15%)  0/659 (0.00%) 
Lung adenocarcinoma  1  1/684 (0.15%)  0/659 (0.00%) 
Lung neoplasm  1  0/684 (0.00%)  1/659 (0.15%) 
Metastases to bladder  1  0/684 (0.00%)  1/659 (0.15%) 
Ovarian neoplasm  1  1/684 (0.15%)  0/659 (0.00%) 
Prostate cancer  1  1/684 (0.15%)  1/659 (0.15%) 
Rectal cancer stage I  1  1/684 (0.15%)  0/659 (0.00%) 
Squamous cell carcinoma  1  1/684 (0.15%)  0/659 (0.00%) 
Nervous system disorders     
Chronic inflammatory demyelinating polyradiculoneuropathy  1  1/684 (0.15%)  0/659 (0.00%) 
Diabetic hyperglycaemic coma  1  1/684 (0.15%)  0/659 (0.00%) 
Hydrocephalus  1  0/684 (0.00%)  1/659 (0.15%) 
Ischaemic stroke  1  0/684 (0.00%)  1/659 (0.15%) 
Nerve compression  1  1/684 (0.15%)  0/659 (0.00%) 
Psychiatric disorders     
Personality disorder  1  1/684 (0.15%)  0/659 (0.00%) 
Reproductive system and breast disorders     
Metrorrhagia  1  0/684 (0.00%)  1/659 (0.15%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  2/684 (0.29%)  4/659 (0.61%) 
Dyspnoea  1  1/684 (0.15%)  2/659 (0.30%) 
Lung disorder  1  1/684 (0.15%)  0/659 (0.00%) 
Pleural effusion  1  2/684 (0.29%)  0/659 (0.00%) 
Pneumothorax  1  1/684 (0.15%)  0/659 (0.00%) 
Pulmonary artery thrombosis  1  0/684 (0.00%)  1/659 (0.15%) 
Pulmonary embolism  1  1/684 (0.15%)  16/659 (2.43%) 
Pulmonary hypertension  1  0/684 (0.00%)  1/659 (0.15%) 
Pulmonary infarction  1  0/684 (0.00%)  2/659 (0.30%) 
Surgical and medical procedures     
Abdominal wall operation  1  0/684 (0.00%)  1/659 (0.15%) 
Vascular disorders     
Deep vein thrombosis  1  2/684 (0.29%)  15/659 (2.28%) 
Embolism venous  1  0/684 (0.00%)  1/659 (0.15%) 
Essential hypertension  1  1/684 (0.15%)  0/659 (0.00%) 
Haematoma  1  0/684 (0.00%)  1/659 (0.15%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dabigatran Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/684 (0.00%)   0/659 (0.00%) 
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
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00558259     History of Changes
Other Study ID Numbers: 1160.63
2007-002586-12 ( EudraCT Number: EudraCT )
First Submitted: November 13, 2007
First Posted: November 14, 2007
Results First Submitted: January 31, 2012
Results First Posted: March 2, 2012
Last Update Posted: June 27, 2014