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Trial record 1 of 1 for:    NCT01955720
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Safety, Tolerability, PK and PD of BI 655075 and Establishment of BI 655075 Dose(s) Effective to Reverse Prolongation of Blood Coagulation Time by Dabigatran

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ClinicalTrials.gov Identifier: NCT01955720
Recruitment Status : Completed
First Posted : October 7, 2013
Results First Posted : February 11, 2016
Last Update Posted : February 11, 2016
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition Hemorrhage
Interventions Drug: BI 655075
Drug: Placebo
Enrollment 46
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 5 Ida / Placebo Placebo / 5 Ida 2.5 Ida / Placebo Placebo / 2.5 Ida 1 Ida / Placebo Placebo / 1 Ida
Hide Arm/Group Description Subjects received dabigatran (DE) 220 mg plus idarucizumab (Ida) 5g followed by dabigatran 220 mg plus placebo 5g (high dose) Subjects received dabigatran (DE) 220 mg plus placebo 5g followed by dabigatran 220 mg plus Ida 5g (high dose) Subjects received dabigatran (DE) 220 mg plus Ida 2.5g followed by dabigatran 220 mg plus placebo 2.5g (medium dose) Subjects received dabigatran (DE) 220 mg plus placebo 2.5g followed by dabigatran 220 mg plus Ida 2.5g (medium dose) Subjects received dabigatran (DE) 220 mg plus Ida 1g followed by dabigatran 220 mg plus placebo 1g (low dose) Subjects received dabigatran (DE) 220 mg plus placebo 1g followed by dabigatran 220 mg plus Ida 1g (low dose)
Period Title: Overall Study
Started 13 13 3 3 7 7
Healthy Subjects Aged 45-64 3 3 3 3 0 0
Healthy Subjects Aged 65-80 4 4 0 0 4 4
Subjects With Mild Renal Impairment 3 3 0 0 3 3
Subjects With Moderate Renal Impairment 3 3 0 0 0 0
Completed 13 13 3 3 7 7
Not Completed 0 0 0 0 0 0
Arm/Group Title Total Subjects Group
Hide Arm/Group Description The total subjects group contains the following sub-groups: high dose (5 g idarucizumab), healthy, aged 45-64 yrs: high dose (5 g idarucizumab), healthy elderly, aged 65-80 yrs: high dose (5 g idarucizumab), mild renal impairment (RI), aged 45-80 yrs: high dose (2.5 g + 2.5 g idarucizumab), with moderate RI, aged 45-80 yrs: medium dose (2.5 g idarucizumab), healthy, aged 45-64 yrs: low dose (1 g idarucizumab), healthy elderly, aged 65-80 yrs: low dose (1 g idarucizumab), with mild RI, aged 45-80 yrs.
Overall Number of Baseline Participants 46
Hide Baseline Analysis Population Description
Treated Set
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 46 participants
63.8  (9.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants
Female
19
  41.3%
Male
27
  58.7%
1.Primary Outcome
Title Reversal of Dabigatran-induced Prolongation of Blood Coagulation Time
Hide Description Percentage of subjects with at least one assay value from diluted thrombin time (dTT) or ecarin clotting time (ECT) reversed within 10min after completion of infusion. Reversal was defined as return to baseline, where the threshold for reversal to baseline was determined using PK/PD correlation between unbound sum dabigatran and the clotting parameters ECT and dTT. Measured at the end of the infusion and 10 min later.
Time Frame End of last infusion and 10 minutes after completion of last infusion of BI 655075
Hide Outcome Measure Data
Hide Analysis Population Description
PD Set (PDS): The PDS included all subjects from the TS who had at least 1 evaluable predose and on-treatment coagulation test measurement value for at least 1 coagulation test and who did not have important protocol violation relevant to the evaluation of PD.
Arm/Group Title Placebo Idarucizumab (Ida)
Hide Arm/Group Description:
idarucizumab-matching placebo
Idarucizumab (Ida).
Overall Number of Participants Analyzed 46 46
Measure Type: Number
Unit of Measure: percentage of participants
at least one time point, dTT 0.0 100.0
both time points, dTT 0.0 100.0
at least one time point, ECT 0.0 100.0
both time points, ECT 0.0 100.0
2.Primary Outcome
Title The Percentage of Subjects With Drug-related Adverse Events
Hide Description The percentage of subjects with possibly drug-related AEs (as defined by the investigator) during the treatment period.
Time Frame From baseline up to the start of follow-up period (from Day 1 to Day 35)
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Hide Analysis Population Description
Treated Set (TS): All randomised subjects who received at least 1 dose of trial medication were included in the treated set.
Arm/Group Title On Treatment Group
Hide Arm/Group Description:
during the treatment period.
Overall Number of Participants Analyzed 46
Measure Type: Number
Unit of Measure: percentage of participants
13.0
3.Secondary Outcome
Title AUC0-infinity (Area Under the Concentration-time Curve of Idarucizumab (Ida) in Plasma Over the Time Interval From 0 Extrapolated to Infinity)
Hide Description

AUC0-infinity. PK/PD sampling time: (p=predose, D=day)

  1. single medium or high dose, healthy subjects(HS) mid-age (45-64 yrs): D4: 8:55p, 9:00,9:10,9:30,10:00,11:00,13:00,15:00,19:00,21:00,01:00; D5: 9:00p, 21:00. D6: 9:00.
  2. single low or high dose, HS elderly or mild renal impaired: D4: 8:55p, 9:00,9:10,9:30,10:00,11:00,13:00,15:00,19:00,21:00,01:00; D5: 9:00; D6: 9:00; D7: 9:00; additional sampling for renal impaired: D8: 9:00;D9: 9:00.
  3. high 2 doses, moderate renal impaired: D4: 8:55p, 9:00, 9:10,9:30,9:55p, 10:00,10:10,10:30,11:00, 13:00, 15:00, 19:00, 21:00, 01:00; D5: 9:00; D6: 9:00; D7: 9:00; additional sampling for renal impaired: D8:9:00; D9:9:00.
Time Frame From Day 4 to Day 9 (details in description)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Set -Ida (PKS-Ida): included all treated subjects who have received at least 1 dose of idarucizumab and who provided data for at least 1 secondary or other PK endpoint in any treatment period, which was judged as evaluable for PK and was not affected by protocol violations relevant to the statistical evaluation of PK endpoints.
Arm/Group Title 220 mg/2.5 g HS 45-64 Yrs 220 mg/2.5 g HS 45-64 Yrs Re-exposure 220 mg/5 g HS 45-64 Yrs 220 mg/1 g HS 65-80 Yrs 220 mg/5 g HS 65-80 Yrs 150 mg/1 g Mild Renal Impairment (RI) 150 mg/5 g Mild RI (CL 60-90) 150 mg /2*2.5 g Moderate RI (CL 30-60)
Hide Arm/Group Description:
HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 2.5g.
HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 2.5g and reexposured Ida in period 3
HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 5g.
HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 1g.
HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 5g.
Mild RI (creatinine clearance [CL] 60-90) with dabigatran (DE) 150 mg/Ida 1g
Mild RI (CL 60-90) with dabigatran (DE) 150 mg/Ida 5g
Moderate RI (CL 30-60) with dabigatran (DE) 150 mg and were infused 2 doses of each Ida 2.5g, given 1 h apart.
Overall Number of Participants Analyzed 6 6 6 8 8 6 6 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol*h/L
22200
(12.7%)
20600
(10.6%)
37000
(18.4%)
8560
(15.2%)
43900
(18.7%)
10700
(14.1%)
53100
(11.1%)
67900
(11.6%)
4.Secondary Outcome
Title AUC2-12, ss (Area Under the Concentration-time Curve of Unbound Sum Dabigatran (DE) in Plasma at Steady State Over the Time Interval From 2 to 12h)
Hide Description

PK/PD sampling time:(d=dose,D=Day,p=predose)

  1. single medium or high dose,healthy, mid-age (45-64 yrs): D4: 7:00p,8:55p,9:00,9:10,9:30,10:00,11:00,13:00,15:00,19:00,21:00, 01:00; D5:9:00p,11:00,21:00p; D6:9:00p, 21:00p; D7:9:00p, 11:00.
  2. single low or high dose,healthy elder or mild renal impaired: D4:7:00p,8:55p,9:00,9:10,9:30,10:00,11:00,13:00,15:00,19:00,21:00,01:00;D5:9:00;D6:9:00;D7:9:00; additional sampling for renal impaired: D8:9:00;D9:9:00.
  3. high 2 doses, moderate renal impaired: D4:7:00p,8:55p,9:00,9:10,9:30,9:55p,10:00,10:10,10:30,11:00,13:00,15:00,19:00,21:00,01:00;D5:9:00;D6:9:00; D7:9:00; additional sampling for renal impaired: D8:9:00;D9:9:00.
Time Frame from 2h to12h of post DE dose at steady state (details in description)
Hide Outcome Measure Data
Hide Analysis Population Description
PKS-DE: The PKS-DE included all treated subjects who have received at least 1 dose of DE and who provided data for at least 1 secondary or further PK endpoint in any treatment period, which was judged as evaluable for PK and was not affected by (important) protocol violations relevant to the statistical evaluation of PK endpoints.
Arm/Group Title 220 mg/2.5g HS 45-64 Years 220 mg/Plc. 2.5g HS 45-64 Years 220 mg/2.5g HS 45-64 Yrs Re-exposure 220 mg/5g HS 45-64 Yrs 220 mg/Plc. 5g HS 45-64 Yrs 220 mg/1g HS 65-80 Yrs 220 mg/Plc. 1g HS 65-80 Yrs 220 mg/5g HS 65-80 Yrs 220 mg/Plc. 5g HS 65-80 Yrs 150 mg/1g Mild RI (CL 60-90) 150 mg/Plc. 1g Mild RI (CL 60-90) 150 mg/5g Mild RI (CL 60-90) 150 mg/Plc. 5g Mild RI (CL 60-90) 150 mg /2*2.5g Moderate RI (CL 30-60) 150 mg /Plc. 2*2.5g Moderate RI (CL 30-60)
Hide Arm/Group Description:
Healthy subjects (HS) mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 2.5g.
Healthy subjects (HS) mid-age (45-64 yrs) with dabigatran (DE) 220 mg/ placebo(plc.) 2.5g.
Healthy subjects (HS) mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 2.5g and reexposured Ida in period 3
Healthy subjects (HS) mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 5g
Healthy subjects (HS) mid-age (45-64 yrs) with dabigatran (DE) 220 mg/plc. 5g.
Healthy subjects (HS) elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 1g.
Healthy subjects (HS) elderly (65-80 yrs) with dabigatran (DE) 220 mg/plc. 1g.
Healthy subjects (HS) elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 5g.
Healthy subjects (HS) elderly (65-80 yrs) with dabigatran (DE) 220 mg/plc. 5g.
Mild RI (CL 60-90) with dabigatran (DE) 150 mg/Ida 1g
Mild RI (CL 60-90) with dabigatran (DE) 150 mg/plc. 1g
Mild RI (CL 60-90) with dabigatran (DE) 150 mg/Ida 5g
Mild RI (CL 60-90) with dabigatran (DE) 150 mg/plc. 5g
Moderate RI (CL 30-60) with dabigatran (DE) 150 mg and were infused as 2 doses of each Ida 2.5g, given 1 h apart.
Moderate RI (CL 30-60) with dabigatran (DE) 150 mg and were infused as 2 doses of each plc. 2.5g, given 1 h apart.
Overall Number of Participants Analyzed 6 6 6 6 6 8 8 8 8 6 6 6 6 6 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
18.5
(75.7%)
924
(25.6%)
36.0
(125%)
10.6
(11.3%)
933
(39.2%)
284
(66.3%)
1220
(40.0%)
11.6
(23.8%)
1270
(32.8%)
100
(192%)
929
(56.0%)
10.0
(0.0828%)
876
(40.5%)
10.2
(3.95%)
1440
(32.3%)
5.Secondary Outcome
Title Aet1-t2, ss (Amount of DE Eliminated in Urine From the Time Point t1 to Time Point t2)
Hide Description

Urinary excretion of sum dabigatran from the time point t1 to t2 at steady state.

PK Urine sampling time:

Urine sampling relative to first DE administration: Planned times 72:00 - 73:55h, 73:55 - 80:00h, 80:00 - 86:00h, 86:00 - 98:00h, 98:00 - 122:00h, 122:00 - 146:00h; additional sampling for renal impaired: 146:00 - 170:00; 170:00 - 194:00h.

Ae0-26,ss was not measured in Period 3 (re-exposure period). Ae0-74,ss was not measured in healthy subjects aged 45 to 64 years.

Time Frame From 0 to 74h post of last DE dose (details in description)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Set - DE (PKS-DE): The PKS-DE included all treated subjects who have received at least 1 dose of DE and who provided data for at least 1 secondary or further PK endpoint in any treatment period, which was judged as evaluable for PK and was not affected by protocol violations relevant to the statistical evaluation of PK endpoints.
Arm/Group Title 220 mg/2.5g HS 45-64 Years 220 mg/Plc. 2.5g HS 45-64 Years 220 mg/2.5g HS 45-64 Yrs Re-exposure 220 mg/5g HS 45-64 Yrs 220 mg/Plc. 5g HS 45-64 Yrs 220 mg/1g HS 65-80 Yrs 220 mg/Plc. 1g HS 65-80 Yrs 220 mg/5g HS 65-80 Yrs 220 mg/Plc. 5g HS 65-80 Yrs 150 mg/1g Mild RI (CL 60-90) 150 mg/Plc. 1g Mild RI (CL 60-90) 150 mg/5g Mild RI (CL 60-90) 150 mg/Plc. 5g Mild RI (CL 60-90) 150 mg /2*2.5g Moderate RI (CL 30-60) 150 mg /Plc. 2*2.5g Moderate RI (CL 30-60)
Hide Arm/Group Description:
HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 2.5g.
HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/ placebo(plc.) 2.5g.
HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 2.5g and reexposured Ida in period 3
HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 5g.
HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/plc. 5g.
HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 1g.
HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/plc. 1g.
HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 5g.
HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/plc. 5g.
Mild RI (CL 60-90) with dabigatran (DE) 150 mg/Ida 1g
Mild RI (CL 60-90) with dabigatran (DE) 150 mg/plc. 1g
Mild RI (CL 60-90) with dabigatran (DE) 150 mg/Ida 5g
Mild RI (CL 60-90) with dabigatran (DE) 150 mg/plc. 5g
Moderate RI (CL 30-60) with dabigatran (DE) 150 mg and were infused as 2 doses of each Ida 2.5g, given 1 h apart.
Moderate RI (CL 30-60) with dabigatran (DE) 150 mg and were infused as 2 doses of each plc. 2.5g, given 1 h apart.
Overall Number of Participants Analyzed 6 6 0 6 6 8 8 8 8 6 6 6 6 6 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: μg
Ae0-26,ss(N=6,6,0,6,6,8,8,8,8,6,6,6,6,6,6)
6080
(26.5%)
7460
(21.0%)
7560
(47.2%)
7790
(43.9%)
8490
(29.4%)
8870
(41.8%)
7460
(39.6%)
10600
(21.9%)
5800
(39.0%)
6040
(44.7%)
4020
(58.3%)
6280
(38.4%)
4760
(26.7%)
8880
(29.8%)
Ae0-74,ss(N=0,0,0,0,0,8,8,8,8,6,6,6,6,6,6)
NA [1] 
(NA%)
NA [1] 
(NA%)
NA [1] 
(NA%)
NA [1] 
(NA%)
10700
(22.0%)
10300
(40.8%)
13900
(26.1%)
12800
(20.6%)
7760
(38.8%)
7170
(45.8%)
9730
(35.3%)
7690
(39.1%)
11100
(24.5%)
10800
(30.4%)
[1]
not measured in healthy subjects aged 45 to 64 years.
6.Secondary Outcome
Title Cmax (Maximum Measured Concentration of the Ida in Plasma)
Hide Description

Cmax. PK/PD sampling time: (p=predose, D=day)

  1. single medium or high dose, HS mid-age (45-64 yrs): D4: 8:55p, 9:00,9:10,9:30,10:00,11:00,13:00,15:00,19:00,21:00,01:00; D5: 9:00p, 21:00. D6: 9:00.
  2. single low or high dose, healthy elderly or mild RI: D4: 8:55p, 9:00,9:10,9:30,10:00,11:00,13:00,15:00,19:00,21:00,01:00; D5: 9:00; D6: 9:00; D7: 9:00; additional sampling for RI: D8: 9:00;D9: 9:00.
  3. high 2 doses, moderate RI: D4: 8:55p, 9:00, 9:10,9:30,9:55p, 10:00,10:10,10:30,11:00, 13:00, 15:00, 19:00, 21:00, 01:00; D5: 9:00; D6: 9:00; D7: 9:00; additional sampling for RI: D8:9:00; D9:9:00.
Time Frame From Ida administration to 4 days post dose (details in description)
Hide Outcome Measure Data
Hide Analysis Population Description
PKS-Ida
Arm/Group Title 220 mg/2.5 g HS 45-64 Years 220 mg/2.5 g HS 45-64 Yrs Re-exposure 220 mg/5 g HS 45-64 Yrs 220 mg/1 g HS 65-80 Yrs 220 mg/5 g HS 65-80 Yrs 150 mg/1 g Mild RI (CL 60-90) 150 mg/5 g Mild RI (CL 60-90) 150 mg /2*2.5 g Moderate RI (CL 30-60)
Hide Arm/Group Description:
HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 2.5g.
HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 2.5g and reexposured Ida in period 3
HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 5g.
HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 1g.
HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 5g.
Mild RI (CL 60-90) with dabigatran (DE) 150 mg/Ida 1g
Mild RI (CL 60-90) with dabigatran (DE) 150 mg/Ida 5g
Moderate RI (CL 30-60) with dabigatran (DE) 150 mg and were infused 2 doses of each Ida 2.5g, given 1 h apart.
Overall Number of Participants Analyzed 6 6 6 8 8 6 6 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
15700
(14.3%)
14900
(12.0%)
25000
(16.9%)
5790
(16.4%)
28300
(28.9%)
6940
(19.4%)
32100
(17.4%)
25600
(11.6%)
7.Secondary Outcome
Title Ae0-6 (Amount of Ida Eliminated in Urine From the Time Point 0 to Time Point 6 h)
Hide Description

Ae0-6 (Amount of Ida Eliminated in Urine From the Time Point 0 to Time point 6 h).

PK Urine sampling time:

Urine sampling relative to DE administration: Planned times 72:00 - 73:55h, 73:55 - 80:00h, 80:00 - 86:00h, 86:00 - 98:00h, 98:00 - 122:00h, 122:00 - 146:00h; additional sampling for renal impaired: 146:00 - 170:00; 170:00 - 194:00h.

Time Frame from 0 to 6 hours of post Ida dose (details in description)
Hide Outcome Measure Data
Hide Analysis Population Description
PKS-Ida: The PKS-Ida included all treated subjects who have received at least 1 dose of idarucizumab and who provided data for at least 1 secondary or other PK endpoint in any treatment period, which was judged as evaluable for PK and was not affected by (important) protocol violations relevant to the statistical evaluation of PK endpoints.
Arm/Group Title 220 mg/2.5 g HS 45-64 Years 220 mg/2.5 g HS 45-64 Yrs Re-exposure 220 mg/5 g HS 45-64 Yrs 220 mg/1 g HS 65-80 Yrs 220 mg/5 g HS 65-80 Yrs 150 mg/1 g Mild RI (CL 60-90) 150 mg/5 g Mild RI (CL 60-90) 150 mg /2*2.5 g Moderate RI (CL 30-60)
Hide Arm/Group Description:
HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 2.5g.
HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 2.5g and reexposured Ida in period 3
HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 5g.
HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 1g.
HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 5g.
Mild RI (CL 60-90) with dabigatran (DE) 150 mg/Ida 1g
Mild RI (CL 60-90) with dabigatran (DE) 150 mg/Ida 5g
Moderate RI (CL 30-60) with dabigatran (DE) 150 mg and were infused 2 doses of each Ida 2.5g, given 1 h apart.
Overall Number of Participants Analyzed 6 0 6 8 8 6 6 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: umol
13.5
(32.6%)
33.5
(60.0%)
1.97
(69.0%)
41.6
(13.7%)
2.60
(46.7%)
33.4
(48.9%)
31.3
(89.0%)
Time Frame From the study drug administration up to start of follow-up period (from Day 1 to Day 35).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dabigatran Etexilate (DE) Low (1g) Idarucizumab Dose Medium (2.5g) Idarucizumab Dose High (5g) Idarucizumab Dose Low (1g) Placebo Dose Medium (2.5g) Placebo Dose High (5g) Placebo Dose
Hide Arm/Group Description subjects with Dabigatran etexilate (DE) treatment Subjects with low 1g idarucizumab dose treatment Subjects with medium (2.5g) idarucizumab dose treatment Subjects with high (5g) idarucizumab dose treatment Subjects with low (1g) placebo dose treatment Subjects with medium (2.5g) placebo dose treatment Subjects with high (5g) placebo dose treatment
All-Cause Mortality
Dabigatran Etexilate (DE) Low (1g) Idarucizumab Dose Medium (2.5g) Idarucizumab Dose High (5g) Idarucizumab Dose Low (1g) Placebo Dose Medium (2.5g) Placebo Dose High (5g) Placebo Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Dabigatran Etexilate (DE) Low (1g) Idarucizumab Dose Medium (2.5g) Idarucizumab Dose High (5g) Idarucizumab Dose Low (1g) Placebo Dose Medium (2.5g) Placebo Dose High (5g) Placebo Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/46 (0.00%)   0/14 (0.00%)   0/12 (0.00%)   0/26 (0.00%)   0/14 (0.00%)   0/12 (0.00%)   0/26 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dabigatran Etexilate (DE) Low (1g) Idarucizumab Dose Medium (2.5g) Idarucizumab Dose High (5g) Idarucizumab Dose Low (1g) Placebo Dose Medium (2.5g) Placebo Dose High (5g) Placebo Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   13/46 (28.26%)   4/14 (28.57%)   1/12 (8.33%)   2/26 (7.69%)   3/14 (21.43%)   3/12 (25.00%)   0/26 (0.00%) 
Gastrointestinal disorders               
Abdominal discomfort  1  2/46 (4.35%)  0/14 (0.00%)  0/12 (0.00%)  1/26 (3.85%)  0/14 (0.00%)  1/12 (8.33%)  0/26 (0.00%) 
Abdominal distension  1  0/46 (0.00%)  0/14 (0.00%)  0/12 (0.00%)  0/26 (0.00%)  0/14 (0.00%)  1/12 (8.33%)  0/26 (0.00%) 
Nausea  1  4/46 (8.70%)  0/14 (0.00%)  0/12 (0.00%)  0/26 (0.00%)  0/14 (0.00%)  1/12 (8.33%)  0/26 (0.00%) 
Vomiting  1  0/46 (0.00%)  0/14 (0.00%)  1/12 (8.33%)  0/26 (0.00%)  0/14 (0.00%)  0/12 (0.00%)  0/26 (0.00%) 
General disorders               
Application site dermatitis  1  0/46 (0.00%)  0/14 (0.00%)  1/12 (8.33%)  0/26 (0.00%)  0/14 (0.00%)  0/12 (0.00%)  0/26 (0.00%) 
Infections and infestations               
Nasopharyngitis  1  0/46 (0.00%)  0/14 (0.00%)  0/12 (0.00%)  0/26 (0.00%)  1/14 (7.14%)  0/12 (0.00%)  0/26 (0.00%) 
Injury, poisoning and procedural complications               
Infusion related reaction  1  0/46 (0.00%)  0/14 (0.00%)  0/12 (0.00%)  0/26 (0.00%)  0/14 (0.00%)  1/12 (8.33%)  0/26 (0.00%) 
Post procedural haematoma  1  0/46 (0.00%)  1/14 (7.14%)  0/12 (0.00%)  0/26 (0.00%)  1/14 (7.14%)  0/12 (0.00%)  0/26 (0.00%) 
Musculoskeletal and connective tissue disorders               
Myalgia  1  1/46 (2.17%)  1/14 (7.14%)  0/12 (0.00%)  0/26 (0.00%)  0/14 (0.00%)  0/12 (0.00%)  0/26 (0.00%) 
Pain in extremity  1  1/46 (2.17%)  1/14 (7.14%)  0/12 (0.00%)  0/26 (0.00%)  0/14 (0.00%)  0/12 (0.00%)  0/26 (0.00%) 
Nervous system disorders               
Dizziness  1  0/46 (0.00%)  1/14 (7.14%)  0/12 (0.00%)  0/26 (0.00%)  0/14 (0.00%)  0/12 (0.00%)  0/26 (0.00%) 
Headache  1  7/46 (15.22%)  3/14 (21.43%)  1/12 (8.33%)  0/26 (0.00%)  0/14 (0.00%)  0/12 (0.00%)  0/26 (0.00%) 
Paraesthesia  1  1/46 (2.17%)  1/14 (7.14%)  0/12 (0.00%)  0/26 (0.00%)  0/14 (0.00%)  0/12 (0.00%)  0/26 (0.00%) 
Respiratory, thoracic and mediastinal disorders               
Epistaxis  1  2/46 (4.35%)  0/14 (0.00%)  0/12 (0.00%)  1/26 (3.85%)  1/14 (7.14%)  0/12 (0.00%)  0/26 (0.00%) 
Skin and subcutaneous tissue disorders               
Ecchymosis  1  0/46 (0.00%)  0/14 (0.00%)  0/12 (0.00%)  0/26 (0.00%)  0/14 (0.00%)  1/12 (8.33%)  0/26 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 17.0
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.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
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
ClinicalTrials.gov Identifier: NCT01955720    
Other Study ID Numbers: 1321.2
2013-003616-52 ( EudraCT Number: EudraCT )
First Submitted: September 30, 2013
First Posted: October 7, 2013
Results First Submitted: November 13, 2015
Results First Posted: February 11, 2016
Last Update Posted: February 11, 2016