NCT00246025

Brief Summary

The goal of this study is to evaluate the comparative efficacy and safety of three different doses ( 110 mg, 150 mg, 220 mg) of BIBR 1048 (Dabigatran etexilate) orally, compared to placebo, in prevention of venous thromboembolism in patient with primary elective total knee replacement surgery, and to evaluate dose-response.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
512

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

38 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

October 1, 2005

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 31, 2005

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

December 17, 2010

Completed
Last Updated

June 9, 2014

Status Verified

February 1, 2014

Enrollment Period

1.7 years

First QC Date

October 28, 2005

Results QC Date

November 18, 2010

Last Update Submit

June 3, 2014

Conditions

Arthroplasty, Replacement, KneeVenous Thrombosis

Outcome Measures

Primary Outcomes (1)

  • 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 (10)

  • Percentage of Participants Who Have a 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

    2 weeks

  • Percentage of Participants With Symptomatic DVT (Deep Vein Thrombosis)

    2 weeks

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

    2 weeks

  • Number of Participants With Pulmonary Embolism During Treatment Period

    2 weeks

  • +5 more secondary outcomes

Study Arms (4)

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

Interventions

Dabigatran EtexilateDRUG

Dabigatran etexilate 110 mg capsule, once a day, oral administration

Dabigatran etexilate 110 mg
placeboDRUG

matching placebo capsule, once a day, oral administration

Placebo

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled to undergo a primary, unilateral elective total knee replacement
  • Male or Female 20 years of age or order
  • Patients weighing at least 40 kg
  • Written informed consent prior to the start of study participation

You may not qualify if:

  • History of bleeding diathesis
  • Constitutional or acquired coagulation disorders that in the investigator's judgment puts the patient at excessive risk for bleeding
  • Major surgery or trauma (e.g. hip fracture) within the last 3 months
  • Recent unstable cardiovascular disease, such as uncontrolled hypertension at the time of enrollment (investigator's judgment) or history of myocardial infarction within the last 3 months
  • Any history of hemorrhagic stroke or any of the following intracranial pathologies: bleeding, neoplasm, AV (arteriovenous) malformation or aneurysm or recent bleeding history
  • Condition requiring anti-coagulant therapy
  • Elevated AST(Aspartate Aminotransferase) , ALT(Alanine Aminotransferase), or any history of clinically relevant liver disease
  • Patients with a history of clinically significant renal diseases or with elevated creatinine values

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (38)

1160.50.001 Boehringer Ingelheim Investigational Site

Eniwa, Hokkaido, Japan

Location

1160.50.018 Boehringer Ingelheim Investigational Site

Fukuoka, Fukuoka, Japan

Location

1160.50.008 Boehringer Ingelheim Investigational Site

Hachioji, Tokyo, Japan

Location

1160.50.006 Boehringer Ingelheim Investigational Site

Hirosaki, Aomori, Japan

Location

1160.50.026 Boehringer Ingelheim Investigational Site

Hiroshima, Hiroshima, Japan

Location

1160.50.011 Boehringer Ingelheim Investigational Site

Iida, Nagano, Japan

Location

1160.50.024 Boehringer Ingelheim Investigational Site

Izumisano, Osaka, Japan

Location

1160.50.045 Boehringer Ingelheim Investigational Site

Izunokuni,Shizuoka, Japan

Location

1160.50.022 Boehringer Ingelheim Investigational Site

Kagoshima, Kagoshima, Japan

Location

1160.50.027 Boehringer Ingelheim Investigational Site

Kawasaki, Kanagawa, Japan

Location

1160.50.032 Boehringer Ingelheim Investigational Site

Kawasaki, Kanagawa, Japan

Location

1160.50.041 Boehringer Ingelheim Investigational Site

Kitakyusyu, Fukuoka, Japan

Location

1160.50.039 Boehringer Ingelheim Investigational Site

Koshigaya,Saitama, Japan

Location

1160.50.037 Boehringer Ingelheim Investigational Site

Kurume ,Fukuoka, Japan

Location

1160.50.038 Boehringer Ingelheim Investigational Site

Kurume ,Fukuoka, Japan

Location

1160.50.013 Boehringer Ingelheim Investigational Site

Kyoto, Kyoto, Japan

Location

1160.50.036 Boehringer Ingelheim Investigational Site

Matsue, Shimane, Japan

Location

1160.50.042 Boehringer Ingelheim Investigational Site

Miyazaki, Miyazaki, Japan

Location

1160.50.028 Boehringer Ingelheim Investigational Site

Musashimurayama, Tokyo, Japan

Location

1160.50.005 Boehringer Ingelheim Investigational Site

Obihiro, Hokkaido, Japan

Location

1160.50.030 Boehringer Ingelheim Investigational Site

Okayama, Okayama, Japan

Location

1160.50.021 Boehringer Ingelheim Investigational Site

Omura, Nagasaki, Japan

Location

1160.50.014 Boehringer Ingelheim Investigational Site

Osaka, Osaka, Japan

Location

1160.50.015 Boehringer Ingelheim Investigational Site

Osaka, Osaka, Japan

Location

1160.50.016 Boehringer Ingelheim Investigational Site

Osaka, Osaka, Japan

Location

1160.50.033 Boehringer Ingelheim Investigational Site

Osaka, Osaka, Japan

Location

1160.50.031 Boehringer Ingelheim Investigational Site

Saga, Saga, Japan

Location

1160.50.009 Boehringer Ingelheim Investigational Site

Sagamihara, Kanagawa, Japan

Location

1160.50.002 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, Japan

Location

1160.50.004 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, Japan

Location

1160.50.020 Boehringer Ingelheim Investigational Site

Sasebo, Nagasaki, Japan

Location

1160.50.025 Boehringer Ingelheim Investigational Site

Sasebo, Nagasaki, Japan

Location

1160.50.034 Boehringer Ingelheim Investigational Site

Sendai, Miyagi, Japan

Location

1160.50.029 Boehringer Ingelheim Investigational Site

Shinjuku-ku,Tokyo, Japan

Location

1160.50.043 Boehringer Ingelheim Investigational Site

Shizuoka, Shizuoka, Japan

Location

1160.50.044 Boehringer Ingelheim Investigational Site

Sumida-ku, Tokyo, Japan

Location

1160.50.023 Boehringer Ingelheim Investigational Site

Tomigusuku, Okinawa, Japan

Location

1160.50.040 Boehringer Ingelheim Investigational Site

Tsukuba , Ibaraki, Japan

Location

MeSH Terms

Conditions

Venous Thrombosis

Interventions

Dabigatran

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Boehringer Ingelheim Call Center
Organization
Boehringer Ingelheim Pharmaceuticals
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127

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 28, 2005

First Posted

October 31, 2005

Study Start

October 1, 2005

Primary Completion

June 1, 2007

Last Updated

June 9, 2014

Results First Posted

December 17, 2010

Record last verified: 2014-02

Locations

JP(38)