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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-002285-21 | EudraCT Number | EudraCT |
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To collect additional data relating to safety and indicators of efficacy for patients who have participated in the 1160.113 study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dabigatran etexilate | Experimental | Patient dose determined by dose allocated in 1160.113 and CrCl levels |
|
| warfarin | Active Comparator | warfarin doses to maintain INR levels |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dabigatran etexilate low dose | Drug | active treatment (low) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Any Adverse Event (AE) | Percentage of patients with Adverse Events. Prespecified clinical outcome events were not recorded as Adverse Events. | From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With AEs Leading to Discontinuation of Trial Drug | Percentage of patients with Adverse Events leading to discontinuation of trial drug. Prespecified clinical outcome events were not recorded as Adverse Events. | From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days) |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1160.138.32003 Boehringer Ingelheim Investigational Site | Brussels | Belgium | ||||
| 1160.138.32002 Boehringer Ingelheim Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23991661 | Derived | Eikelboom JW, Connolly SJ, Brueckmann M, Granger CB, Kappetein AP, Mack MJ, Blatchford J, Devenny K, Friedman J, Guiver K, Harper R, Khder Y, Lobmeyer MT, Maas H, Voigt JU, Simoons ML, Van de Werf F; RE-ALIGN Investigators. Dabigatran versus warfarin in patients with mechanical heart valves. N Engl J Med. 2013 Sep 26;369(13):1206-14. doi: 10.1056/NEJMoa1300615. Epub 2013 Aug 31. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dabigatran Etexilate (DE) | Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily. |
| FG001 | Warfarin | Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| warfarin 5mg |
| Drug |
comparator warfarin |
|
| dabigatran etexilate intermediate dose | Drug | active treatment (medium) |
|
| warfarin 1mg | Drug | comparator warfarin |
|
| dabigatran etexilate high dose | Drug | active treatment (high) |
|
| warfarin 3mg | Drug | comparator warfarin |
|
| Percentage of Patients With Serious AEs |
Percentage of patients with Serious Adverse Events (SAE). Prespecified clinical outcome events were not recorded as Adverse Events. |
| From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days) |
| Percentage of Deaths, Venous Thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attacks (TIA), Strokes, Systemic Embolism, and Valve Thrombosis. | Clinical efficacy outcome events presented are: Death, Venous thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attack (TIA), Stroke, Systemic embolism and Valve thrombosis | From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days) |
| Genk |
| Belgium |
| 1160.138.32001 Boehringer Ingelheim Investigational Site | Leuven | Belgium |
| 1160.138.11001 Boehringer Ingelheim Investigational Site | Saint John | New Brunswick | Canada |
| 1160.138.11009 Boehringer Ingelheim Investigational Site | Hamilton | Ontario | Canada |
| 1160.138.11011 Boehringer Ingelheim Investigational Site | London | Ontario | Canada |
| 1160.138.11012 Boehringer Ingelheim Investigational Site | Newmarket | Ontario | Canada |
| 1160.138.11007 Boehringer Ingelheim Investigational Site | Toronto | Ontario | Canada |
| 1160.138.42002 Boehringer Ingelheim Investigational Site | Brno | Czechia |
| 1160.138.42003 Boehringer Ingelheim Investigational Site | Olomouc | Czechia |
| 1160.138.42004 Boehringer Ingelheim Investigational Site | Ostrava | Czechia |
| 1160.138.42001 Boehringer Ingelheim Investigational Site | Prague | Czechia |
| 1160.138.45001 Boehringer Ingelheim Investigational Site | Copenhagen | Denmark |
| 1160.138.45002 Boehringer Ingelheim Investigational Site | Odense C | Denmark |
| 1160.138.33004 Boehringer Ingelheim Investigational Site | Bron | France |
| 1160.138.33001 Boehringer Ingelheim Investigational Site | Paris | France |
| 1160.138.33002 Boehringer Ingelheim Investigational Site | Pessac | France |
| 1160.138.33003 Boehringer Ingelheim Investigational Site | Rennes | France |
| 1160.138.49001 Boehringer Ingelheim Investigational Site | Dresden | Germany |
| 1160.138.49002 Boehringer Ingelheim Investigational Site | Essen | Germany |
| 1160.138.49004 Boehringer Ingelheim Investigational Site | Freiburg im Breisgau | Germany |
| 1160.138.49003 Boehringer Ingelheim Investigational Site | Heidelberg | Germany |
| 1160.138.49010 Boehringer Ingelheim Investigational Site | Witten | Germany |
| 1160.138.31002 Boehringer Ingelheim Investigational Site | Amsterdam | Netherlands |
| 1160.138.31004 Boehringer Ingelheim Investigational Site | Breda | Netherlands |
| 1160.138.47002 Boehringer Ingelheim Investigational Site | Bergen | Norway |
| 1160.138.47001 Boehringer Ingelheim Investigational Site | Oslo | Norway |
| 1160.138.48004 Boehringer Ingelheim Investigational Site | Gdansk | Poland |
| 1160.138.48003 Boehringer Ingelheim Investigational Site | Warsaw | Poland |
| 1160.138.48001 Boehringer Ingelheim Investigational Site | Wroclaw | Poland |
| COMPLETED |
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| NOT COMPLETED |
|
|
Treated set (TRT): The TRT comprised all patients who were documented to have taken at least 1 dose of study drug
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| ID | Title | Description |
|---|---|---|
| BG000 | Dabigatran Etexilate (DE) | Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily |
| BG001 | Warfarin | Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Patients With Any Adverse Event (AE) | Percentage of patients with Adverse Events. Prespecified clinical outcome events were not recorded as Adverse Events. | Treated set (TRT): The TRT comprised all patients who were documented to have taken at least 1 dose of study drug | Posted | Number | percentage of participants | From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days) |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With AEs Leading to Discontinuation of Trial Drug | Percentage of patients with Adverse Events leading to discontinuation of trial drug. Prespecified clinical outcome events were not recorded as Adverse Events. | Treated set (TRT): The TRT comprised all patients who were documented to have taken at least 1 dose of study drug | Posted | Number | percentage of participants | From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With Serious AEs | Percentage of patients with Serious Adverse Events (SAE). Prespecified clinical outcome events were not recorded as Adverse Events. | Treated set (TRT): The TRT comprised all patients who were documented to have taken at least 1 dose of study drug | Posted | Number | percentage of participants | From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Deaths, Venous Thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attacks (TIA), Strokes, Systemic Embolism, and Valve Thrombosis. | Clinical efficacy outcome events presented are: Death, Venous thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attack (TIA), Stroke, Systemic embolism and Valve thrombosis | Treated set (TRT): The TRT comprised all patients who were documented to have taken at least 1 dose of study drug | Posted | Number | percentage of participants | From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days) |
|
|
From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)
Patients are presented according to the treatment they received except for 2 patients, who mistakenly switched to study warfarin during the study. These patients are presented under the Dabigatran columns only.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dabigatran Etexilate | Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily | 3 | 99 | 5 | 99 | ||
| EG001 | Warfarin | Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator | 4 | 59 | 4 | 59 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Fibrocystic breast disease | Reproductive system and breast disorders | MEDDRA 16.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | MEDDRA 16.0 | Systematic Assessment |
|
This study was terminated prematurely due to safety concerns arising during conduct of the trial.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000069604 | Dabigatran |
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
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| Male |
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