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BIBR 1048 Dose Range Finding Study in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Hip or Knee Replacement Surgery

Primary Purpose

Venous Thromboembolism

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Enoxaparin
BIBR 1048
BIBR 1048
BIBR 1048
BIBR 1048
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Venous Thromboembolism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria

  1. Patients scheduled to undergo a primary elective total hip or knee replacement.
  2. Male of female being 18 years or older.
  3. Patients weighing at least 40 kg.
  4. Written informed consent for study participation.

Exclusion criteria

  1. Bleeding diathesis, constitutional or acquired coagulation disorders.
  2. Major surgery or trauma(e.g., hip fracture) within the last 3 months.
  3. Cardiovascular disease
  4. Any history of haemorrhagic stroke, intracranial or intraocular bleeding or cerebral ischaemic attacks lasting more than 24 hours and / or with cardiovascular pathological findings.
  5. Deep vein thrombosis(DVT), gastrointestinal or pulmonary bleeding, gastric or duodenal ulcer within the last year.
  6. History of or acute intracranial disease
  7. Liver disease
  8. Renal disease
  9. Use of long-term anticoagulants or antiplatelet drugs within 7 days prior to hip/knee replacement operation.
  10. Pre-menopausal women who are not surgically steriles, are nursing and are of child-bearing potential and are not practising acceptable methods of birth control
  11. Known allergy to contrast media
  12. Thrombocytopenia
  13. Allergy against heparin.
  14. Active malignant disease or current cytostatic treatment.
  15. Treatment with an investigational drug in the past month.
  16. Leg amputee
  17. Known alcohol or drug abuse

Sites / Locations

  • 1160.19.43004 Krankenhaus der Barmherzigen Schwestern Linz
  • 1160.19.43002 Orthopädisches Spital Speising
  • 1160.19.43001 A.ö. Krankenhaus d. Statutarstadt Wiener Neustadt
  • 1160.19.32002 V.U.B. Jette
  • 1160.19.32004 UZ Gent
  • 1160.19.32005 Virga Jesseziekenhuis
  • 1160.19.32006 Boehringer Ingelheim Investigational Site
  • 1160.19.32007 C.H.U. de Tivoli
  • 1160.19.42004 University Hospital Brno
  • 1160.19.42001 Hospital Kladno
  • 1160.19.42006 Hospital Mlada Boleslav
  • 1160.19.42003 University Hospital Ostrava
  • 1160.19.42005 University Hospital Plzen
  • 1160.19.42009 University Hospital Na Bulovce
  • 1160.19.45042 Orthopedic Surgical Clinic
  • 1160.19.45045 Gentofte Hospital
  • 1160.19.45043 Herlev Hospital
  • 1160.19.45041 Hørsholm Sygehus
  • 1160.19.45044 Orthopedic Surgical Dept.
  • 1160.19.35802 Keski-Suomen keskussairaala
  • 1160.19.35801 Oulun yliopistollinen sairaala, Leikkaus- ja tehohoidon yks.
  • 1160.19.33004 Div
  • 1160.19.33007 Clinique du Mail
  • 1160.19.33009 Hôpital Edouard Herriot
  • 1160.19.33006 Clinique Mutualiste
  • 1160.19.33008 Clinique de l'Atlantique
  • 1160.19.36003 Sándor Péterfy Hospital
  • 1160.19.36001 Kálmán Pándy County Hospital
  • 1160.19.36004 Bács-Kiskun County Hospital
  • 1160.19.36002 Albert Szent-Györgyi Medical and Pharmacological Center
  • 1160.19.36005 Szent György Hospital
  • 1160.19.39003 U. O. Ortopedia e Traumatologia
  • 1160.19.39005 Modulo Coordinazione Dipartimentale di Ricerca e Anestesia
  • 1160.19.39002 Fondazione Centro S. Raffaele
  • 1160.19.39001 IRCCS Policlinico San Matteo
  • 1160.19.39004 Ospedale di Circolo di Varese
  • 1160.19.31001 Boehringer Ingelheim Investigational Site
  • 1160.19.31003 Boehringer Ingelheim Investigational Site
  • 1160.19.31005 Hengstdal 3
  • 1160.19.31006 Boehringer Ingelheim Investigational Site
  • 1160.19.31004 Boehringer Ingelheim Investigational Site
  • 1160.19.47001 Nordlandssykehuset HF, Bodø
  • 1160.19.47004 Martina Hansens Hospital
  • 1160.19.47008 Martina Hansens Hospital
  • 1160.19.47007 Sykehuset Innlandet HF, Avd. Elverum
  • 1160.19.47005 Haugesund sjukehus HF
  • 1160.19.47002 Sykehuset Telemark HF, Avd. Skien
  • 1160.19.47003 Helse Sunnmøre HF, Ålesund sykehus
  • 1160.19.27001 Dept. of Haematology
  • 1160.19.27002 Suite 203
  • 1160.19.46002 Kirurgavdelningen
  • 1160.19.46001
  • 1160.19.46004 Ortopediska kliniken, Länssjukhuset, Halmstad
  • 1160.19.46003 Ortopediska kliniken, Länssjukhuset i Kalmar
  • 1160.19.46007 Kungälvs sjukhus
  • 1160.19.46005 Kirurg Ortopediska kliniken, Sjukhuset i Lidköping
  • 1160.19.46008 Ortopediska Institutionen
  • 1160.19.46009 Sahlgrenska Universitetssjukhuset, Mölndal
  • 1160.19.46006 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

BIBR 1048 50 mg bis in die(b.i.d)

BIBR 1048 150 mg b.i.d

BIBR 1048 225 mg b.i.d

BIBR 1048 300 mg quaque die(q.d)

Enoxaparin 40 mg subcutaneous(s.c)

Arm Description

BIBR 1048 50 mg b.i.d twice a day plus two capsules of placebo matching BIBR 1048 0 mg twice a day plus one placebo matching enoxaparin 0 mg once a day for the treatment period

BIBR 1048 150 mg b.i.d twice a day plus two capsules of placebo matching BIBR 1048 0 mg twice a day plus placebo matching enoxaparin 0 mg once a day for the treatment period

BIBR 1048 225 mg b.i.d twice a day plus two capsules of placebo matching BIBR 1048 0 mg twice a day plus placebo matching enoxaparin 0 mg once a day for the treatment period

BIBR 1048 150 mg q.d once a day plus placebo matching BIBR 1048 0 mg twice a day plus placebo matching enoxaparin 0 mg once a day for the treatment period

placebo matching BIBR 1048 0 mg twice a day plus enoxaparin 40 mg s.c once a day for the treatment period

Outcomes

Primary Outcome Measures

Number of Participants With Venous Thromboembolic (VTE) Events
Deep vein thrombosis (DVT) (proximal and distal) as detected by routine bilateral venography on day 8 +/- 2, plus symptomatic DVT confirmed by venography during the treatment period or PE confirmed by objective testing
Number of Participants With Major Bleeding Events (MBE)

Secondary Outcome Measures

Number of Participants With VTE Events and All Cause Mortality
Deep venous thrombosis (DVT) (proximal and distal) as detected by routine bilateral venography on day 8 +/- 2, plus symptomatic DVT confirmed by venography during the treatment period or Pulmonary Embolism (PE) confirmed by objective testing and all deaths.
Number of Participants With Proximal DVT, PE (Pulmonary Embolism) and VTE Related Mortality
Deep venous thrombosis (DVT) (proximal) as detected by routine bilateral venography on day 8 +/- 2, plus symptomatic proximal DVT confirmed by venography during the treatment period or PE confirmed by objective testing plus VTE related mortality
Number of Participants With Proximal DVT
Deep venous thrombosis (DVT) (proximal) as detected by routine bilateral venography on day 8 +/- 2, plus symptomatic proximal DVT confirmed by venography during the treatment period
Volume of Blood Loss
Volume of blood loss was to be analysed using an analysis of variance (ANOVA), which included treatment and centre.
Rate of Transfusions Due to Bleedings
Percentage of patients requiring transfusions due to bleeding .Rate of need of transfusion were to be analysed using a logistic regression with treatment and centre.
Number of Participants With Clinically Significant, Minor or Any Bleeding Events
Number of participants with Clinically Significant, minor or any bleeding events. Clinically significant bleeding events are defined as Spontaneous skin haematoma larger than >25 cm² Wound haematoma >100 cm² Spontaneous nose bleed >5 minutes Macroscopic haematurea, either spontaneous or lasting more than 24 hours if associated with an intervention Spontaneous rectal bleeding (more than spot on toilet paper) Gingival bleeding >5 minutes Any other bleeding event considered as clinically significant by the investigator All other bleeding events that did not fulfil the criteria of MBE or clinically significant bleeding event were classified as minor bleeding events.
Laboratory Analyses
Number of patients with possible clinically significant abnormalities, i.e. with values out of normal range. Normal ranges are defined as: Haematocrit [%]: (0.35-0.45) for women and (0.39-0.51) for men Haemoglobin [g/dL]: (11.6-15.4) for women and (13.2-17.3) for men White Blood Cell count [10^9/L]: (4-10.3) for women and (3.9-10.3) for men Platelets [10^9/L]: (145-420) for women and men Sodium [mmol/L]: (135-146) for women and men Potassium [mmol/L]: (3.5-5) for women and men Aspartate aminotransferase (AST) [U/L]: (11-37) for women and (11-39) for men Alanine aminotransferase (ALT) [U/L]: (8-43) for women and (8-45) for men Alkaline Phosphatase [U/L]: (36-118) for women and (35-123) for men Creatinine [mg/dL]: (0.57-1.06)for women and (0.72-1.3) for men Bilirubin, total [mg/dL]: (0.22-1.28) for women and men Uric acid [mg/dL]: (2.4-6.47) for women and men
Plasma Concentration (Cmax) of Dabigatran
Maximum plasma concentration of Dabigatran (at steady-state) and Pre-dose plasma concentrations at steady state. Cmax represents the maximum concentration of Dabigatran in plasma. Cmax,ss represents the maximum concentration of Dabigatran in plasma at steady state. Cpre,ss represents pre-dose concentration of Dabigatran in plasma at steady state
Area Under the Plasma Concentration-time Curve During a Dosing Interval
Area under the plasma concentration-time curve during a dosing interval (at steady-state). The AUC0-12h (for b.i.d. treatment regimens) and AUC0-24h (300 mg q.d.) after the first dose on day of surgery calculated by extrapolation using the elimination rate constant, reported only if the extrapolated fraction of AUC was less than 30 % of the total AUC.

Full Information

First Posted
October 20, 2010
Last Updated
May 8, 2014
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT01225822
Brief Title
BIBR 1048 Dose Range Finding Study in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Hip or Knee Replacement Surgery
Official Title
BIBR 1048 Dose Range Finding Study in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Hip or Knee Replacement Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
August 2003 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary
The primary objective of this study is to establish the dose-response relationship with regard to efficacy and safety of BIBR 1048 (50 mg bis in die(b.i.d), 150 mg b.i.d, 225 mg b.i.d. and 300 mg quaque die(q.d) ) in preventing venous thromboembolism(VTE) in patients undergoing primary elective total hip and knee replacement.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
1973 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BIBR 1048 50 mg bis in die(b.i.d)
Arm Type
Experimental
Arm Description
BIBR 1048 50 mg b.i.d twice a day plus two capsules of placebo matching BIBR 1048 0 mg twice a day plus one placebo matching enoxaparin 0 mg once a day for the treatment period
Arm Title
BIBR 1048 150 mg b.i.d
Arm Type
Experimental
Arm Description
BIBR 1048 150 mg b.i.d twice a day plus two capsules of placebo matching BIBR 1048 0 mg twice a day plus placebo matching enoxaparin 0 mg once a day for the treatment period
Arm Title
BIBR 1048 225 mg b.i.d
Arm Type
Experimental
Arm Description
BIBR 1048 225 mg b.i.d twice a day plus two capsules of placebo matching BIBR 1048 0 mg twice a day plus placebo matching enoxaparin 0 mg once a day for the treatment period
Arm Title
BIBR 1048 300 mg quaque die(q.d)
Arm Type
Experimental
Arm Description
BIBR 1048 150 mg q.d once a day plus placebo matching BIBR 1048 0 mg twice a day plus placebo matching enoxaparin 0 mg once a day for the treatment period
Arm Title
Enoxaparin 40 mg subcutaneous(s.c)
Arm Type
Active Comparator
Arm Description
placebo matching BIBR 1048 0 mg twice a day plus enoxaparin 40 mg s.c once a day for the treatment period
Intervention Type
Drug
Intervention Name(s)
Enoxaparin
Intervention Description
Enoxaparin 40 mg s.c once a day for 5-10 days of treatment period
Intervention Type
Drug
Intervention Name(s)
BIBR 1048
Intervention Description
50 mg b.i.d BIBR 1048 capsule twice a day for 5-10 days of treatment period
Intervention Type
Drug
Intervention Name(s)
BIBR 1048
Intervention Description
150 mg b.i.d BIBR 1048 capsule twice a day for 5-10 treatment period
Intervention Type
Drug
Intervention Name(s)
BIBR 1048
Intervention Description
225 mg b.i.d BIBR 1048 capsule twice a day for 5-10 treatment period
Intervention Type
Drug
Intervention Name(s)
BIBR 1048
Intervention Description
300 mg q.d BIBR 1048 capsule for 5-10 treatment period
Primary Outcome Measure Information:
Title
Number of Participants With Venous Thromboembolic (VTE) Events
Description
Deep vein thrombosis (DVT) (proximal and distal) as detected by routine bilateral venography on day 8 +/- 2, plus symptomatic DVT confirmed by venography during the treatment period or PE confirmed by objective testing
Time Frame
Treatment period (up to day 8+/-2 days visit)
Title
Number of Participants With Major Bleeding Events (MBE)
Time Frame
From approximately 14 days prior to surgery to 4-6 weeks post surgery
Secondary Outcome Measure Information:
Title
Number of Participants With VTE Events and All Cause Mortality
Description
Deep venous thrombosis (DVT) (proximal and distal) as detected by routine bilateral venography on day 8 +/- 2, plus symptomatic DVT confirmed by venography during the treatment period or Pulmonary Embolism (PE) confirmed by objective testing and all deaths.
Time Frame
Treatment period (up to day 8+/-2 days visit)
Title
Number of Participants With Proximal DVT, PE (Pulmonary Embolism) and VTE Related Mortality
Description
Deep venous thrombosis (DVT) (proximal) as detected by routine bilateral venography on day 8 +/- 2, plus symptomatic proximal DVT confirmed by venography during the treatment period or PE confirmed by objective testing plus VTE related mortality
Time Frame
Treatment period (up to day 10)
Title
Number of Participants With Proximal DVT
Description
Deep venous thrombosis (DVT) (proximal) as detected by routine bilateral venography on day 8 +/- 2, plus symptomatic proximal DVT confirmed by venography during the treatment period
Time Frame
Treatment period (up to day 8+/-2 days visit)
Title
Volume of Blood Loss
Description
Volume of blood loss was to be analysed using an analysis of variance (ANOVA), which included treatment and centre.
Time Frame
Day 1 (Day of surgery)
Title
Rate of Transfusions Due to Bleedings
Description
Percentage of patients requiring transfusions due to bleeding .Rate of need of transfusion were to be analysed using a logistic regression with treatment and centre.
Time Frame
Day 1 (Day of surgery)
Title
Number of Participants With Clinically Significant, Minor or Any Bleeding Events
Description
Number of participants with Clinically Significant, minor or any bleeding events. Clinically significant bleeding events are defined as Spontaneous skin haematoma larger than >25 cm² Wound haematoma >100 cm² Spontaneous nose bleed >5 minutes Macroscopic haematurea, either spontaneous or lasting more than 24 hours if associated with an intervention Spontaneous rectal bleeding (more than spot on toilet paper) Gingival bleeding >5 minutes Any other bleeding event considered as clinically significant by the investigator All other bleeding events that did not fulfil the criteria of MBE or clinically significant bleeding event were classified as minor bleeding events.
Time Frame
Treatment period (up to day 8+/-2 days visit)
Title
Laboratory Analyses
Description
Number of patients with possible clinically significant abnormalities, i.e. with values out of normal range. Normal ranges are defined as: Haematocrit [%]: (0.35-0.45) for women and (0.39-0.51) for men Haemoglobin [g/dL]: (11.6-15.4) for women and (13.2-17.3) for men White Blood Cell count [10^9/L]: (4-10.3) for women and (3.9-10.3) for men Platelets [10^9/L]: (145-420) for women and men Sodium [mmol/L]: (135-146) for women and men Potassium [mmol/L]: (3.5-5) for women and men Aspartate aminotransferase (AST) [U/L]: (11-37) for women and (11-39) for men Alanine aminotransferase (ALT) [U/L]: (8-43) for women and (8-45) for men Alkaline Phosphatase [U/L]: (36-118) for women and (35-123) for men Creatinine [mg/dL]: (0.57-1.06)for women and (0.72-1.3) for men Bilirubin, total [mg/dL]: (0.22-1.28) for women and men Uric acid [mg/dL]: (2.4-6.47) for women and men
Time Frame
Screening to end of treatment
Title
Plasma Concentration (Cmax) of Dabigatran
Description
Maximum plasma concentration of Dabigatran (at steady-state) and Pre-dose plasma concentrations at steady state. Cmax represents the maximum concentration of Dabigatran in plasma. Cmax,ss represents the maximum concentration of Dabigatran in plasma at steady state. Cpre,ss represents pre-dose concentration of Dabigatran in plasma at steady state
Time Frame
Day 1 to end of treatment
Title
Area Under the Plasma Concentration-time Curve During a Dosing Interval
Description
Area under the plasma concentration-time curve during a dosing interval (at steady-state). The AUC0-12h (for b.i.d. treatment regimens) and AUC0-24h (300 mg q.d.) after the first dose on day of surgery calculated by extrapolation using the elimination rate constant, reported only if the extrapolated fraction of AUC was less than 30 % of the total AUC.
Time Frame
up to day 8+/-2 days visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria Patients scheduled to undergo a primary elective total hip or knee replacement. Male of female being 18 years or older. Patients weighing at least 40 kg. Written informed consent for study participation. Exclusion criteria Bleeding diathesis, constitutional or acquired coagulation disorders. Major surgery or trauma(e.g., hip fracture) within the last 3 months. Cardiovascular disease Any history of haemorrhagic stroke, intracranial or intraocular bleeding or cerebral ischaemic attacks lasting more than 24 hours and / or with cardiovascular pathological findings. Deep vein thrombosis(DVT), gastrointestinal or pulmonary bleeding, gastric or duodenal ulcer within the last year. History of or acute intracranial disease Liver disease Renal disease Use of long-term anticoagulants or antiplatelet drugs within 7 days prior to hip/knee replacement operation. Pre-menopausal women who are not surgically steriles, are nursing and are of child-bearing potential and are not practising acceptable methods of birth control Known allergy to contrast media Thrombocytopenia Allergy against heparin. Active malignant disease or current cytostatic treatment. Treatment with an investigational drug in the past month. Leg amputee Known alcohol or drug abuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
1160.19.43004 Krankenhaus der Barmherzigen Schwestern Linz
City
Linz
Country
Austria
Facility Name
1160.19.43002 Orthopädisches Spital Speising
City
Wien
Country
Austria
Facility Name
1160.19.43001 A.ö. Krankenhaus d. Statutarstadt Wiener Neustadt
City
Wr. Neustadt
Country
Austria
Facility Name
1160.19.32002 V.U.B. Jette
City
Brussel
Country
Belgium
Facility Name
1160.19.32004 UZ Gent
City
Gent
Country
Belgium
Facility Name
1160.19.32005 Virga Jesseziekenhuis
City
Gent
Country
Belgium
Facility Name
1160.19.32006 Boehringer Ingelheim Investigational Site
City
Huy
Country
Belgium
Facility Name
1160.19.32007 C.H.U. de Tivoli
City
La Louvière
Country
Belgium
Facility Name
1160.19.42004 University Hospital Brno
City
Brno-Bohunice
Country
Czech Republic
Facility Name
1160.19.42001 Hospital Kladno
City
Kladno
Country
Czech Republic
Facility Name
1160.19.42006 Hospital Mlada Boleslav
City
Mlada Boleslav
Country
Czech Republic
Facility Name
1160.19.42003 University Hospital Ostrava
City
Ostrava
Country
Czech Republic
Facility Name
1160.19.42005 University Hospital Plzen
City
Plzen
Country
Czech Republic
Facility Name
1160.19.42009 University Hospital Na Bulovce
City
Prague 8
Country
Czech Republic
Facility Name
1160.19.45042 Orthopedic Surgical Clinic
City
Frederiksberg
Country
Denmark
Facility Name
1160.19.45045 Gentofte Hospital
City
Hellerup
Country
Denmark
Facility Name
1160.19.45043 Herlev Hospital
City
Herlev
Country
Denmark
Facility Name
1160.19.45041 Hørsholm Sygehus
City
Hørsholm
Country
Denmark
Facility Name
1160.19.45044 Orthopedic Surgical Dept.
City
Silkeborg
Country
Denmark
Facility Name
1160.19.35802 Keski-Suomen keskussairaala
City
Jyväskylä
Country
Finland
Facility Name
1160.19.35801 Oulun yliopistollinen sairaala, Leikkaus- ja tehohoidon yks.
City
Oulu
Country
Finland
Facility Name
1160.19.33004 Div
City
Illkirch cedex
Country
France
Facility Name
1160.19.33007 Clinique du Mail
City
La Rochelle
Country
France
Facility Name
1160.19.33009 Hôpital Edouard Herriot
City
Lyon cedex 03
Country
France
Facility Name
1160.19.33006 Clinique Mutualiste
City
Saint-Etienne cedex 2
Country
France
Facility Name
1160.19.33008 Clinique de l'Atlantique
City
St Herblain cedex
Country
France
Facility Name
1160.19.36003 Sándor Péterfy Hospital
City
Budapest
Country
Hungary
Facility Name
1160.19.36001 Kálmán Pándy County Hospital
City
Gyula
Country
Hungary
Facility Name
1160.19.36004 Bács-Kiskun County Hospital
City
Kecskemét
Country
Hungary
Facility Name
1160.19.36002 Albert Szent-Györgyi Medical and Pharmacological Center
City
Szeged
Country
Hungary
Facility Name
1160.19.36005 Szent György Hospital
City
Székesfehérvár
Country
Hungary
Facility Name
1160.19.39003 U. O. Ortopedia e Traumatologia
City
Bergamo
Country
Italy
Facility Name
1160.19.39005 Modulo Coordinazione Dipartimentale di Ricerca e Anestesia
City
Bologna
Country
Italy
Facility Name
1160.19.39002 Fondazione Centro S. Raffaele
City
Milano
Country
Italy
Facility Name
1160.19.39001 IRCCS Policlinico San Matteo
City
Pavia
Country
Italy
Facility Name
1160.19.39004 Ospedale di Circolo di Varese
City
Varese
Country
Italy
Facility Name
1160.19.31001 Boehringer Ingelheim Investigational Site
City
Amsterdam
Country
Netherlands
Facility Name
1160.19.31003 Boehringer Ingelheim Investigational Site
City
Hilversum
Country
Netherlands
Facility Name
1160.19.31005 Hengstdal 3
City
Nijmegen
Country
Netherlands
Facility Name
1160.19.31006 Boehringer Ingelheim Investigational Site
City
Sittard
Country
Netherlands
Facility Name
1160.19.31004 Boehringer Ingelheim Investigational Site
City
Zwolle
Country
Netherlands
Facility Name
1160.19.47001 Nordlandssykehuset HF, Bodø
City
Bodø
Country
Norway
Facility Name
1160.19.47004 Martina Hansens Hospital
City
Bærum Postterminal
Country
Norway
Facility Name
1160.19.47008 Martina Hansens Hospital
City
Bærum Postterminal
Country
Norway
Facility Name
1160.19.47007 Sykehuset Innlandet HF, Avd. Elverum
City
Elverum
Country
Norway
Facility Name
1160.19.47005 Haugesund sjukehus HF
City
Haugesund
Country
Norway
Facility Name
1160.19.47002 Sykehuset Telemark HF, Avd. Skien
City
Skien
Country
Norway
Facility Name
1160.19.47003 Helse Sunnmøre HF, Ålesund sykehus
City
Ålesund
Country
Norway
Facility Name
1160.19.27001 Dept. of Haematology
City
Johannesburg
Country
South Africa
Facility Name
1160.19.27002 Suite 203
City
Johannesburg
Country
South Africa
Facility Name
1160.19.46002 Kirurgavdelningen
City
Falköping
Country
Sweden
Facility Name
1160.19.46001
City
Göteborg
Country
Sweden
Facility Name
1160.19.46004 Ortopediska kliniken, Länssjukhuset, Halmstad
City
Halmstad
Country
Sweden
Facility Name
1160.19.46003 Ortopediska kliniken, Länssjukhuset i Kalmar
City
Kalmar
Country
Sweden
Facility Name
1160.19.46007 Kungälvs sjukhus
City
Kungälvs
Country
Sweden
Facility Name
1160.19.46005 Kirurg Ortopediska kliniken, Sjukhuset i Lidköping
City
Lidköping
Country
Sweden
Facility Name
1160.19.46008 Ortopediska Institutionen
City
Linköping
Country
Sweden
Facility Name
1160.19.46009 Sahlgrenska Universitetssjukhuset, Mölndal
City
Mölndal
Country
Sweden
Facility Name
1160.19.46006 Boehringer Ingelheim Investigational Site
City
Varberg
Country
Sweden

12. IPD Sharing Statement

Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1160/1160.19_U04-1195-01-DS.pdf
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URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1160/1160.19_literature.pdf
Description
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BIBR 1048 Dose Range Finding Study in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Hip or Knee Replacement Surgery

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