A Study of BIBR 1048 in Prevention of Venous Thromboembol... | NCT00246025

NCT00246025

Status Module

Sponsor/Collaborators Module

Oversight Module

No data available

No data is available for this block.

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dabigatran etexilate 110 mg	Experimental	Dabigatran etexilate 110 mg capsule, once a day, oral administration	Drug: Dabigatran etexilate
Dabigatran etexilate 150 mg	Experimental	Dabigatran etexilate 150 mg capsule, once a day, oral administration	Drug: Dabigatran etexilate
Dabigatran etexilate 220 mg	Experimental	Dabigatran etexilate 110 mg capsule, 2capsules, once a day, oral administration	Drug: Dabigatran Etexilate
Placebo	Placebo Comparator	matching placebo capsule, once a day, oral administration	Drug: placebo

Name	Type	Description	Arm Group Labels	Other Names
Dabigatran etexilate	Drug	Dabigatran etexilate 110 mg capsule, once a day, oral administration	Dabigatran etexilate 110 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants Who Have a Composite Endpoint Consisting of Total Venous Thromboembolic Event (VTE) and All Cause Mortality During the Treatment Period.	number of participants with the composite endpoint (total Venous Thromboembolic Event (VTE) and all cause mortality	2 weeks study medication

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants Who Have a Composite of Major VTE (Defined as Proximal DVT and PE) and VTE Related Mortality	Number of participants with the composite of major VTE (defined as proximal DVT and PE) and VTE related mortality	2 weeks
Percentage of Participants Who Have Proximal DVT (Deep Vein Thrombosis) During Treatment Period

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
1160.50.001 Boehringer Ingelheim Investigational Site		Eniwa, Hokkaido			Japan
1160.50.018 Boehringer Ingelheim Investigational Site

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Treatment Group With Placebo	Patients were treated with matching Placebo.
FG001	Dabigatran Etexilate 110 mg	Patients were treated with 110mg dabigatran etexilate once daily.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Treatment Group With Placebo	Patients were treated with matching Placebo.
BG001	Dabigatran Etexilate 110 mg	Patients were treated with 110mg dabigatran etexilate once daily.
BG002	Dabigatran Etexilate 150 mg	Patients were treated with 150mg dabigatran etexilate once daily.
BG003	Dabigatran Etexilate 220 mg	Patients were treated with 220mg dabigatran etexilate once daily.
BG004	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG00056.4 OG00139.6 OG00232.7 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Superiority of dabigatran etexilate to placebo was tested by means of hierarchical tests. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.	normal approximation method	Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.	0.0155	Multiplicity was not adjusted because of hierarchical testing from highest to lowest dose.	Risk Difference (RD)	-16.8				95	-30.2	-3.4			The risk differences are calculated as risk in the dabigatran groups minus risk in the placebo group.	No

Secondary

Percentage of Participants Who Have a Composite of Major VTE (Defined as Proximal DVT and PE) and VTE Related Mortality

Number of participants with the composite of major VTE (defined as proximal DVT and PE) and VTE related mortality

FAS-major - FAS-major includes all patients who were randomised, treated, operated, and had an evaluable venogram for proximal DVT or confirmed symptomatic proximal DVT, PE, or VTE-related death.

Posted

Number

percentage of participants

2 weeks

ID	Title	Description
OG000	Treatment Group With Placebo	Patients were treated with matching Placebo.
OG001	Dabigatran Etexilate 110 mg	Patients were treated with 110mg dabigatran etexilate once daily.
OG002	Dabigatran Etexilate 150 mg	Patients were treated with 150mg dabigatran etexilate once daily.
OG003	Dabigatran Etexilate 220 mg	Patients were treated with 220mg dabigatran etexilate once daily.

Secondary

Percentage of Participants Who Have Proximal DVT (Deep Vein Thrombosis) During Treatment Period

Number of participants who have Proximal DVT during treatment period

FAS-pDVT - FAS-pDVT includes all patients who were randomised, treated, operated, and had an evaluable venogram for proximal DVT or confirmed symptomatic proximal DVT.

Posted

Number

percentage of participants

2 weeks

ID	Title	Description
OG000	Treatment Group With Placebo	Patients were treated with matching Placebo.
OG001	Dabigatran Etexilate 110 mg	Patients were treated with 110mg dabigatran etexilate once daily.
OG002	Dabigatran Etexilate 150 mg	Patients were treated with 150mg dabigatran etexilate once daily.
OG003	Dabigatran Etexilate 220 mg	Patients were treated with 220mg dabigatran etexilate once daily.

Secondary

Percentage of Participants With Symptomatic DVT (Deep Vein Thrombosis)

Number of Participants expressing DVT with symptoms

FAS-op - FAS-op includes all patients who were randomly assigned to the treatment, received at least one oral dose and went through surgery.

Posted

Number

Percentage of participants

2 weeks

ID	Title	Description
OG000	Treatment Group With Placebo	Patients were treated with matching Placebo.
OG001	Dabigatran Etexilate 110 mg	Patients were treated with 110mg dabigatran etexilate once daily.
OG002	Dabigatran Etexilate 150 mg	Patients were treated with 150mg dabigatran etexilate once daily.
OG003	Dabigatran Etexilate 220 mg	Patients were treated with 220mg dabigatran etexilate once daily.

Secondary

Percentage of Participants Who Have Total DVT (Deep Vein Thrombosis) During Treatment Period

Number of participants who have Total DVT during treatment period

FAS-tDVT - FAS-tDVT includes all patients who were randomised, treated, operated, and had evaluable venogram or confirmed symptomatic DVT.

Posted

Number

percentage of participants

2 weeks

ID	Title	Description
OG000	Treatment Group With Placebo	Patients were treated with matching Placebo.
OG001	Dabigatran Etexilate 110 mg	Patients were treated with 110mg dabigatran etexilate once daily.
OG002	Dabigatran Etexilate 150 mg	Patients were treated with 150mg dabigatran etexilate once daily.
OG003	Dabigatran Etexilate 220 mg	Patients were treated with 220mg dabigatran etexilate once daily.

Secondary

Number of Participants With Pulmonary Embolism During Treatment Period

Pulmonary embolism confirmed by pulmonary scintigraphy, pulmonary angiography or contrast CT.

FAS-op

Posted

Number

percentage of participants

2 weeks

ID	Title	Description
OG000	Treatment Group With Placebo	Patients were treated with matching Placebo.
OG001	Dabigatran Etexilate 110 mg	Patients were treated with 110mg dabigatran etexilate once daily.
OG002	Dabigatran Etexilate 150 mg	Patients were treated with 150mg dabigatran etexilate once daily.
OG003	Dabigatran Etexilate 220 mg	Patients were treated with 220mg dabigatran etexilate once daily.

Units	Counts

Secondary

Number of Participants Who Died During Treatment Period

All cause death, as adjudicated by the VTE events committee.

FAS-op

Posted

Number

percentage of participants

2 weeks

ID	Title	Description
OG000	Treatment Group With Placebo	Patients were treated with matching Placebo.
OG001	Dabigatran Etexilate 110 mg	Patients were treated with 110mg dabigatran etexilate once daily.
OG002	Dabigatran Etexilate 150 mg	Patients were treated with 150mg dabigatran etexilate once daily.
OG003	Dabigatran Etexilate 220 mg	Patients were treated with 220mg dabigatran etexilate once daily.

Units	Counts

Secondary

Number of Participants With Bleeding Events During Treatment Period

Major bleeding events were defined as

fatal
clinically overt associated with loss of haemoglobin >=2g/dL in excess of what was expected
clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected
symptomatic retroperitoneal, intracranial, intraocular or intraspinal
requiring treatment cessation
leading to re-operation

Clinically-relevant was defined as

spontaneous skin hematoma >=25 cm²
wound hematoma >=100 cm²
spontaneous nose bleed >5 min
macroscopic hematuria spontaneous or >24 hours if associated with an intervention
spontaneous rectal bleeding (more than a spot on toilet paper)
gingival bleeding >5 min
any other bleeding event considered clinically relevant by the investigator

Any bleeding events were defined as major, clinically-relevant and minor bleeding events. Minor bleeding events were defined as all other bleeding events that did not fulfil the criteria from above.

Safety set - Safety set includes all patients who were randomly assigned to the treatment, received at least one oral dose and went through surgery.

Posted

Number

participants

2 weeks

ID	Title	Description
OG000	Treatment Group With Placebo	Patients were treated with matching Placebo.
OG001	Dabigatran Etexilate 110 mg	Patients were treated with 110mg dabigatran etexilate once daily.

Secondary

Blood Transfusion

Blood transfusion for treated and operated patients on Day of surgery.

Safety set

Posted

Number

participants

Day 0

ID	Title	Description
OG000	Treatment Group With Placebo	Patients were treated with matching Placebo.
OG001	Dabigatran Etexilate 110 mg	Patients were treated with 110mg dabigatran etexilate once daily.
OG002	Dabigatran Etexilate 150 mg	Patients were treated with 150mg dabigatran etexilate once daily.
OG003	Dabigatran Etexilate 220 mg	Patients were treated with 220mg dabigatran etexilate once daily.

Units	Counts
Participants

Secondary

Volume of Blood Loss

Volume of blood loss for treated and operated patients during surgery.

Safety set

Posted

Mean

Standard Deviation

Day 0

ID	Title	Description
OG000	Treatment Group With Placebo	Patients were treated with matching Placebo.
OG001	Dabigatran Etexilate 110 mg	Patients were treated with 110mg dabigatran etexilate once daily.
OG002	Dabigatran Etexilate 150 mg	Patients were treated with 150mg dabigatran etexilate once daily.
OG003	Dabigatran Etexilate 220 mg	Patients were treated with 220mg dabigatran etexilate once daily.

Units	Counts
Participants

Secondary

Laboratory Analyses

Frequency of patients with possible clinically significant abnormalities.

Posted

Number

participants

First administration to end of study

ID	Title	Description
OG000	Treatment Group With Placebo	Patients were treated with matching Placebo.
OG001	Dabigatran Etexilate 110 mg	Patients were treated with 110mg dabigatran etexilate once daily.
OG002	Dabigatran Etexilate 150 mg	Patients were treated with 150mg dabigatran etexilate once daily.
OG003	Dabigatran Etexilate 220 mg	Patients were treated with 220mg dabigatran etexilate once daily.

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Treatment Group With Placebo	Patients were treated with matching Placebo.	2	124	62	124
EG001	Dabigatran Etexilate 110 mg	Patients were treated with 110mg dabigatran etexilate once daily.	3	133	47	133
EG002	Dabigatran Etexilate 150 mg	Patients were treated with 150mg dabigatran etexilate once daily.	3	126	60	126
EG003	Dabigatran Etexilate 220 mg	Patients were treated with 220mg dabigatran etexilate once daily.	2	129	55	129

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Post procedural infestation	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected124 at risk EG0011 affected133 at risk EG0020 affected126 at risk EG0030 affected129 at risk
Wound infection bacterial	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected124 at risk EG0010 affected133 at risk EG0021 affected126 at risk EG003
Diplegia	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected124 at risk EG0010 affected133 at risk EG0021 affected126 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected124 at risk EG0010 affected133 at risk EG0020 affected126 at risk EG003
Wound haemorrhage	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected124 at risk EG0010 affected133 at risk EG0020 affected126 at risk EG003
Haematemesis	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected124 at risk EG0010 affected133 at risk EG0020 affected126 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected124 at risk EG0011 affected133 at risk EG0020 affected126 at risk EG003
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected124 at risk EG0010 affected133 at risk EG0021 affected126 at risk EG003
Muscle contracture	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected124 at risk EG0011 affected133 at risk EG0020 affected126 at risk EG003
Liver function test abnormal	Investigations	MedDRA 10.0	Systematic Assessment	EG0001 affected124 at risk EG0010 affected133 at risk EG0021 affected126 at risk EG003
Wound secretion	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 affected124 at risk EG0010 affected133 at risk EG0021 affected126 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0002 affected124 at risk EG0016 affected133 at risk EG0028 affected126 at risk EG0034 affected129 at risk
Insomnia	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG00014 affected124 at risk EG0017 affected133 at risk EG00215 affected126 at risk EG003
Headache	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0007 affected124 at risk EG0011 affected133 at risk EG0021 affected126 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG00029 affected124 at risk EG00123 affected133 at risk EG00210 affected126 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0007 affected124 at risk EG0018 affected133 at risk EG0027 affected126 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG00012 affected124 at risk EG0013 affected133 at risk EG0024 affected126 at risk EG003
Stomach discomfort	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0005 affected124 at risk EG0014 affected133 at risk EG0028 affected126 at risk EG003
Blister	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0007 affected124 at risk EG0015 affected133 at risk EG00210 affected126 at risk EG003
Oedema peripheral	General disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected124 at risk EG0011 affected133 at risk EG0029 affected126 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0004 affected124 at risk EG0013 affected133 at risk EG0023 affected126 at risk EG003

ID	Term
D020246	Venous Thrombosis

ID	Term
D000069604	Dabigatran

Ancestor Terms

ID	Term
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D001562	Benzimidazoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Units	Counts
Participants	OG000104 OG001115 OG002113 OG003102

OG000120
OG001131
OG002122
OG003127

ID	Term
D013927	Thrombosis
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases