BIBR 1048 Dose Range Finding Study in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Hip or Knee Replacement Surgery
This study has been completed.
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01225822
First received: October 20, 2010
Last updated: May 23, 2012
Last verified: May 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Venous Thromboembolism |
Drug: Enoxaparin Drug: BIBR 1048 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
| Official Title: | BIBR 1048 Dose Range Finding Study in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Hip or Knee Replacement Surgery |
Resource links provided by NLM:
Drug Information available for:
Dabigatran
Dabigatran etexilate
Enoxaparin sodium
Dabigatran etexilate mesylate
U.S. FDA Resources
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
Primary Outcome Measures:
- Number of Participants With Venous Thromboembolic (VTE) Events [ Time Frame: Treatment period (up to day 8+/-2 days visit) ] [ Designated as safety issue: No ]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
Secondary Outcome Measures:
- Number of Participants With VTE Events and All Cause Mortality [ Time Frame: Treatment period (up to day 8+/-2 days visit) ] [ Designated as safety issue: No ]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 [ Time Frame: Treatment period (up to day 10) ] [ Designated as safety issue: No ]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 [ Time Frame: Treatment period (up to day 8+/-2 days visit) ] [ Designated as safety issue: No ]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
- Number of Participants With Major Bleeding Events (MBE) [ Time Frame: From approximately 14 days prior to surgery to 4-6 weeks post surgery ] [ Designated as safety issue: Yes ]
| Enrollment: | 1973 |
| Study Start Date: | November 2002 |
| Primary Completion Date: | August 2003 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: BIBR 1048 50 mg bis in die(b.i.d)
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
50 mg b.i.d BIBR 1048 capsule twice a day for 5-10 days of treatment period
|
|
Experimental: BIBR 1048 150 mg b.i.d
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
150 mg b.i.d BIBR 1048 capsule twice a day for 5-10 treatment period
|
|
Experimental: BIBR 1048 225 mg b.i.d
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
225 mg b.i.d BIBR 1048 capsule twice a day for 5-10 treatment period
|
|
Experimental: BIBR 1048 300 mg quaque die(q.d)
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
300 mg q.d BIBR 1048 capsule for 5-10 treatment period
|
|
Active Comparator: Enoxaparin 40 mg subcutaneous(s.c)
placebo matching BIBR 1048 0 mg twice a day plus enoxaparin 40 mg s.c once a day for the treatment period
|
Drug: Enoxaparin
Enoxaparin 40 mg s.c once a day for 5-10 days of treatment period
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01225822
Show 59 Study Locations
Show 59 Study LocationsSponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
Additional Information:
No publications provided
| Responsible Party: | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT01225822 History of Changes |
| Other Study ID Numbers: | 1160.19 |
| Study First Received: | October 20, 2010 |
| Results First Received: | November 18, 2010 |
| Last Updated: | May 23, 2012 |
| Health Authority: | Austria: Belgium: Czech Republic: Denmark: Finland: France: Hungary: Italy: Ethics Committee Netherlands: Norway: South Africa: Sweden: |
Additional relevant MeSH terms:
|
Thromboembolism Venous Thromboembolism Venous Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Thrombosis Enoxaparin |
Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 21, 2013