Venous ThromboembolismPhase 2NCT02170935
Pharmacokinetic (PK) Assessment of BIBR 1048 in Patients After Primary Elective Total Hip Replacement Surgery
A Phase 2 study testing BIBR 1048 capsule in people with Venous Thromboembolism, run by Boehringer Ingelheim.
Trial summary
To determine the PK profile of a single dose 150 mg BIBR 1048, oral capsule, administered 1-3 hours post surgery in hip replacement patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- BIBR 1048 capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- Apr 2002to Jun 2002
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
Who may be able to join
- Patients scheduled to undergo a primary elective total hip replacement
- Male or female being 18 years or older (women of child bearing potential may not be included)
- Patients weighing at least 40 kg
- Written informed consent for participation
Who cannot join
- Bleeding disorders, e.g. history of intracranial, intraocular, gastrointestinal or pulmonary bleeding, known thrombocytopenia, history of haemorrhagic stroke
- Known renal disease
- Known liver disease, alcohol or drug misuse
- Known malignancy
- Treatment with another study drug in the past month
About this study
Official title: Multicenter, Open-label-study to Assess PK Profile of a Single Oral Dose of 150 mg BIBR 1048 (Capsule) in Patients Shortly After Primary Elective Total Hip Replacement Surgery.
To determine the PK profile of a single dose 150 mg BIBR 1048, oral capsule, administered 1-3 hours post surgery in hip replacement patients.
- Conditions
- Venous Thromboembolism
- Being tested
- BIBR 1048 capsule
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIBR 1048 capsuleDrug
| Study group | Role | What they receive |
|---|---|---|
| BIBR 1048 capsule | Experimental | Not described Receives: Drug: BIBR 1048 capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum plasma concentration (Cmax)
Measured: pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose
time to maximum plasma concentration (Tmax)
Measured: pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose
total clearance of drug from plasma
Measured: pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose
terminal elimination constant
Measured: pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose
time of last measureable BIBR 953 ZW plasma concentration (Tf)
Measured: pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose
area under the plasma concentration time curve until Tf (AUC0-Tf)
Measured: pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose
area under the plasma concentration time extrapolated to infinity (AUC0-infinity)
Measured: pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose
Secondary outcomes (1)
Occurrence of adverse events
Measured: up to 24 hours after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study startApr 2002
- Primary completionJun 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02170935
- Sponsor's protocol ID
- 1160.30
- Status last verified
- Jun 2014
- First submitted
- 20 Jun 2014
- Last updated
- 23 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Open-label-study to Assess PK Profile of a Single Oral Dose of 150 mg BIBR 1048 (Capsule) in Patients Shortly After Primary Elective Total Hip Replacement Surgery.
- ClinicalTrials.gov ID
- NCT02170935
- Acronym / sponsor ID
- 1160.30
- Conditions
- Venous Thromboembolism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 2002
- Primary completion
- Jun 2002 (actual)
- First posted
- 23 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the PK profile of a single dose 150 mg BIBR 1048, oral capsule, administered 1-3 hours post surgery in hip replacement patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BIBR 1048 capsule | Experimental | Drug: BIBR 1048 capsule |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients scheduled to undergo a primary elective total hip replacement
- Male or female being 18 years or older (women of child bearing potential may not be included)
- Patients weighing at least 40 kg
- Written informed consent for participation
Key exclusion criteria (5 listed)
- Bleeding disorders, e.g. history of intracranial, intraocular, gastrointestinal or pulmonary bleeding, known thrombocytopenia, history of haemorrhagic stroke
- Known renal disease
- Known liver disease, alcohol or drug misuse
- Known malignancy
- Treatment with another study drug in the past month
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 |
|---|---|---|
| BIBR 1048 capsule | Drug | BIBR 1048 capsule |
Primary outcome
maximum plasma concentration (Cmax)
Time frame: pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose
time to maximum plasma concentration (Tmax)
Time frame: pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose
total clearance of drug from plasma
Time frame: pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose
terminal elimination constant
Time frame: pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose
time of last measureable BIBR 953 ZW plasma concentration (Tf)
Time frame: pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose
area under the plasma concentration time curve until Tf (AUC0-Tf)
Time frame: pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose
area under the plasma concentration time extrapolated to infinity (AUC0-infinity)
Time frame: pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose
1 secondary outcome
Occurrence of adverse events
Time frame: up to 24 hours after drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2014.
- Related InfoLink provided by the sponsor.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BIBR 1048 capsule in people with Venous Thromboembolism, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. 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 23 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
maximum plasma concentration (Cmax) (time frame: pre dose, 1, 2, 4, 6-8, 10-18 and 24 hours post dose). The study lists 7 primary outcomes in all. 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 23 Jun 2014.