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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,973

participants targeted

Target at P75+ for phase_2

Geographic Reach

12 countries

59 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed

9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2003

Completed

7.2 years until next milestone

First Submitted

Initial submission to the registry

October 20, 2010

Completed

1 day until next milestone

First Posted

Study publicly available on registry

October 21, 2010

Completed

2 months until next milestone

Results Posted

Study results publicly available

December 16, 2010

Completed

Last Updated

May 19, 2014

Status Verified

February 1, 2014

Enrollment Period

9 months

First QC Date

October 20, 2010

Results QC Date

November 18, 2010

Last Update Submit

May 8, 2014

Conditions

Venous Thromboembolism

Outcome Measures

Primary Outcomes (2)

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
Treatment period (up to day 8+/-2 days visit)
Number of Participants With Major Bleeding Events (MBE)
From approximately 14 days prior to surgery to 4-6 weeks post surgery

Secondary Outcomes (9)

Number of Participants With VTE Events and All Cause Mortality
Treatment period (up to day 8+/-2 days visit)
Number of Participants With Proximal DVT, PE (Pulmonary Embolism) and VTE Related Mortality
Treatment period (up to day 10)
Number of Participants With Proximal DVT
Treatment period (up to day 8+/-2 days visit)
Volume of Blood Loss
Day 1 (Day of surgery)
Rate of Transfusions Due to Bleedings
Day 1 (Day of surgery)
+4 more secondary outcomes

Study Arms (5)

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

EXPERIMENTAL

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

Drug: BIBR 1048

BIBR 1048 150 mg b.i.d

EXPERIMENTAL

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

Drug: BIBR 1048

BIBR 1048 225 mg b.i.d

EXPERIMENTAL

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

Drug: BIBR 1048

BIBR 1048 300 mg quaque die(q.d)

EXPERIMENTAL

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

Drug: BIBR 1048

Enoxaparin 40 mg subcutaneous(s.c)

ACTIVE COMPARATOR

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

Drug: Enoxaparin

Interventions

EnoxaparinDRUG

Enoxaparin 40 mg s.c once a day for 5-10 days of treatment period

Enoxaparin 40 mg subcutaneous(s.c)

BIBR 1048DRUG

50 mg b.i.d BIBR 1048 capsule twice a day for 5-10 days of treatment period

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

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.
+2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Boehringer Ingelheimlead

Study Sites (59)

1160.19.43004 Krankenhaus der Barmherzigen Schwestern Linz

Linz, Austria

Location

1160.19.43002 Orthopädisches Spital Speising

Vienna, Austria

Location

1160.19.43001 A.ö. Krankenhaus d. Statutarstadt Wiener Neustadt

Wiener Neustadt, Austria

Location

1160.19.32002 V.U.B. Jette

Brussels, Belgium

Location

1160.19.32004 UZ Gent

Ghent, Belgium

Location

1160.19.32005 Virga Jesseziekenhuis

Ghent, Belgium

Location

1160.19.32006 Boehringer Ingelheim Investigational Site

Huy, Belgium

Location

1160.19.32007 C.H.U. de Tivoli

La Louvière, Belgium

Location

1160.19.42004 University Hospital Brno

Brno-Bohunice, Czechia

Location

1160.19.42001 Hospital Kladno

Kladno, Czechia

Location

1160.19.42006 Hospital Mlada Boleslav

Mladá Boleslav, Czechia

Location

1160.19.42003 University Hospital Ostrava

Ostrava, Czechia

Location

1160.19.42005 University Hospital Plzen

Pilsen, Czechia

Location

1160.19.42009 University Hospital Na Bulovce

Prague, Czechia

Location

1160.19.45042 Orthopedic Surgical Clinic

Frederiksberg, Denmark

Location

1160.19.45045 Gentofte Hospital

Hellerup, Denmark

Location

1160.19.45043 Herlev Hospital

Herlev, Denmark

Location

1160.19.45041 Hørsholm Sygehus

Hørsholm, Denmark

Location

1160.19.45044 Orthopedic Surgical Dept.

Silkeborg, Denmark

Location

1160.19.35802 Keski-Suomen keskussairaala

Jyväskylä, Finland

Location

1160.19.35801 Oulun yliopistollinen sairaala, Leikkaus- ja tehohoidon yks.

Oulu, Finland

Location

1160.19.33004 Div

Illkirch-Graffenstaden, France

Location

1160.19.33007 Clinique du Mail

La Rochelle, France

Location

1160.19.33009 Hôpital Edouard Herriot

Lyon, France

Location

1160.19.33006 Clinique Mutualiste

Saint-Etienne, France

Location

1160.19.33008 Clinique de l'Atlantique

Saint-Herblain, France

Location

1160.19.36003 Sándor Péterfy Hospital

Budapest, Hungary

Location

1160.19.36001 Kálmán Pándy County Hospital

Gyula, Hungary

Location

1160.19.36004 Bács-Kiskun County Hospital

Kecskemét, Hungary

Location

1160.19.36002 Albert Szent-Györgyi Medical and Pharmacological Center

Szeged, Hungary

Location

1160.19.36005 Szent György Hospital

Székesfehérvár, Hungary

Location

1160.19.39003 U. O. Ortopedia e Traumatologia

Bergamo, Italy

Location

1160.19.39005 Modulo Coordinazione Dipartimentale di Ricerca e Anestesia

Bologna, Italy

Location

1160.19.39002 Fondazione Centro S. Raffaele

Milan, Italy

Location

1160.19.39001 IRCCS Policlinico San Matteo

Pavia, Italy

Location

1160.19.39004 Ospedale di Circolo di Varese

Varese, Italy

Location

1160.19.31001 Boehringer Ingelheim Investigational Site

Amsterdam, Netherlands

Location

1160.19.31003 Boehringer Ingelheim Investigational Site

Hilversum, Netherlands

Location

1160.19.31005 Hengstdal 3

Nijmegen, Netherlands

Location

1160.19.31006 Boehringer Ingelheim Investigational Site

Sittard, Netherlands

Location

1160.19.31004 Boehringer Ingelheim Investigational Site

Zwolle, Netherlands

Location

1160.19.47003 Helse Sunnmøre HF, Ålesund sykehus

Ålesund, Norway

Location

1160.19.47001 Nordlandssykehuset HF, Bodø

Bodø, Norway

Location

1160.19.47004 Martina Hansens Hospital

Bærum Postterminal, Norway

Location

1160.19.47008 Martina Hansens Hospital

Bærum Postterminal, Norway

Location

1160.19.47007 Sykehuset Innlandet HF, Avd. Elverum

Elverum, Norway

Location

1160.19.47005 Haugesund sjukehus HF

Haugesund, Norway

Location

1160.19.47002 Sykehuset Telemark HF, Avd. Skien

Skien, Norway

Location

1160.19.27001 Dept. of Haematology

Johannesburg, South Africa

Location

1160.19.27002 Suite 203

Johannesburg, South Africa

Location

1160.19.46002 Kirurgavdelningen

Falköping, Sweden

Location

1160.19.46001

Gothenburg, Sweden

Location

1160.19.46004 Ortopediska kliniken, Länssjukhuset, Halmstad

Halmstad, Sweden

Location

1160.19.46003 Ortopediska kliniken, Länssjukhuset i Kalmar

Kalmar, Sweden

Location

1160.19.46007 Kungälvs sjukhus

Kungälvs, Sweden

Location

1160.19.46005 Kirurg Ortopediska kliniken, Sjukhuset i Lidköping

Lidköping, Sweden

Location

1160.19.46008 Ortopediska Institutionen

Linköping, Sweden

Location

1160.19.46009 Sahlgrenska Universitetssjukhuset, Mölndal

Mölndal, Sweden

Location

1160.19.46006 Boehringer Ingelheim Investigational Site

Varberg, Sweden

Location

MeSH Terms

Conditions

Venous Thromboembolism

Interventions

EnoxaparinDabigatran

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydratesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals

Study Officials

Boehringer Ingelheim
Boehringer Ingelheim
STUDY CHAIR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: DOUBLE
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

October 20, 2010

First Posted

October 21, 2010

Study Start

November 1, 2002

Primary Completion

August 1, 2003

Last Updated

May 19, 2014

Results First Posted

December 16, 2010

Record last verified: 2014-02

Locations

IT(5)NO(7)HU(5)BE(5)FI(2)FR(5)DK(5)ZA(2)AU(3)NL(5)SE(9)CZ(6)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Results Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (9)

Study Arms (5)

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)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (59)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations