Cardiovascular DiseaseNCT01390883
Special Drug Use Investigation for ARIXTRA (Fondaparinux) Abdominal (Urology,Obstetrics,Gynecology)
An observational study of Cardiovascular Disease, run by GlaxoSmithKline.
Trial summary
The purpose of this study is to collect and assess information on safety and efficacy of fondaparinux in patients undergoing abdominal surgery in urology, obstetrics and gynecology departments who are at high risk of venous thromboembolism. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Fondaparinux Sodium
- How many people
- 475 participants
- Where
- No sites listed yet
- Study dates
- Dec 2008to Oct 2013
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Japanese patients undergoing abdominal surgery in urology, obstetrics and gynecology departments who are at high risk of venous thromboembolism
Who may be able to join
- Patients undergoing abdominal surgery in urology, obstetrics and gynecology departments
Who cannot join
- Patients with a history of hypersensitivity to the ingredients of fondaparinux
- Patients with bleeding (bleeding in important organs, sucn as retroperitoneal bleed)
- Patients with acute bacterial endocarditis
- Patients with severe renal impairment
About this study
The purpose of this study is to collect and assess information on safety and efficacy of fondaparinux in patients undergoing abdominal surgery in urology, obstetrics and gynecology departments who are at high risk of venous thromboembolism.
- Conditions
- Cardiovascular Disease
- Being tested
- Fondaparinux Sodium
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fondaparinux SodiumDrug
| Study group | Role | What they receive |
|---|---|---|
| Patients prescribed fondaparinux | Patients undergoing abdominal surgery in urology, obstetrics and gynecology departments prescribed fondaparinux during study period Receives: Drug: Fondaparinux Sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of adverse events in Japanese patients treated with fondaparinux
Measured: 4 months at maximum
Presence or absence of venous thromboembolism after treatment of fondaparinux
Measured: 4 months at maximum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2011 (estimated)
- Study startDec 2008
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 475 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01390883
- Sponsor's protocol ID
- 112721
- Status last verified
- Mar 2015
- First submitted
- 7 Jul 2011
- Last updated
- 27 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Special Drug Use Investigation for ARIXTRA (Fondaparinux) Abdominal (Urology,Obstetrics,Gynecology)
- ClinicalTrials.gov ID
- NCT01390883
- Acronym / sponsor ID
- 112721
- Conditions
- Cardiovascular Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 475 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 11 Jul 2011 (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.
The purpose of this study is to collect and assess information on safety and efficacy of fondaparinux in patients undergoing abdominal surgery in urology, obstetrics and gynecology departments who are at high risk of venous thromboembolism.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients prescribed fondaparinux | – | Drug: Fondaparinux SodiumPatients undergoing abdominal surgery in urology, obstetrics and gynecology departments prescribed fondaparinux during study period |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Japanese patients undergoing abdominal surgery in urology, obstetrics and gynecology departments who are at high risk of venous thromboembolism
Key inclusion criteria (1 listed)
- Patients undergoing abdominal surgery in urology, obstetrics and gynecology departments
Key exclusion criteria (4 listed)
- Patients with a history of hypersensitivity to the ingredients of fondaparinux
- Patients with bleeding (bleeding in important organs, sucn as retroperitoneal bleed)
- Patients with acute bacterial endocarditis
- Patients with severe renal impairment
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 |
|---|---|---|
| Fondaparinux Sodium | Drug | Patients prescribed fondaparinux |
Primary outcome
The number of adverse events in Japanese patients treated with fondaparinux
Time frame: 4 months at maximum
Presence or absence of venous thromboembolism after treatment of fondaparinux
Time frame: 4 months at maximum
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 27 Mar 2015.
Related trials for Cardiovascular Disease
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
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.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Disease, run by GlaxoSmithKline.
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 1 inclusion and 4 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 27 Mar 2015. 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.
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?
The number of adverse events in Japanese patients treated with fondaparinux (time frame: 4 months at maximum). The study lists 2 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 27 Mar 2015.