ThrombosisPhase 2NCT00398216
A Study of DU-176b in Preventing Blood Clots After Hip Replacement Surgery
A Phase 2 study testing DU176b - action is the prevention of venous thromboembolism by the use of a Factor Xa inhibitor in people with Thrombosis and Hip Replacement, run by Daiichi Sankyo at 29 sites in 7 countries.
Trial summary
This study is to assess if DU176b is effective in prevention of blood clots following hip replacement surgery. The duration is 7-10 days of treatment and 30 and 60 day follow-up visits. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombosis, Hip Replacement
- What is being tested?
- DU176b - action is the prevention of venous thromboembolism by the use of a Factor Xa inhibitor
- How many people
- 903 participants
- Where
- 29 sitesin 7 countries
- Study dates
- May 2006to Jun 2007
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- 18 years of age or older; male or female.
- Able to provide written informed consent.
- Must be scheduled for elective unilateral total hip replacement surgery. Only primary surgeries accepted.
- If female, must be either one year post-menopausal, surgically sterile, or using medically accepted contraceptive measures as judged by the Investigator and in accordance with local regulatory requirements.
Trial locations and contacts
29 sites in 7 countries.
29 sites in 7 countries
Ukraine8 sites
Study site
Chernivtsy
Study site
Dnipro
Study site
Donetsk
Study site
Kharkiv
Study site
Kiev
Study site
Lutsk
Study site
Lviv
Study site
Odesa
Russia6 sites
Study site
Krasnoyarsk
Study site
Moscow
Study site
Saint Petersburg
Study site
Saratov
Study site
Velikiy Novgorod
Study site
Volgograd
Canada5 sites
Study site
Ajax, Ontario
Study site
Cambridge, Ontario
Study site
Guelph, Ontario
Study site
Kitchner, Ontario
Study site
Toronto, Ontario
United States3 sites
Study site
Austin, Texas
Study site
Hartford, Connecticut
Study site
Sarasota, Florida
About this study
Official title: A Phase IIb, Randomized, Parallel Group, Double-Blind, Double-Dummy, Multi-Center, Multi-National, Multi-Dose, Study of DU-176b Compared to Dalteparin in Patients Undergoing Elective Unilateral Total Hip Replacement
This study is to assess if DU176b is effective in prevention of blood clots following hip replacement surgery. The duration is 7-10 days of treatment and 30 and 60 day follow-up visits.
- Conditions
- Thrombosis, Hip Replacement
- Being tested
- DU176b - action is the prevention of venous thromboembolism by the use of a Factor Xa inhibitor
- Keywords
- Anti-coagulant, hip replacement, hip replacement surgery, unilateral hip replacement surgery, DeepVein Thrombosis, Venous Thromboembolism, pulmonary embolism, Prevention of Blood Clots
- Medical subject headings
- Thrombosis, Venous Thromboembolism, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DU176b - action is the prevention of venous thromboembolism by the use of a Factor Xa inhibitorDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Adjudicated Incidence of VTE
Assess the efficacy of DU-176b in the prevention of venous thromboembolism (VTE) from 6 to 8 hours after hip replacement surgery to 7 to 10 days after the surgery.
A subject was judged to have a VTE if one or more of the following criteria were met:
- Observed lower extremity deep vein thrombosis (DVT) (either proximal, distal, or both ) as assessed by bilateral or unilateral ascending contrast venography prior to or at the end-of-treatment (EOT) visit
- Symptomatic and objectively proven pulmonary embolism prior to or at the EOT visit
- Symptomatic and objectively proven DVT prior to or at EOT visit end of treatment defined as 6 to 8 hours after after hip replacement surgery to 7 to 10 days after the surgery.
Measured: end of treatment
Secondary outcomes (3)
Change in Prothrombin Time (PT) From Baseline
change in prothrombin time (PT) from baseline to end of treatment end of treatment defined as 6-8 hours after hip replacement surgery to 7 to 10 days after the surgery
Measured: end of treatment
Change in Activated Partial Thromboplastin Time (aPTT) From Baseline
change in Activated Partial Thromboplastin Time (aPTT) from baseline to end of treatment end of treatment defined as 6-8 hours after hip replacement surgery to 7 to 10 days after the surgery
Measured: end of treatment
Adjudicated Incidence of Major or Clinically Relevant Non-major Bleeding Events
adjudicated incidence of major or clinically relevant non-major bleeding events through 10 days after first dose
Measured: 10 days after first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2006 (estimated)
- Study startMay 2006
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ThrombosisStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 903 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00398216
- Sponsor's protocol ID
- DU176b-PRT011
- Other IDs
- 2006-000758-29
- Status last verified
- Feb 2015
- First submitted
- 9 Nov 2006
- Last updated
- 26 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIb, Randomized, Parallel Group, Double-Blind, Double-Dummy, Multi-Center, Multi-National, Multi-Dose, Study of DU-176b Compared to Dalteparin in Patients Undergoing Elective Unilateral Total Hip Replacement
- ClinicalTrials.gov ID
- NCT00398216
- Acronym / sponsor ID
- DU176b-PRT011
- Conditions
- Thrombosis, Hip Replacement
- Keywords
- Anti-coagulant, hip replacement, hip replacement surgery, unilateral hip replacement surgery, DeepVein Thrombosis, Venous Thromboembolism, pulmonary embolism, Prevention of Blood Clots
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 903 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 10 Nov 2006 (estimated)
- Results
- Posted 25 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to assess if DU176b is effective in prevention of blood clots following hip replacement surgery. The duration is 7-10 days of treatment and 30 and 60 day follow-up visits.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DU176b - action is the prevention of venous thromboembolism by the use of a Factor Xa inhibitor | Drug | – |
Primary outcome
Adjudicated Incidence of VTE
Time frame: end of treatment
Assess the efficacy of DU-176b in the prevention of venous thromboembolism (VTE) from 6 to 8 hours after hip replacement surgery to 7 to 10 days after the surgery. A subject was judged to have a VTE if one or more of the following criteria were met: * Observed lower extremity deep vein thrombosis (DVT) (either proximal, distal, or both ) as assessed by bilateral or unilateral ascending contrast venography prior to or at the end-of-treatment (EOT) visit * Symptomatic and objectively proven pulmonary embolism prior to or at the EOT visit * Symptomatic and objectively proven DVT prior to or at EOT visit end of treatment defined as 6 to 8 hours after after hip replacement surgery to 7 to 10 days after the surgery.
3 secondary outcomes
Change in Prothrombin Time (PT) From Baseline
Time frame: end of treatment
Change in Activated Partial Thromboplastin Time (aPTT) From Baseline
Time frame: end of treatment
Adjudicated Incidence of Major or Clinically Relevant Non-major Bleeding Events
Time frame: 10 days after first dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
29 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DU176b - action is the prevention of venous thromboembolism by the use of a Factor Xa inhibitor in people with Thrombosis and Hip Replacement, run by Daiichi Sankyo at 29 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Ukraine, Russia, Canada, United States, Denmark and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adjudicated Incidence of VTE (time frame: end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2019.