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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02104947
Registration number
NCT02104947
Ethics application status
Date submitted
2/04/2014
Date registered
7/04/2014
Date last updated
5/01/2018
Titles & IDs
Public title
Reversal of Dabigatran Anticoagulant Effect With Idarucizumab
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Scientific title
A Phase III Case Series Clinical Study of the Reversal of the Anticoagulant Effects of Dabigatran by Intravenous Administration of 5.0g Idarucizumab (BI 655075) in Patients Treated Wtih Dabigatran Etexilate Who Have Uncontrolled Bleeding or Require Emergency Surgery or Procedures.RE-VERSE AD (A Study of the RE-VERSal Effects of Idarucizumab on Active Dabigatran) Trial
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Secondary ID [1]
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0
2013-004813-41
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Secondary ID [2]
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1321.3
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hemorrhage
0
0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - idarucizumab
Experimental: idarucizumab - idarucizumab Only 1 treatment, no placebo or comparator
Treatment: Drugs: idarucizumab
idarucizumab
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Intervention code [1]
0
0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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0
Maximum Reversal of Anticoagulant Effect of Dabigatran Based on Central Laboratory Determination of dTT or ECT
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Assessment method [1]
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Maximum reversal of anticoagulant effect of dabigatran based on central laboratory determination of diluted thrombin time (dTT) or ecarin clotting time (ECT), at any time point from the end of the first infusion up to 4 hours after the last infusion.
Reversal is defined for patients with at least one post-dose coagulation test results and pre-dose result higher than 100% ULN (evaluable patients).
Reversal is calculated as 100\* (pre-dose value minus post dose value)/(pre-dose value minus 100% x ULN); if calculated reversal is \> 100, it was set to 100.
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Timepoint [1]
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from the end of the first infusion up to 4 hours after the last infusion on Day 1
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Secondary outcome [1]
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Reversal of aPTT and TT From Central Laboratory
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Assessment method [1]
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Reversal of anticoagulation as measured by Activated Partial Thromboplastin Time (aPTT) and Thrombin time (TT), at any time point since the end of first infusion up to 4 hours after the completion of the last infusion. Reversal is defined for patients with at least one post-dose coagulation test results and pre-dose result higher than 100% ULN (evaluable patients).
Reversal is calculated as 100\* (pre-dose value minus post dose value)/(pre-dose value minus 100% x ULN); if calculated reversal is \> 100, it was set to 100.
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Timepoint [1]
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0
from the end of the first infusion up to 4 hours after the last infusion on Day 1
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Secondary outcome [2]
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Duration of Reversal
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Assessment method [2]
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Duration of reversal, defined as the time period a patient remained completely reversed based on dTT or ECT, up to 24 hours or re-starting the treatment of dabigatran.
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Timepoint [2]
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from the first infusion up to 24 hours after the last infusion on Day 1
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Secondary outcome [3]
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Occurrence of Major/Life-threatening/Fatal Bleeding (for Group B Only) Intraoperatively
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Assessment method [3]
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Occurrence of major/life-threatening/fatal bleeding (for group B only) intraoperatively and up to 24 hours post-surgery were classified according to major or life-threatening bleeding (ISTH \[International Society for Thrombosis and Hemostasis\] definition). 95% Confidence Interval (CI) is from Clopper-Pearson method.
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Timepoint [3]
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within 24 hours of surgery
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Secondary outcome [4]
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Time to Cessation of Bleeding (for Group A Only)
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Assessment method [4]
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Time to cessation of bleeding (for Group A only) since first infusion up to 24 hours after the completion of second infusion; bleeding status was to be categorized before and at several time points after treatment.
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Timepoint [4]
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from the first infusion up to 24 hours after the last infusion on Day 1
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Secondary outcome [5]
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Cmin,1 of Unbound Sum (Free) Dabigatran
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Assessment method [5]
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Cmin,1 (Minimum concentrations at any time point since the end of first vial of idarucizumab up to 4 hours after the completion of second vial) of unbound sum (free) dabigatran, provided that two vials given not more than 15 min apart in group A and B.
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Timepoint [5]
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Since the end of first vial of idarucizumab up to 4 hours after the completion of second vial
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Secondary outcome [6]
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Reversal of Anticoagulation as Measured by Diluted Thrombin Time (dTT) or Ecarin Clotting Time (ECT) After the First Vial of Idarucizumab and Before the Start of Second Vial
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Assessment method [6]
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Reversal of anticoagulation as measured by diluted Thrombin Time (dTT) or Ecarin Clotting Time (ECT) after the first vial of idarucizumab and before the start of second vial.
Reversal is defined for patients with at least one post-dose coagulation test results and pre-dose result higher than 100% ULN (evaluable patients). Reversal is calculated as 100\*(pre-dose value minus post dose value)/(pre-dose value minus 100% x ULN); if calculated reversal is \> 100, it was set to 100.
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Timepoint [6]
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after the first vial of idarucizumab and before the start of second vial on Day1
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Eligibility
Key inclusion criteria
Inclusion criteria:
* Group A (Bleeding patients)
* Overt bleeding judged by the physician to require a reversal agent
* Currently taking dabigatran etexilate
* At least 18 years of age
* Written informed consent
* Group B (Patients who are taking dabigatran who may not be bleeding, but do require an emergency surgery or procedure for a condition other than bleeding
* Condition requiring emergency surgery or invasive procedure where adequate hemostasis is required. Emergency is defined as within the following 8 hours.
* Current treatment with dabigatran
* At least 18 years of age
* Written Informed consent.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria:
* Group A (Bleeding Patients)
* Patients with minor bleeds (epistaxis, hematuria) who can be managed with standard supportive care.
* Patients with no clinical signs of bleeding
* Contraindications to study medication including known hypersensitivity to the drug or its excipients.
* Group B (Patients who require emergency surgery or procedure)
* A surgery or procedure which is elective or where the risk of uncontrolled or unmanageable bleeding is low.
* Contraindications to study medication including known hypersensitivity to the drug or its excipients (subjects with hereditary fructose intolerance may react to sorbitol).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
6/05/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
20/10/2016
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Sample size
Target
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Accrual to date
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Final
503
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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Concord Repatriation General Hospital - Concord
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St George Hospital - Kogarah
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Royal North Shore Hospital - St Leonards
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Westmead Hospital-Clinical Haematology Dept - Westmead
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Flinders Medical Centre - Bedford Park
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St. Vincents Hospital (MEL) - Fitzroy
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2139 - Concord
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2217 - Kogarah
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2065 - St Leonards
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2145 - Westmead
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5042 - Bedford Park
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3065 - Fitzroy
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Recruitment outside Australia
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Saint Petersburg
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Russian Federation
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Singapore
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Singapore
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South Africa
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Sandton
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Alicante
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Barcelona
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Madrid
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Valencia
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Zaragoza
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Sweden
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Göteborg
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Sweden
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Lund
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Sweden
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Uppsala
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Taiwan
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Taiwan
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Taipei
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United Kingdom
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Basingstoke
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Liverpool
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United Kingdom
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London
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United Kingdom
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Oxford
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United Kingdom
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Southampton
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United Kingdom
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Taunton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Boehringer Ingelheim
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Summary
Brief summary
Evaluate the reversal of the anticoagulant effects of dabigatran by IV administration of 5.0g idarucizumab in patients treated with dabigatran etexilate who have uncontrolled bleeding or require emergency surgery or procedures.
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Trial website
https://clinicaltrials.gov/study/NCT02104947
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Trial related presentations / publications
Eikelboom JW, van Ryn J, Reilly P, Hylek EM, Elsaesser A, Glund S, Pollack CV, Weitz JI. Dabigatran Reversal With Idarucizumab in Patients With Renal Impairment. J Am Coll Cardiol. 2019 Oct 8;74(14):1760-1768. doi: 10.1016/j.jacc.2019.07.070. Glund S, Coble K, Gansser D, Stangier J, Hoermann K, Pollack CV, Reilly P. Pharmacokinetics of idarucizumab and its target dabigatran in patients requiring urgent reversal of the anticoagulant effect of dabigatran. J Thromb Haemost. 2019 Aug;17(8):1319-1328. doi: 10.1111/jth.14476. Epub 2019 Jun 18. Van der Wall SJ, Lopes RD, Aisenberg J, Reilly P, van Ryn J, Glund S, Elsaesser A, Klok FA, Pollack CV Jr, Huisman MV. Idarucizumab for Dabigatran Reversal in the Management of Patients With Gastrointestinal Bleeding. Circulation. 2019 Feb 5;139(6):748-756. doi: 10.1161/CIRCULATIONAHA.118.036710. Erratum In: Circulation. 2019 Feb 5;139(6):e36. doi: 10.1161/CIR.0000000000000660. Pollack CV Jr, Reilly PA, van Ryn J, Eikelboom JW, Glund S, Bernstein RA, Dubiel R, Huisman MV, Hylek EM, Kam CW, Kamphuisen PW, Kreuzer J, Levy JH, Royle G, Sellke FW, Stangier J, Steiner T, Verhamme P, Wang B, Young L, Weitz JI. Idarucizumab for Dabigatran Reversal - Full Cohort Analysis. N Engl J Med. 2017 Aug 3;377(5):431-441. doi: 10.1056/NEJMoa1707278. Epub 2017 Jul 11. Pollack CV Jr, Reilly PA, Eikelboom J, Glund S, Verhamme P, Bernstein RA, Dubiel R, Huisman MV, Hylek EM, Kamphuisen PW, Kreuzer J, Levy JH, Sellke FW, Stangier J, Steiner T, Wang B, Kam CW, Weitz JI. Idarucizumab for Dabigatran Reversal. N Engl J Med. 2015 Aug 6;373(6):511-20. doi: 10.1056/NEJMoa1502000. Epub 2015 Jun 22. Pollack CV Jr, Reilly PA, Bernstein R, Dubiel R, Eikelboom J, Glund S, Huisman MV, Hylek E, Kam CW, Kamphuisen PW, Kreuzer J, Levy JH, Sellke F, Stangier J, Steiner T, Wang B, Weitz JI. Design and rationale for RE-VERSE AD: A phase 3 study of idarucizumab, a specific reversal agent for dabigatran. Thromb Haemost. 2015 Jul;114(1):198-205. doi: 10.1160/TH15-03-0192. Epub 2015 May 28.
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Public notes
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Contacts
Principal investigator
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Boehringer Ingelheim
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Boehringer Ingelheim
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02104947
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