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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00558259
First received: November 13, 2007
Last updated: February 28, 2013
Last verified: February 2013
History of Changes
Results First Received: January 31, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Prevention
Condition: Venous Thromboembolism
Interventions: Drug: dabigatran etexilate 150 mg twice daily (BID)
Drug: matching placebo twice daily (BID)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Dabigatran Dabigatran 150mg bid (twice daily)
Placebo Matching placebo

Participant Flow:   Overall Study
    Dabigatran     Placebo  
STARTED     681 [1]   662 [2]
COMPLETED     610 [3]   563 [3]
NOT COMPLETED     71     99  
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.



  Baseline Characteristics
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Reporting Groups
  Description
Dabigatran Dabigatran 150mg bid
Placebo Matching placebo
Total Total of all reporting groups

Baseline Measures
    Dabigatran     Placebo     Total  
Number of Participants  
[units: participants]
 		  681     662     1343  
Age  
[units: Years]
Mean ± Standard Deviation 		  56.1  ± 15.5     55.5  ± 15.1     55.8  ± 15.3  
Gender  
[units: Participants]
 		     
Female     300     298     598  
Male     381     364     745  
Body mass index (BMI) continuous  
[units: kg/m^2]
Mean ± Standard Deviation 		  28.45  ± 5.44     28.41  ± 5.56     28.43  ± 5.50  



  Outcome Measures
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1.  Primary:   Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Including Unexplained Death During the Intended Treatment Period   [ Time Frame: 6 months ]
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2.  Secondary:   Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Excluding Unexplained Death During the Intended Treatment Period   [ Time Frame: 6 months ]
  Show Outcome Measure 2

3.  Secondary:   Centrally Confirmed Symptomatic Recurrent Deep Venous Thrombotic (DVT) Events During the Intended Treatment Period   [ Time Frame: 6 months ]
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4.  Secondary:   Centrally Confirmed Symptomatic Pulmonary Embolism (PE) Events During the Intended Treatment Period   [ Time Frame: 6 months ]
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5.  Secondary:   Centrally Confirmed Unexplained Deaths During the Intended Treatment Period   [ Time Frame: 6 months ]
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6.  Secondary:   First Centrally Confirmed Major Bleeding Event (MBE) During the Treatment Period   [ Time Frame: 6 months ]
  Show Outcome Measure 6


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


No publications provided by Boehringer Ingelheim Pharmaceuticals

Publications automatically indexed to this study:


Responsible Party: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00558259     History of Changes
Other Study ID Numbers: 1160.63, 2007-002586-12
Study First Received: November 13, 2007
Results First Received: January 31, 2012
Last Updated: February 28, 2013
Health Authority: Australia: Dept of Health and Ageing Therapeutic Goods Admin
Austria: Federal Office for Safety in Health Care
Belgium: Federal Agency for Medicines and Health Products
Canada: Health Canada
Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10
Estonia: State Agency of Medicines, EE-5041Tartu
Germany: BfArM-Federal Authorities for Drugs and Medical Devices
Italy: Comitato di Bioetica dell'Azienda Ospedaliero-Universitaria Policlinico "Giaccone" di Palermo
Korea, Republic of: Korea Drug and Food Administration
Latvia: State Agency of Medicines, LV-1003 Riga
Lithuania: State Medicines Control Agency, LT-01132 Vilnius
Netherlands: Central Committee on Research Involving Human Subjects (CCMO)
New Zealand: Multicentre Ethics Committee/Medsafe
Poland: Registration Medicinal Product Medical Device Biocidal Product
Russia: Pharmacological Committee, Ministry of Health
Singapore: Health Sciences Authority,Ministry of Health
South Africa: Medicines Control Council
Sweden: Medical Products Agency Regional Ethics Committee of Gothenburg
Switzerland: Swissmedic Schweizerisches Heilmittelinstitut (Swiss Agency for Therapeutic Products
Thailand: Ministry of Public Health
United States: Food and Drug Administration