ThromboembolismPhase 4NCT00655122
Prophylaxis In Venous Thromboembolism In Primary Care, A Pilot Study
A Phase 4 study testing Dalteparin sodium in people with Thromboembolism and Deep Vein Thrombosis, run by Pfizer at 5 sites in Spain.
Trial summary
The primary objective was to study the clinical benefit with dalteparin sodium in thromboprophylaxis in primary care medical subjects. The secondary objective was a pharmacoeconomic evaluation of hromboprophylaxis with dalteparin sodium in primary care medical subjects. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Thromboembolism, Deep Vein Thrombosis, Dalteparin
- What is being tested?
- Dalteparin sodium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 5 sitesSpain
- Study dates
- Apr 2003to Dec 2003
- Phase
- Phase 4
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age > 65 years
- Confinement to bed for more than 3 days, due to:
- Heart failure
- Exacerbated chronic obstructive pulmonary disease
- Acute rheumatic involvement
- Written informed consent
Who cannot join
- Cancer
- Anticoagulant treatment in the previous 3 months
- Stroke or major surgery in the previous 3 months
- Systolic pressure >200 mmHg or diastolic pressure >120 mmHg
- Known chronic hepatopathy
- Active hemorrhage in any site in the previous 3 months
Show all 13Show fewer
- Active peptic ulcer
- Bacterial endocarditis
- Conditions that can increase the risk of hemorrhage
- Known coagulation disorders
- Hypersensitivity to heparin or HIT
- Life expectancy of less than 3 months
- Previous confinement to bed during more than 3 days
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Spain5 sites
Pfizer Investigational Site
León, 24005
Pfizer Investigational Site
Madrid, 28001
Pfizer Investigational Site
Madrid
Pfizer Investigational Site
Parla
Pfizer Investigational Site
Torremolinos, 29620
About this study
Official title: Double-Blind, Placebo-Controlled, Pilot Study, In Medical Patients With Prophylaxis Of Venous Thromboembolism in Primary Care
The primary objective was to study the clinical benefit with dalteparin sodium in thromboprophylaxis in primary care medical subjects. The secondary objective was a pharmacoeconomic evaluation of hromboprophylaxis with dalteparin sodium in primary care medical subjects.
Read the detailed description
The study was prematurely terminated on December 9, 2003. The reason for the early termination was not related to a safety or efficacy issue. It was related to the difficulty in recruiting patients.
- Conditions
- Thromboembolism, Deep Vein Thrombosis, Dalteparin
- Being tested
- Dalteparin sodium, Placebo
- Medical subject headings
- Thromboembolism, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dalteparin sodiumDrug
Dalteparin sodium was administered at a daily dosage of 5,000 UI anti-Xa by subcutaneous route. The treatment duration was 7 days in a single daily injection throughout the bedridden period.
PlaceboDrug
Placebo was administered with a daily injection of 0.2 mL by subcutaneous route. The treatment duration was 7 days in a single daily injection throughout the bedridden period.
| Study group | Role | What they receive |
|---|---|---|
| Dalteparin sodium | Active comparator | Not described Receives: Drug: Dalteparin sodium |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of the endpoint made up of objectively demonstrated deep vein thrombosis (DVT), pulmonary embolism (PE) diagnosed by objective tests or death at the end of the follow-up period, 1 month after the end of the bedridden period.
Measured: 1 month
Secondary outcomes (1)
Incidence of symptomatic deep vein thrombosis (DVT), symptomatic pulmonary embolism (PE) and tolerability at the end of the follow-up period.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2008 (estimated)
- Study startApr 2003
- Study completionDec 2003
Why it stopped: See Detailed Description.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThromboembolismStudies of the same condition, open and under way.
- More trials run by PfizerThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00655122
- Sponsor's protocol ID
- FGMAEI-0042-046
- Other IDs
- A6301036
- Status last verified
- Sep 2008
- First submitted
- 4 Apr 2008
- Last updated
- 29 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Placebo-Controlled, Pilot Study, In Medical Patients With Prophylaxis Of Venous Thromboembolism in Primary Care
- ClinicalTrials.gov ID
- NCT00655122
- Acronym / sponsor ID
- FGMAEI-0042-046
- Conditions
- Thromboembolism, Deep Vein Thrombosis, Dalteparin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: See Detailed Description.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2003
- Study completion
- Dec 2003 (actual)
- First posted
- 9 Apr 2008 (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 primary objective was to study the clinical benefit with dalteparin sodium in thromboprophylaxis in primary care medical subjects. The secondary objective was a pharmacoeconomic evaluation of hromboprophylaxis with dalteparin sodium in primary care medical subjects.
Detailed description
The study was prematurely terminated on December 9, 2003. The reason for the early termination was not related to a safety or efficacy issue. It was related to the difficulty in recruiting patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dalteparin sodium | Active comparator | Drug: Dalteparin sodium |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Age > 65 years
- Confinement to bed for more than 3 days, due to:
- Heart failure
- Exacerbated chronic obstructive pulmonary disease
- Acute rheumatic involvement
Key exclusion criteria (13 listed)
- Cancer
- Anticoagulant treatment in the previous 3 months
- Stroke or major surgery in the previous 3 months
- Systolic pressure >200 mmHg or diastolic pressure >120 mmHg
- Known chronic hepatopathy
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 |
|---|---|---|
| Dalteparin sodiumDalteparin sodium was administered at a daily dosage of 5,000 UI anti-Xa by subcutaneous route. The treatment duration was 7 days in a single daily injection throughout the bedridden period. | Drug | Dalteparin sodium |
| PlaceboPlacebo was administered with a daily injection of 0.2 mL by subcutaneous route. The treatment duration was 7 days in a single daily injection throughout the bedridden period. | Drug | Placebo |
Primary outcome
Incidence of the endpoint made up of objectively demonstrated deep vein thrombosis (DVT), pulmonary embolism (PE) diagnosed by objective tests or death at the end of the follow-up period, 1 month after the end of the bedridden period.
Time frame: 1 month
1 secondary outcome
Incidence of symptomatic deep vein thrombosis (DVT), symptomatic pulmonary embolism (PE) and tolerability at the end of the follow-up period.
Time frame: 1 month
Results and safety
The study was stopped early (reason given: See Detailed Description.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2008.
- To obtain contact information for a study center near you, click here.Link 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.
Pfizer CT.gov Call Center study director
Pfizer
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dalteparin sodium in people with Thromboembolism and Deep Vein Thrombosis, run by Pfizer at 5 sites in Spain.
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 6 inclusion and 13 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: stopped early, as of the sponsor's last update on 29 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: See Detailed Description.). Results are not available in the source record.
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?
Incidence of the endpoint made up of objectively demonstrated deep vein thrombosis (DVT), pulmonary embolism (PE) diagnosed by objective tests or death at the end of the follow-up period, 1 month after the end of the bedridden period. (time frame: 1 month). 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 29 Sep 2008.